HYRIMOZ 40 mg Injectable Solution

Зміст інструкції

1. Hyrimoz 20 mg injectable solution in pre-filled syringe
   1. What is Hyrimoz and what is it used for
   2. What you need to know before your child uses Hyrimoz
   3. How to use Hyrimoz
   4. Possible side effects
   5. How to store Hyrimoz
   6. Contents of the pack and other information
   7. Instructions for Use
   8. Choice of injection site:
   9. Injection site cleaning:
   10. Administration of the injection:
   11. Disposal of used syringes:
2. Hyrimoz 20 mg injectable solution in pre-filled syringe
   1. What is Hyrimoz and what is it used for
   2. What you need to know before your child uses Hyrimoz
   3. How to use Hyrimoz
   4. Possible side effects
   5. How to store Hyrimoz
   6. Package contents and other information
   7. Instructions for Use
   8. Choice of injection site:
   9. Injection site cleaning:
   10. Administration of the injection:
   11. Disposal of used pre-filled syringes:
3. Hyrimoz 40 mg solution for injection in pre-filled syringe
   1. Cos’è Hyrimoz e a cosa serve
   2. What you need to know before using Hyrimoz
   3. How to use Hyrimoz
   4. Possible side effects
   5. How to store Hyrimoz
   6. Package contents and other information
   7. Instructions for Use
   8. Choice of injection site:
   9. Injection site cleaning:
   10. Administration of the injection:
   11. Disposal of used syringes:
4. Hyrimoz 40 mg solution for injection in pre-filled pen
   1. Cos’è Hyrimoz e a cosa serve
   2. What you need to know before using Hyrimoz
   3. How to use Hyrimoz
   4. Possible side effects
   5. How to store Hyrimoz
   6. Contents of the pack and other information
   7. Instructions for Use
   8. Choice of injection site:
   9. Injection site cleaning:
   10. Removing the pen cap:
   11. How to hold the pen:
   12. Start of injection:
   13. Completion of the injection:
   14. Disposal of used pens:
5. Hyrimoz 40 mg injectable solution in pre-filled syringe
   1. What is Hyrimoz and what is it used for
   2. What you need to know before using Hyrimoz
   3. How to use Hyrimoz
   4. Possible side effects
   5. How to store Hyrimoz
   6. Package contents and other information
   7. Instructions for Use
   8. Choice of injection site:
   9. Injection site cleaning:
   10. Administration of the injection:
   11. Disposal of used syringes:
6. Hyrimoz 40 mg solution for injection in pre-filled pen
   1. What is Hyrimoz and what is it used for
   2. What you need to know before using Hyrimoz
   3. How to use Hyrimoz
   4. Possible side effects
   5. How to store Hyrimoz
   6. Contents of the pack and other information
   7. Instructions for Use
   8. Choice of injection site:
   9. Cleaning the injection site:
   10. Removing the cap from your pen:
   11. How to hold the pen:
   12. Start of injection:
   13. Completion of the injection:
   14. Check that the green indicator
   15. Disposal of used pens:
7. Hyrimoz 80 mg injectable solution in pre-filled syringe
   1. What is Hyrimoz and what is it used for
   2. What you need to know before using Hyrimoz
   3. How to use Hyrimoz
   4. Possible side effects
   5. How to store Hyrimoz
   6. Contents of the pack and other information
   7. Instructions for Use
   8. Choice of injection site:
   9. Injection site cleaning:
   10. Administration of the injection:
   11. Disposal of used syringes:
8. Hyrimoz 80 mg solution for injection in pre-filled pen
   1. What is Hyrimoz and what is it used for?
   2. What you need to know before using Hyrimoz
   3. How to use Hyrimoz
   4. Possible side effects
   5. How to store Hyrimoz
   6. Contents of the pack and other information
   7. Instructions for Use
   8. Choice of injection site:
   9. Injection site cleaning:
   10. Removing the pen cap:
   11. How to hold the pen:
   12. Start of injection:
   13. Completion of the injection:
   14. Check that the green indicator
   15. Disposal of used pens:

Hyrimoz 20 mg injectable solution in pre-filled syringe

adalimumab

20 mg/0.4 mL
Read this leaflet carefully before your child uses this medicine because it contains
important information.

• Keep this leaflet. You may need to read it again.
• Your doctor will give you a Patient Reminder Card, which contains important safety information that you need to know before your child starts using Hyrimoz and during treatment with Hyrimoz. Keep this Patient Reminder Cardwith you or your child during treatment and for 4 months after the last Hyrimoz injection given to your child.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for your child. Do not give it to other people, even if their symptoms are the same as those of your child, as it could be dangerous.
• If your child experiences any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Hyrimoz is and what it is used for
• 2. What you need to know before your child uses Hyrimoz
• 3. How to use Hyrimoz
• 4. Possible side effects
• 5. How to store Hyrimoz
• 6. Contents of the pack and other information
• 7. Instructions for use

1. What is Hyrimoz and what is it used for

Hyrimoz contains the active ingredient adalimumab, a medicine that acts on the body’s immune system
(defense system).
Hyrimoz is indicated for the treatment of the inflammatory diseases listed below:

• polyarticular juvenile idiopathic arthritis,
• arthritis associated with enthesitis,
• pediatric plaque psoriasis,
• pediatric Crohn’s disease,
• pediatric non-infectious uveitis.

The active ingredient contained in Hyrimoz, adalimumab, is a human monoclonal antibody. Monoclonal
antibodies are proteins that bind to a specific target.
The target of adalimumab is a protein called tumor necrosis factor (TNFα), which is
involved in the immune system (defense system) and is present at higher concentrations in the
inflammatory diseases listed above. By binding to TNFα, Hyrimoz blocks its action and decreases
the inflammatory process in these diseases.
Polyarticular juvenile idiopathic arthritis and arthritis associated with enthesitis
Polyarticular juvenile idiopathic arthritis and arthritis associated with enthesitis are inflammatory
diseases of the joints, which typically first appear during childhood.
Hyrimoz is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents
aged 2 to 17 years and arthritis associated with enthesitis in children and adolescents aged 6-17 years.
Other disease-modifying drugs, such as
methotrexate, may be administered at diagnosis. If these drugs do not work satisfactorily, patients will be given
Hyrimoz to treat polyarticular juvenile idiopathic arthritis or arthritis associated with
enthesitis.
Pediatric plaque psoriasis
Plaque psoriasis is an inflammatory skin condition that causes red, scaly, and hardened patches of
skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to break, thicken, and lift from the nail bed, which can be
painful. Psoriasis is thought to be caused by a problem with the body’s immune system that
leads to increased production of skin cells.
Hyrimoz is used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years
in whom topical medications and UV light therapy have not worked optimally or are not indicated.
Pediatric Crohn’s disease
Crohn’s disease is an inflammation of the intestine.
Hyrimoz is used to treat moderate to severe Crohn’s disease in children and adolescents
aged 6 to 17 years.
Your child may first be given other medications. If these drugs do not work in
a satisfactory manner, Hyrimoz will be given to your child to reduce the typical symptoms
of their disease.
Pediatric non-infectious uveitis
Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye.
Inflammation leads to decreased vision and/or the presence of mobile bodies in the eye
(black dots or thin lines that move across the field of vision). Hyrimoz works by reducing this
inflammation.
Hyrimoz is used for the treatment of children aged 2 years and older with chronic non-infectious uveitis
with inflammation affecting the front of the eye.
Your child may first be given other medications. If these drugs do not work in
a satisfactory manner, Hyrimoz will be given to your child to reduce the typical symptoms
of their disease.

2. What you need to know before your child uses Hyrimoz

Do not use Hyrimoz

• If your child is allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
• If there is a severe infection, including tuberculosis, sepsis (blood poisoning) or other opportunistic infections (unusual infections associated with a weakened immune system). It is important to tell your doctor if your child has signs or symptoms of infection, such as, for example, fever, wounds, feeling tired, dental problems (see “Warnings and precautions”).
• If there is moderate or severe heart failure. It is important to tell your doctor if there has been or is a serious heart condition (see “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before using Hyrimoz
Allergic reaction

• If you experience allergic reactions with symptoms such as a feeling of tightness in the chest, wheezing, dizziness, swelling or skin rash, do not administer Hyrimoz again and contact your doctor immediately, as these reactions can be life-threatening in rare cases.

Infection

• If an infection occurs, including long-term or localized infections (for example, leg ulcers), consult your doctor before starting treatment with Hyrimoz. If you have doubts, contact your doctor.
• You may be more likely to get infections during treatment with Hyrimoz. This risk may increase if your child's lung function is reduced. These infections can be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other unusual infectious organisms and sepsis (blood poisoning).
• In rare cases, these infections can be life-threatening. It is important to tell your doctor about the presence of symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may advise you to temporarily stop Hyrimoz.

Tuberculosis (TB)

• Since cases of tuberculosis have occurred in patients treated with adalimumab, your doctor will need to check if your child has signs or symptoms typical of tuberculosis before starting therapy with Hyrimoz. This will involve collecting a detailed medical assessment including your child's medical history and clinical examinations (e.g. a chest X-ray and a tuberculin test). The performance and results of these tests must be recorded on your child's Patient Reminder Card. It is very important to tell your doctor if your child has ever had tuberculosis, or if they have had close contact with people with tuberculosis. Tuberculosis can develop during therapy even if your child has received preventive treatment for tuberculosis. Contact your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, fatigue, moderate fever) or other infections appear during or after therapy.

Travel/recurring infection

• Tell your doctor if your child has lived in or travelled to regions where fungal infections, such as histoplasmosis, coccidioidomycosis or blastomycosis, are common.
• Tell your doctor if your child has had recurrent infections or if they have conditions that increase the risk of infection.

Hepatitis B virus

• Tell your doctor if your child is a carrier of the hepatitis B virus (HBV), has an active infection with the hepatitis B virus or thinks they may be at risk of contracting the hepatitis B virus. Your doctor should test your child for hepatitis B virus infection. Taking adalimumab can reactivate hepatitis B virus infection in subjects who are carriers of this virus. In some rare cases, especially if your child is taking other medications that suppress the immune system, reactivation of hepatitis B virus infection can be life-threatening.

Surgery or dental procedures

• Before surgery or dental procedures, tell your doctor that your child is taking Hyrimoz. Your doctor may advise you to temporarily stop Hyrimoz.

Demyelinating disease

• If your child suffers from or develops demyelinating diseases (diseases that affect the insulating layer around the nerves), such as multiple sclerosis, your doctor will decide whether to start or continue treatment with Hyrimoz. Tell your doctor immediately if your child experiences symptoms such as changes in vision, weakness of arms or legs, or numbness or tingling that affects any part of the body.

Vaccination

• Certain vaccines contain live but weakened forms of bacteria or viruses that cause diseases and should not be administered during treatment with Hyrimoz if they cause infections. Consult your doctor before vaccinating your child. In children, it is recommended, if possible, to administer the vaccinations recommended for their age before starting therapy with Hyrimoz.
• If your daughter is taking Hyrimoz during pregnancy, the baby may have a higher risk of contracting an infection up to about 5 months after the last dose your daughter received during pregnancy. It is important that you tell your daughter's pediatrician or other healthcare provider about your daughter's use of Hyrimoz during pregnancy, so that they can decide when the baby should receive any type of vaccination.

Heart failure

• It is important to inform your doctor about any heart problems, both past and present. If your child has mild heart failure and is receiving concomitant treatment with Hyrimoz, your doctor must carefully assess and monitor the condition of your heart. If new symptoms of heart failure or worsening of existing symptoms (e.g. shortness of breath or swelling of the feet) appear, contact your doctor immediately.

Fever, bruising, bleeding or pallor

• In some patients, the body may not be able to produce enough blood cells to fight infections or stop bleeding. If your child has persistent fever, bruising or easy bleeding, or pallor, seek immediate medical attention. The doctor may decide to discontinue therapy.

Tumor

• Very rarely, some types of tumors have occurred in children and adults treated with Hyrimoz or other anti-TNFα drugs. Patients with severe, long-standing rheumatoid arthritis may have a higher than average risk of developing lymphoma and leukemia (cancers that affect blood cells and bone marrow). If your child takes Hyrimoz, the risk of developing lymphomas, leukemia or other tumors may increase. In rare circumstances, a specific and serious type of lymphoma has been observed in patients treated with adalimumab. Some of these patients were also taking azathioprine or mercaptopurine. Tell your doctor if your child is taking azathioprine or mercaptopurine with Hyrimoz.
• Cases of skin cancer other than melanoma have been observed in patients taking adalimumab. If damaged skin areas appear during or after treatment or if the appearance of signs or damaged areas changes, report it to your doctor.

There have been cases of neoplasms, other than lymphoma, in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another anti-TNFα. If your child suffers from COPD, or smokes heavily, they should discuss with their doctor whether treatment with an anti-TNFα is appropriate.

Autoimmune diseases

• Rarely, treatment with Hyrimoz can lead to the manifestation of a syndrome like lupus. Tell your doctor if you experience symptoms such as persistent unexplained skin rash, fever, joint pain or fatigue.

Children and adolescents

• Do not give Hyrimoz to children with polyarticular juvenile idiopathic arthritis under the age of 2 years.
• Do not give Hyrimoz to children with pediatric plaque psoriasis or pediatric ulcerative colitis under the age of 4 years.
• Do not give Hyrimoz to children with pediatric Crohn's disease under the age of 6 years.
• Do not use the 40 mg pre-filled syringe if doses less than 40 mg are recommended.

Other medicines and Hyrimoz
Tell your doctor or pharmacist if your child is taking, has recently taken or might
take any other medicines.
Hyrimoz can be taken both with methotrexate and with other disease-modifying
antirheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide and parenteral
gold salts), corticosteroids or analgesics, including non-steroidal anti-inflammatory
drugs (NSAIDs).
Hyrimoz should not be taken at the same time as medicines containing the active
ingredients anakinra or abatacept due to the increased risk of serious infections. The
combination of adalimumab and other anti-TNF and anakinra or abatacept is not
recommended due to the possible increase in the risk of infections, including serious
infections and other possible drug interactions. If you have doubts, consult your doctor.

Pregnancy and breastfeeding

• Your daughter should consider using adequate contraception to prevent pregnancy and continue it for at least 5 months after the last therapy with Hyrimoz
• If a pregnancy is in progress, if your daughter suspects or is planning a pregnancy, ask her doctor for advice on taking this medicine.
• Hyrimoz should only be used during pregnancy if necessary.
• According to a pregnancy study, no increased risk of birth defects was found when the mother had received adalimumab during pregnancy, compared to mothers who had the same condition but had not received adalimumab.
• Hyrimoz can be used during breastfeeding.
• If your daughter takes Hyrimoz during pregnancy, the baby may have a higher risk of contracting an infection.
• It is important that you tell your daughter's pediatrician or other healthcare provider about her use of Hyrimoz during pregnancy, before the baby receives any type of vaccination (for more information on vaccines, see “Warnings and precautions”).

Driving and using machines
Hyrimoz can affect, albeit only to a modest extent, the ability to drive, ride a bicycle
or operate machinery. After taking Hyrimoz, you may experience vision disturbances and
a feeling that the environment around you is rotating (dizziness).

Hyrimoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 0.4 mL dose, which is
essentially ‘sodium-free’.

3. How to use Hyrimoz

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
Hyrimoz is available in 40 mg pens and prefilled syringes of 20 mg and 40 mg for the
administration to patients of a full dose of 20 mg or 40 mg.

How to administer and route of administration
Hyrimoz is administered by injection under the skin (subcutaneous injection).
Detailed instructions on how to inject Hyrimoz are provided in section 7, “Instructions for Use”.

If you use more Hyrimoz than you should
If you accidentally inject Hyrimoz more frequently than you should, contact your doctor or
pharmacist explaining that your child has received more medicine than they should. Always keep the
medicine box, even if empty.

If you forget to use Hyrimoz
If you forget to give your child an injection, you should inject the next dose of Hyrimoz as soon
as you remember. Then resume your child’s dose regularly according to the prescribed dosage schedule.

If you stop using Hyrimoz
The decision to stop using Hyrimoz should be discussed with your child’s doctor. Symptoms may return after treatment is stopped.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Most side effects are mild to moderate in form. However, some can be serious and require treatment. Side effects may occur
up to 4 months or more after the last injection of Hyrimoz.

Seek urgent medical attentionif you notice any of the following signs of an allergic reaction or
heart failure

• severe skin rash, hives;
• swelling of the face, hands, feet;
• difficulty breathing, difficulty swallowing;
• shortness of breath during exertion or when lying down, or swollen feet.

Inform your doctor as soon as possibleif you notice any of the following reactions

• signs and symptoms of infection such as fever, feeling unwell, wounds, dental problems, burning when urinating, fatigue or weakness, or cough;
• symptoms of nerve problems, such as tingling, numbness, double vision, or weakness of the arms or legs;
• signs of skin cancer such as swelling or an open sore that does not heal;
• signs and symptoms suggesting the onset of blood system disorders, such as persistent fever, bruising, bleeding, paleness.

The following side effects have been observed with Hyrimoz:

Very common(may affect more than 1 in 10 people)

• reactions at the injection site (including pain, swelling, redness or itching);
• respiratory tract infections (including cold, runny nose, sinusitis and pneumonia);
• headache;
• abdominal pain (stomach ache);
• nausea and vomiting;
• skin rash;
• muscle pain.

Common(may affect up to 1 in 10 people)

• serious infections (including sepsis and influenza);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes zoster infection);
• ear infections;
• mouth infections (including tooth infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• infections of the joints;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergies);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, pricking or numbness;
• migraine;
• symptoms of nerve root compression (including lower back pain and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• dizziness (feeling of spinning);
• feeling of a fast heartbeat;
• high blood pressure;
• hot flashes;
• bruise (solid swelling with coagulated blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, heartburn);
• acid reflux;
• dry eye syndrome (including dry eyes and dry mouth);
• itching;
• itchy skin rash;
• contusion;
• skin inflammation (such as eczema);
• nail breakage of the fingers and toes;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in the urine;
• kidney problems;
• chest pain;
• edema (fluid retention in the body, causing swelling of the affected tissue);
• fever;
• reduced platelets in the blood, which increases the risk of bleeding or bruising;
• difficulty healing wounds.

Uncommon(may affect up to 1 in 100 people)

• unusual infections (including tuberculosis and other infections) that occur when immune defenses are reduced;
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumors, including tumors of the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• immune system disorders that can affect the lungs, skin and lymph nodes (most commonly a condition called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor;
• neuropathy (nerve damage);
• stroke;
• hearing loss, ringing in the ears;
• feeling of irregular heartbeat such as palpitations;
• heart problems that can cause shortness of breath or swelling of the ankles;
• acute myocardial infarction (heart attack);
• formation of a sac in the wall of a major artery, inflammation and blood clot in a vein, blockage of a blood vessel;
• lung disease causing shortness of breath (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal accumulation of fluid in the pleural space);
• inflammation of the pancreas causing severe pain in the abdomen and back;
• difficulty swallowing;
• facial edema (swelling);
• inflammation of the gallbladder, gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scarring;
• abnormal muscle catabolism;
• systemic lupus erythematosus (immune system disorder, including inflammation of

the skin, heart, lungs, joints and other organs);

• interrupted sleep;
• impotence;
• inflammations.

Rare(may affect up to 1 in 1,000 people)

• leukemia (a cancer that affects the blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as optic nerve inflammation in the eye and Guillain-Barré syndrome, a condition that can cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring of the lungs);
• intestinal perforation (hole in the wall of the intestine);
• hepatitis (inflammation of the liver);
• reactivation of hepatitis B infection;
• autoimmune hepatitis (inflammation of the liver caused by your own immune system);
• cutaneous vasculitis (inflammation of the blood vessels in the skin);
• Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and skin rash with blisters);
• facial edema (swelling) associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (itchy, reddish-purple skin rash).

Not known(frequency cannot be estimated based on available data)

• T-cell hepatosplenic lymphoma (a rare blood cancer that is often fatal);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi's sarcoma, a rare cancer associated with human herpes virus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin;
• liver failure;
• worsening of a condition called dermatomyositis (which manifests as a skin rash accompanied by muscle weakness);
• weight gain (weight gain has been small for most patients).

Some of the side effects observed with adalimumab may be asymptomatic and can
only be detected through blood tests. These include:

Very common(may affect more than 1 in 10 people)

• low white blood cell count;
• low red blood cell count;
• increased lipids in the blood;
• increased liver enzymes.

Common(may affect up to 1 in 10 people)

• increased white blood cell count;
• reduced platelet count;
• increased uric acid in the blood;
• alteration of sodium in the blood;
• reduced calcium in the blood;
• reduced phosphorus in the blood;
• increased sugar in the blood;
• increased lactate dehydrogenase in the blood;
• presence of autoantibodies in the blood;
• reduced potassium in the blood.

Uncommon(may affect up to 1 in 100 people)

• high levels of bilirubin in the blood (liver blood test).

Rare(may affect up to 1 in 1,000 people)

• low white blood cell count, red blood cell count and platelet count.

Reporting of side effects
If your child experiences any side effects, including those not listed in this
leaflet, please tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system detailed in Annex V. By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store Hyrimoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label/blister/box after the
word Exp.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
Alternative storage conditions:
When necessary (for example when travelling), Hyrimoz can be stored at room temperature (up to 25°C) for a maximum period of 21 days – ensure the medicine is
protected from light. Once removed from the refrigerator for storage at room temperature, the
pre-filled syringe must be used within 21 days or discarded, even if subsequently
returned to the refrigerator. You must record the date on which the pre-filled syringe is removed from
the refrigerator for the first time and the date after which the syringe must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Hyrimoz contains

• The active substance is adalimumab. Each pre-filled syringe contains 20 mg of adalimumab in 0.4 mL of solution.
• The excipients are adipic acid, citric acid monohydrate, sodium chloride, mannitol (E 421), polysorbate 80 (E 433), hydrochloric acid (E 507), sodium hydroxide (E 524) and water for injections (see section 2 “Hyrimoz contains sodium”).

Description of the appearance of Hyrimoz and contents of the pack
Hyrimoz 20 mg solution for injection in pre-filled syringe for paediatric use is supplied in 0.4 mL of
solution from clear to slightly opalescent, colourless or slightly yellowish.
Hyrimoz is supplied in a single-use glass type I transparent syringe with 29 gauge stainless steel
needle and needle safety device with finger grip, rubber needle cap (thermoplastic elastomer) and plastic
plunger, containing 0.4 mL of solution.
The pack contains 2 pre-filled syringes of Hyrimoz.
Not all pack sizes may be marketed.
Hyrimoz is available in pre-filled syringe and pre-filled pen.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestr. 10
6250 Kundl
Austria

Manufacturer
Sandoz GmbH Schaftenau
Biochemiestr. 10
6336 Langkampfen
Austria
Novartis Pharmaceutical Manufacturing GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Sandoz nv/sa
Tél/Tel: +32 2 722 97 97

Lietuva
Sandoz Pharmaceuticals d.d filialas
Tel: +370 5 2636 037

Luxembourg/Luxemburg
Sandoz nv/sa
Tél/Tel.: +32 2 722 97 97

Česká republika
Sandoz s.r.o.
Tel: +420 225 775 111

България
Сандоз България КЧТ
Тел.: +359 2 970 47 47

Magyarország
Sandoz Hungária Kft.
Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige
Sandoz A/S
Tlf: +45 63 95 10 00

Malta
Sandoz Pharmaceuticals d.d.
Tel: +356 99644126

Deutschland
Hexal AG
Tel: +49 8024 908 0

Nederland
Sandoz B.V.
Tel: +31 36 52 41 600

Eesti
Sandoz d.d. Eesti filiaal
Tel: +372 665 2400

Österreich
Sandoz GmbH
Tel: +43 5338 2000

Ελλάδα
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
Τηλ: +30 216 600 5000

Polska
Sandoz Polska Sp. z o.o.
Tel.: +48 22 209 70 00

España
Sandoz Farmacéutica, S.A.
Tel: +34 900 456 856

Portugal
Sandoz Farmacêutica Lda.
Tel: +351 21 000 86 00

France
Sandoz SAS
Tél: +33 1 49 64 48 00

România
Sandoz Pharmaceuticals SRL
Tel: +40 21 407 51 60

Hrvatska
Sandoz d.o.o.
Tel: +385 1 23 53 111

Slovenija
Sandoz farmacevtska družba d.d.
Tel: +386 1 580 29 02

Ireland
Rowex Ltd.
Tel: + 353 27 50077

Slovenská republika
Sandoz d.d. - organizačná zložka
Tel: +421 2 50 70 6111

Italia
Sandoz S.p.A.
Tel: +39 02 96541

Suomi/Finland
Sandoz A/S
Puh/Tel: +358 10 6133 400

Κύπρος
Sandoz Pharmaceuticals d.d.
Τηλ: +357 22 69 0690

United Kingdom (Northern Ireland)
Sandoz GmbH
Tel: +43 5338 2000

Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu.

7. Instructions for Use

To avoid possible infections and to ensure you use the medicine correctly, it is important that
you follow these instructions.
Make sure to read, understand and follow these Instructions for Use before injecting Hyrimoz.
The healthcare professional must show you how to prepare and inject Hyrimoz correctly using the
prefilled syringe before you use the medicine for the first time. If you have any doubts, please contact
your healthcare professional.

Hyrimoz single-use prefilled syringe with safety device for the needle and additional finger grip

Figure A: Hyrimoz prefilled syringe with safety device for the needle and grip

additional finger grip

It is important that you:

• do not openthe outer carton until you are ready to use the syringe;
• do not usethe syringe if the blister seals are broken, as use may not be safe;
• never leavethe syringe unattended where it could be tampered with by others;
• if you drop the syringe, do not useit if it appears damaged or if it was dropped after you had removed the needle cap;
• do not removethe needle cap until the time of injection;
• be careful not to touchthe wings of the needle safety device before use. If you do, the needle safety device may be activated too early. Do not removethe finger grip before injection;
• inject Hyrimoz 15-30 minutes after removing it from the refrigerator, for a more comfortable injection;
• dispose of the used syringe immediately after use. Do not reuse the syringe.See “4. Disposal of used syringes”at the end of these Instructions for Use.

How should you store Hyrimoz?

• Store the outer packaging of the syringes in a refrigerator, at a temperature between 2° and 8°C.
• When necessary (for example when travelling), Hyrimoz can be stored at room temperature (up to 25°C) for a maximum period of 21 days - make sure to protect the medicine from light. Once it is removed from the refrigerator to be stored at room temperature, the prefilled syringe must be used within 21 days or discarded, even if it is subsequently placed back in the refrigerator. You must record the date on which the prefilled syringe is removed from the refrigerator for the first time and the date after which it must be discarded.
• Store the syringes in the original packaging until you are ready to use them, to protect the medicine from light.
• Do not store the syringes at extremely high or low temperatures.
• Do not freeze the syringes.

Keep Hyrimoz and all medicines out of the reach of children.
What do you need for the injection?
Place the following items on a clean, flat surface.
The pack contains:

• Syringe(s)/prefilled syringe(s) of Hyrimoz (see Figure A). Each syringe contains 20 mg/0.4 mL of Hyrimoz.

The pack does not contain (see Figure B):

• Alcohol swab.
• Cotton wool or gauze.
• Sharps container.

Figure B: items not included in the pack
See “4. Disposal of used syringes”at the end of these Instructions for Use.

Before the injection

Figure C: the needle safety device is not

activated – the syringe is ready for use

Figure D: the needle safety device

is activated – do not use
In this configuration, the
needle safety device
is ACTIVATED.
DO NOT USEthe syringe (see

Figure D).

Preparing the syringe

• For a more comfortable injection, remove the blister containing the syringe from the refrigerator and leave it closed on the work surface for about 15-30 minutes to reach room temperature.
• Remove the syringe from the blister.
• Look through the window. The solution should be colourless or slightly yellowish and from clear to slightly opalescent. Do not use the syringe if you notice particles and/or changes in colour. If you have any doubts about the appearance of the solution, please contact your pharmacist for assistance.
• Do not use the syringe if it is broken or if the needle safety device is activated. Return the syringe and the pack to the pharmacy. In this configuration, the needle safety device IS NOT ACTIVATED. The syringe is ready for use (see Figure C).
• Check the expiry date (Exp.) of the syringe. Do not use the syringe if the expiry date has passed.

Contact your pharmacist if the syringe does not pass any of the checks above.

1. Choice of injection site:

• The recommended injection site is the front of the thighs. You can also use the lower abdomen, but not the area within 5 cm around the navel (see Figure E).
• Choose a different site each time you administer an injection.
• Do not inject the medicine into areas where the skin is painful, bruised, reddened, flaky, or hardened. Avoid areas with scars or stretch marks. If you suffer from psoriasis, DO NOT inject the medicine directly into areas with psoriasis plaques.

Figure E: how to choose the injection

site

2. Injection site cleaning:

• Wash your hands thoroughly with water and soap.
• Using a circular motion, clean the injection site with a swab soaked in alcohol. Allow to dry before administering the injection (see Figure F).
• Do not touch the cleaned area before the injection.

Figure F: how to clean the

injection site

3. Administration of the injection:

• Carefully pull off the needle cap to remove it from the syringe (see Figure G).
• Discard the needle cap.
• You may see a drop of liquid at the end of the needle. This is normal.

Figure G: how to pull off the cap

of the needle

• Gently create a skin fold at the injection site (see Figure H).
• Insert the needle into the skin as shown.
• Push the entire needle into the skin to ensure that all of the medicine is administered.

Figure H: how to insert the needle

• Hold the syringe as shown (see Figure I).
• Slowly press the plunger all the way down so that the plunger head is completely between the fins of the needle safety device.
• While holding the syringe in position, keep the plunger pressed down completely for 5 seconds.

Figure I: how to hold the syringe

• Keep the plunger fully depressedwhile carefully withdrawing the needle from the injection site, then release the skin (see Figure J).

Figure J: how to withdraw the needle

• Slowly release the plunger and allow the needle safety device to automatically cover the exposed needle (see Figure K).
• You may notice a small amount of blood at the injection site. You can press a cotton ball or gauze on the injection site and hold for 10 seconds. Do not rub the injection site. If necessary, you can cover the injection site with a small adhesive bandage.

Figure K: how to slowly release

the plunger

4. Disposal of used syringes:

• Dispose of the used syringe in a sharps disposal container (reclosable, puncture-resistant container). For your safety and health and that of others, used needles and syringes must never be reused.
• Do not dispose of any medicine down the drain or in household waste. Ask your doctor or pharmacist how to dispose of medicines you no longer use. This will help protect the environment. Unused medicine and waste derived from that medicine must be disposed of in accordance with local regulations.

If you have any doubts, consult a doctor, pharmacist, or nurse who is familiar with
Hyrimoz.

Hyrimoz 20 mg injectable solution in pre-filled syringe

adalimumab

20 mg/0.2 mL
Read this leaflet carefully before your childuses this medicine as it contains
important information.

• Keep this leaflet. You may need to read it again.
• Your doctor will give you a Patient Reminder Card, which contains important safety information that you need to know before your child starts using Hyrimoz and during treatment with Hyrimoz. Keep this Patient Reminder Cardwith you or your child during treatment and for 4 months after the last Hyrimoz injection given to your child.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for your child. Do not give it to other people, even if their symptoms are the same as those of your child, as it could be dangerous.
• If your child experiences any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Hyrimoz is and what it is used for
• 2. What you need to know before your child uses Hyrimoz
• 3. How to use Hyrimoz
• 4. Possible side effects
• 5. How to store Hyrimoz
• 6. Contents of the pack and other information
• 7. Instructions for use

1. What is Hyrimoz and what is it used for

Hyrimoz contains the active ingredient adalimumab, a medicine that acts on the body’s immune system
(defense).
Hyrimoz is indicated for the treatment of the inflammatory diseases listed below:

• polyarticular juvenile idiopathic arthritis,
• arthritis associated with enthesitis,
• pediatric plaque psoriasis,
• pediatric Crohn’s disease,
• pediatric non-infectious uveitis.

The active ingredient contained in Hyrimoz, adalimumab, is a human monoclonal antibody. Monoclonal
antibodies are proteins that bind to a specific target.
The target of adalimumab is a protein called tumor necrosis factor (TNFα), which is
involved in the immune system (defense) and is present in higher concentrations in the inflammatory
diseases listed above. By binding to TNFα, Hyrimoz blocks its action and decreases
the inflammatory process in these diseases.
Polyarticular juvenile idiopathic arthritis
Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints.
Hyrimoz is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents
aged 2 to 17 years. Other disease-modifying drugs, such as methotrexate, may be given at diagnosis.
If these drugs do not work satisfactorily, patients will be
given Hyrimoz for the treatment of polyarticular juvenile idiopathic arthritis.
Arthritis associated with enthesitis
Arthritis associated with enthesitis is an inflammatory disease of the joints and the areas where the
tendons attach to the bones.
Hyrimoz is used to treat arthritis associated with enthesitis in children and adolescents aged
6 to 17 years.
Other disease-modifying medications, such as methotrexate, may initially be given to patients.
If these medications do not work well enough, patients will be given
Hyrimoz to treat arthritis associated with enthesitis.
Pediatric plaque psoriasis
Plaque psoriasis is an inflammatory skin condition that causes red, scaly, and hardened patches of skin
covered with silvery scales. Plaque psoriasis can also affect the
nails, causing them to break, thicken, and lift from the nail bed, which can be
painful. Psoriasis is thought to be caused by a problem with the body’s immune system that
leads to increased production of skin cells.
Hyrimoz is used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years
in whom medications applied to the skin and treatment with UV rays have not worked optimally or are not indicated.
Pediatric Crohn’s disease
Crohn’s disease is an inflammation of the intestine.
Hyrimoz is used to treat moderate to severe Crohn’s disease in children and adolescents
aged 6 to 17 years.
Your child may first be given other medications. If these medications do not work in
a satisfactory manner, your child will be given Hyrimoz to reduce the typical symptoms
of their disease.
Pediatric non-infectious uveitis
Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye.
Inflammation leads to decreased vision and/or the presence of mobile bodies in the eye
(black dots or thin lines that move across the visual field). Hyrimoz works by reducing this
inflammation.
Hyrimoz is used for the treatment of children from 2 years of age with chronic non-infectious uveitis
with inflammation affecting the front of the eye.
Your child may first be given other medications. If these medications do not work in
a satisfactory manner, your child will be given Hyrimoz to reduce the typical symptoms
of their disease.

2. What you need to know before your child uses Hyrimoz

Do not use Hyrimoz

• If your child is allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
• If there is a severe infection, including tuberculosis, sepsis (blood poisoning) or other opportunistic infections (unusual infections associated with a weakened immune system). It is important to tell your doctor if your child has signs or symptoms of infection, such as, for example, fever, wounds, feeling tired, dental problems (see “Warnings and precautions”).
• If there is moderate or severe heart failure. It is important to tell your doctor if there has been or is a serious heart condition (see “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before using Hyrimoz
Allergic reaction

• If you experience allergic reactions with symptoms such as a feeling of tightness in the chest, wheezing, dizziness, swelling or skin rash, do not administer Hyrimoz again and contact your doctor immediately as, in rare cases, these reactions can be life-threatening.

Infections

• If an infection occurs, including long-term or localized infections (for example, leg ulcers), consult your doctor before starting treatment with Hyrimoz. If you have any doubts, contact your doctor.
• You may be more likely to get infections during treatment with Hyrimoz. This risk may increase if your child's lung function is reduced. These infections can be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other unusual infectious organisms and sepsis (blood poisoning).
• In rare cases, these infections can be life-threatening to the patient. It is important to tell your doctor about the presence of symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may advise you to temporarily stop Hyrimoz.

Tuberculosis (TB)

• Since cases of tuberculosis have occurred in patients treated with adalimumab, your doctor will need to check if your child has signs or symptoms typical of tuberculosis before starting therapy with Hyrimoz. This will involve collecting a detailed medical assessment including your child's medical history and clinical examinations (e.g. a chest X-ray and a tuberculin test). The performance and results of these tests must be recorded in your child's Patient Reminder Card. It is very important to tell your doctor if your child has ever had tuberculosis, or if they have had close contact with people with tuberculosis. Tuberculosis may develop during therapy even if your child has received preventive treatment for tuberculosis. Contact your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, lack of energy, mild fever) or other infections appear during or after therapy.

Travel/recurring infection

• Tell your doctor if your child has lived in or travelled to regions where fungal infections, such as histoplasmosis, coccidioidomycosis or blastomycosis, are very common.
• Tell your doctor if your child has had recurrent infections or has conditions that increase the risk of infection.

Hepatitis B virus

• Tell your doctor if your child is a carrier of the hepatitis B virus (HBV), has an active infection with the hepatitis B virus or thinks they may be at risk of contracting the hepatitis B virus. Your doctor should test your child for hepatitis B virus infection. Taking adalimumab can reactivate hepatitis B virus infection in subjects who are carriers of this virus. In some rare cases, especially if your child is taking other medications that suppress the immune system, reactivation of hepatitis B virus infection can be life-threatening.

Surgery or dental procedures

• Before surgery or dental procedures, tell your doctor that your child is taking Hyrimoz. Your doctor may advise you to temporarily stop Hyrimoz.

Demyelinating disease

• If your child has or develops demyelinating diseases (diseases that affect the insulating layer around nerves), such as multiple sclerosis, your doctor will decide whether or not to start or continue treatment with Hyrimoz. Tell your doctor immediately if your child develops symptoms such as changes in vision, weakness of arms or legs, or numbness or tingling that affects any part of the body.

Vaccination

• Certain vaccines contain live but weakened forms of bacteria or viruses that cause diseases and should not be given during treatment with Hyrimoz if they cause infections. Consult your doctor before having your child vaccinated. In children, it is recommended, if possible, to administer the vaccinations recommended for their age before starting therapy with Hyrimoz.
• If your daughter is taking Hyrimoz during pregnancy, the baby may have a higher risk of contracting an infection for up to about 5 months after the last dose your daughter received during pregnancy. It is important that you tell your daughter's pediatrician or other healthcare provider about your daughter's use of Hyrimoz during pregnancy, so they can decide when the baby should receive any type of vaccination.

Heart failure

• It is important to inform your doctor about any heart problems, both past and present. If mild heart failure is present and concomitant treatment with Hyrimoz, your doctor should carefully assess and monitor your heart condition. If new symptoms of heart failure appear or existing symptoms worsen (e.g. shortness of breath or swelling of the feet), contact your doctor immediately.

Fever, bruising, bleeding or paleness

• In some patients, the body may not be able to produce enough blood cells to fight infections or stop bleeding. If your child has persistent fever, bruising or easy bleeding or paleness, contact your doctor immediately. The latter may decide to interrupt the therapy.
  Tumor

In children and adults treated with Hyrimoz or other anti-TNFα drugs, very rare cases of certain types of tumors have occurred. Patients with severe, long-standing rheumatoid arthritis may have a higher than average risk of developing lymphoma and leukemia (cancers affecting blood cells and bone marrow). If your child is taking Hyrimoz, the risk of developing lymphomas, leukemia or other tumors may increase. In rare circumstances, a specific and serious type of lymphoma has been observed in patients treated with adalimumab. Some of these patients were also taking azathioprine or mercaptopurine. Tell your doctor if your child is taking azathioprine or mercaptopurine with Hyrimoz.

Cases of non-melanoma skin cancer have been observed in patients taking adalimumab. If damaged areas of skin appear during or after treatment or if the appearance of existing damaged areas changes, report it to your doctor.

Cases of neoplasms, other than lymphoma, have occurred in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another anti-TNFα. If your child suffers from COPD, or smokes heavily, they should discuss with their doctor whether treatment with an anti-TNFα is appropriate.

Autoimmune diseases

• Rarely, treatment with Hyrimoz can lead to the manifestation of a syndrome like lupus. Tell your doctor if symptoms such as a persistent unexplained skin rash, fever, joint pain or fatigue develop.

Children and adolescents

• Do not give Hyrimoz to children with polyarticular juvenile idiopathic arthritis under the age of 2 years.
• Do not give Hyrimoz to children with pediatric plaque psoriasis or pediatric ulcerative colitis under the age of 4 years.
• Do not give Hyrimoz to children with pediatric Crohn's disease under the age of 6 years.
• Do not use the pre-filled syringe of 40 mg if doses less than 40 mg are recommended.

Other medicines and Hyrimoz
Tell your doctor or pharmacist if your child is taking, has recently taken or might
take any other medicines.
Hyrimoz can be taken both with methotrexate and with other disease-modifying antirheumatic
drugs (sulfasalazine, hydroxychloroquine, leflunomide and parenteral gold salts), corticosteroids
or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Hyrimoz should not be taken at the same time as medicines containing the active ingredients anakinra or
abatacept due to the increased risk of serious infections. The combination of adalimumab and other
anti-TNF and anakinra or abatacept is not recommended due to the possible increase in the risk of
infections, including serious infections and other possible drug interactions. If you have any doubts, ask
your doctor.

Pregnancy and breastfeeding

• Your daughter should consider using adequate contraceptive measures to prevent pregnancy and continue using them for at least 5 months after the last therapy with Hyrimoz
• If a pregnancy is in progress, if your daughter suspects or is planning a pregnancy, ask her doctor for advice on taking this medicine.
• Hyrimoz should only be used during pregnancy if necessary.
• According to a pregnancy study, no increased risk of birth defects was found when the mother had received adalimumab during pregnancy, compared to mothers who had the same condition but had not received adalimumab.
• Hyrimoz can be used during breastfeeding.
• If your daughter takes Hyrimoz during pregnancy, the baby may have a higher risk of contracting an infection.
• It is important that you tell your daughter's pediatrician or other healthcare provider about her use of Hyrimoz during pregnancy, before the baby receives any type of vaccination (for more information on vaccines, see “Warnings and precautions”).

Driving and using machines
Hyrimoz may affect, albeit only to a modest extent, the ability to drive, ride a bicycle
or use machinery. Following the administration of Hyrimoz, vision disturbances and a
feeling that the surrounding environment is rotating (dizziness) may occur.

Hyrimoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 0.2 mL of dose, i.e. essentially
‘sodium-free’.

3. How to use Hyrimoz

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended doses of Hyrimoz in each approved indication are listed in the following
table. The doctor may prescribe a different concentration of Hyrimoz if the child needs a
different dose.

Method and route of administration
Hyrimoz is administered by injection under the skin (for subcutaneous injection).
Detailed instructions on how to inject Hyrimoz are provided in section 7, “Instructions for Use”.

If you use more Hyrimoz than you should
If you accidentally inject Hyrimoz more frequently than you should, contact your doctor or
pharmacist explaining that your child has received more medicine than they should. Always keep the
medicine box, even if empty.

If you forget to use Hyrimoz
If you forget to give your child an injection, you should inject the next dose of Hyrimoz as soon
as you remember. Then resume your child's dose regularly according to the established dosage
schedule.

If you stop treatment with Hyrimoz
The decision to stop using Hyrimoz should be discussed with your child's doctor. The
symptoms may return after stopping treatment.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Most side effects are mild to moderate. However, some may be serious and require treatment. Side effects may occur
up to 4 months or more after the last injection of Hyrimoz.

Seek urgent medical attentionif you notice any of the following signs of an allergic reaction or
heart failure

• severe skin rash, hives;
• swelling of the face, hands, feet;
• difficulty breathing, difficulty swallowing;
• shortness of breath during activity or when lying down, or swollen feet.

Inform your doctor as soon as possibleif you notice any of the following reactions

• signs and symptoms of infection such as fever, feeling unwell, wounds, dental problems, burning when urinating, fatigue or weakness, or cough;
• symptoms of nerve problems, such as tingling, numbness, double vision, or weakness of the arms or legs;
• signs of skin cancer such as swelling or an open sore that does not heal;
• signs and symptoms suggesting the onset of blood system disorders, such as persistent fever, bruising, bleeding, paleness.

The following side effects have been observed with Hyrimoz:

Very common(may affect more than 1 in 10 people)

• reactions at the injection site (including pain, swelling, redness or itching);
• respiratory tract infections (including common cold, runny nose, sinusitis and pneumonia);
• headache;
• abdominal pain;
• nausea and vomiting;
• skin rash;
• muscle pain.

Common(may affect up to 1 in 10 people)

• serious infections (including sepsis and influenza);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes zoster infection);
• ear infections;
• mouth infections (including tooth infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• infections of the joints;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergy);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, stabbing sensation or numbness;
• migraine;
• symptoms of nerve root compression (including back pain and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• dizziness (feeling of spinning);
• feeling of a fast heartbeat;
• high blood pressure;
• hot flashes;
• hematoma (solid swelling with clotted blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, heartburn);
• acid reflux;
• dry eye syndrome (including dry eyes and dry mouth);
• itching;
• itchy rash;
• bruising;
• skin inflammation (such as eczema);
• nail breakage of the fingers and toes;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in urine;
• kidney problems;
• chest pain;
• edema (fluid buildup in the body, causing swelling of the affected tissue);
• fever;
• reduced platelets in the blood, which increases the risk of bleeding or bruising;
• difficulty healing wounds.

Uncommon(may affect up to 1 in 100 people)

• unusual infections (including tuberculosis and other infections) that occur when immune defenses are reduced;
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumors, including tumors of the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• immune system disorders that can affect lungs, skin and lymph nodes (most commonly a condition called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor (shaking);
• neuropathy (nerve damage);
• stroke;
• hearing loss, ringing in the ears;
• feeling of irregular heartbeat such as palpitations;
• heart problems that can cause shortness of breath or swelling in the ankles;
• acute myocardial infarction (heart attack);
• formation of a sac in the wall of a major artery, inflammation and blood clot in a vein, blockage of a blood vessel;
• lung disease causing shortness of breath (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal accumulation of fluid in the pleural space);
• inflammation of the pancreas causing severe pain in the abdomen and back;
• difficulty swallowing;
• facial edema (swelling);
• inflammation of the gallbladder, gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scarring;
• abnormal muscle catabolism;
• systemic lupus erythematosus (immune system disorder, including inflammation of the skin, heart, lungs, joints and other organs);
• interrupted sleep;
• impotence;
• inflammations.

Rare(may affect up to 1 in 1,000 people)

• leukemia (a cancer that affects the blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as inflammation of the optic nerve in the eye and Guillain-Barré syndrome, a condition that can cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring of the lungs);
• intestinal perforation (hole in the wall of the intestine);
• hepatitis (inflammation of the liver);
• reactivation of hepatitis B infection;
• autoimmune hepatitis (inflammation of the liver caused by your own immune system);
• cutaneous vasculitis (inflammation of the blood vessels in the skin);
• Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and skin rash with blisters);
• facial edema (swelling) associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (itchy red-violet rash).

Not known(frequency cannot be estimated based on available data)

• T-cell hepatosplenic lymphoma (a rare blood cancer that is often fatal);
• Merkel cell carcinoma, a type of skin cancer;
• Kaposi's sarcoma, a rare cancer related to human herpes virus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin;
• liver failure;
• worsening of a condition called dermatomyositis (which manifests as a skin rash accompanied by muscle weakness);
• weight gain (weight gain has been low for most patients).

Some of the side effects observed with adalimumab may be asymptomatic and may
only be detected through blood tests. These include:

Very common(may affect more than 1 in 10 people)

• low white blood cell count;
• low red blood cell count;
• increased lipids in the blood;
• increased liver enzymes.

Common(may affect up to 1 in 10 people)

• increased white blood cell count;
• reduced platelet count;
• increased uric acid in the blood;
• alteration of sodium in the blood;
• reduced calcium in the blood;
• reduced phosphorus in the blood;
• increased sugar in the blood;
• increased lactate dehydrogenase in the blood;
• presence of autoantibodies in the blood;
• reduced potassium in the blood.

Uncommon(may affect up to 1 in 100 people)

• high levels of bilirubin in the blood (liver blood test).

Rare(may affect up to 1 in 1,000 people)

• low white blood cell count, red blood cell count and platelet count.

Reporting of side effects
If your child experiences any side effects, including those not listed in this
leaflet, please tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store Hyrimoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label/blister/box after the
word Exp.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
Alternative storage conditions:
When necessary (for example when travelling), Hyrimoz can be stored at room temperature (up to 25°C) for a maximum period of 42 days – ensure to protect the medicine
from light. Once it is removed from the refrigerator to be stored at room temperature, the
pre-filled syringe must be used within 42 days or discarded, even if it is subsequently
placed back in the refrigerator. You must record the date on which the pre-filled syringe is removed from
the refrigerator for the first time and the date after which the syringe must be discarded.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Hyrimoz contains

• The active ingredient is adalimumab. Each pre-filled syringe contains 20 mg of adalimumab in 0.2 mL of solution.
• The excipients are adipic acid, mannitol (E 421), polysorbate 80 (E 433), hydrochloric acid (E 507), sodium hydroxide (E 524) and water for injections.

Description of Hyrimoz and package contents
Hyrimoz 20 mg solution for injection in pre-filled syringe for paediatric use is supplied in 0.2 mL of
solution from clear to slightly opalescent, colourless or slightly yellowish.
Hyrimoz is supplied in a single-use glass type I transparent syringe with a 29 gauge stainless
steel needle with finger flange, rubber needle cap (thermoplastic elastomer) and
plastic plunger, containing 0.2 mL of solution.
The multipack contains 2 (2 packs of 1) pre-filled syringes of Hyrimoz.
Not all pack sizes may be marketed.
Hyrimoz is available in pre-filled syringe and pre-filled pen.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestr. 10
6250 Kundl
Austria

Manufacturer
Sandoz GmbH Schaftenau
Biochemiestr. 10
6336 Langkampfen
Austria
Novartis Pharmaceutical Manufacturing GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Sandoz nv/sa
Tél/Tel: +32 2 722 97 97

Lietuva
Sandoz Pharmaceuticals d.d filialas
Tel: +370 5 2636 037

Luxembourg/Luxemburg
Sandoz nv/sa
Tél/Tel.: +32 2 722 97 97

Česká republika
Sandoz s.r.o.
Tel: +420 225 775 111

България
Сандоз България КЧТ
Тел.: +359 2 970 47 47

Magyarország
Sandoz Hungária Kft.
Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige
Sandoz A/S
Tlf: +45 63 95 10 00

Malta
Sandoz Pharmaceuticals d.d.
Tel: +356 99644126

Deutschland
Hexal AG
Tel: +49 8024 908 0

Nederland
Sandoz B.V.
Tel: +31 36 52 41 600

Eesti
Sandoz d.d. Eesti filiaal
Tel: +372 665 2400

Österreich
Sandoz GmbH
Tel: +43 5338 2000

Ελλάδα
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
Τηλ: +30 216 600 5000

Polska
Sandoz Polska Sp. z o.o.
Tel.: +48 22 209 70 00

España
Sandoz Farmacéutica, S.A.
Tel: +34 900 456 856

Portugal
Sandoz Farmacêutica Lda.
Tel: +351 21 000 86 00

France
Sandoz SAS
Tél: +33 1 49 64 48 00

România
Sandoz Pharmaceuticals SRL
Tel: +40 21 407 51 60

Hrvatska
Sandoz d.o.o.
Tel: +385 1 23 53 111

Slovenija
Sandoz farmacevtska družba d.d.
Tel: +386 1 580 29 02

Ireland
Rowex Ltd.
Tel: + 353 27 50077

Slovenská republika
Sandoz d.d. - organizačná zložka
Tel: +421 2 50 70 6111

Italia
Sandoz S.p.A.
Tel: +39 02 96541

Suomi/Finland
Sandoz A/S
Puh/Tel: +358 10 6133 400

Κύπρος
Sandoz Pharmaceuticals d.d.
Τηλ: +357 22 69 0690

United Kingdom (Northern Ireland)
Sandoz GmbH
Tel: +43 5338 2000

Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu .

7. Instructions for Use

To avoid possible infections and to ensure you use the medicine correctly, it is important that
you follow these instructions.
Make sure you read, understand and follow these Instructions for Use before injecting Hyrimoz.
The healthcare professional must show you how to prepare and inject Hyrimoz correctly using the
single-dose pre-filled syringe before you use the medicine for the first time. If you have any doubts, ask
your healthcare professional.

Hyrimoz Single-Dose Pre-filled Syringe

Figure A:Hyrimoz pre-filled syringe

It is important that you:

• do not usethe pre-filled syringe if the seal of the outer pack is broken, because use may not be safe;
• do notopen the inner pack until you are ready to use the Hyrimoz pre-filled syringe;
• never leavethe pre-filled syringe unattended where it could be tampered with by others;
• if you drop the syringe, do not useit if it appears damaged or if it was dropped after you had removed the needle cap;
• do not removethe needle cap until the time of injection;
• inject Hyrimoz15-30 minutes after taking it out of the refrigerator, for a more comfortable injection;
• dispose of the used syringe immediately after use. Do not reuse the syringe.See “4. Disposal of used syringes”at the end of these Instructions for Use;
• ask your doctor or nurse for advice on the appropriate injection site and technique if you are underweight or if you are injecting a child.

How should you store the Hyrimoz single-dose pre-filled syringe?

• Store the single-dose syringe of Hyrimozin the original packaging to protect the medicine from light.
• Store the outer pack of the pre-filled syringes in a refrigerator, at a temperature between 2° and 8°C.
• If necessary (for example if you are travelling), you can store the pre-filled syringe at room temperature up to 25°C for a maximum of 42 days.
• After 42 days, discard the pre-filled syringe stored at room temperature.
• You must record the date on which the pre-filled syringe is removed from the refrigerator for the first time and the date after which it must be discarded.
• Do notstore the pre-filled syringe at extremely hot or cold temperatures.
• Do notfreeze the pre-filled syringe.
• Do notuse the pre-filled syringe after the expiry date stated on the outer pack or on the syringe label. If the expiry date has passed, return the entire pack to the pharmacy.

Keep Hyrimoz and all medicines out of the reach of children.
What do you need for the injection?
Place the following items on a clean, flat surface.
The syringe pack contains:

• Hyrimoz pre-filled syringe (see Figure A). Each pre-filled syringe contains 20 mg/0.2 mL of adalimumab.

The Hyrimoz pre-filled syringe pack does not contain (see Figure B):

• Alcohol swab.
• Cotton ball or gauze.
• Sharps disposal container. See “4. Disposal of used syringes”at the end of these Instructions for Use.
• Adhesive bandage.

Figure B:items not included in the pack

Preparing the pre-filled syringe

• For a more comfortable injection, remove the pack containing the pre-filled syringe from the refrigerator and leave it closedon the work surface for about 15-30 minutes to reach room temperature.
• Remove the pre-filled syringe from the box and inspect it. The solution should be colourless or slightly yellowish and from clear to slightly opalescent. Do not usethe syringe if you notice particles and/or changes in colour. If you have any doubts about the appearance of the solution, ask your pharmacist for assistance.
• Do notuse the pre-filled syringe if it is broken. Return the entire product pack to the pharmacy.
• Check the expiry date (Exp.) on the pre-filled syringe. Do not use the pre-filled syringe if the expiry date has passed.

Ask your pharmacist if the pre-filled syringe fails any of the checks
above.

1. Choice of injection site:

The injection site is the point on the body where you will administer
the injection with the prefilled syringe of Hyrimoz.

• The recommended injection site is the front of the thighs. You can also use the lower abdomen, but not the area within 5 cm around the navel (see Figure C).
• Choose a different site each time you administer an injection.
• Do notinject the medicine into areas where the skin is painful, bruised, reddened, flaky, or hardened. Avoid areas with scars or stretch marks. If you suffer from psoriasis, do notinject the medicine directly into areas with psoriasis plaques.

Figure C:how to choose the injection
site

2. Injection site cleaning:

• When you are ready to use the pre-filled syringe, wash your hands thoroughly with water and soap.
• Using a circular motion, clean the injection site with a swab soaked in alcohol. Allow it to dry before administering the injection (see Figure D).
• Do nottouch this area again before administering the injection. Allow the skin to dry before the injection. Do not fan or blow air onto the cleaned area.

Figure D:how to clean the injection
site

3. Administration of the injection:

• Carefully pull off the needle cap to remove it from the syringe (see Figure E).
• Dispose of (eliminate) the needle cap.
• You may see a drop of liquid at the end of the needle. This is normal.

Figure E:how to pull off the needle cap

• Gently create a skin fold at the injection site (see Figure F).
• Insert the needle into the skin at a 45° angle, as shown (see Figure F).

Figure F:how to insert the needle

• Hold the prefilled single-dose syringe as shown (see Figure G).
• Press the plunger slowlyuntil it stops.
• While holding the syringe in place, keep the plunger fully pressed for 5 seconds.
• Carefully withdraw the needle from the injection site, then release the skin. You may notice a small amount of blood at the injection site. You can press a cotton ball or gauze on the injection site and hold it for 10 seconds. Do notrub the injection site. If necessary, you can cover the injection site with a small adhesive bandage.

Figure G:how to press the plunger

4. Disposal of used pre-filled syringes:

• Dispose of the used syringe in a sharps disposal container (reclosable, puncture-resistant container). For your safety and health and that of others, used needles and syringes must never be reused.
• Do not dispose of any medicine down the drain or in household waste. Ask your doctor or pharmacist how to dispose of medicines you no longer use. This will help protect the environment. Unused medicine and waste from that medicine must be disposed of in accordance with local regulations.

Figure H:how to dispose of the used
pre-filled syringe

If you have any doubts, consult a doctor, pharmacist or nurse familiar with
Hyrimoz.

Hyrimoz 40 mg solution for injection in pre-filled syringe

adalimumab

40 mg/0.8 mL
Read this leaflet carefully before you use this medicine as it contains important
information for you

• Keep this leaflet. You may need to read it again.
• Your doctor will give you a Patient Reminder Card, which contains important safety information that you need to know before administering Hyrimoz and during treatment with Hyrimoz. Keep this Patient Reminder Cardwith you during treatment and for 4 months after the last injection (or the last injection given to your child) of Hyrimoz.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, see your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Hyrimoz is and what it is used for
• 2. What you need to know before you use Hyrimoz
• 3. How to use Hyrimoz
• 4. Possible side effects
• 5. How to store Hyrimoz
• 6. Contents of the pack and other information
• 7. Instructions for use

1. Cos’è Hyrimoz e a cosa serve

Hyrimoz contiene il principio attivo adalimumab, a medicine that acts on the body's immune system.
Hyrimoz is indicated for the treatment of the inflammatory diseases listed below:

• rheumatoid arthritis,
• polyarticular juvenile idiopathic arthritis,
• arthritis associated with enthesitis,
• ankylosing spondylitis,
• axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
• psoriatic arthritis,
• psoriasis,
• hidradenitis suppurativa,
• Crohn’s disease,
• ulcerative colitis and
• non-infectious uveitis

The active ingredient contained in Hyrimoz, adalimumab, is a human monoclonal antibody. Monoclonal
antibodies are proteins that bind to a specific target.
The target of adalimumab is a protein called tumor necrosis factor (TNFα), which is
involved in the immune system and is present at higher concentrations in the
inflammatory diseases listed above. By binding to TNFα, Hyrimoz blocks its action and reduces
the inflammatory process in these diseases.
Rheumatoid Arthritis
Rheumatoid arthritis is an inflammatory condition of the joints.
Hyrimoz is used to treat rheumatoid arthritis in adults. If you have moderate to severe rheumatoid
arthritis, other disease-modifying drugs, such as methotrexate, may be initially administered. If these
drugs do not work satisfactorily, you will be given Hyrimoz to treat rheumatoid arthritis.
Hyrimoz can also be used to treat severe, active, and progressive rheumatoid arthritis without prior
treatment with methotrexate.
Hyrimoz may slow the progression of cartilage and bone damage in the joints, caused by the disease,
and improve physical function.
Generally Hyrimoz is used with methotrexate. If your doctor believes that treatment with
methotrexate is not appropriate, Hyrimoz may be administered alone.
Polyarticular Juvenile Idiopathic Arthritis and Arthritis Associated with Enthesitis
Polyarticular juvenile idiopathic arthritis and arthritis associated with enthesitis are inflammatory
diseases of the joints, which typically manifest for the first time during childhood.
Hyrimoz is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents
aged 2 to 17 years and arthritis associated with enthesitis in children and adolescents aged 6-17 years.
Other disease-modifying drugs, such as methotrexate, may be administered at diagnosis. If these drugs
do not work satisfactorily, patients will be given Hyrimoz for the treatment of polyarticular juvenile
idiopathic arthritis or arthritis associated with enthesitis.
Ankylosing Spondylitis and Axial Spondyloarthritis without Radiographic Evidence of Ankylosing Spondylitis
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing
spondylitis are inflammations of the spine.
Hyrimoz is used in adults to treat these conditions. If you have ankylosing spondylitis or axial
spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first take other
medications. If these drugs do not work satisfactorily, you will take Hyrimoz to reduce the signs
and symptoms of the disease.
Plaque Psoriasis in Adults and Children
Plaque psoriasis is an inflammatory skin condition that causes red, scaly, and hardened patches of skin
covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to break, thicken, and
lift from the nail bed, which can be painful. Psoriasis is believed to be caused by a problem with the
body's immune system that leads to increased skin cell production.
Hyrimoz is used to treat moderate to severe plaque psoriasis in adults. Hyrimoz is also used to treat
severe plaque psoriasis in children and adolescents aged 4 to 17 years in whom topical medications and
UV light therapy have not worked optimally or are not indicated.
Psoriatic Arthritis
Psoriatic arthritis is an inflammatory disease of the joints associated with psoriasis.
Hyrimoz is used to treat psoriatic arthritis in adults. Hyrimoz may slow the damage to the cartilage and
bones of the joints, caused by the disease, and improve physical function.
Hidradenitis Suppurativa in Adults and Adolescents
Hidradenitis Suppurativa (sometimes called inverse acne) is a long-term inflammatory skin disease and is
often painful. Symptoms may include painful nodules and abscesses (cysts) that may drain pus.
It most frequently affects specific areas of the skin, such as the submammary region, armpits,
inner thighs, groin, and buttocks. Scars can also form in the affected areas.
Hyrimoz is used to treat Hidradenitis Suppurativa in adults and adolescents aged 12 years and older. Hyrimoz
may reduce the number of nodules and abscesses you have and the pain that is often associated with this
disease. Initially, you may receive other medications. If these medications do not work satisfactorily, you will
receive Hyrimoz.
Crohn’s Disease in Adults and Children
Crohn’s disease is an inflammation of the intestine.
Hyrimoz is used to treat Crohn’s disease in adults and children aged 6 to 17 years. If you suffer from
Crohn’s disease, you will first be given other medications. If you do not respond adequately to these
medications, you will be given Hyrimoz to reduce the typical symptoms of Crohn’s disease.
Ulcerative Colitis in Adults and Children
Ulcerative colitis is an inflammation of the large intestine.
Hyrimoz is used to treat moderate to severe ulcerative colitis in adults and children aged 6 to 17 years. If
you have ulcerative colitis, you may first take other medications. If these medications do not work
satisfactorily, you will take Hyrimoz to reduce the signs and symptoms of the disease.
Non-Infectious Uveitis in Adults and Children
Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye.
The inflammation leads to a decrease in vision and/or the presence of floaters in the eye (small dark spots or
lines that move across the field of vision). Hyrimoz works by reducing this inflammation.
Hyrimoz is used for the treatment of:

• Adults with non-infectious uveitis with inflammation affecting the back of the eye
• Children aged 2 years and older with chronic non-infectious uveitis with inflammation affecting the front of the eye

2. What you need to know before using Hyrimoz

Do not use Hyrimoz

• If you are allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
• If you have a severe infection, including tuberculosis, sepsis (blood poisoning) or other opportunistic infections (unusual infections associated with a weakened immune system). It is important to tell your doctor if you have signs or symptoms of infection, such as e.g. fever, wounds, feeling tired, dental problems (see “Warnings and precautions”).
• If you have moderate or severe heart failure. It is important to tell your doctor if you have had or have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before using Hyrimoz
Allergic reaction

• If you experience allergic reactions with symptoms such as a feeling of tightness in the chest, wheezing, dizziness, swelling or skin rash, do not administer Hyrimoz again and contact your doctor immediately as, in rare cases, these reactions can be life-threatening.

Infection

• If you have an infection, including long-term or localized infections (for example, leg ulcers), consult your doctor before starting treatment with Hyrimoz. If you have doubts, contact your doctor.
• You may be more likely to get infections during treatment with Hyrimoz. This risk may increase if your lung function is reduced. These infections can be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other unusual infectious organisms and sepsis (blood poisoning).
• In rare cases, these infections can be life-threatening. It is important to tell your doctor about the presence of symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may advise you to temporarily stop Hyrimoz.

Tuberculosis (TB)

• Since cases of tuberculosis have occurred in patients treated with adalimumab, your doctor will need to check if you have signs or symptoms typical of tuberculosis before starting therapy with Hyrimoz. This will involve collecting a detailed medical assessment including your medical history and clinical examinations (e.g. a chest X-ray and a tuberculin test). The performance and results of these tests must be recorded on the Patient Reminder Card. It is very important to tell your doctor if you have ever had tuberculosis, or if you have had close contact with people with tuberculosis. Tuberculosis may develop during therapy even if you have received preventive treatment for tuberculosis. Contact your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, fatigue, mild fever) or other infections appear during or after therapy.

Travel/recurrent infection

• Tell your doctor if you have lived in or travelled to regions where fungal infections, such as histoplasmosis, coccidioidomycosis or blastomycosis, are common.
• Tell your doctor if you have had recurrent infections or if you have conditions that increase your risk of infection.

Hepatitis B virus

• Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active infection with the hepatitis B virus or if you think you may be at risk of contracting the hepatitis virus
• B. Your doctor should test you for hepatitis B virus infection. Taking adalimumab can reactivate hepatitis B virus infection in subjects who are carriers of this virus. In some rare cases, especially if the patient is undergoing therapy with other drugs that suppress the immune system, reactivation of hepatitis B virus infection can be life-threatening.

Age over 65 years

• If you are over 65 years of age, you may be more susceptible to infections while taking Hyrimoz. You and your doctor should pay particular attention to signs of infection while you are being treated with Hyrimoz. It is important to tell your doctor if symptoms of infections such as fever, wounds, feeling tired or dental problems appear.

Surgery or dental procedures

• Before surgery or dental procedures, tell your doctor that you are taking Hyrimoz. Your doctor may advise you to temporarily stop Hyrimoz.

Demyelinating disease

• If you have or develop demyelinating diseases (diseases that affect the insulating layer around nerves), such as multiple sclerosis, your doctor will decide whether to start or continue treatment with Hyrimoz. Tell your doctor immediately if you experience symptoms such as changes in vision, weakness of arms or legs or numbness or tingling that affects any part of the body.

Vaccination

• Certain vaccines contain live but weakened forms of bacteria or viruses that cause diseases and should not be administered during treatment with Hyrimoz if they cause infections. Consult your doctor before getting vaccinated. In children, it is recommended, if possible, to administer the vaccinations scheduled for their age before starting therapy with Hyrimoz. If you take Hyrimoz during pregnancy, the baby may have a higher risk of contracting an infection up to about 5 months after the last dose you took during pregnancy. It is important that you inform your pediatrician or other healthcare provider of your use of Hyrimoz during pregnancy, so that they can decide when the baby should receive any type of vaccination.

Heart failure

• It is important to inform your doctor about any heart problems, both past and present. If you have mild heart failure and are receiving concomitant treatment with Hyrimoz, your doctor should carefully assess and monitor your heart condition. If new symptoms of heart failure appear or if existing symptoms worsen (e.g. shortness of breath or swelling of the feet), contact your doctor immediately.

Fever, bruising, bleeding or paleness

• In some patients, the body may not be able to produce enough blood cells to fight infections or stop bleeding. If you have persistent fever, bruising or easy bleeding or paleness, see your doctor immediately. The latter may decide to interrupt the therapy.

Cancer

• In children and adults treated with Hyrimoz or other anti-TNFα drugs, some types of cancer have occurred very rarely. Patients with severe, long-standing rheumatoid arthritis may have a higher than average risk of developing lymphoma and leukemia (cancers that affect blood cells and bone marrow). If you take Hyrimoz, the risk of developing lymphomas, leukemia or other cancers may increase. In rare circumstances, a specific and serious type of lymphoma has been observed in patients treated with adalimumab. Some of these patients were also being treated with azathioprine or

mercaptopurine. Tell your doctor if you are taking azathioprine or mercaptopurine with Hyrimoz.

• Cases of non-melanoma skin cancer have been observed in patients taking adalimumab. If damaged areas of skin appear during or after treatment, or if the appearance of existing damaged areas changes, report it to your doctor.
• There have been cases of neoplasms, in addition to lymphoma, in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another anti-TNFα. If you suffer from COPD, or smoke heavily, you should discuss with your doctor whether treatment with an anti-TNFα is appropriate.

Autoimmune diseases

• Rarely, treatment with Hyrimoz may lead to the manifestation of a syndrome like lupus. Tell your doctor if you experience symptoms such as persistent unexplained skin rash, fever, joint pain or fatigue.

Children and adolescents

• Do not give Hyrimoz to children with polyarticular juvenile idiopathic arthritis under the age of 2 years.
• Do not give Hyrimoz to children with pediatric plaque psoriasis or pediatric ulcerative colitis under the age of 4 years.
• Do not give Hyrimoz to children with pediatric Crohn's disease under the age of 6 years.
• Do not use the pre-filled syringe of 40 mg if doses less than 40 mg are recommended.

Other medicines and Hyrimoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Hyrimoz can be taken both with methotrexate and with other disease-modifying antirheumatic drugs
(sulfasalazine, hydroxychloroquine, leflunomide and parenteral gold salts), corticosteroids
or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Hyrimoz should not be taken at the same time as medicines containing the active ingredients anakinra or
abatacept due to the increased risk of serious infections. The combination of adalimumab and other anti-TNF and anakinra or abatacept is not recommended due to the possible increase in the risk of
infections, including serious infections and other possible drug interactions. If you have doubts, ask your
doctor.

Pregnancy and breastfeeding

• You should consider using adequate contraceptive measures to prevent pregnancy and continue using them for at least 5 months after the last therapy with Hyrimoz
• If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice about taking this medicine.
• Hyrimoz should only be used during pregnancy if necessary.
• According to a pregnancy study, no increased risk of birth defects was found when the mother received adalimumab during pregnancy, compared to mothers with the same condition who had not received adalimumab.
• Hyrimoz can be used during breastfeeding.
• If you take Hyrimoz during pregnancy, the baby may have a higher risk of contracting an infection.
• It is important that you inform your pediatrician or other healthcare provider of your use of Hyrimoz during pregnancy, before the baby receives any type of vaccination (for more information on vaccines, see “Warnings and precautions”).

Driving and using machines
Hyrimoz may affect, albeit only to a modest extent, your ability to drive, ride a bicycle or use
machinery. After taking Hyrimoz, you may experience visual disturbances and a sensation that the
environment around you is spinning (dizziness).

Hyrimoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 mL of dose, i.e. essentially
‘sodium-free’.

3. How to use Hyrimoz

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
Hyrimoz is available in pens of 40 mg and pre-filled syringes of 20 mg and 40 mg for the
administration to patients of a full dose of 20 mg or 40 mg.

How and route of administration
Hyrimoz is administered by injection under the skin (for subcutaneous injection).
Detailed instructions on how to inject Hyrimoz are reported in paragraph 7, “Instructions for use”.

If you use more Hyrimoz than you should
If you accidentally inject Hyrimoz more frequently than you should, contact your doctor or
pharmacist explaining that you have taken more medicine than you should. Always keep the box of the
medicine, even if empty.

If you forget to use Hyrimoz
If you forget to make an injection, you should inject the next dose of Hyrimoz as soon as you
remember. Then resume the dose regularly according to the established dosage schedule.

If you stop treatment with Hyrimoz
The decision to stop using Hyrimoz must be discussed with your doctor. Symptoms may
return after stopping treatment.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Most side effects are mild to moderate in form. However, some may be serious and require treatment. Side effects may occur
up to 4 months or more after the last injection of Hyrimoz.

Seek urgent medical attentionif you notice any of the following signs of an allergic reaction or
heart failure

• severe skin rash, hives;
• swelling of the face, hands, feet;
• difficulty breathing, difficulty swallowing;
• shortness of breath on exertion or when lying down, or swollen feet.

Inform your doctor as soon as possibleif you notice any of the following reactions

• signs and symptoms of infection such as fever, feeling unwell, wounds, dental problems, burning when urinating, fatigue or weakness, or cough;
• symptoms of nerve problems, such as tingling, numbness, double vision, or weakness of the arms or legs;
• signs of skin cancer such as swelling or an open sore that does not heal;
• signs and symptoms suggesting the onset of blood system disorders, such as persistent fever, bruising, bleeding, pallor.

The following side effects have been observed with Hyrimoz:

Very common(may affect more than 1 in 10 people)

• reactions at the injection site (including pain, swelling, redness or itching);
• respiratory tract infections (including cold, runny nose, sinusitis and pneumonia);
• headache;
• abdominal pain (stomach ache);
• nausea and vomiting;
• skin rash;
• muscle pain.

Common(may affect up to 1 in 10 people)

• serious infections (including sepsis and influenza);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes zoster infection);
• ear infections;
• mouth infections (including tooth infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• infections affecting the joints;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergy);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, stabbing sensation or numbness;
• migraine;
• symptoms of nerve root compression (including lower back pain and leg pain);
• visual disturbances;
• eye inflammation;
• inflammation of the eyelids and swelling of the eyes;
• dizziness (feeling of spinning);
• feeling of a fast heartbeat;
• high blood pressure;
• hot flashes;
• hematoma (solid swelling with coagulated blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, heartburn);
• acid reflux;
• dry syndrome (including dry eyes and dry mouth);
• itching;
• itchy skin rash;
• bruise;
• skin inflammation (such as eczema);
• breaking of fingernails and toenails;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in urine;
• kidney problems;
• chest pain;
• edema (fluid retention in the body, causing swelling of the affected tissue);
• fever;
• reduced platelets in the blood, which increases the risk of bleeding or bruising;
• difficulty healing.

Uncommon(may affect up to 1 in 100 people)

• unusual infections (including tuberculosis and other infections) that occur when immune defenses are reduced;
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumors, including tumors of the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• immune system disorders that can affect lungs, skin and lymph nodes (most commonly a condition called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor;
• neuropathy (nerve damage);
• stroke;
• hearing loss, ringing in the ears;
• feeling of irregular heartbeat such as palpitations;
• heart problems that can cause shortness of breath or swelling of the ankles;
• acute myocardial infarction (heart attack);
• formation of a sac in the wall of a major artery, inflammation and blood clot in a vein, blockage of a blood vessel;
• lung disease causing shortness of breath (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal accumulation of fluid in the pleural space);
• inflammation of the pancreas causing severe pain in the abdomen and back;
• difficulty swallowing;
• facial edema (swelling);
• inflammation of the gallbladder, gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scarring;
• abnormal muscle catabolism;
• systemic lupus erythematosus (immune system disorder, including inflammation of the skin, heart, lungs, joints and other organs);
• interrupted sleep;
• impotence;
• inflammations.

Rare(may affect up to 1 in 1,000 people)

• leukemia (a cancer that affects the blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as inflammation of the optic nerve in the eye and Guillain-Barré syndrome, a condition that can cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring of the lung);
• intestinal perforation (hole in the wall of the intestine);
• hepatitis (inflammation of the liver);
• reactivation of hepatitis B infection;
• autoimmune hepatitis (inflammation of the liver caused by your own immune system);
• cutaneous vasculitis (inflammation of the blood vessels in the skin);
• Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and skin rash with blisters);
• facial edema (swelling) associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (itchy, reddish-purple rash).

Not known(frequency cannot be estimated from available data)

• T-cell hepatosplenic lymphoma (a rare blood cancer that is often fatal);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi's sarcoma, a rare cancer associated with human herpes virus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin;
• liver failure;
• worsening of a condition called dermatomyositis (which manifests as a skin rash accompanied by muscle weakness);
• weight gain (weight gain has been small for most patients).

Some of the side effects observed with adalimumab may be asymptomatic and can
only be detected through blood tests. These include:

Very common(may affect more than 1 in 10 people)

• low white blood cell count;
• low red blood cell count;
• increased lipids in the blood;
• increased liver enzymes.

Common(may affect up to 1 in 10 people)

• increased white blood cell count;
• reduced platelet count;
• increased uric acid in the blood;
• alteration of sodium in the blood;
• reduced calcium in the blood;
• reduced phosphorus in the blood;
• increased sugar in the blood;
• increased lactate dehydrogenase in the blood;
• presence of autoantibodies in the blood;
• reduced potassium in the blood.

Uncommon(may affect up to 1 in 100 people)

• high levels of bilirubin in the blood (liver blood test).

Rare(may affect up to 1 in 1,000 people)

• low white blood cell, red blood cell and platelet counts.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system detailed in
Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Hyrimoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label/blister/box after the
wording Exp.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
Alternative storage conditions:
When necessary (for example when travelling), Hyrimoz can be stored at room temperature (up to 25°C) for a maximum period of 21 days – ensure the medicine is
protected from light. Once it has been removed from the refrigerator to be stored at room temperature, the
pre-filled syringe must be used within 21 days or discarded, even if it is subsequently
placed back in the refrigerator. You must record the date on which the pre-filled syringe is removed from
the refrigerator for the first time and the date after which the syringe must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Hyrimoz contains

• The active substance is adalimumab. Each pre-filled syringe contains 40 mg of adalimumab in 0.8 mL of solution.
• The excipients are adipic acid, citric acid monohydrate, sodium chloride, mannitol (E 421), polysorbate 80 (E 433), hydrochloric acid (E 507), sodium hydroxide (E 524) and water for injections (see section 2 “Hyrimoz contains sodium”).

Description of the appearance of Hyrimoz and contents of the pack
Hyrimoz 40 mg solution for injection in pre-filled syringe is presented in 0.8 mL of solution which is from clear to slightly opalescent, colourless or slightly yellowish.
Hyrimoz is presented in a single-use glass type I syringe with a 29 gauge stainless steel needle and a needle safety device with finger grip, rubber needle cap (thermoplastic elastomer) and plastic plunger, containing 0.8 mL of solution.
Packs contain 1 and 2 pre-filled syringes of Hyrimoz.
Multipacks contain 6 (3 packs of 2) pre-filled syringes of Hyrimoz.
Not all pack sizes may be marketed.
Hyrimoz is available in pre-filled syringe and in pre-filled pen.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestr. 10
6250 Kundl
Austria

Manufacturer
Sandoz GmbH Schaftenau
Biochemiestr. 10
6336 Langkampfen
Austria
Novartis Pharmaceutical Manufacturing GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Sandoz nv/sa
Tél/Tel: +32 2 722 97 97

Lietuva
Sandoz Pharmaceuticals d.d filialas
Tel: +370 5 2636 037

България
Сандоз България КЧТ
Тел.: +359 2 970 47 47

Luxembourg/Luxemburg
Sandoz nv/sa
Tél/Tel.: +32 2 722 97 97

Česká republika
Sandoz s.r.o.
Tel: +420 225 775 111

Magyarország
Sandoz Hungária Kft.
Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige
Sandoz A/S
Tlf: +45 63 95 10 00

Malta
Sandoz Pharmaceuticals d.d.
Tel: +356 99644126

Deutschland
Hexal AG
Tel: +49 8024 908 0

Nederland
Sandoz B.V.
Tel: +31 36 52 41 600

Eesti
Sandoz d.d. Eesti filiaal
Tel: +372 665 2400

Österreich
Sandoz GmbH
Tel: +43 5338 2000

Ελλάδα
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
Τηλ: +30 216 600 5000

Polska
Sandoz Polska Sp. z o.o.
Tel.: +48 22 209 70 00

España
Sandoz Farmacéutica, S.A.
Tel: +34 900 456 856

Portugal
Sandoz Farmacêutica Lda.
Tel: +351 21 000 86 00

France
Sandoz SAS
Tél: +33 1 49 64 48 00

România
Sandoz Pharmaceuticals SRL
Tel: +40 21 407 51 60

Hrvatska
Sandoz d.o.o.
Tel: +385 1 23 53 111

Slovenija
Sandoz farmacevtska družba d.d.
Tel: +386 1 580 29 02

Ireland
Rowex Ltd.
Tel: + 353 27 50077

Slovenská republika
Sandoz d.d. - organizačná zložka
Tel: +421 2 50 70 6111

Italia
Sandoz S.p.A.
Tel: +39 02 96541

Suomi/Finland
Sandoz A/S
Puh/Tel: +358 10 6133 400

Κύπρος
Sandoz Pharmaceuticals d.d.
Τηλ: +357 22 69 0690

United Kingdom (Northern Ireland)
Sandoz GmbH
Tel: +43 5338 2000

Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu.

7. Instructions for Use

To avoid possible infections and to ensure you use the medicine correctly, it is important that you follow these instructions.
Make sure you read, understand and follow these Instructions for Use before injecting Hyrimoz.
The healthcare professional must show you how to prepare and inject Hyrimoz correctly using the pre-filled syringe before you use the medicine for the first time. If you have any doubts, please contact your healthcare professional.

Hyrimoz single-use pre-filled syringe with safety device for the needle and additional finger grip

Figure A: Hyrimoz pre-filled syringe with safety device for the needle and finger grip

additional finger grip

It is important that you:

• do not openthe outer carton until you are ready to use the syringe;
• do not usethe syringe if the blister seals are broken, as use may not be safe;
• never leavethe syringe unattended where it could be tampered with by others;
• if you drop the syringe, do not useit if it appears damaged or if it was dropped after you removed the needle cap;
• do not removethe needle cap until the time of injection;
• be careful not to touchthe wings of the needle safety device before use. If you do, the needle safety device may be activated too early. Do not removethe finger grip before the injection;
• inject Hyrimoz 15-30 minutes after removing it from the refrigerator, for a more comfortable injection;
• dispose of the used syringe immediately after use. Do not reuse the syringe.See “4. Disposal of used syringes”at the end of these Instructions for Use.

How should you store Hyrimoz?

• Store the outer carton of the syringes in a refrigerator, at a temperature between 2° and 8°C.
• When necessary (for example when travelling), Hyrimoz can be stored at room temperature (up to 25°C) for a maximum period of 21 days - make sure to protect the medicine from light. Once it is removed from the refrigerator to be stored at room temperature, the pre-filled syringe must be used within 21 days or discarded, even if it is subsequently placed back in the refrigerator. You must record the date on which the pre-filled syringe is removed from the refrigerator for the first time and the date after which it must be discarded.
• Store the syringes in the original packaging until you are ready to use them, to protect the medicine from light.
• Do not store the syringes at extremely hot or cold temperatures.
• Do not freeze the syringes.

Keep Hyrimoz and all medicines out of the reach of children.
What do you need for the injection?
Place the following items on a clean, flat surface.
The pack contains:

• Hyrimoz pre-filled syringe/s (see Figure A). Each syringe contains 40 mg/0.8 mL of Hyrimoz.

The pack does not contain (see Figure B):

• Alcohol swab.
• Cotton wool or gauze.
• Sharps container.

Figure B: items not included in the pack
See “4. Disposal of used syringes”at the end of these Instructions for Use.

Before the injection

Figure C: the needle safety device is not activated – the syringe is ready for use

Figure D: the needle safety device is activated – do not use
In this configuration, the needle safety device is ACTIVATED.
DO NOT USEthe syringe (see

Figure D).

Preparing the syringe

• For a more comfortable injection, remove the blister containing the syringe from the refrigerator and leave it closed on the work surface for about 15-30 minutes to reach room temperature.
• Remove the syringe from the blister. In this configuration, the needle safety device is NOT ACTIVATED. The syringe is ready for use (see Figure C).
• Look through the window. The solution should be colourless or slightly yellowish and from clear to slightly opalescent. Do not use the syringe if you notice particles and/or changes in colour. If you have any doubts about the appearance of the solution, contact your pharmacist for assistance.
• Do not use the syringe if it is broken or if the needle safety device is activated. Return the syringe and the pack to the pharmacy.
• Check the expiry date (Exp.) on the syringe. Do not use the syringe if the expiry date has passed.

Contact your pharmacist if the syringe does not pass any of the checks above.

1. Choice of injection site:

• The recommended injection site is the front of the thighs. You can also use the lower abdomen, but not the area within 5 cm around the navel (see Figure E).
• Choose a different site each time you administer an injection.
• Do not inject the medicine into areas where the skin is painful, bruised, reddened, flaky or hardened. Avoid areas with scars or stretch marks. If you suffer from psoriasis, DO NOT inject the medicine directly into areas with psoriasis plaques.

Figure E: how to choose the injection

site

2. Injection site cleaning:

• Wash your hands thoroughly with water and soap.
• Using a circular motion, clean the injection site with a swab soaked in alcohol. Allow to dry before administering the injection (see Figure F).
• Do not touch the cleaned area before the injection.

Figure F: how to clean the

injection site

3. Administration of the injection:

• Carefully pull off the needle cap to remove it from the syringe (see Figure G).
• Discard the needle cap.
• You may see a drop of liquid at the end of the needle. This is normal.

Figure G: how to pull off the cap

of the needle

• Gently create a skin fold at the injection site (see Figure H).
• Insert the needle into the skin as shown.
• Push the entire needle into the skin to ensure that all of the medicine is administered.

Figure H: how to insert the needle

• Hold the syringe as shown (see Figure I).
• Slowly press the plunger all the way down so that the plunger head is completely between the wings of the needle safety device.
• While holding the syringe in position, keep the plunger pressed down completely for 5 seconds.

Figure I: how to hold the syringe

• Keep the plunger fully depressedwhile carefully withdrawing the needle from the injection site, then release the skin (see Figure J) .

Figure J: how to withdraw the needle

• Slowly release the plunger and allow the needle safety device to automatically cover the exposed needle (see Figure K).
• You may notice a small amount of blood at the injection site. You can press a cotton ball or gauze on the injection site and hold it for 10 seconds. Do not rub the injection site. If necessary, you can cover the injection site with a small adhesive bandage.

Figure K: how to release slowly

the plunger

4. Disposal of used syringes:

• Dispose of the used syringe in a sharps disposal container (reclosable, puncture-resistant container). For your safety and health and that of others, used needles and syringes must never be reused.
• Do not dispose of any medicine down the drain or in household waste. Ask your doctor or pharmacist how to dispose of medicines you no longer use. This will help protect the environment. Unused medicine and waste derived from that medicine must be disposed of in accordance with current local regulations.

If you have any doubts, consult a doctor, pharmacist or nurse who is familiar with
Hyrimoz.

Hyrimoz 40 mg solution for injection in pre-filled pen

adalimumab

40 mg/0.8 mL
Read this leaflet carefully before you start using this medicine as it contains important
information for you

• Keep this leaflet. You may need to read it again.
• Your doctor will give you a Patient Reminder Card, which contains important safety information that you need to know before administering Hyrimoz and during treatment with Hyrimoz. Keep this Patient Reminder Cardwith you during treatment and for 4 months after the last injection (or the last injection given to your child) of Hyrimoz.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Hyrimoz is and what it is used for
• 2. What you need to know before you use Hyrimoz
• 3. How to use Hyrimoz
• 4. Possible side effects
• 5. How to store Hyrimoz
• 6. Contents of the pack and other information
• 7. Instructions for use

1. Cos’è Hyrimoz e a cosa serve

Hyrimoz contiene il principio attivo adalimumab, a medicine that acts on the body’s immune system
(defense system).
Hyrimoz is indicated for the treatment of the inflammatory diseases listed below:

• rheumatoid arthritis,
• polyarticular juvenile idiopathic arthritis,
• arthritis associated with enthesitis,
• ankylosing spondylitis,
• axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
• psoriatic arthritis,
• psoriasis,
• hidradenitis suppurativa,
• Crohn’s disease,
• ulcerative colitis and
• non-infectious uveitis.

The active ingredient contained in Hyrimoz, adalimumab, is a human monoclonal antibody. Monoclonal
antibodies are proteins that bind to a specific target.
The target of adalimumab is a protein called tumor necrosis factor (TNFα), which is
involved in the immune system (defense system) and is present at higher concentrations in the
inflammatory diseases listed above. By binding to TNFα, Hyrimoz blocks its action and decreases
the inflammatory process in these diseases.
Rheumatoid Arthritis
Rheumatoid arthritis is an inflammatory condition of the joints.
Hyrimoz is used to treat rheumatoid arthritis in adults. If you have moderate to severe rheumatoid
arthritis, other disease-modifying drugs, such as methotrexate, may be initially administered. If these
drugs do not work satisfactorily, you will be given Hyrimoz to treat rheumatoid arthritis.
Hyrimoz can also be used for the treatment of severe, active and progressive rheumatoid arthritis
without prior treatment with methotrexate.
Hyrimoz may slow the progression of damage to the cartilage and bones of the joints,
caused by the disease, and improve physical function.
Generally Hyrimoz is used with methotrexate. If your doctor believes that treatment with
methotrexate is not appropriate, Hyrimoz may be administered alone.
Polyarticular Juvenile Idiopathic Arthritis and Arthritis Associated with Enthesitis
Polyarticular juvenile idiopathic arthritis and arthritis associated with enthesitis are inflammatory
diseases of the joints, which typically manifest for the first time during childhood.
Hyrimoz is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents
aged 2 to 17 years and arthritis associated with enthesitis in children and adolescents aged 6-17 years.
Other disease-modifying drugs, such as methotrexate, may be administered at diagnosis. If these
drugs do not work satisfactorily, patients will be given Hyrimoz for the treatment of polyarticular
juvenile idiopathic arthritis or arthritis associated with enthesitis.
Ankylosing Spondylitis and Axial Spondyloarthritis without Radiographic Evidence of Ankylosing Spondylitis
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing
spondylitis are inflammations of the spine.
Hyrimoz is used in adults to treat these conditions. If you suffer from ankylosing spondylitis or axial
spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first take other
medications. If these drugs do not work satisfactorily, you will take Hyrimoz to reduce the signs
and symptoms of the disease.
Plaque Psoriasis in Adults and Children
Plaque psoriasis is an inflammatory skin condition that causes red, scaly and hardened patches of
skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to break,
thicken and lift from the nail bed, which can be painful. Psoriasis is thought to be caused by a
problem with the body’s immune system that leads to an increase in skin cell production.
Hyrimoz is used to treat moderate to severe plaque psoriasis in adults. Hyrimoz is also used to treat
severe plaque psoriasis in children and adolescents from 4 to 17 years of age in whom topical
medications and UV light therapy have not worked optimally or are not indicated.
Psoriatic Arthritis
Psoriatic arthritis is an inflammatory disease of the joints associated with psoriasis.
Hyrimoz is used to treat psoriatic arthritis in adults. Hyrimoz may slow the damage to the cartilage
and bones of the joints, caused by the disease, and improve physical function.
Hidradenitis Suppurativa in Adults and Adolescents
Hidradenitis Suppurativa (sometimes called inverse acne) is a long-term inflammatory skin disease
and is often painful. Symptoms may include painful nodules and abscesses (cysts) that may drain pus.
It most frequently affects specific areas of the skin, such as the submammary region, armpits, inner
thighs, groin and buttocks. Scars may also form in the affected areas.
Hyrimoz is used to treat Hidradenitis Suppurativa in adults and adolescents aged 12 years and over.
Hyrimoz may reduce the number of nodules and abscesses you have and the pain that is often associated
with this disease. Initially, you may receive other medications. If these drugs do not work
satisfactorily, you will receive Hyrimoz.
Crohn’s Disease in Adults and Children
Crohn’s disease is an inflammation of the intestine.
Hyrimoz is used to treat Crohn’s disease in adults and children aged 6 to 17 years. If you suffer from
Crohn’s disease, you will first be given other medications. In the event that you do not respond
adequately to these drugs, you will be given Hyrimoz to reduce the typical symptoms of Crohn’s disease.
Ulcerative Colitis in Adults and Children
Ulcerative colitis is an inflammation of the large intestine.
Hyrimoz is used to treat moderate to severe ulcerative colitis in adults and children aged 6 to 17 years.
If you have ulcerative colitis, you may first take other medications. If these drugs do not work
satisfactorily, you will take Hyrimoz to reduce the signs and symptoms of the disease.
Non-Infectious Uveitis in Adults and Children
Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye.
Inflammation leads to a decrease in vision and/or the presence of mobile bodies in the eye
(black dots or thin lines that move across the visual field). Hyrimoz works by reducing this
inflammation.
Hyrimoz is used for the treatment of:

• Adults with non-infectious uveitis with inflammation affecting the back of the eye
• Children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye

2. What you need to know before using Hyrimoz

Do not use Hyrimoz

• If you are allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
• If you have a severe infection, including tuberculosis, sepsis (blood poisoning) or other opportunistic infections (unusual infections associated with a weakened immune system). It is important to tell your doctor if you have signs or symptoms of infection, such as e.g. fever, wounds, feeling tired, dental problems (see “Warnings and precautions”).
• If you have moderate or severe heart failure. It is important to tell your doctor if you have had or currently have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before using Hyrimoz.
Allergic reaction

• If you experience allergic reactions with symptoms such as a feeling of tightness in the chest, wheezing, dizziness, swelling or skin rash, do not administer Hyrimoz again and contact your doctor immediately as, in rare cases, these reactions can be life-threatening.

Infection

• If you have an infection, including long-term or localized infections (for example, leg ulcers), consult your doctor before starting treatment with Hyrimoz. If you have doubts, contact your doctor.
• You may be more likely to get infections during treatment with Hyrimoz. This risk may increase if your lung function is reduced. These infections can be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other unusual infectious organisms and sepsis (blood poisoning).
• In rare cases, these infections can be life-threatening. It is important to tell your doctor about the presence of symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may advise you to temporarily stop Hyrimoz.

Tuberculosis (TB)

• Because cases of tuberculosis have occurred in patients treated with adalimumab, your doctor will need to check if you have signs or symptoms typical of tuberculosis before starting therapy with Hyrimoz. This will involve collecting a detailed medical assessment including your medical history and clinical examinations (e.g. a chest X-ray and a tuberculin test). The performance and results of these tests must be recorded on the Patient Reminder Card. It is very important to tell your doctor if you have ever had tuberculosis, or if you have had close contact with people with tuberculosis. Tuberculosis can develop during therapy even if you have received preventive treatment for tuberculosis. Contact your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, fatigue, moderate fever) or other infections appear during or after therapy.

Travel/recurrent infection

• Tell your doctor if you have lived in or travelled to regions where fungal infections, such as histoplasmosis, coccidioidomycosis or blastomycosis, are common.
• Tell your doctor if you have had recurrent infections or if you have conditions that increase your risk of infection.

Hepatitis B virus

• Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active infection with the hepatitis B virus or if you think you may be at risk of contracting the hepatitis virus

• B. Your doctor should test you for hepatitis B virus infection. Taking adalimumab can reactivate hepatitis B virus infection in subjects who are carriers of this virus. In some rare cases, especially if the patient is undergoing therapy with other drugs that suppress the immune system, reactivation of hepatitis B virus infection can endanger the patient’s life.

Age over 65 years

• If you are over 65 years of age, you may be more susceptible to infections while taking Hyrimoz. You and your doctor should pay particular attention to signs of infection while you are being treated with Hyrimoz. It is important to tell your doctor if symptoms of infections such as fever, wounds, feeling tired or dental problems appear.

Surgery or dental procedures

• Before surgery or dental procedures, tell your doctor that you are taking Hyrimoz. Your doctor may advise you to temporarily stop Hyrimoz.

Demyelinating disease

• If you have or develop demyelinating diseases (diseases that affect the insulating layer around nerves), such as multiple sclerosis, your doctor will decide whether to start or continue treatment with Hyrimoz. Tell your doctor immediately if you experience symptoms such as changes in vision, weakness of arms or legs or numbness or tingling that affects any part of the body.

Vaccination

• Certain vaccines contain live but weakened forms of bacteria or viruses that cause diseases and should not be administered during treatment with Hyrimoz if they cause infections. Consult your doctor before getting vaccinated. In children, it is recommended, if possible, to administer the vaccinations appropriate for their age before starting therapy with Hyrimoz. If you have taken Hyrimoz during pregnancy, the child may have a greater risk of contracting such an infection up to about 5 months after the last dose you took during pregnancy. It is important that you inform your pediatrician or other healthcare provider of your use of Hyrimoz during pregnancy, so that they can decide when the child should receive any type of vaccination.

Heart failure

• It is important to inform your doctor about any heart problems, whether past or present. If you have mild heart failure and are receiving concomitant treatment with Hyrimoz, your doctor should carefully assess and monitor your heart condition. If new symptoms of heart failure appear or if existing symptoms worsen (e.g. shortness of breath or swelling of the feet), contact your doctor immediately.

Fever, bruising, bleeding or paleness

• In some patients, the body may not be able to produce enough blood cells to fight infections or stop bleeding. If you have persistent fever, bruising or easy bleeding or paleness, see your doctor immediately. The latter may decide to interrupt the therapy.

Cancer

• In children and adults treated with adalimumab or other anti-TNFα drugs, some types of cancer have occurred very rarely. Patients with severe, long-standing rheumatoid arthritis may have a higher than average risk of developing a

lymphoma and leukemia (cancers that affect blood cells and bone marrow). If you
take Hyrimoz, the risk of developing lymphomas, leukemia or other cancers may increase. In rare
circumstances, a specific and serious type of lymphoma has been observed in patients treated with
adalimumab. Some of these patients were also taking azathioprine or mercaptopurine. Tell your doctor
if you are taking azathioprine or mercaptopurine with Hyrimoz.

• In addition, cases of non-melanoma skin cancer have been observed in patients taking adalimumab. If damaged skin areas appear during or after treatment or if the appearance of damaged areas changes, report it to your doctor.
• There have been cases of neoplasms, in addition to lymphoma, in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another anti-TNFα. If you suffer from COPD, or smoke heavily, you should discuss with your doctor whether treatment with an anti-TNFα is appropriate.

Autoimmune diseases

• Rarely, treatment with Hyrimoz can lead to the manifestation of a syndrome such as lupus. Tell your doctor if you experience symptoms such as persistent unexplained skin rash, fever, joint pain or fatigue.

Children and adolescents

• Do not give Hyrimoz to children with polyarticular juvenile idiopathic arthritis under the age of 2 years.
• Do not give Hyrimoz to children with pediatric plaque psoriasis or pediatric ulcerative colitis under the age of 4 years.
• Do not give Hyrimoz to children with pediatric Crohn's disease under the age of 6 years.
• Do not use the 40 mg pre-filled pen if doses less than 40 mg are recommended.

Other medicines and Hyrimoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Hyrimoz can be taken both with methotrexate and with other disease-modifying antirheumatic drugs
(sulfasalazine, hydroxychloroquine, leflunomide and parenteral gold salts), corticosteroids
or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Hyrimoz should not be taken at the same time as medicines containing the active ingredients anakinra or
abatacept due to the increased risk of serious infections. The combination of adalimumab and other
anti-TNF and anakinra or abatacept is not recommended due to the possible increase in the risk of
infections, including serious infections and other possible drug interactions. If you have doubts, ask your
doctor.

Pregnancy and breastfeeding

• You should consider using appropriate contraceptive measures to prevent pregnancy and continue using them for at least 5 months after the last therapy with Hyrimoz.
• If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice about taking this medicine.
• Hyrimoz should only be used during pregnancy if necessary.
• According to a pregnancy study, no increased risk of birth defects was found when the mother received adalimumab during pregnancy, compared to mothers with the same condition who had not received adalimumab.
• Hyrimoz can be used during breastfeeding.
• If you take Hyrimoz during pregnancy, the child may have a greater risk of contracting an infection.
• It is important that you inform your pediatrician or other healthcare provider of your use of Hyrimoz during pregnancy, before the child receives any type of vaccination (for more information on vaccines, see “Warnings and precautions”).

Driving and using machines
Hyrimoz can affect, albeit only to a modest extent, your ability to drive, ride a bicycle or use
machines. After taking Hyrimoz, you may experience visual disturbances and a sensation that the
environment around you is rotating (dizziness).

Hyrimoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 mL of dose, i.e. essentially
‘sodium-free’.

3. How to use Hyrimoz

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Hyrimoz is available in pens of 40 mg and pre-filled syringes of 20 mg and 40 mg for the
administration to patients of a full dose of 20 mg or 40 mg.

How and route of administration
Hyrimoz is administered by injection under the skin (for subcutaneous injection).
Detailed instructions on how to inject Hyrimoz are reported in paragraph 7, “Instructions for use”.

If you use more Hyrimoz than you should
If you accidentally inject Hyrimoz more frequently than you should, contact your doctor or
pharmacist explaining that you have taken more medicine than you should. Always keep the box of the
medicine, even if empty.

If you forget to use Hyrimoz
If you forget to make an injection, you must inject the next dose of Hyrimoz as soon as you
remember. Then resume the dose regularly according to the established dosage schedule.

If you stop the treatment with Hyrimoz
The decision to stop using Hyrimoz must be discussed with your doctor. Symptoms may
return after stopping treatment.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Most side effects are mild to moderate in form. However, some may be serious and require treatment. Side effects may occur
up to 4 months or more after the last injection of Hyrimoz.

Seek medical attention urgentlyif you notice any of the following signs of an allergic reaction or
heart failure

• severe skin rash, hives;
• swelling of the face, hands, feet;
• difficulty breathing, difficulty swallowing;
• shortness of breath on exertion or when lying down, or swollen feet.

Inform your doctor as soon as possibleif you notice any of the following reactions

• signs and symptoms of infection such as fever, feeling unwell, wounds, dental problems, burning when urinating; fatigue or weakness or cough;
• symptoms of nerve problems, such as tingling, numbness, double vision, or weakness of the arms or legs;
• signs of skin cancer such as swelling or an open sore that does not heal;
• signs and symptoms suggesting the onset of blood system disorders, such as persistent fever, bruising, bleeding, paleness.

The following side effects have been observed with Hyrimoz

Very common(may affect more than 1 in 10 people)

• reactions at the injection site (including pain, swelling, redness or itching);
• respiratory tract infections (including cold, runny nose, sinusitis and pneumonia);
• headache;
• abdominal pain (stomach ache);
• nausea and vomiting;
• skin rash;
• muscle pain.

Common(may affect up to 1 in 10 people)

• serious infections (including sepsis and influenza);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes zoster infection);
• ear infections;
• mouth infections (including tooth infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• infections of the joints;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergy);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, pricking sensations or numbness;
• migraine;
• symptoms of nerve root compression (including back pain and leg pain);
• visual disturbances;
• eye inflammation;
• inflammation of the eyelids and swelling of the eyes;
• dizziness (feeling of spinning);
• feeling of a racing heartbeat;
• high blood pressure;
• hot flashes;
• hematoma (solid swelling with coagulated blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, heartburn);
• acid reflux;
• dry eye syndrome (including dry eyes and dry mouth);
• itching;
• itchy rash;
• bruising;
• skin inflammation (such as eczema);
• nail breakage of the fingers and toes;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in the urine;
• kidney problems;
• chest pain;
• edema (fluid retention in the body, causing swelling of the affected tissue);
• fever;
• reduced platelets in the blood, which increases the risk of bleeding or bruising;
• difficulty healing wounds.

Uncommon(may affect up to 1 in 100 people)

• unusual infections (including tuberculosis and other infections) that occur when immune defenses are reduced;
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumors, including tumors of the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• immune system disorders that can affect the lungs, skin and lymph nodes (most commonly a condition called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor;
• neuropathy (nerve damage);
• stroke;
• hearing loss, ringing in the ears;
• feeling of irregular heartbeat such as palpitations;
• heart problems that can cause shortness of breath or swelling of the ankles;
• acute myocardial infarction (heart attack);
• formation of a sac in the wall of a major artery, inflammation and blood clot in a vein, blockage of a blood vessel;
• lung disease causing shortness of breath (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal accumulation of fluid in the pleural space);
• inflammation of the pancreas causing severe abdominal and back pain;
• difficulty swallowing;
• facial edema (swelling);
• inflammation of the gallbladder, gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scarring;
• abnormal muscle catabolism;
• systemic lupus erythematosus (immune system disorder, including inflammation of the skin, heart, lungs, joints and other organs);
• interrupted sleep;
• impotence;
• inflammations.

Rare(may affect up to 1 in 1,000 people)

• leukemia (a cancer that affects the blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as inflammation of the optic nerve in the eye and Guillain-Barré syndrome, a condition that can cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring of the lungs);
• intestinal perforation (hole in the wall of the intestine);
• hepatitis (inflammation of the liver);
• reactivation of hepatitis B infection;
• autoimmune hepatitis (inflammation of the liver caused by your own immune system);
• cutaneous vasculitis (inflammation of the blood vessels in the skin);
• Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and skin rash with blisters);
• facial edema (swelling) associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (itchy, reddish-purple skin rash).

Not known(frequency cannot be estimated from available data)

• T-cell hepatosplenic lymphoma (a rare blood cancer that is often fatal);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi's sarcoma, a rare cancer related to human herpes virus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin;
• liver failure;
• worsening of a condition called dermatomyositis (which manifests as a skin rash accompanied by muscle weakness);
• weight gain (weight gain has been small for most patients).

Some of the side effects observed with adalimumab may be asymptomatic and can
only be detected through blood tests. These include:

Very common(may affect more than 1 in 10 people)

• low white blood cell count;
• low red blood cell count;
• increased lipids in the blood;
• increased liver enzymes.

Common(may affect up to 1 in 10 people)

• increased white blood cell count;
• reduced platelet count;
• increased uric acid in the blood;
• alteration of sodium in the blood;
• reduced calcium in the blood;
• reduced phosphorus in the blood;
• increased sugar in the blood;
• increased lactate dehydrogenase in the blood;
• presence of autoantibodies in the blood;
• reduced potassium in the blood.

Uncommon(may affect up to 1 in 100 people)

• high levels of bilirubin in the blood (liver blood test).

Rare(may affect up to 1 in 1,000 people)

• low white blood cell, red blood cell and platelet counts.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell
your doctor or pharmacist. You can also report side effects directly through the national
reporting system listed in Annex V. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Hyrimoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label/blister/box after the
word Exp.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the pre-filled pen in the outer packaging to protect the medicine from light.
Alternative storage conditions:
When necessary (for example when travelling), Hyrimoz can be stored at room temperature (up to 25°C) for a maximum period of 21 days – ensure that the medicine is
protected from light. Once it has been removed from the refrigerator to be stored at room temperature, the
pre-filled pen must be used within 21 days or discarded, even if it is subsequently
placed back in the refrigerator. You must record the date on which the pre-filled pen is removed from the
refrigerator for the first time and the date after which the pen must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Hyrimoz contains

• The active substance is adalimumab. Each pre-filled pen contains 40 mg of adalimumab in 0.8 mL of solution.
• The excipients are adipic acid, citric acid monohydrate, sodium chloride, mannitol (E 421), polysorbate 80 (E 433), hydrochloric acid (E 507), sodium hydroxide (E 524) and water for injections (see section 2 “Hyrimoz contains sodium”).

Description of the appearance of Hyrimoz and contents of the pack
Hyrimoz 40 mg solution for injection in pre-filled pen is supplied as 0.8 mL of solution which is
from clear to slightly opalescent, from colourless to slightly yellowish.
Hyrimoz is supplied in a single-use pre-filled syringe assembled in a triangular shaped pen
with a transparent window and label. The syringe inside the pen is type I glass with a
29 gauge needle in stainless steel, an internal rubber needle cap (thermoplastic elastomer)
and a rubber stopper, containing 0.8 mL of solution.
The packs contain 1 and 2 pre-filled pens of Hyrimoz.
Multipacks contain 6 (3 packs of 2) pre-filled pens of Hyrimoz.
Not all pack sizes may be marketed.
Hyrimoz is available in pre-filled syringe and in pre-filled pen.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestr. 10
6250 Kundl
Austria

Manufacturer
Sandoz GmbH Schaftenau
Biochemiestr. 10
6336 Langkampfen
Austria
Novartis Pharmaceutical Manufacturing GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Sandoz nv/sa
Tél/Tel: +32 2 722 97 97

Lietuva
Sandoz Pharmaceuticals d.d filialas
Tel: +370 5 2636 037

Luxembourg/Luxemburg
Sandoz nv/sa
Tél/Tel.: +32 2 722 97 97

Česká republika
Sandoz s.r.o.
Tel: +420 225 775 111

България
Сандоз България КЧТ
Тел.: +359 2 970 47 47

Magyarország
Sandoz Hungária Kft.
Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige
Sandoz A/S
Tlf: +45 63 95 10 00

Malta
Sandoz Pharmaceuticals d.d.
Tel: +356 99644126

Deutschland
Hexal AG
Tel: +49 8024 908 0

Nederland
Sandoz B.V.
Tel: +31 36 52 41 600

Eesti
Sandoz d.d. Eesti filiaal
Tel: +372 665 2400

Österreich
Sandoz GmbH
Tel: +43 5338 2000

Ελλάδα
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
Τηλ: +30 216 600 5000

Polska
Sandoz Polska Sp. z o.o.
Tel.: +48 22 209 70 00

España
Sandoz Farmacéutica, S.A.
Tel: +34 900 456 856

Portugal
Sandoz Farmacêutica Lda.
Tel: +351 21 000 86 00

France
Sandoz SAS
Tél: +33 1 49 64 48 00

România
Sandoz Pharmaceuticals SRL
Tel: +40 21 407 51 60

Hrvatska
Sandoz d.o.o.
Tel: +385 1 23 53 111

Slovenija
Sandoz farmacevtska družba d.d.
Tel: +386 1 580 29 02

Ireland
Rowex Ltd.
Tel: + 353 27 50077

Slovenská republika
Sandoz d.d. - organizačná zložka
Tel: +421 2 50 70 6111

Italia
Sandoz S.p.A.
Tel: +39 02 96541

Suomi/Finland
Sandoz A/S
Puh/Tel: +358 10 6133 400

Κύπρος
Sandoz Pharmaceuticals d.d.
Τηλ: +357 22 69 0690

United Kingdom (Northern Ireland)
Sandoz GmbH
Tel: +43 5338 2000

Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu.

7. Instructions for Use

To avoid possible infections and to ensure you use the medicine correctly, it is important that
you follow these instructions.
Make sure you read, understand and follow these Instructions for Use before injecting Hyrimoz.
The healthcare professional must show you how to prepare and inject Hyrimoz correctly using the
pre-filled pen before you use the medicine for the first time. If you have any doubts, please contact
your healthcare professional.

Single-use pre-filled pen of Hyrimoz

Figure A: parts of the Hyrimoz pen
In Figure A, the pen is shown without the cap. Do notremove the cap until you are ready to administer
the injection.

It is important that you:

• do not openthe outer carton until you are ready to use the pen;
• do not usethe pen if the outer packaging seal or the pen safety seal is broken;
• never leavethe pen unattended where it could be tampered with by others;
• if you drop the pen, do not use itif it appears damaged or if it was dropped after you removed the cap;
• inject Hyrimoz 15-30 minutes after removing it from the refrigerator, for a more comfortable injection;
• dispose of the used pen immediately after use. Do not reuse the pen.See “4. Disposal of used pens”at the end of these Instructions for Use.

How should you store the pen?

• Store the pen in the carton in a refrigerator, at a temperature between 2° and 8°C.
• When necessary (for example when travelling), Hyrimoz can be stored at room temperature (up to 25°C) for a maximum period of 21 days - make sure to protect the medicine from light. Once it is removed from the refrigerator to be stored at room temperature, the pre-filled pen must be used within 21 days or discarded, even if it is subsequently placed back in the refrigerator. You should record the date on which the pre-filled pen is removed from the refrigerator for the first time and the date after which it must be discarded.
• Store the pen in the original packaging until you are ready to use it, to protect the medicine from light.
• Do not store the pen at extremely hot or cold temperatures.
• Do not freeze the pen.

Keep Hyrimoz and all medicines out of the reach of children.
What is needed for the injection?
Place the following items on a clean, flat surface.
The package contains:

• Pen/s pre-filled with Hyrimoz (see Figure A). Each pen contains 40 mg/0.8 mL of Hyrimoz. The package does not contain (see Figure B):
• Alcohol swab.
• Cotton ball or gauze.
• Sharps disposal container.

Figure B: items not included in the package
See “4. Disposal of used pens”at the end of these Instructions for Use.

Before the injection
Preparing the pen

• For a more comfortable injection, remove the pen from the refrigerator approximately 15-30 minutes before the injection to allow it to reach room temperature.
• Look through the window. The solution should be colourless or slightly yellowish and from clear to slightly opalescent. Do not usethe pen if you notice particles and/or changes in colour. If you have any doubts about the appearance of the solution, contact your pharmacist for assistance.

Figure C: safety checks before

the injection

• Check the expiry date (Exp.) of the pen. Do not use the pen if the expiry date has passed.
• Do not use the pen if the safety seal is broken.

Contact your pharmacist if the pen fails any of the checks above.

1. Choice of injection site:

• The recommended injection site is the front of the thighs. You can also use the lower abdomen, but not the area within 5 cm around the navel (see Figure D).
• Choose a different site each time you administer an injection.
• Do not inject the medicine into areas where the skin is painful, bruised, reddened, flaky or hardened. Avoid areas with scars or stretch marks. If you suffer from psoriasis, DO NOT inject the medicine directly into areas with psoriasis plaques.

Figure D: how to choose the injection

site

2. Injection site cleaning:

• Wash your hands thoroughly with water and soap.
• Using a circular motion, clean the injection site with a swab soaked in alcohol. Allow to dry before administering the injection (see Figure E).
• Do not touch the cleaned area before the injection.

Figure E: how to clean the

injection site

3. Removing the pen cap:

• Remove the cap only when you are ready to use the pen.
• Rotate the cap in the direction of the arrows (see Figure F).
• Once the cap is removed, discard it. Never try toreplace the cap.
• Use the pen within 5 minutes of removing the cap.
• You may notice a few drops of liquid coming out of the needle. This is normal.

Figure F: how to remove the cap

4. How to hold the pen:

• Hold the pen at 90 degrees to the clean injection site (see Figure G).

CorrectIncorrect

Figure G: how to hold the pen

Injection
Read before performing the injection
During the injection you will feel 2 clicks:
o The first clickindicates that the injection has started.
o A moment later, a second clickindicates that the injection is almostfinished.
You must keep the pen pressed firmly against the skin until you see a green
indicatorfill the window and stop moving.

5. Start of injection:

• Press the pen firmly against the skin to start the injection (see Figure H).
• The first clickindicates that the injection has started.
• Keep pressingthe pen firmly against the skin.
• The green indicatorshows the injection progress.

Figure H: how to start the injection

6. Completion of the injection:

• Pay attention to the second clickwhich indicates that the injection is almostcomplete.
• Check that the green indicatorfills the window and has stopped moving (see Figure I).
• Now you can remove the pen.

Figure I: how to complete

the injection

After the injection

• 7.Check that the green indicator fills the window(see Figure J) :
• This means that the medicine has been administered. Contact your doctor if the green indicator is not visible.
• You may notice a small amount of blood at the injection site. You can press a cotton ball or gauze on the injection site and hold it for 10 seconds. Do not rub the injection site. If necessary, you can cover the injection site with a small adhesive bandage.

Figure J: how to check

the green indicator

8. Disposal of used pens:

• Dispose of the used pen in a sharps container (a resealable, puncture-resistant container). For your safety and the safety of others, used pens must never be reused.
• Do not dispose of any medicine in wastewater or household waste. Ask your doctor or pharmacist how to dispose of medicines you no longer use. This will help protect the environment. Unused medicine and waste derived from that medicine must be disposed of in accordance with local regulations.

If you have any doubts, consult a doctor, pharmacist, or nurse who is familiar with
Hyrimoz.

Hyrimoz 40 mg injectable solution in pre-filled syringe

adalimumab

40 mg/0.4 mL
Read this leaflet carefully before using this medicine as it contains important
information for you

• Keep this leaflet. You may need to read it again.
• Your doctor will give you a Patient Information Card, which contains important safety information, that you need to know before administering Hyrimoz and during treatment with Hyrimoz. Keep this Patient Information Card with you during treatment and for 4 months after the last injection (or the last injection given to your son/daughter) of Hyrimoz.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Hyrimoz is and what it is used for
• 2. What you need to know before you use Hyrimoz
• 3. How to use Hyrimoz
• 4. Possible side effects
• 5. How to store Hyrimoz
• 6. Contents of the pack and other information
• 7. Instructions for use

1. What is Hyrimoz and what is it used for

Hyrimoz contains the active ingredient adalimumab, a medicine that acts on the body’s immune system
(defense system).
Hyrimoz is indicated for the treatment of the inflammatory diseases listed below:

• rheumatoid arthritis,
• polyarticular juvenile idiopathic arthritis,
• arthritis associated with enthesitis,
• ankylosing spondylitis,
• axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
• psoriatic arthritis,
• plaque psoriasis,
• hidradenitis suppurativa,
• Crohn’s disease,
• ulcerative colitis,
• non-infectious uveitis

The active ingredient contained in Hyrimoz, adalimumab, is a human monoclonal antibody. Monoclonal
antibodies are proteins that bind to a specific target.
The target of adalimumab is a protein called tumor necrosis factor (TNFα), which is
involved in the immune system (defense system) and is present at higher concentrations in the
inflammatory diseases listed above. By binding to TNFα, Hyrimoz blocks its action and decreases
the inflammatory process in these diseases.
Rheumatoid Arthritis
Rheumatoid arthritis is an inflammatory condition of the joints.
Hyrimoz is used to treat rheumatoid arthritis in adults. If you have moderate to severe rheumatoid arthritis, other disease-modifying drugs, such as
methotrexate, may be initially administered. If these drugs do not work satisfactorily, you will be given Hyrimoz to treat
rheumatoid arthritis.
Hyrimoz can also be used for the treatment of severe, active, and
progressive rheumatoid arthritis without prior treatment with methotrexate.
Hyrimoz may slow the progression of damage to the cartilage and bones of the joints,
caused by the disease, and improve physical function.
Generally Hyrimoz is used with methotrexate. If your doctor believes that treatment with
methotrexate is not appropriate, Hyrimoz can be administered alone.
Polyarticular Juvenile Idiopathic Arthritis
Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints.
Hyrimoz is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents
aged 2 to 17 years. Other disease-modifying drugs, such as methotrexate, may be administered at diagnosis. If these drugs do not work satisfactorily, patients will be
administered Hyrimoz.
Arthritis associated with Enthesitis
Arthritis associated with enthesitis is an inflammatory disease of the joints and the areas in which the
tendons attach to the bones. Hyrimoz is used to treat arthritis associated with enthesitis in patients aged
6 years and older.
Other disease-modifying drugs, such as methotrexate, may initially be administered. If
these medicines do not work well enough, patients will be administered Hyrimoz.
Ankylosing Spondylitis and Axial Spondyloarthritis without Radiographic Evidence of Ankylosing Spondylitis
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of spondylitis
ankylosing are inflammations of the spine.
Hyrimoz is used in adults to treat these conditions. If you have ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first take other
drugs. If these drugs do not work satisfactorily, you will take Hyrimoz to reduce the signs
and symptoms of the disease.
Plaque Psoriasis in Adults and Children
Plaque psoriasis is an inflammatory skin condition that causes red, scaly, and hardened patches of skin covered with silvery scales. Plaque psoriasis can also affect the
nails, causing them to break, thicken, and lift from the nail bed, which can be
painful. Psoriasis is believed to be caused by a problem with the body’s immune system that
leads to increased production of skin cells.
Hyrimoz is used to treat moderate to severe plaque psoriasis in adults. Hyrimoz is also used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years in
whom topical medications and UV light therapy have not worked optimally or are not indicated.
Psoriatic Arthritis
Psoriatic arthritis is an inflammatory disease of the joints associated with psoriasis.
Hyrimoz is used to treat psoriatic arthritis in adults. Hyrimoz may slow the damage to the
cartilage and bones of the joints, caused by the disease, and improve physical function.
Hidradenitis Suppurativa in Adults and Adolescents
Hidradenitis Suppurativa (sometimes called inverse acne) is a long-term inflammatory disease of the skin and is often painful. Symptoms may include painful nodules and abscesses (cysts)
that may drain pus.
It most frequently affects specific areas of the skin, such as the submammary region, armpits,
inner thighs, groin, and buttocks. Scars may also form in the affected areas.
Hyrimoz is used to treat

• moderate to severe Hidradenitis Suppurativa in adults and
• moderate to severe Hidradenitis Suppurativa in adolescents aged 12 to 17 years.

Hyrimoz may reduce the number of nodules and abscesses you have and the pain that is often associated with
this disease. Initially, you may receive other medications. If these drugs do not work in
a satisfactory manner, you will receive Hyrimoz.
Crohn’s Disease in Adults and Children
Crohn’s disease is an inflammation of the intestine.
Hyrimoz is used to treat

• moderate to severe Crohn’s disease in adults and
• moderate to severe Crohn’s disease in children and adolescents aged 6 to 17 years.

If you suffer from Crohn’s disease, you will first be administered other medications. In the event that you do not
respond adequately to these drugs, you will be administered Hyrimoz to
reduce the typical symptoms of Crohn’s disease.
Ulcerative Colitis in Adults and Children
Ulcerative colitis is an inflammation of the large intestine.
Hyrimoz is used to treat

• moderate to severe ulcerative colitis in adults and
• moderate to severe ulcerative colitis in children and adolescents aged 6 to 17 years.

If you have ulcerative colitis, you may initially take other medications. If these drugs do not work
satisfactorily, you will take Hyrimoz to reduce the signs and symptoms of ulcerative colitis.
Non-Infectious Uveitis in Adults and Children
Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye.
Inflammation leads to decreased vision and/or the presence of floaters in the eye
(small black dots or thin lines that move across the field of vision). Hyrimoz works by reducing this
inflammation.
Hyrimoz is used for the treatment of:

• Adults with non-infectious uveitis with inflammation affecting the back of the eye
• Children aged 2 years and older with chronic non-infectious uveitis with inflammation affecting the front of the eye. Other medications may initially be administered. If the response to these medications is not adequate, you will be given Hyrimoz.

2. What you need to know before using Hyrimoz

Do not use Hyrimoz

• If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
• If you have a severe infection, including tuberculosis, sepsis (blood poisoning) or other opportunistic infections (unusual infections associated with a weakened immune system). It is important to tell your doctor if you have signs or symptoms of infection, such as e.g. fever, wounds, feeling tired, dental problems (see “Warnings and precautions”).
• If you have moderate or severe heart failure. It is important to tell your doctor if you have had or have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before using Hyrimoz
Allergic reaction

• If you experience allergic reactions with symptoms such as a feeling of tightness in the chest, wheezing, dizziness, swelling or skin rash, do not administer Hyrimoz again and contact your doctor immediately as, in rare cases, these reactions can be life-threatening.

Infections

• If you have an infection, including long-term or localized infections (for example, leg ulcers), consult your doctor before starting treatment with Hyrimoz. If you have doubts, contact your doctor.
• You may be more likely to get infections during treatment with Hyrimoz. This risk may increase if your lung function is reduced. These infections can be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other unusual infectious organisms and sepsis (blood poisoning).
• In rare cases, these infections can be life-threatening to the patient. It is important to tell your doctor about the presence of symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may advise you to temporarily stop Hyrimoz.

Tuberculosis (TB)

• Since cases of tuberculosis have occurred in patients treated with adalimumab, your doctor will need to check if you have signs or symptoms typical of tuberculosis

before starting therapy with Hyrimoz. This will involve collecting a detailed medical assessment including your medical history and clinical examinations (e.g. a chest X-ray and a tuberculin test). The performance and results of these tests must be recorded on the Patient Reminder Card. It is very important to tell your doctor if you have ever had tuberculosis, or if you have had close contact with people with tuberculosis. Tuberculosis can develop during therapy even if you have received preventive treatment for tuberculosis. Contact your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, lack of energy, moderate fever) or other infections appear during or after therapy.
Travel/recurring infection

• Tell your doctor if you have lived in or travelled to regions where fungal infections, such as histoplasmosis, coccidioidomycosis or blastomycosis, are very common.
• Tell your doctor if you have had recurrent infections or if you have conditions that increase your risk of infection.

Hepatitis B virus

• Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active infection with the hepatitis B virus or if you think you may be at risk of contracting the hepatitis
• B virus. Your doctor should test you for hepatitis B virus infection. Taking adalimumab can reactivate hepatitis B virus infection in subjects who are carriers of this virus. In some rare cases, especially if the patient is undergoing therapy with other drugs that suppress the immune system, reactivation of hepatitis B virus infection can be life-threatening.

Age over 65 years

• If you are over 65 years old, you may be more susceptible to infections while taking Hyrimoz. You and your doctor should pay particular attention to signs of infection while you are being treated with Hyrimoz. It is important to tell your doctor if symptoms of infections such as fever, wounds, feeling tired or dental problems appear.

Surgery or dental procedures

• Before surgery or dental procedures, tell your doctor that you are taking Hyrimoz. Your doctor may advise you to temporarily stop Hyrimoz.

Demyelinating disease

• If you have or develop demyelinating diseases (diseases that affect the insulating layer around nerves), such as multiple sclerosis, your doctor will decide whether to start or continue treatment with Hyrimoz. Tell your doctor immediately if you experience symptoms such as changes in vision, weakness of arms or legs, or numbness or tingling that affects any part of the body.

Vaccination

• Certain vaccines contain live but weakened forms of bacteria or viruses that cause diseases and should not be administered during treatment with Hyrimoz if they cause infections. Consult your doctor before getting vaccinated. In children, it is recommended to administer the vaccinations prescribed for their age before starting therapy with Hyrimoz, if possible. If you take Hyrimoz during pregnancy, the baby may have a higher risk of contracting an infection up to about 5 months after the last dose you took during pregnancy. It is important that you inform your pediatrician or other healthcare provider of

your use of Hyrimoz during pregnancy, so that they can decide when the baby should receive any type of vaccination.
Heart failure

• It is important to inform your doctor about any heart problems, past or present. If you have mild heart failure and are receiving concomitant treatment with Hyrimoz, your doctor will need to carefully assess and monitor your heart condition. If new symptoms of heart failure or worsening of existing symptoms (e.g. shortness of breath or swelling of the feet) appear, contact your doctor immediately.

Fever, bruising, bleeding or paleness

• In some patients, the body may not be able to produce enough blood cells to fight infections or stop bleeding. If you have persistent fever, bruising or easy bleeding or paleness, see your doctor immediately. The latter may decide to stop therapy.

Cancer

• In children and adults treated with Hyrimoz or other anti-TNFα drugs, some types of cancer have occurred very rarely. Patients with severe, long-standing rheumatoid arthritis may have a higher than average risk of developing lymphoma and leukemia (cancers that affect blood cells and bone marrow). If you take Hyrimoz, the risk of developing lymphomas, leukemia or other cancers may increase. In rare circumstances, a specific and serious type of lymphoma has been observed in patients treated with adalimumab. Some of these patients were also taking azathioprine or mercaptopurine. Tell your doctor if you are taking azathioprine or mercaptopurine with Hyrimoz.
• Cases of non-melanoma skin cancer have been observed in patients taking adalimumab. If damaged areas of skin appear during or after treatment, or if the appearance of existing damaged areas changes, report it to your doctor.
• Cases of neoplasms, in addition to lymphoma, have been reported in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another anti-TNFα. If you suffer from COPD, or smoke heavily, you should discuss with your doctor whether treatment with an anti-TNFα is appropriate.

Autoimmune diseases

• Rarely, treatment with Hyrimoz can lead to the manifestation of a syndrome such as lupus. Tell your doctor if you experience symptoms such as persistent unexplained skin rash, fever, joint pain or fatigue.

Children and adolescents

• Do not give Hyrimoz to children with polyarticular juvenile idiopathic arthritis under the age of 2 years.
• Do not give Hyrimoz to children with pediatric plaque psoriasis or pediatric ulcerative colitis under the age of 4 years.
• Do not give Hyrimoz to children with pediatric Crohn's disease under the age of 6 years.
• Do not use the 40 mg pre-filled syringe if doses less than 40 mg are recommended.

Other medicines and Hyrimoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Hyrimoz can be taken both with methotrexate and with other disease-modifying antirheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide and parenteral gold salts), corticosteroids
or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Hyrimoz should not be taken at the same time as medicines containing the active ingredients anakinra or
abatacept due to the increased risk of serious infections. The combination of adalimumab and other anti-TNF and anakinra or abatacept is not recommended due to the possible increased risk of
infections, including serious infections and other possible drug interactions. If you have doubts, consult
your doctor.

Pregnancy and breastfeeding

• You should consider using appropriate contraceptive measures to prevent pregnancy and continue them for at least 5 months after the last therapy with Hyrimoz
• If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice about taking this medicine.
• Hyrimoz should only be used during pregnancy if necessary.
• According to a pregnancy study, no increased risk of birth defects was found when the mother had received adalimumab during pregnancy, compared to mothers who had the same condition but had not received adalimumab.
• Hyrimoz can be used during breastfeeding.
• If you take Hyrimoz during pregnancy, the baby may have a higher risk of contracting an infection.
• It is important that you inform your pediatrician or other healthcare provider of your use of Hyrimoz during pregnancy, before the baby receives any type of vaccination (for more information on vaccines, see “Warnings and precautions”).

Driving and using machines
Hyrimoz may affect, albeit only to a modest extent, your ability to drive, ride a bicycle or use
machinery. After taking Hyrimoz, you may experience visual disturbances and a sensation that the
environment around you is rotating (dizziness).

Hyrimoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 0.4 mL of dose, i.e. essentially
‘sodium-free’.

3. How to use Hyrimoz

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The recommended doses of Hyrimoz in each approved indication are listed in the following
table. Your doctor may prescribe a different concentration of Hyrimoz if you need a different dose.

How and route of administration
Hyrimoz is administered by injection under the skin (for subcutaneous injection).
Detailed instructions on how to inject Hyrimoz are provided in section 7, “Instructions for Use”.

If you use more Hyrimoz than you should
If you accidentally inject Hyrimoz more frequently than you should, contact your doctor or
pharmacist explaining that you have taken more medicine than you should. Always keep the box of the
medicine, even if empty.

If you forget to use Hyrimoz
If you forget to give an injection, you should inject the next dose of Hyrimoz as soon as you
remember. Then resume the dose regularly according to the prescribed dosage schedule.

If you stop using Hyrimoz
The decision to stop using Hyrimoz must be discussed with your doctor. Symptoms may
return after stopping treatment.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Most side effects are mild to moderate in form. However, some may be serious and require treatment. Side effects may occur
up to 4 months or more after the last injection of Hyrimoz.

Seek medical attention urgentlyif you notice any of the following signs of an allergic reaction or
heart failure

• severe skin rash, hives;
• swelling of the face, hands, feet;
• difficulty breathing, difficulty swallowing;
• shortness of breath on exertion or when lying down, or swollen feet.

Inform your doctor as soon as possibleif you notice any of the following reactions

• signs and symptoms of infection such as fever, feeling unwell, wounds, dental problems, burning when urinating, fatigue or weakness, or cough;
• symptoms of nerve problems, such as tingling, numbness, double vision, or weakness of the arms or legs;
• signs of skin cancer such as swelling or an open sore that does not heal;
• signs and symptoms suggesting the onset of blood system disorders, such as persistent fever, bruising, bleeding, pallor.

The following side effects have been observed with adalimumab:

Very common(may affect more than 1 in 10 people)

• reactions at the injection site (including pain, swelling, redness or itching);
• respiratory tract infections (including cold, runny nose, sinusitis and pneumonia);
• headache;
• abdominal pain (stomach ache);
• nausea and vomiting;
• skin rash;
• muscle pain.

Common(may affect up to 1 in 10 people)

• serious infections (including sepsis and influenza);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes zoster infection);
• ear infections;
• mouth infections (including tooth infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• infections of the joints;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergies);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, stabbing sensation or numbness;
• migraine;
• symptoms of nerve root compression (including lower back pain and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• dizziness (feeling of spinning);
• feeling of a fast heartbeat;
• high blood pressure;
• hot flashes;
• hematoma (solid swelling with clotted blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, heartburn);
• acid reflux;
• dry eye syndrome (including dry eyes and dry mouth);
• itching;
• itchy skin rash;
• bruising;
• skin inflammation (such as eczema);
• nail breakage of the fingers and toes;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in urine;
• kidney problems;
• chest pain;
• edema (fluid retention in the body, causing swelling of the affected tissue);
• fever;
• reduced platelets in the blood, which increases the risk of bleeding or bruising;
• difficulty healing wounds.

Uncommon(may affect up to 1 in 100 people)

• unusual infections (including tuberculosis and other infections) that occur when immune defenses are reduced;
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumors, including tumors of the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• immune system disorders that can affect the lungs, skin and lymph nodes (most commonly a condition called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor (shaking);
• neuropathy (nerve damage);
• stroke;
• hearing loss, ringing in the ears;
• feeling of irregular heartbeat such as palpitations;
• heart problems that can cause shortness of breath or swelling of the ankles;
• acute myocardial infarction (heart attack);
• formation of a sac in the wall of a major artery, inflammation and blood clot in a vein, blockage of a blood vessel;
• lung disease causing shortness of breath (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal accumulation of fluid in the pleural space);
• inflammation of the pancreas causing severe pain in the abdomen and back;
• difficulty swallowing;
• facial edema (swelling);
• inflammation of the gallbladder, gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scarring;
• abnormal muscle catabolism;
• systemic lupus erythematosus (immune system disorder, including inflammation of the skin, heart, lungs, joints and other organs);
• interrupted sleep;
• impotence;
• inflammations.

Rare(may affect up to 1 in 1,000 people)

• leukemia (a cancer that affects the blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as optic nerve inflammation in the eye and Guillain-Barré syndrome, a condition that can cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring of the lungs);
• intestinal perforation (hole in the wall of the intestine);
• hepatitis (inflammation of the liver);
• reactivation of hepatitis B infection;
• autoimmune hepatitis (inflammation of the liver caused by your own immune system);
• cutaneous vasculitis (inflammation of the blood vessels in the skin);
• Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and skin rash with blisters);
• facial edema (swelling) associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (itchy reddish-purple rash).

Not known(frequency cannot be estimated based on available data)

• T-cell hepatosplenic lymphoma (a rare blood cancer that is often fatal);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi's sarcoma, a rare cancer associated with human herpes virus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin;
• liver failure;
• worsening of a condition called dermatomyositis (which manifests as a skin rash accompanied by muscle weakness);
• weight gain (weight gain has been small for most patients).

Some of the side effects observed with adalimumab may be asymptomatic and can
only be detected through blood tests. These include:

Very common(may affect more than 1 in 10 people)

• low white blood cell count;
• low red blood cell count;
• increased lipids in the blood;
• increased liver enzymes.

Common(may affect up to 1 in 10 people)

• increased white blood cell count;
• reduced platelet count;
• increased uric acid in the blood;
• alteration of sodium in the blood;
• reduced calcium in the blood;
• reduced phosphorus in the blood;
• increased sugar in the blood;
• increased lactate dehydrogenase in the blood;
• presence of autoantibodies in the blood;
• reduced potassium in the blood.

Uncommon(may affect up to 1 in 100 people)

• high levels of bilirubin in the blood (liver blood test).

Rare(may affect up to 1 in 1,000 people)

• low white blood cell count, red blood cell count and platelet count.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell
your doctor or pharmacist. You can also report side effects directly through the national reporting system reported in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Hyrimoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label/blister/box after the
word Exp.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
Alternative storage conditions:
When necessary (for example when travelling), Hyrimoz can be stored at room temperature (up to 25°C) for a maximum period of 42 days – ensure the medicine is
protected from light. Once removed from the refrigerator for storage at room temperature, the
pre-filled syringe must be used within 42 days or discarded, even if subsequently
returned to the refrigerator. You must record the date on which the pre-filled syringe is removed from
the refrigerator for the first time and the date after which the syringe must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Hyrimoz contains

• The active substance is adalimumab. Each pre-filled syringe contains 40 mg of adalimumab in 0.4 mL of solution.
• The excipients are adipic acid, mannitol (E 421), polysorbate 80 (E 433), hydrochloric acid (E 507), sodium hydroxide (E 524) and water for injections.

Description of Hyrimoz and package contents
Hyrimoz 40 mg solution for injection in pre-filled syringe is supplied in 0.4 mL of solution ranging from clear
to slightly opalescent, colourless or slightly yellowish.
Hyrimoz is supplied in a single-use glass type I transparent syringe with a 29 gauge stainless steel needle
and a needle safety device with finger grip, rubber needle cap (thermoplastic elastomer) and plastic plunger, containing 0.4 mL of solution.
The packs contain 1 and 2 pre-filled syringes of Hyrimoz.
Multipacks contain 6 (3 packs of 2) pre-filled syringes of Hyrimoz.
Not all pack sizes may be marketed.
Hyrimoz is available in pre-filled syringe and pre-filled pen.

Marketing authorisation holder
Sandoz GmbH
Biochemiestr. 10
6250 Kundl
Austria

Manufacturer
Sandoz GmbH Schaftenau
Biochemiestr. 10
6336 Langkampfen
Austria
Novartis Pharmaceutical Manufacturing GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Sandoz nv/sa
Tél/Tel: +32 2 722 97 97

Lietuva
Sandoz Pharmaceuticals d.d filialas
Tel: +370 5 2636 037

Luxembourg/Luxemburg
Sandoz nv/sa
Tél/Tel.: +32 2 722 97 97

Česká republika
Sandoz s.r.o.
Tel: +420 225 775 111

България
Сандоз България КЧТ
Тел.: +359 2 970 47 47

Magyarország
Sandoz Hungária Kft.
Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige
Sandoz A/S
Tlf: +45 63 95 10 00

Malta
Sandoz Pharmaceuticals d.d.
Tel: +356 99644126

Deutschland
Hexal AG
Tel: +49 8024 908 0

Nederland
Sandoz B.V.
Tel: +31 36 52 41 600

Eesti
Sandoz d.d. Eesti filiaal
Tel: +372 665 2400

Österreich
Sandoz GmbH
Tel: +43 5338 2000

Ελλάδα
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
Τηλ: +30 216 600 5000

Polska
Sandoz Polska Sp. z o.o.
Tel.: +48 22 209 70 00

España
Sandoz Farmacéutica, S.A.
Tel: +34 900 456 856

Portugal
Sandoz Farmacêutica Lda.
Tel: +351 21 000 86 00

France
Sandoz SAS
Tél: +33 1 49 64 48 00

România
Sandoz Pharmaceuticals SRL
Tel: +40 21 407 51 60

Hrvatska
Sandoz d.o.o.
Tel: +385 1 23 53 111

Slovenija
Sandoz farmacevtska družba d.d.
Tel: +386 1 580 29 02

Ireland
Rowex Ltd.
Tel: + 353 27 50077

Slovenská republika
Sandoz d.d. - organizačná zložka
Tel: +421 2 50 70 6111

Italia
Sandoz S.p.A.
Tel: +39 02 96541

Suomi/Finland
Sandoz A/S
Puh/Tel: +358 10 6133 400

Κύπρος
Sandoz Pharmaceuticals d.d.
Τηλ: +357 22 69 0690

United Kingdom (Northern Ireland)
Sandoz GmbH
Tel: +43 5338 2000

Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu .

7. Instructions for Use

To avoid possible infections and to ensure you use the medicine correctly, it is important that you follow these instructions.
Make sure you read, understand and follow these Instructions for Use before injecting Hyrimoz.
The healthcare professional must show you how to prepare and inject Hyrimoz correctly using the pre-filled single-dose syringe before you use the medicine for the first time. If you have any doubts, ask your healthcare professional.

Hyrimoz single-use pre-filled syringe with needle safety device and additional finger grip

Figure A:Hyrimoz pre-filled syringe with needle safety device and finger grip

It is important that you:

• do not usethe pre-filled syringe if the blister seals are broken, because use may not be safe;
• do not openthe outer carton until you are ready to use the pre-filled syringe;
• never leavethe pre-filled syringe unattended where it could be tampered with by others;
• if you drop the syringe, do not use itif it appears damaged or if it was dropped after you removed the needle cap;
• do not removethe needle cap until the time of injection;
• be careful not to touch the wings of the needle safety devicebefore use. If you do, the needle safety device may be activated too early.
• do not removethe finger grip before the injection;
• injectHyrimoz 15-30 minutes after removing it from the refrigerator, for a more comfortable injection;
• dispose of the used syringe immediately after use. Do not reuse the pre-filled syringe.See “4. Disposal of used pre-filled syringes”at the end of these Instructions for Use.

How should you store the Hyrimoz single-dose pre-filled syringe?

• Store the outer packaging of the pre-filled syringes in a refrigerator, at a temperature between 2° and 8°C.
• When necessary (for example when travelling), Hyrimoz can be stored at room temperature (up to 25°C) for a maximum period of 42 days - make sure to protect the medicine from light. Once it is removed from the refrigerator to be stored at room temperature, the pre-filled syringe must be used within 42 days or discarded, even if it is subsequently placed back in the refrigerator. You must record the date on which the pre-filled syringe is removed from the refrigerator for the first time and the date after which it must be discarded.
• Store the pre-filled syringes in the original packaging until you are ready to use them, to protect the medicine from light.
• Do not store the pre-filled syringes at extremely hot or cold temperatures.
• Do not freeze the pre-filled syringes.

Keep Hyrimoz and all medicines out of the reach of children.
What do you need for the injection?
Place the following items on a clean flat surface.
The syringe packaging contains:

• Hyrimoz pre-filled syringe/s ( seeFigure A). Each pre-filled syringe contains 40 mg/0.4 mL of adalimumab.

The Hyrimoz pre-filled syringe packaging does not contain ( seeFigure B):

• Alcohol swab.
• Cotton ball or gauze.
• Sharps disposal container. See “4. Disposal of used syringes” at the end of these Instructions for Use.
• Adhesive bandage.

Figure B:items notincluded in the packaging

Before the injection

Figure D:the needle safety device is
activated – do not use

Figure C:the needle safety device is
not activated – the syringe is ready for use
or In this configuration, the needle safety
device is NOT ACTIVATED.
or The syringe is ready for use (see

Figure C).
or In this configuration, the needle safety
device is ACTIVATED.
or DO NOT USEthe syringe (see

Figure D).

Preparing the syringe

• For a more comfortable injection, remove the carton containing the pre-filled syringe from the refrigerator and leave it closedon the work surface for about 15-30 minutes to reach room temperature.
• Remove the pre-filled syringe from the blister.
• Look through the window. The solution should be colourless to slightly yellowish and from clear to slightly opalescent. Do not use the syringe if you notice particles and/or changes in colour. If you have any doubts about the appearance of the solution, ask your pharmacist for assistance.
• Do not usethe pre-filled syringe if it is broken or if the needle safety device is activated. Return the pre-filled syringe and packaging to the pharmacy.
• Check the expiry date (Exp.) of the pre-filled syringe. Do not use the pre-filled syringe if the expiry date has passed

Ask your pharmacistif the syringe does not pass any of the checks above.

1. Choice of injection site:

• The recommended injection site is the front of the thighs. You can also use the lower abdomen, but not the area within 5 cm around the navel (see Figure E).
• Choose a different site each time you administer an injection.
• Do notinject the medicine into areas where the skin is painful, bruised, reddened, flaky or hardened. Avoid areas with scars or stretch marks. If you suffer from psoriasis, DO NOT inject the medicine directly into areas with psoriasis plaques.

Figure E:how to choose the injection site

2. Injection site cleaning:

• Wash your hands thoroughly with water and soap.
• Using a circular motion, clean the injection site with a swab soaked in alcohol. Allow to dry before administering the injection (see Figure F).
• Do nottouch the cleaned area before the injection.

Figure F:how to clean the injection site

3. Administration of the injection:

• Carefully pull off the needle cap to remove it from the prefilled syringe (see Figure G).
• Discard the needle cap.
• You may see a drop of liquid at the end of the needle. This is normal.

Figure G:how to pull off the needle cap

• Gently create a skin fold at the injection site (see Figure H).
• Insert the needle into the skin as shown.
• Push the entire needle into the skin to ensure that all of the medicine is delivered.
• Use the syringe within 5 minutes of removing the cap.

FigureH:how to insert the needle

• Hold the prefilled syringe as shown (see Figure I).
• Slowly press the plunger all the way down so that the plunger head is completely between the fins of the needle safety device.
• While holding the syringe in position, keep the plunger pressed down completely for 5 seconds.

Figure I:how to hold the syringe

• Keep the plunger completelypressedwhile carefully withdrawing the needle from the injection site, then release the skin (see Figure J) .

Figure J:how to withdraw the needle

• Slowly release the plunger and let the needle safety device automatically cover the exposed needle (see Figure K).
• You may notice a small amount of blood at the injection site. You can press a cotton ball or gauze on the injection site and hold for 10 seconds. Do not rub the injection site. If necessary, you can cover the injection site with a small adhesive bandage. Figure K:how to slowly release the plunger

4. Disposal of used syringes:

• Dispose of the used syringe in a sharps disposal container (reclosable, puncture-resistant container, see Figure L). For your safety and health, and that of others, used needles and syringes must never be reused.
• Do not dispose of any medicine down the drain or with household waste. Ask your doctor or pharmacist how to dispose of medicines you no longer use. This will help protect the environment. Unused medicine and waste derived from that medicine must be disposed of in accordance with local regulations.

Figure L:how to dispose of the used
prefilled syringe

If you have any doubts, consult a doctor, pharmacist or nurse familiar with
Hyrimoz.

Hyrimoz 40 mg solution for injection in pre-filled pen

adalimumab

40 mg/0.4 mL
Read this leaflet carefully before using this medicine as it contains important
information for you

• Keep this leaflet. You may need to read it again.
• Your doctor will give you a Patient Reminder Card, which contains important safety information that you need to know before administering Hyrimoz and during treatment with Hyrimoz. Keep this Patient Reminder Cardwith you during treatment and for 4 months after the last injection (or the last injection given to your/your child's) of Hyrimoz.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Hyrimoz is and what it is used for
• 2. What you need to know before you use Hyrimoz
• 3. How to use Hyrimoz
• 4. Possible side effects
• 5. How to store Hyrimoz
• 6. Contents of the pack and other information
• 7. Instructions for use

1. What is Hyrimoz and what is it used for

Hyrimoz contains the active ingredient adalimumab, a medicine that acts on the body's immune system
(defense system).
Hyrimoz is indicated for the treatment of the inflammatory diseases listed below:

• rheumatoid arthritis,
• polyarticular juvenile idiopathic arthritis,
• arthritis associated with enthesitis,
• ankylosing spondylitis,
• axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
• psoriatic arthritis,
• plaque psoriasis,
• hidradenitis suppurativa,
• Crohn’s disease,
• ulcerative colitis,
• non-infectious uveitis.

The active ingredient contained in Hyrimoz, adalimumab, is a human monoclonal antibody. Monoclonal
antibodies are proteins that bind to a specific target.
The target of adalimumab is a protein called tumor necrosis factor (TNFα), which is
involved in the immune system (defense system) and is present at higher concentrations in the
inflammatory diseases listed above. By binding to TNFα, Hyrimoz blocks its action and reduces
the inflammatory process in these diseases.
Rheumatoid Arthritis
Rheumatoid arthritis is an inflammatory disease of the joints.
Hyrimoz is used to treat rheumatoid arthritis in adults. If you have moderate to severe rheumatoid
arthritis, other disease-modifying drugs, such as methotrexate, may be initially administered. If these
drugs do not work satisfactorily, you will be given Hyrimoz to treat rheumatoid arthritis.
Hyrimoz can also be used to treat severe, active and progressive rheumatoid arthritis without prior
treatment with methotrexate.
Hyrimoz may slow the progression of cartilage and bone damage in the joints caused by the disease,
and improve physical function.
Generally Hyrimoz is used with methotrexate. If your doctor believes that treatment with
methotrexate is not appropriate, Hyrimoz may be administered alone.
Polyarticular Juvenile Idiopathic Arthritis
Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints, which generally
manifests for the first time during childhood.
Hyrimoz is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents
aged 2 to 17 years. Other disease-modifying drugs, such as methotrexate, may be administered at
diagnosis. If these drugs do not work satisfactorily, patients will be given Hyrimoz.
Arthritis Associated with Enthesitis
Arthritis associated with enthesitis is an inflammatory disease of the joints and areas where
tendons attach to bones. Hyrimoz is used to treat arthritis associated with enthesitis in patients
aged 6 years and older.
Other disease-modifying drugs, such as methotrexate, may be initially administered. If these
medicines do not work well enough, patients will be given Hyrimoz.
Ankylosing Spondylitis and Axial Spondyloarthritis without Radiographic Evidence of Ankylosing Spondylitis
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing
spondylitis are inflammations of the spine.
Hyrimoz is used in adults to treat these conditions. If you have ankylosing spondylitis or axial
spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first take other
medications. If these drugs do not work satisfactorily, you will take Hyrimoz to reduce the signs
and symptoms of the disease.
Plaque Psoriasis in Adults and Children
Plaque psoriasis is an inflammatory skin condition that causes red, scaly, and hardened patches of
skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to break,
thicken, and lift from the nail bed, which can be painful. Psoriasis is believed to be caused by a
problem with the body's immune system that leads to increased skin cell production.
Hyrimoz is used to treat moderate to severe plaque psoriasis in adults. Hyrimoz is also used to treat
severe plaque psoriasis in children and adolescents aged 4 to 17 years in whom topical medications
and UV light therapy have not worked optimally or are not indicated.
Psoriatic Arthritis
Psoriatic arthritis is an inflammatory disease of the joints associated with psoriasis.
Hyrimoz is used to treat psoriatic arthritis in adults. Hyrimoz may slow the damage to cartilage and
bone in the joints caused by the disease, and improve physical function.
Hidradenitis Suppurativa in Adults and Adolescents
Hidradenitis Suppurativa (sometimes called inverse acne) is a long-term inflammatory skin disease
and is often painful. Symptoms can include painful lumps and abscesses (cysts) that can drain pus.
It most frequently affects specific areas of the skin, such as the submammary region, armpits, inner
thighs, groin, and buttocks. Scars can also form in the affected areas.
Hyrimoz is used to treat

• moderate to severe Hidradenitis Suppurativa in adults and
• moderate to severe Hidradenitis Suppurativa in adolescents aged 12 to 17 years.

Hyrimoz may reduce the number of lumps and abscesses you have and the pain that is often associated
with this disease. Initially, you may receive other medications. If these drugs do not work in
a satisfactory manner, you will receive Hyrimoz.
Crohn’s Disease in Adults and Children
Crohn’s disease is an inflammation of the intestine.
Hyrimoz is used to treat

• moderate to severe Crohn’s disease in adults and
• moderate to severe Crohn’s disease in children and adolescents aged 6 to 17 years.

If you suffer from Crohn’s disease, you will first be given other medications. If you do not
respond adequately to these medications, you will be given Hyrimoz to reduce the typical symptoms of
Crohn’s disease.
Ulcerative Colitis in Adults and Children
Ulcerative colitis is an inflammation of the large intestine.
Hyrimoz is used to treat

• moderate to severe ulcerative colitis in adults and
• moderate to severe ulcerative colitis in children and adolescents aged 6 to 17 years.

If you have ulcerative colitis, you may first take other medications. If these drugs do not work
satisfactorily, you will take Hyrimoz to reduce the signs and symptoms of ulcerative colitis.
Non-Infectious Uveitis in Adults and Children
Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye.
Inflammation leads to decreased vision and/or the presence of floaters in the eye
(black spots or thin lines that move across the field of vision). Hyrimoz works by reducing this
inflammation.
Hyrimoz is used for the treatment of:

• Adults with non-infectious uveitis with inflammation affecting the back of the eye.
• Children aged 2 years and older with chronic non-infectious uveitis with inflammation affecting the front of the eye.

Other medications may be initially administered. If the response to these medications is not
adequate, you will be given Hyrimoz.

2. What you need to know before using Hyrimoz

Do not use Hyrimoz

• If you are allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
• If you have a severe infection, including tuberculosis, sepsis (blood poisoning) or other opportunistic infections (unusual infections associated with a weakened immune system). It is important to tell your doctor if you have signs or symptoms of infection, such as e.g. fever, wounds, feeling tired, dental problems (see “Warnings and precautions”).
• If you have moderate or severe heart failure. It is important to tell your doctor if you have had or have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before using Hyrimoz.
Allergic reaction

• If you experience allergic reactions with symptoms such as a feeling of tightness in the chest, wheezing, dizziness, swelling or skin rash, do not administer Hyrimoz again and contact your doctor immediately as, in rare cases, these reactions can be life-threatening.

Infections

• If you have an infection, including long-term or localized infections (for example, leg ulcers), consult your doctor before starting treatment with Hyrimoz. If you have doubts, contact your doctor.
• You may be more likely to get infections during treatment with Hyrimoz. This risk may increase if your lung function is reduced. These infections can be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other unusual infectious organisms and sepsis (blood poisoning).
• In rare cases, these infections can be life-threatening. It is important to tell your doctor about the presence of symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may advise you to temporarily stop Hyrimoz.

Tuberculosis (TB)

• Because cases of tuberculosis have occurred in patients treated with adalimumab, your doctor will need to check if you have signs or symptoms typical of tuberculosis before starting therapy with Hyrimoz. This will involve collecting a detailed medical assessment including your medical history and clinical examinations (e.g. a chest X-ray and a tuberculin test). The performance and results of these tests must be recorded on the Patient Reminder Card. It is very important to tell your doctor if you have ever had tuberculosis, or if you have had close contact with people with tuberculosis. Tuberculosis can develop during therapy even if you have received preventive treatment for tuberculosis. Contact your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, lack of energy, moderate fever) or other infections appear during or after therapy.

Travel/recurring infection

• Tell your doctor if you have lived in or travelled to regions where fungal infections, such as histoplasmosis, coccidioidomycosis or blastomycosis, are common.
• Tell your doctor if you have had recurrent infections or if you have conditions that increase your risk of infection.

Hepatitis B virus

• Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active infection with the hepatitis B virus or if you think you may be at risk of contracting the hepatitis virus
• B. Your doctor should test you for hepatitis B virus infection. Taking adalimumab can reactivate hepatitis B virus infection in subjects who are carriers of this virus. In some rare cases, especially if the patient is undergoing therapy with other drugs that suppress the immune system, reactivation of hepatitis B virus infection can be life-threatening.

Age over 65 years

• If you are over 65 years of age, you may be more susceptible to infections while taking Hyrimoz. You and your doctor should pay particular attention to signs of infection while you are being treated with Hyrimoz. It is important to inform your doctor if symptoms of infections such as fever, wounds, feeling tired or dental problems appear.

Surgery or dental procedures

• Before surgery or dental procedures, tell your doctor that you are taking Hyrimoz. Your doctor may advise you to temporarily stop Hyrimoz.

Demyelinating disease

• If you have or develop demyelinating diseases (diseases that affect the insulating layer around nerves), such as multiple sclerosis, your doctor will decide whether to start or continue treatment with Hyrimoz. Tell your doctor immediately if you experience symptoms such as changes in vision, weakness of arms or legs, or numbness or tingling that affects any part of the body.

Vaccination

• Certain vaccines contain live but weakened forms of bacteria or viruses that cause diseases and should not be administered during treatment with Hyrimoz if they cause infections. Consult your doctor before getting vaccinated. In children, it is recommended, if possible, to administer the vaccinations scheduled for their

age before starting therapy with Hyrimoz. If you have taken Hyrimoz during pregnancy, the baby may have a higher risk
of contracting such an infection up to about 5 months after the last dose you took
during pregnancy. It is important that you inform your pediatrician or other healthcare provider of
your use of Hyrimoz during pregnancy, so that they can decide when the baby
should receive any type of vaccination.
Heart failure

• It is important to inform your doctor about any heart problems, both past and present. If you have mild heart failure and are receiving concomitant treatment with Hyrimoz, your doctor should carefully assess and monitor your heart condition. If new symptoms of heart failure or worsening of existing symptoms (e.g. shortness of breath or swelling of the feet) appear, contact your doctor immediately.

Fever, bruising, bleeding or paleness

• In some patients, the body may not be able to produce enough blood cells to fight infections or stop bleeding. If you have persistent fever, bruising or easy bleeding, or paleness, see your doctor immediately. The latter may decide to interrupt the therapy.

Cancer

• Very rarely, some types of cancer have occurred in children and adults treated with adalimumab or other anti-TNFα drugs. Patients with severe, long-standing rheumatoid arthritis may have a higher than average risk of developing lymphoma and leukemia (cancers that affect blood cells and bone marrow). If you take Hyrimoz, your risk of developing lymphomas, leukemia or other cancers may increase. In rare circumstances, a specific and serious type of lymphoma has been observed in patients treated with adalimumab. Some of these patients were also taking azathioprine or mercaptopurine. Tell your doctor if you are taking azathioprine or mercaptopurine with Hyrimoz.
• In addition, cases of non-melanoma skin cancer have been observed in patients taking adalimumab. If damaged skin areas appear during or after treatment, or if the appearance of existing damaged areas changes, report it to your doctor.
• There have been cases of neoplasms, in addition to lymphoma, in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another anti-TNFα. If you suffer from COPD, or smoke heavily, you should discuss with your doctor whether treatment with an anti-TNFα is appropriate.

Autoimmune diseases

• Rarely, treatment with Hyrimoz can lead to the manifestation of a syndrome like lupus. Tell your doctor if you experience symptoms such as persistent unexplained skin rash, fever, joint pain or fatigue.

Children and adolescents

• Do not give Hyrimoz to children with polyarticular juvenile idiopathic arthritis under the age of 2 years.
• Do not give Hyrimoz to children with pediatric plaque psoriasis or pediatric ulcerative colitis under the age of 4 years.
• Do not give Hyrimoz to children with pediatric Crohn's disease under the age of 6 years.
• Do not use the pre-filled pen of 40 mg if doses less than 40 mg are recommended.

Other medicines and Hyrimoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Hyrimoz can be taken with methotrexate and other disease-modifying antirheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide and parenteral gold salts), corticosteroids
or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Hyrimoz should not be taken at the same time as medicines containing the active ingredients anakinra or
abatacept due to the increased risk of having serious infections. The combination of adalimumab and other anti-TNF and anakinra or abatacept is not recommended due to the possible increase in the risk of
infections, including serious infections and other possible drug interactions. If you have doubts, ask your
doctor.

Pregnancy and breastfeeding

• You should consider using adequate contraceptive measures to prevent pregnancy and continue using them for at least 5 months after the last therapy with Hyrimoz.
• If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice on taking this medicine.
• Hyrimoz should only be used during pregnancy if necessary.
• According to a pregnancy study, no increased risk of birth defects was found when the mother had received adalimumab during pregnancy, compared to mothers who had the same condition but had not received adalimumab.
• Hyrimoz can be used during breastfeeding.
• If you take Hyrimoz during pregnancy, the baby may have a higher risk of contracting an infection.
• It is important that you inform your pediatrician or other healthcare provider of your use of Hyrimoz during pregnancy, before the baby receives any type of vaccination (for more information on vaccines see “Warnings and precautions”).

Driving and using machines
Hyrimoz can affect, albeit only to a modest extent, your ability to drive, ride a bicycle or use
machinery. After taking Hyrimoz, you may experience vision disturbances and a sensation that the
environment around you is rotating (dizziness).

Hyrimoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 0.4 mL of dose, i.e. essentially
‘sodium-free’.

3. How to use Hyrimoz

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The recommended doses of Hyrimoz in each approved indication are listed in the following
table. Your doctor may prescribe a different concentration of Hyrimoz if you need a different dose.

How and route of administration
Hyrimoz is administered by injection under the skin (subcutaneous injection).
Detailed instructions on how to inject Hyrimoz are provided in section 7, “Instructions for Use”.

If you use more Hyrimoz than you should
If you accidentally inject Hyrimoz more frequently than you should, contact your doctor or
pharmacist explaining that you have taken more medicine than you should. Always keep the box of the
medicine, even if empty.

If you forget to use Hyrimoz
If you forget to give an injection, you should inject the next dose of Hyrimoz as soon as you
remember. Then resume the dose regularly according to the established dosage schedule.

If you stop taking Hyrimoz
The decision to stop using Hyrimoz must be discussed with your doctor. Symptoms may
return after stopping treatment.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects are mild to moderate. However, some can be serious and require treatment. Side effects may occur
up to 4 months or more after the last injection of Hyrimoz.

Seek medical attention urgentlyif you notice any of the following signs of an allergic reaction or
heart failure

• severe skin rash, hives;
• swelling of the face, hands, feet;
• difficulty breathing, difficulty swallowing;
• shortness of breath on exertion or when lying down, or swollen feet.

Tell your doctor as soon as possibleif you notice any of the following reactions

• signs and symptoms of infection such as fever, feeling unwell, sores, dental problems, burning when urinating; fatigue or weakness or cough;
• symptoms of nerve problems, such as tingling, numbness, double vision or weakness of the arms or legs;
• signs of skin cancer such as swelling or an open sore that does not heal;
• signs and symptoms suggesting the development of blood disorders, such as persistent fever, bruising, bleeding, paleness.

The following side effects have been observed with Hyrimoz

Very common(may affect more than 1 in 10 people)

• reactions at the injection site (including pain, swelling, redness or itching);
• respiratory tract infections (including common cold, runny nose, sinusitis and pneumonia);
• headache;
• abdominal pain (stomach ache);
• nausea and vomiting;
• skin rash;
• muscle pain.

Common(may affect up to 1 in 10 people)

• serious infections (including sepsis and influenza);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes zoster infection);
• ear infections;
• mouth infections (including tooth infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• infections of the joints;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergy);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, prickling or numbness;
• migraine;
• symptoms of nerve root compression (including back pain and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• dizziness (sensation of spinning);
• feeling of a fast heartbeat;
• high blood pressure;
• hot flushes;
• bruise (solid swelling with clotted blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, heartburn);
• acid reflux;
• dry eye syndrome (including dry eyes and dry mouth);
• itching;
• itchy skin rash;
• contusion;
• skin inflammation (such as eczema);
• nail breakage of the fingers and toes;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in urine;
• kidney problems;
• chest pain;
• edema (fluid retention in the body, causing swelling of the affected tissue);
• fever;
• decreased platelets in the blood, which increases the risk of bleeding or bruising;
• difficulty with wound healing.

Uncommon(may affect up to 1 in 100 people)

• unusual infections (including tuberculosis and other infections) that occur when the immune defenses are reduced;
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumors, including tumors of the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• immune system disorders that can affect lungs, skin and lymph nodes (most commonly a condition called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor (shaking);
• neuropathy (nerve damage);
• stroke;
• hearing loss, ringing in the ears;
• feeling of irregular heartbeat such as palpitations;
• heart problems that can cause shortness of breath or swelling of the ankles;
• acute myocardial infarction (heart attack);
• formation of a sac in the wall of a major artery, inflammation and blood clot in a vein, blockage of a blood vessel;
• lung disease causing shortness of breath (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal collection of fluid in the pleural space);
• inflammation of the pancreas causing severe pain in the abdomen and back;
• difficulty swallowing;
• facial edema (swelling);
• inflammation of the gallbladder, gallstones;
• fatty liver (accumulation of fat in the liver cells);
• night sweats;
• scarring;
• abnormal muscle catabolism;
• systemic lupus erythematosus (disorder of the immune system, including inflammation of the skin, heart, lungs, joints and other organs);
• interrupted sleep;
• impotence;
• inflammations.

Rare(may affect up to 1 in 1,000 people)

• leukemia (a cancer that affects the blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as optic nerve inflammation in the eye and Guillain-Barré syndrome, a condition that can cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring of the lung);
• intestinal perforation (hole in the wall of the intestine);
• hepatitis (inflammation of the liver);
• reactivation of hepatitis B infection;
• autoimmune hepatitis (inflammation of the liver caused by your own immune system);
• cutaneous vasculitis (inflammation of the blood vessels in the skin);
• Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and skin rash with blisters);
• facial edema (swelling) associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (itchy reddish-purple skin rash).

Not known(frequency cannot be estimated from the available data)

• T-cell lymphoproliferative disorder of the hepatosplenic (a rare blood cancer that is often fatal);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi's sarcoma, a rare cancer related to human herpes virus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin;
• liver failure;
• worsening of a condition called dermatomyositis (which manifests as a skin rash accompanied by muscle weakness);
• weight gain (weight gain has been small for most patients).

Some of the side effects observed with adalimumab may be asymptomatic and can
only be detected through blood tests. These include:

Very common(may affect more than 1 in 10 people)

• low white blood cell count;
• low red blood cell count;
• increased lipids in the blood;
• increased liver enzymes.

Common(may affect up to 1 in 10 people)

• increased white blood cell count;
• decreased platelet count;
• increased uric acid in the blood;
• altered sodium in the blood;
• decreased calcium in the blood;
• decreased phosphorus in the blood;
• increased sugar in the blood;
• increased lactate dehydrogenase in the blood;
• presence of autoantibodies in the blood;
• decreased potassium in the blood.

Uncommon(may affect up to 1 in 100 people)

• high levels of bilirubin in the blood (liver blood test).

Rare(may affect up to 1 in 1,000 people)

• low white blood cell, red blood cell and platelet counts.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system listed in
Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Hyrimoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label/blister/box after the
word Exp.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the pre-filled pen in the outer packaging to protect the medicine from light.
Alternative storage conditions:
When necessary (for example when travelling), Hyrimoz can be stored at room temperature (up to 25°C) for a maximum period of 42 days – ensure that the medicine is protected
from light. Once it has been removed from the refrigerator to be stored at room temperature, the
pre-filled pen must be used within 42 days or discarded, even if it is subsequently
placed back in the refrigerator. You must record the date on which the pre-filled pen is removed from
the refrigerator for the first time and the date after which the pen must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Hyrimoz contains

• The active substance is adalimumab. Each pre-filled pen contains 40 mg of adalimumab in 0.4 mL of solution.
• The excipients are adipic acid, mannitol (E 421), polysorbate 80 (E 433), hydrochloric acid (E 507), sodium hydroxide (E 524) and water for injections.

Description of the appearance of Hyrimoz and contents of the pack
Hyrimoz 40 mg solution for injection in pre-filled pen is supplied as 0.4 mL of solution that is
clear to slightly opalescent, colourless or slightly yellowish.
Hyrimoz is supplied in a single-use pre-filled syringe assembled in a triangular-shaped pen
with a transparent window and label. The syringe inside the pen is type I glass with a
29 gauge needle in stainless steel, an internal rubber needle cap (thermoplastic elastomer)
and a rubber stopper, containing 0.4 mL of solution.
The packs contain 1, 2 and 4 pre-filled pens of Hyrimoz.
Multipacks contain 6 (3 packs of 2) pre-filled pens of Hyrimoz.
Not all pack sizes may be marketed.
Hyrimoz is available in pre-filled syringe and in pre-filled pen.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestr. 10
6250 Kundl
Austria

Manufacturer
Sandoz GmbH Schaftenau
Biochemiestr. 10
6336 Langkampfen
Austria
Novartis Pharmaceutical Manufacturing GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Sandoz nv/sa
Tél/Tel: +32 2 722 97 97

Lietuva
Sandoz Pharmaceuticals d.d filialas
Tel: +370 5 2636 037

Luxembourg/Luxemburg
Sandoz nv/sa
Tél/Tel.: +32 2 722 97 97

Česká republika
Sandoz s.r.o.
Tel: +420 225 775 111

България
Сандоз България КЧТ
Тел.: +359 2 970 47 47

Magyarország
Sandoz Hungária Kft.
Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige
Sandoz A/S
Tlf: +45 63 95 10 00

Malta
Sandoz Pharmaceuticals d.d.
Tel: +356 99644126

Deutschland
Hexal AG
Tel: +49 8024 908 0

Nederland
Sandoz B.V.
Tel: +31 36 52 41 600

Eesti
Sandoz d.d. Eesti filiaal
Tel: +372 665 2400

Österreich
Sandoz GmbH
Tel: +43 5338 2000

Ελλάδα
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
Τηλ: +30 216 600 5000

Polska
Sandoz Polska Sp. z o.o.
Tel.: +48 22 209 70 00

España
Sandoz Farmacéutica, S.A.
Tel: +34 900 456 856

Portugal
Sandoz Farmacêutica Lda.
Tel: +351 21 000 86 00

France
Sandoz SAS
Tél: +33 1 49 64 48 00

România
Sandoz Pharmaceuticals SRL
Tel: +40 21 407 51 60

Hrvatska
Sandoz d.o.o.
Tel: +385 1 23 53 111

Slovenija
Sandoz farmacevtska družba d.d.
Tel: +386 1 580 29 02

Ireland
Rowex Ltd.
Tel: + 353 27 50077

Slovenská republika
Sandoz d.d. - organizačná zložka
Tel: +421 2 50 70 6111

Italia
Sandoz S.p.A.
Tel: +39 02 96541

Suomi/Finland
Sandoz A/S
Puh/Tel: +358 10 6133 400

Κύπρος
Sandoz Pharmaceuticals d.d.
Τηλ: +357 22 69 0690

United Kingdom (Northern Ireland)
Sandoz GmbH
Tel: +43 5338 2000

Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu.

7. Instructions for Use

To avoid possible infections and to ensure you use Hyrimoz correctly, it is important that you
follow these instructions.
Make sure you read, understand and follow these Instructions for Use before injecting Hyrimoz.
The healthcare professional must show you how to prepare and inject Hyrimoz correctly using the
Hyrimoz single-dose pre-filled pen before you use the medicine for the first time. If you have
any doubts, ask your healthcare professional.

Single-use pre-filled pen of Hyrimoz

Figure A:parts of the Hyrimoz pen
In Figure A, the pen is shown without the cap. Do not removethe cap until you are ready to administer
the injection.

It is important that you:

• do not usethe pen if the outer packaging seal or the pen safety seal is broken;
• keep the pen in the sealed outer packaging until you are ready to use it;
• never leavethe pen unattended where it could be tampered with by others;
• do not usethe pen if it has been dropped, appears damaged, or has been dropped after you have removed the cap;
• injectHyrimoz 15-30 minutes after removing it from the refrigerator, for a more comfortable injection;
• dispose of the used pen immediately after use. Do not reuse the pen.See “4. Disposal of used pens”at the end of these Instructions for Use.

How should you store the pen?

• Store the pen pack in a refrigerator, at a temperature between 2° and 8°C.
• When necessary, for example when travelling, Hyrimoz can be stored at room temperature (up to 25°C) for a maximum period of 42 days - make sure to protect the medicine from light. Once it is removed from the refrigerator to be stored at room temperature, the pre-filled pen must be used within 42 days or thrown away, even if it is subsequently placed back in the refrigerator.
• You must record the date on which the pre-filled pen is removed from the refrigerator for the first time and the date after which it must be thrown away.
• Store the pen in its original packaging until you are ready to use it, to protect the medicine from light.
• Do not store the pen at extremely hot or cold temperatures.
• Do not freeze the pen.

Keep Hyrimoz and all medicines out of the reach of children.
What do you need for the injection?
Place the following items on a clean, flat surface.
The pack contains:

• Hyrimoz pre-filled pen/s (see Figure A). Each pen contains 40 mg/0.4 mL of adalimumab.

The pen pack does not contain (see Figure B):

• Alcohol wipe.
• Cotton wool or gauze.
• Sharps disposal container. See “8. Disposal of used pens”at the end of these Instructions for Use.
• Adhesive bandage.

Figure B:items not included in the pack

Preparing the pen
Before the injection

• For a more comfortable injection, remove the pen from the refrigerator about 15-30 minutes before the injection so that it reaches room temperature.
• Look through the window. The solution should be colourless or slightly yellowish and from clear to slightly opalescent. Do not usethe pen if you notice particles and/or colour changes. You may notice some air bubbles. This is normal. If you have any doubts about the appearance of the solution, ask your pharmacist for assistance.
• Check the expiry date (Exp.) of the pen (see Figure C). Do not use the pen if the expiry date has passed.
• Do not use the pen if the safety seal is broken.

Figure C:safety checks before
the injection

Ask your pharmacist if the pen does not pass
any of the checks listed above.

1. Choice of injection site:

• The recommended injection site is the front of the thighs. You can also use the lower abdomen, but not the area within 5 cm around the navel (see Figure D).
• Choose a different site each time you administer an injection.
• Do notinject the medicine into areas where the skin is painful, bruised, reddened, flaky or hardened. Avoid areas with scars or stretch marks. If you suffer from psoriasis, DO NOTinject the medicine directly into areas with psoriasis plaques.

Figure D:how to choose the injection site

2. Cleaning the injection site:

• Wash your hands thoroughly with water and soap.
• Using a circular motion, clean the injection site with a swab soaked in alcohol. Allow to dry before administering the injection (see Figure E).
• Do nottouch the cleaned area before the injection.

Figure E:how to clean the injection site

3. Removing the cap from your pen:

• Remove the cap only when you are ready to use the pen.
• Rotate the cap in the direction of the arrows (see Figure F).
• Once the cap is removed, discard it. Do notattempt to replace the cap.
• Use the pen within 5 minutes of removing the cap.
• You may notice a few drops of liquid coming out of the needle. This is normal.

Figure F:how to remove the cap

4. How to hold the pen:

• Hold the pen at 90 degrees to the clean injection site (see Figure G).

CorrectIncorrect
Figure G:how to hold the pen

Injection
Read before performing the injection
During the injection you will feel 2 clicks:
o The first clickindicates that the injection has started.
o A moment later, a second clickindicates that the injection is almostfinished.
You must keep the pen firmly pressed against the skin until you see a green
indicatorfill the window and stop moving.

5. Start of injection:

• Press the pen firmly against the skin to start the injection (see Figure H).
• The first click indicates that the injection has started.
• Keep pressingthe pen firmly against the skin.
• The green indicator shows the injection progress. Figure H:how to start the injection

6. Completion of the injection:

• Pay attention to the second click which indicates that the injection is almost complete.
• Check that the green indicator fills the window and has stopped moving (see Figure I).
• You can now remove the pen.

Figure I:how to complete the injection

After the injection

7. Check that the green indicator

fills the window(see Figure J) :

• This means that the medicine has been administered. Contact your doctor if the green indicator is not visible.
• You may notice a small amount of blood at the injection site. You can press a cotton ball or gauze on the injection site and hold it for 10 seconds. Do not rub the injection site. If necessary, you can cover the injection site with a small adhesive bandage.

Figure J:how to check the green indicator

8. Disposal of used pens:

• Dispose of the used pen in a sharps disposal container (a resealable, puncture-resistant container, see Figure K). For your safety and the safety of others, used pens should never be reused.
• Do not dispose of any medicine down the drain or in household waste. Ask your doctor or pharmacist how to dispose of medicines you no longer use. This will help protect the environment. Unused medicine and waste from such medicine must be disposed of in accordance with local regulations.

Figure K:how to dispose of the used pen

If you have any doubts, consult a doctor, pharmacist, or nurse familiar with
Hyrimoz.

Hyrimoz 80 mg injectable solution in pre-filled syringe

adalimumab

Read this leaflet carefully before using this medicine as it contains important
information for you

• Keep this leaflet. You may need to read it again.
• Your doctor will give you a Patient Reminder Card, which contains important safety information that you need to know before administering Hyrimoz and during treatment with Hyrimoz. Keep this Patient Reminder Cardwith you during treatment and for 4 months after the last injection (or the last injection given to your child) of Hyrimoz.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Hyrimoz is and what it is used for
• 2. What you need to know before you use Hyrimoz
• 3. How to use Hyrimoz
• 4. Possible side effects
• 5. How to store Hyrimoz
• 6. Contents of the pack and other information
• 7. Instructions for use

1. What is Hyrimoz and what is it used for

Hyrimoz contains the active ingredient adalimumab, a medicine that acts on the body's immune system
(defense system).
Hyrimoz is indicated for the treatment of the inflammatory diseases listed below:

• rheumatoid arthritis,
• plaque psoriasis,
• hidradenitis suppurativa,
• Crohn's disease,
• ulcerative colitis,
• non-infectious uveitis

The active ingredient contained in Hyrimoz, adalimumab, is a human monoclonal antibody. Monoclonal
antibodies are proteins that bind to a specific target.
The target of adalimumab is a protein called tumor necrosis factor (TNFα), which is
involved in the immune system (defense system) and is present at higher concentrations in the
inflammatory diseases listed above. By binding to TNFα, Hyrimoz blocks its action and decreases
the inflammatory process in these diseases.
Rheumatoid Arthritis
Rheumatoid arthritis is an inflammatory condition of the joints.
Hyrimoz is used to treat rheumatoid arthritis in adults. If you have moderate to severe rheumatoid
arthritis, other disease-modifying drugs, such as methotrexate, may be initially taken. If these drugs
do not work satisfactorily, you will be given Hyrimoz to treat rheumatoid arthritis.
Hyrimoz can also be used to treat severe, active and progressive rheumatoid arthritis without prior
treatment with methotrexate.
Hyrimoz may slow the progression of damage to the cartilage and bones of the joints,
caused by the disease, and improve physical function.
Generally Hyrimoz is used with methotrexate. If your doctor believes that treatment with
methotrexate is not appropriate, Hyrimoz may be administered alone.
Plaque Psoriasis
Plaque psoriasis is an inflammatory skin condition that causes red, scaly, and hardened patches of
skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to break,
thicken, and lift from the nail bed, which can be painful. Psoriasis is believed to be caused by a
problem with the body's immune system that leads to increased production of skin cells.
Hyrimoz is used to treat moderate to severe plaque psoriasis in adults.
Hidradenitis Suppurativa in adults and adolescents
Hidradenitis Suppurativa (sometimes called inverse acne) is a long-term inflammatory skin disease
and is often painful. Symptoms may include painful nodules and abscesses (cysts) that may drain pus.
It most frequently affects specific areas of the skin, such as the underarm area, armpits,
inner thighs, groin, and buttocks. Scars may also form in the affected areas.
Hyrimoz is used to treat

• moderate to severe hidradenitis suppurativa in adults and
• moderate to severe hidradenitis suppurativa in adolescents aged 12 to 17 years.

Hyrimoz may reduce the number of nodules and abscesses you have and the pain often associated
with this disease. Initially, you may receive other medicines. If these medicines do not work in
a satisfactory manner, you will receive Hyrimoz.
Crohn's Disease in adults and children
Crohn's disease is an inflammation of the intestine.
Hyrimoz is used to treat

• moderate to severe Crohn's disease in adults and
• Crohn's disease in children and adolescents aged 6 to 17 years.

If you suffer from Crohn's disease, you will first be given other medications. If you do not
respond adequately to these medications, you will be given Hyrimoz to
reduce the typical symptoms of Crohn's disease.
Ulcerative Colitis in adults and children
Ulcerative colitis is an inflammation of the large intestine.
Hyrimoz is used to treat

• moderate to severe ulcerative colitis in adults and
• moderate to severe ulcerative colitis in children aged 6 to 17 years.

If you have ulcerative colitis, you may take other medications first. If these medications do not work
satisfactorily, you will take Hyrimoz to reduce the signs and symptoms of ulcerative colitis.
Non-infectious Uveitis in adults and children
Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye.
Inflammation leads to a decrease in vision and/or the presence of floaters in the eye
(small dark spots or thin lines that move across the field of vision). Hyrimoz works by reducing this
inflammation.
Hyrimoz is used to treat:

• Adults with non-infectious uveitis with inflammation affecting the back of the eye.
• Children aged 2 years and older with chronic non-infectious uveitis with inflammation affecting the front of the eye.

You may first be given other medications. If you do not respond satisfactorily to
these medications, you will be given Hyrimoz.

2. What you need to know before using Hyrimoz

Do not use Hyrimoz

• If you are allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
• If you have a severe infection, including tuberculosis, sepsis (blood poisoning) or other opportunistic infections (unusual infections associated with a weakened immune system). It is important to tell your doctor if you have signs or symptoms of infection, such as e.g. fever, wounds, feeling tired, dental problems (see “Warnings and precautions”).
• If you have moderate or severe heart failure. It is important to tell your doctor if you have had or currently have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before using Hyrimoz.
Allergic reaction

• If you experience allergic reactions with symptoms such as a feeling of tightness in the chest, wheezing, dizziness, swelling or skin rash, do not administer Hyrimoz again and contact your doctor immediately as, in rare cases, these reactions can be life-threatening.

Infections

• If you have an infection, including long-term or localized infections (for example, leg ulcers), consult your doctor before starting treatment with Hyrimoz. If you have doubts, contact your doctor.
• You may be more likely to get infections during treatment with Hyrimoz. This risk may increase if your lung function is reduced. These infections can be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other unusual infectious organisms and sepsis (blood poisoning).
• In rare cases, these infections can be life-threatening. It is important to tell your doctor about the presence of symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may advise you to temporarily stop Hyrimoz.

Tuberculosis (TB)

• Because cases of tuberculosis have occurred in patients treated with adalimumab, your doctor will need to check if you have signs or symptoms typical of tuberculosis before starting therapy with Hyrimoz. This will involve collecting a detailed medical assessment including your medical history and clinical examinations (e.g. a chest X-ray and a tuberculin test). The performance and results of these tests must be recorded in the Patient Reminder Card. It is very important to tell your doctor if you have ever had tuberculosis, or if you have had close contact with people with tuberculosis. Tuberculosis can develop during therapy even if you have received preventive treatment for tuberculosis. Contact your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, lack of energy, moderate fever) or other infections appear during or after therapy.

Travel/recurring infection

• Tell your doctor if you have lived in or travelled to regions where fungal infections, such as histoplasmosis, coccidioidomycosis or blastomycosis, are very common.
• Tell your doctor if you have had recurrent infections or if you have conditions that increase your risk of infection.

Hepatitis B virus

• Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active infection with the hepatitis B virus or if you think you may be at risk of contracting the hepatitis virus
• B. Your doctor should test you for hepatitis B virus infection. Taking adalimumab can reactivate hepatitis B virus infection in subjects who are carriers of this virus. In some rare cases, especially if the patient is undergoing therapy with other drugs that suppress the immune system, reactivation of hepatitis B virus infection can be life-threatening.

Age over 65 years

• If you are over 65 years of age, you may be more susceptible to infections while taking Hyrimoz. You and your doctor should pay particular attention to signs of infection while you are being treated with Hyrimoz. It is important to inform your doctor if symptoms of infections such as fever, wounds, feeling tired or dental problems appear.

Surgery or dental procedures

• Before surgery or dental procedures, tell your doctor that you are taking Hyrimoz. Your doctor may advise you to temporarily stop Hyrimoz.

Demyelinating disease

• If you have or develop demyelinating diseases (diseases that affect the insulating layer around the nerves), such as multiple sclerosis, your doctor will decide whether to start or continue treatment with Hyrimoz. Tell your doctor immediately if you experience symptoms such as changes in vision, weakness of arms or legs or numbness or tingling that affects any part of the body.

Vaccination

• Certain vaccines contain live but weakened forms of bacteria or viruses that cause diseases and should not be administered during treatment with Hyrimoz if they cause infections. Consult your doctor before getting vaccinated. In children, it is recommended, if possible, to administer the vaccinations scheduled for their age before starting therapy with Hyrimoz. If you take Hyrimoz during pregnancy, the baby may have a greater risk of contracting an infection up to about 5 months after the last dose you took during pregnancy. It is important that you tell the pediatrician or other healthcare provider about your use of Hyrimoz during pregnancy, so that they can decide when the baby should receive any type of vaccination.

Heart failure

• It is important to inform your doctor about any heart problems, both past and present. If you have mild heart failure and are receiving concomitant treatment with Hyrimoz, your doctor will need to carefully assess and monitor your heart condition. If new symptoms of heart failure appear or existing symptoms worsen (e.g. shortness of breath or swelling of the feet), contact your doctor immediately.

Fever, bruising, bleeding or paleness

• In some patients, the body may not be able to produce a sufficient quantity of blood cells to fight infections or stop bleeding. If you have persistent fever, bruising or easy bleeding or paleness, see your doctor immediately. The latter may decide to interrupt the therapy.

Cancer

• Very rarely, some types of cancer have occurred in children and adults treated with Hyrimoz or other anti-TNFα drugs. Patients with severe, long-standing rheumatoid arthritis may have a higher than average risk of developing lymphoma and leukemia (cancers that affect blood cells and bone marrow). If you take Hyrimoz, the risk of developing lymphomas, leukemia or other cancers may increase. In rare circumstances, a specific and serious type of lymphoma has been observed in patients undergoing therapy with adalimumab. Some of these patients were also taking azathioprine or mercaptopurine. Tell your doctor if you are taking azathioprine or mercaptopurine with Hyrimoz.
• Cases of non-melanoma skin cancer have been observed in patients taking adalimumab. If damaged areas of skin appear during or after treatment or if the appearance of existing damaged areas changes, report it to your doctor.
• There have been cases of neoplasms, in addition to lymphoma, in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another anti-TNFα. If you suffer from COPD, or smoke heavily, you should discuss with your doctor whether treatment with an anti-TNFα is appropriate.

Autoimmune diseases

• Rarely, treatment with Hyrimoz can lead to the manifestation of a syndrome such as lupus. Tell your doctor if you experience symptoms such as a persistent unexplained skin rash, fever, joint pain or fatigue.

Children and adolescents

• Do not give Hyrimoz to children with polyarticular juvenile idiopathic arthritis under the age of 2 years.
• Do not give Hyrimoz to children with pediatric plaque psoriasis or pediatric ulcerative colitis under the age of 4 years.
• Do not give Hyrimoz to children with pediatric Crohn's disease under the age of 6 years.
• Do not use the pre-filled syringe of 80 mg if doses other than 80 mg are recommended.

Other medicines and Hyrimoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Hyrimoz can be taken both with methotrexate and with other disease-modifying antirheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide and parenteral gold salts), corticosteroids
or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Hyrimoz should not be taken at the same time as medicines containing the active ingredients anakinra or
abatacept due to the increased risk of serious infections. The combination of adalimumab and other anti-TNF and anakinra or abatacept is not recommended due to the possible increase in the risk of
infections, including serious infections and other possible drug interactions. If you have any doubts, consult
your doctor.

Pregnancy and breastfeeding

• You should consider using appropriate contraceptive measures to prevent pregnancy and continue using them for at least 5 months after the last therapy with Hyrimoz
• If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice about taking this medicine.
• Hyrimoz should only be used during pregnancy if necessary.
• According to a pregnancy study, no increased risk of birth defects was found when the mother received adalimumab during pregnancy, compared to mothers who had the same condition but did not receive adalimumab.
• Hyrimoz can be used during breastfeeding.
• If you take Hyrimoz during pregnancy, the baby may have a greater risk of contracting an infection.
• It is important that you tell the pediatrician or other healthcare provider about your use of Hyrimoz during pregnancy, before the baby receives any type of vaccination (for more information about vaccines, see “Warnings and precautions”).

Driving and using machines
Hyrimoz may affect, albeit only to a modest extent, your ability to drive, ride a bicycle or use machinery. After taking Hyrimoz, you may experience visual disturbances and a feeling that the environment around you is rotating (dizziness).

Hyrimoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 mL of dose, i.e. essentially
‘sodium-free’.

3. How to use Hyrimoz

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended doses of Hyrimoz in each approved indication are listed in the following
table. Your doctor may prescribe a different concentration of Hyrimoz if the child needs a
different dose.

How and route of administration
Hyrimoz is administered by injection under the skin (subcutaneous injection).
Detailed instructions on how to inject Hyrimoz are provided in section 7, “Instructions for Use”.

If you use more Hyrimoz than you should
If you accidentally inject Hyrimoz more frequently than you should, contact your doctor or
pharmacist explaining that you have taken more medicine than you should. Always keep the box of
the medicine, even if empty.

If you forget to use Hyrimoz
If you forget to give an injection, you should inject the next dose of Hyrimoz as soon as you
remember. Then resume the dose regularly according to the established dosage schedule.

If you stop using Hyrimoz
The decision to stop using Hyrimoz should be discussed with your doctor. Symptoms may
return after stopping treatment.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Most side effects are mild to moderate. However, some can be serious and require treatment. Side effects may occur
up to 4 months or more after the last injection of Hyrimoz.

Seek urgent medical attentionif you notice any of the following signs of an allergic reaction or
heart failure

• severe skin rash, hives;
• swelling of the face, hands, feet;
• difficulty breathing, difficulty swallowing;
• shortness of breath during activity or when lying down, or swollen feet.

Inform your doctor as soon as possibleif you notice any of the following reactions

• signs and symptoms of infection such as fever, feeling unwell, wounds, dental problems, burning when urinating, fatigue or weakness, or cough;
• symptoms of nerve problems, such as tingling, numbness, double vision, or weakness of the arms or legs;
• signs of skin cancer such as swelling or an open sore that does not heal;
• signs and symptoms suggesting the development of blood system disorders, such as persistent fever, bruising, bleeding, paleness.

The following side effects have been observed with Hyrimoz:

Very common(may affect more than 1 in 10 people)

• reactions at the injection site (including pain, swelling, redness or itching);
• respiratory tract infections (including common cold, runny nose, sinusitis and pneumonia);
• headache;
• abdominal pain (stomach pain);
• nausea and vomiting;
• skin rash;
• muscle pain.

Common(may affect up to 1 in 10 people)

• serious infections (including sepsis and influenza);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes zoster infection);
• ear infections;
• mouth infections (including dental infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• infections affecting the joints;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergies);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, prickling or numbness;
• migraine;
• symptoms of nerve root compression (including back pain and leg pain);
• visual disturbances;
• eye inflammation;
• inflammation of the eyelids and swelling of the eyes;
• dizziness (sensation of spinning);
• feeling of a fast heartbeat;
• high blood pressure;
• hot flushes;
• hematoma (solid swelling with clotted blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, heartburn);
• acid reflux;
• dry eye syndrome (including dry eyes and dry mouth);
• itching;
• itchy skin rash;
• bruising;
• skin inflammation (such as eczema);
• nail breakage of the fingers and toes;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in the urine;
• kidney problems;
• chest pain;
• edema (fluid retention in the body, causing swelling of the affected tissue);
• fever;
• decreased platelets in the blood, which increases the risk of bleeding or bruising;
• difficulty healing.

Uncommon(may affect up to 1 in 100 people)

• unusual infections (including tuberculosis and other infections) that occur when immune defenses are reduced;
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumors, including tumors of the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• immune system disorders that can affect the lungs, skin and lymph nodes (most commonly a condition called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor (shaking);
• neuropathy (nerve damage);
• stroke;
• hearing loss, ringing in the ears;
• feeling of irregular heartbeat such as palpitations;
• heart problems that can cause shortness of breath or swelling of the ankles;
• acute myocardial infarction (heart attack);
• formation of a sac in the wall of a major artery, inflammation and blood clot in a vein, blockage of a blood vessel;
• lung disease causing shortness of breath (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal collection of fluid in the pleural space);
• inflammation of the pancreas causing severe pain in the abdomen and back;
• difficulty swallowing;
• facial edema (swelling);
• inflammation of the gallbladder, gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scarring;
• abnormal muscle catabolism;
• systemic lupus erythematosus (immune system disorder, including inflammation of the skin, heart, lungs, joints and other organs);
• interrupted sleep;
• impotence;
• inflammations.

Rare(may affect up to 1 in 1,000 people)

• leukemia (a cancer that affects the blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as optic nerve inflammation in the eye and Guillain-Barré syndrome, a condition that can cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring of the lungs);
• intestinal perforation (hole in the wall of the intestine);
• hepatitis (inflammation of the liver);
• reactivation of hepatitis B infection;
• autoimmune hepatitis (inflammation of the liver caused by your own immune system);
• cutaneous vasculitis (inflammation of the blood vessels in the skin);
• Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and skin rash with blisters);
• facial edema (swelling) associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (itchy, reddish-purple rash).

Not known(frequency cannot be estimated from available data)

• T-cell hepatosplenic lymphoma (a rare blood cancer that is often fatal);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi's sarcoma, a rare cancer associated with human herpes virus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin;
• liver failure;
• worsening of a condition called dermatomyositis (which manifests as skin rash accompanied by muscle weakness);

andnbsp;

• weight gain (weight gain has been small for most patients).

Some of the side effects observed with adalimumab may be asymptomatic and can
only be detected through blood tests. These include:

Very common(may affect more than 1 in 10 people)

• low white blood cell count;
• low red blood cell count;
• increased blood lipids;
• increased liver enzymes.

Common(may affect up to 1 in 10 people)

• increased white blood cell count;
• decreased platelet count;
• increased uric acid in the blood;
• alteration of sodium in the blood;
• decreased calcium in the blood;
• decreased phosphorus in the blood;
• increased blood sugar;
• increased lactate dehydrogenase in the blood;
• presence of autoantibodies in the blood;
• decreased potassium in the blood.

Uncommon(may affect up to 1 in 100 people)

• high levels of bilirubin in the blood (liver blood test).

Rare(may affect up to 1 in 1,000 people)

• low white blood cell, red blood cell and platelet counts.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system detailed in Annex V. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Hyrimoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label/blister/box after the
word Exp.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
Alternative storage conditions:
When necessary (for example when travelling), Hyrimoz can be stored at room temperature (up to 25°C) for a maximum period of 42 days – ensure you protect the medicine
from light. Once it has been removed from the refrigerator to be stored at room temperature, the
pre-filled syringe must be used within 42 days or discarded, even if it is subsequently
placed back in the refrigerator. You must record the date on which the pre-filled syringe is removed from
the refrigerator for the first time and the date after which the syringe must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Hyrimoz contains

• The active substance is adalimumab. Each pre-filled syringe contains 80 mg of adalimumab in 0.8 mL of solution.
• The excipients are adipic acid, mannitol (E 421), polysorbate 80 (E 433), hydrochloric acid (E 507), sodium hydroxide (E 524) and water for injections.

Description of the appearance of Hyrimoz and contents of the pack
Hyrimoz 80 mg solution for injection in a pre-filled syringe is supplied in 0.8 mL of solution from clear
to slightly opalescent, colourless or slightly yellowish.
Hyrimoz is supplied in a single-use glass type I transparent syringe with a 29 gauge stainless
steel needle and a needle safety device with finger grip, rubber needle cap (thermoplastic elastomer) and plastic plunger, containing 0.8 mL of solution.
Packs contain 1 and 2 pre-filled syringes of Hyrimoz.
Not all pack sizes may be marketed.
Hyrimoz is available in pre-filled syringe and pre-filled pen.

Marketing authorisation holder
Sandoz GmbH
Biochemiestr. 10
6250 Kundl
Austria

Manufacturer
Sandoz GmbH Schaftenau
Biochemiestr. 10
6336 Langkampfen
Austria
Novartis Pharmaceutical Manufacturing GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Sandoz nv/sa
Tél/Tel: +32 2 722 97 97

Lietuva
Sandoz Pharmaceuticals d.d filialas
Tel: +370 5 2636 037

Luxembourg/Luxemburg
Sandoz nv/sa
Tél/Tel.: +32 2 722 97 97

Česká republika
Sandoz s.r.o.
Tel: +420 225 775 111

България
Сандоз България КЧТ
Тел.: +359 2 970 47 47

Magyarország
Sandoz Hungária Kft.
Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige
Sandoz A/S
Tlf: +45 63 95 10 00

Malta
Sandoz Pharmaceuticals d.d.
Tel: +356 99644126

Deutschland
Hexal AG
Tel: +49 8024 908 0

Nederland
Sandoz B.V.
Tel: +31 36 52 41 600

Eesti
Sandoz d.d. Eesti filiaal
Tel: +372 665 2400

Österreich
Sandoz GmbH
Tel: +43 5338 2000

Ελλάδα
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
Τηλ: +30 216 600 5000

Polska
Sandoz Polska Sp. z o.o.
Tel.: +48 22 209 70 00

España
Sandoz Farmacéutica, S.A.
Tel: +34 900 456 856

Portugal
Sandoz Farmacêutica Lda.
Tel: +351 21 000 86 00

France
Sandoz SAS
Tél: +33 1 49 64 48 00

România
Sandoz Pharmaceuticals SRL
Tel: +40 21 407 51 60

Hrvatska
Sandoz d.o.o.
Tel: +385 1 23 53 111

Slovenija
Sandoz farmacevtska družba d.d.
Tel: +386 1 580 29 02

Ireland
Rowex Ltd.
Tel: + 353 27 50077

Slovenská republika
Sandoz d.d. - organizačná zložka
Tel: +421 2 50 70 6111

Italia
Sandoz S.p.A.
Tel: +39 02 96541

Suomi/Finland
Sandoz A/S
Puh/Tel: +358 10 6133 400

Κύπρος
Sandoz Pharmaceuticals d.d.
Τηλ: +357 22 69 0690

United Kingdom (Northern Ireland)
Sandoz GmbH
Tel: +43 5338 2000

Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu .

7. Instructions for Use

To avoid possible infections and to ensure you use the medicine correctly, it is important that
you follow these instructions.
Make sure you read, understand and follow these Instructions for Use before injecting Hyrimoz.
The healthcare professional must show you how to prepare and inject Hyrimoz correctly using the
single-use pre-filled syringe before you use the medicine for the first time. If you have any doubts, ask
your healthcare professional.

Hyrimoz single-use pre-filled syringe with safety device for the needle and additional finger grip

Figure A:Hyrimoz pre-filled syringe with safety device for the needle and finger grip

It is important that you:

• do not usethe syringe if the pre-filled seals are broken, because use may not be safe;
• do not openthe outer carton until you are ready to use the pre-filled syringe;
• never leavethe pre-filled syringe unattended where it can be tampered with by others;
• if you drop the syringe, do not use itif it appears damaged or if it was dropped after you removed the needle cap;
• do not removethe needle cap until the time of injection;
• be careful not to touch the wings of the needle safety devicebefore use. If you do, the needle safety device may be activated too early.
• do not removethe finger grip before injection;
• injectHyrimoz 15-30 minutes after removing it from the refrigerator, for a more comfortable injection;
• dispose of the used syringe immediately after use. Do not reuse the pre-filled syringe.See “4. Disposal of used pre-filled syringes”at the end of these Instructions for Use.

How should you store the Hyrimoz single-dose pre-filled syringe?

• Store the outer packaging of the pre-filled syringes in a refrigerator, at a temperature between 2° and 8°C.
• When necessary (for example when travelling), Hyrimoz can be stored at room temperature (up to 25°C) for a maximum period of 42 days - make sure to protect the medicine from light. Once it is removed from the refrigerator to be stored at room temperature, the pre-filled syringe must be used within 42 days or thrown away, even if it is subsequently placed back in the refrigerator. You must record the date on which the pre-filled syringe is removed from the refrigerator for the first time and the date after which it must be thrown away.
• Store the pre-filled syringes in the original packaging until you are ready to use them, to protect the medicine from light.
• Do not store the pre-filled syringes at extremely hot or cold temperatures.
• Do not freeze the pre-filled syringes.

Keep Hyrimoz and all medicines out of the reach of children.
What do you need for the injection?
Place the following items on a clean, flat surface.
The syringe packaging contains:

• Syringe/s pre-filled with Hyrimoz (see Figure A). Each pre-filled syringe contains 80 mg/0.8 mL of adalimumab.

The Hyrimoz pre-filled syringe packaging does not contain (see Figure B):

• Alcohol swab.
• Cotton ball or gauze.
• Sharps disposal container. See “4. Disposal of used syringes”at the end of these Instructions for Use.
• Adhesive bandage.

Figure B:items notincluded in the packaging

Before the injection

Figure C:the needle safety device is not
activated – the single-dose pre-filled syringe is
ready for use

Figure D:the needle safety device is
activated – do not use
In this configuration, the needle safety device of the pre-filled syringe
is activated.
o do not usethe syringe (see Figure D).
o In this configuration, the needle safety device is not activated.
o The syringe is ready for use (see

Figure C).

Preparing the syringe

• For a more comfortable injection, remove the packaging containing the pre-filled syringe from the refrigerator and leave it closedon the work surface for about 15-30 minutes to reach room temperature.
• Remove the pre-filled syringe from the blister.
• Look through the window. The solution should be colourless or slightly yellowish and from clear to slightly opalescent. Do not use the syringe if you notice particles and/or changes in colour. If you have any doubts about the appearance of the solution, ask your pharmacist for assistance.
• Do not usethe pre-filled syringe if it is broken or if the needle safety device is activated. Return the pre-filled syringe and packaging to the pharmacy.
• Check the expiry date (Exp.) of the pre-filled syringe. Do not use the pre-filled syringe if the expiry date has passed.

Ask your pharmacist if the syringe fails any of the above checks.

1. Choice of injection site:

• The recommended injection site is the front of the thighs. You can also use the lower abdomen, but not the area within 5 cm around the navel (see Figure E).
• Choose a different site each time you administer an injection.
• Do notinject the medicine into areas where the skin is painful, bruised, reddened, flaky, or hardened. Avoid areas with scars or stretch marks. If you suffer from psoriasis, DO NOT inject the medicine directly into areas with psoriasis plaques.

Figure E:how to choose the injection site
of injection

2. Injection site cleaning:

• Wash your hands thoroughly with water and soap.
• Using a circular motion, clean the injection site with a swab soaked in alcohol. Allow to dry before administering the injection (see Figure F).
• Do nottouch the cleaned area before the injection.

Figure F:how to clean the injection
site

3. Administration of the injection:

• Carefully pull off the needle cap to remove it from the prefilled syringe (see Figure G).
• Discard the needle cap.
• You may see a drop of liquid at the end of the needle. This is normal.

Figure G:how to pull off the cap
of the needle

• Gently create a skin fold at the injection site (see Figure H).
• Insert the needle into the skin as shown.
• Push the entire needle into the skin to ensure that all of the medicine is delivered.
• Use the syringe within 5 minutes of removing the cap.

Figure H:how to insert the needle

• Hold the prefilled syringe as shown (see Figure I).
• Slowly press the plunger all the way in so that the plunger head is completely between the fins of the needle safety device.
• While holding the syringe in position, keep the plunger pressed in completely for 5 seconds.

Figure I:how to hold the syringe

• Keep the plunger fully depressedwhile carefully withdrawing the needle from the injection site, then release the skin (see Figure J) .

Figure J:how to withdraw the needle

• Slowly release the plunger and let the needle safety device automatically cover the exposed needle (see Figure K).
• You may notice a small amount of blood at the injection site. You can press a cotton ball or gauze on the injection site and hold it for 10 seconds. Do not rub the injection site. If necessary, you can cover the injection site with a small adhesive bandage. Figure K:how to slowly release the plunger

4. Disposal of used syringes:

• Dispose of the used syringe in a sharps disposal container (a resealable, puncture-resistant container, see Figure L). For your safety and health, and that of others, used needles and syringes must never be reused.
• Do not dispose of any medicine down the drain or in household waste. Ask your doctor or pharmacist how to dispose of medicines you no longer use. This will help protect the environment. Unused medicine and waste from that medicine must be disposed of in accordance with local regulations.

Figure L:how to dispose of the used
prefilled syringe

If you have any doubts, consult a doctor, pharmacist or nurse who is familiar with
Hyrimoz.

Hyrimoz 80 mg solution for injection in pre-filled pen

adalimumab

Read this leaflet carefully before using this medicine as it contains important
information for you

• Keep this leaflet. You may need to read it again.
• Your doctor will give you a Patient Reminder Card, which contains important safety information that you need to know before administering Hyrimoz and during treatment with Hyrimoz. Keep this Patient Reminder Cardwith you during treatment and for 4 months after the last injection (or the last injection given to your child) of Hyrimoz.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Hyrimoz is and what it is used for
• 2. What you need to know before you use Hyrimoz
• 3. How to use Hyrimoz
• 4. Possible side effects
• 5. How to store Hyrimoz
• 6. Contents of the pack and other information
• 7. Instructions for use

1. What is Hyrimoz and what is it used for?

Hyrimoz contains the active ingredient adalimumab, a medicine that acts on the body's immune system
(defense system).
Hyrimoz is indicated for the treatment of the inflammatory diseases listed below:

• rheumatoid arthritis,
• plaque psoriasis,
• hidradenitis suppurativa,
• Crohn's disease,
• ulcerative colitis,
• non-infectious uveitis.

The active ingredient contained in Hyrimoz, adalimumab, is a human monoclonal antibody. Monoclonal
antibodies are proteins that bind to a specific target.
The target of adalimumab is a protein called tumor necrosis factor (TNFα), which is
involved in the immune system (defense system) and is present in higher concentrations in the
inflammatory diseases listed above. By binding to TNFα, Hyrimoz blocks its action and decreases
the inflammatory process in these diseases.
Rheumatoid Arthritis
Rheumatoid arthritis is an inflammatory condition of the joints.
Hyrimoz is used to treat rheumatoid arthritis in adults. If you have moderate to severe rheumatoid
arthritis, other disease-modifying drugs, such as methotrexate, may be initially administered. If these
drugs do not work satisfactorily, you will be given Hyrimoz to treat rheumatoid arthritis.
Hyrimoz can also be used for the treatment of severe, active and progressive rheumatoid arthritis
without prior treatment with methotrexate.
Hyrimoz may slow the progression of damage to the cartilage and bones of the joints,
caused by the disease, and improve physical function.
Generally Hyrimoz is used with methotrexate. If your doctor believes that treatment with
methotrexate is not appropriate, Hyrimoz may be administered alone.
Plaque Psoriasis
Plaque psoriasis is an inflammatory skin condition that causes reddish, scaly and hardened patches
of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to break,
thicken and lift from the nail bed, which can be painful. Psoriasis is believed to be caused by a
problem with the body's immune system that leads to an increase in skin cell production.
Hyrimoz is used to treat moderate to severe plaque psoriasis in adults.
Hidradenitis Suppurativa in adults and adolescents
Hidradenitis Suppurativa (sometimes called inverse acne) is a long-term inflammatory skin disease
and is often painful. Symptoms may include painful nodules and abscesses (cysts) that may drain pus.
It most frequently affects specific areas of the skin, such as the submammary region, armpits,
inner thighs, groin and buttocks. Scars can also form in the affected areas.
Hyrimoz is used to treat

• moderate to severe hidradenitis suppurativa in adults and
• moderate to severe hidradenitis suppurativa in adolescents aged 12 to 17 years.

Hyrimoz may reduce the number of nodules and abscesses you have and the pain often associated with
this disease. Initially, you may receive other medications. If these medications do not work
satisfactorily, you will receive Hyrimoz.
Crohn's Disease in adults and children
Crohn's disease is an inflammation of the intestine.
Hyrimoz is used to treat

• moderate to severe Crohn's disease in adults and
• moderate to severe Crohn's disease in children and adolescents aged 6 to 17 years.

If you suffer from Crohn's disease, you will first be given other medications. If you do not
respond adequately to these medications, you will be given Hyrimoz to
reduce the typical symptoms of Crohn's disease.
Ulcerative Colitis in adults and children
Ulcerative colitis is an inflammation of the large intestine.
Hyrimoz is used to treat

• moderate to severe ulcerative colitis in adults and
• moderate to severe ulcerative colitis in children and adolescents aged 6 to 17 years.

If you have ulcerative colitis, you may take other medications first. If these medications do not work
satisfactorily, you will take Hyrimoz to reduce the signs and symptoms of the disease.
Non-infectious Uveitis in adults and children
Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye.
Inflammation leads to a decrease in vision and/or the presence of mobile bodies in the eye
(black dots or thin lines that move across the field of vision). Hyrimoz works by reducing this
inflammation.
Hyrimoz is used for the treatment of:

• Adults with non-infectious uveitis with inflammation affecting the back of the eye
• Children aged 2 years and older with chronic non-infectious uveitis with inflammation affecting the front of the eye

You may first be given other medications. If you do not respond satisfactorily to
these medications, you will be given Hyrimoz.

2. What you need to know before using Hyrimoz

Do not use Hyrimoz

• If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
• If you have a severe infection, including tuberculosis, sepsis (blood poisoning) or other opportunistic infections (unusual infections associated with a weakened immune system). It is important to tell your doctor if you have signs or symptoms of infection, such as e.g. fever, wounds, feeling tired, dental problems (see “Warnings and precautions”).
• If you have moderate or severe heart failure. It is important to tell your doctor if you have had or currently have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before using Hyrimoz.
Allergic reaction

• If you experience allergic reactions with symptoms such as a feeling of tightness in the chest, wheezing, dizziness, swelling or skin rash, do not administer Hyrimoz again and contact your doctor immediately as, in rare cases, these reactions can be life-threatening.

Infections

• If you have an infection, including long-term or localized infections (for example, leg ulcers), consult your doctor before starting treatment with Hyrimoz. If you have doubts, contact your doctor.
• You may be more likely to get infections during treatment with Hyrimoz. This risk may increase if your lung function is reduced. These infections can be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other unusual infectious organisms and sepsis (blood poisoning).
• In rare cases, these infections can be life-threatening. It is important to tell your doctor about the presence of symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may advise you to temporarily stop Hyrimoz.

Tuberculosis (TB)

• Because cases of tuberculosis have occurred in patients treated with adalimumab, your doctor will need to check if you have signs or symptoms typical of tuberculosis before starting therapy with Hyrimoz. This will involve collecting a detailed medical assessment including your medical history and clinical examinations (e.g. a chest X-ray and a tuberculin test). The performance and results of these tests must be recorded on the Patient Reminder Card. It is very important to tell your doctor if you have ever had tuberculosis, or if you have been in close contact with people with tuberculosis. Tuberculosis can develop during therapy even if you have received preventive treatment for tuberculosis. Contact your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, lack of energy, moderate fever) or other infections appear during or after therapy.

Travel/recurring infection

• Tell your doctor if you have lived in or travelled to regions where fungal infections, such as histoplasmosis, coccidioidomycosis or blastomycosis, are very common.
• Tell your doctor if you have had recurrent infections or if you have conditions that increase your risk of infection.

Hepatitis B virus

• Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active infection with the hepatitis B virus or if you think you may be at risk of contracting the hepatitis virus
• B. Your doctor should test you for hepatitis B virus infection. Taking adalimumab can reactivate hepatitis B virus infection in subjects who are carriers of this virus. In some rare cases, especially if the patient is undergoing therapy with other drugs that suppress the immune system, reactivation of hepatitis B virus infection can be life-threatening.

Age over 65 years

• If you are over 65 years of age, you may be more susceptible to infections while taking Hyrimoz. You and your doctor should pay particular attention to signs of infection while you are being treated with Hyrimoz. It is important to tell your doctor if symptoms of infections such as fever, wounds, feeling tired or dental problems appear.

Surgery or dental procedures

• Before surgery or dental procedures, tell your doctor that you are taking Hyrimoz. Your doctor may advise you to temporarily stop Hyrimoz.

Demyelinating disease

• If you have or develop demyelinating diseases (diseases that affect the insulating layer around nerves), such as multiple sclerosis, your doctor will decide whether to start or continue treatment with Hyrimoz. Tell your doctor immediately if you experience symptoms such as changes in vision, weakness of arms or legs, or numbness or tingling that affects any part of the body.

Vaccination

• Certain vaccines contain live but weakened forms of bacteria or viruses that cause diseases and should not be administered during treatment with Hyrimoz if they cause infections. Consult your doctor before getting vaccinated. In children, it is advisable to administer the vaccinations recommended for their age before starting therapy with Hyrimoz, if possible. If you have taken Hyrimoz during pregnancy, the child may be at increased risk of contracting such an infection up to about 5 months after the last dose you took during pregnancy. It is important that you tell the pediatrician or other healthcare provider about your use of Hyrimoz during pregnancy, so that they can decide when the child should receive any type of vaccination.

Heart failure

• It is important to inform your doctor about any heart problems, both past and present. If you have mild heart failure and are receiving concomitant treatment with Hyrimoz, your doctor must carefully assess and monitor your heart condition. If new symptoms of heart failure or worsening of existing symptoms (e.g. shortness of breath or swelling of the feet) appear, contact your doctor immediately.

Fever, bruising, bleeding or paleness

• In some patients, the body may not be able to produce enough blood cells to fight infections or stop bleeding. If you have persistent fever, bruising or easy bleeding or paleness, see your doctor immediately. The latter may decide to interrupt the therapy.

Cancer

• Very rarely, some types of cancer have occurred in children and adults treated with adalimumab or other anti-TNFα drugs. Patients with severe, long-standing rheumatoid arthritis may have a higher than average risk of developing lymphoma and leukemia (cancers that affect blood cells and bone marrow). If you are taking Hyrimoz, the risk of developing lymphomas, leukemia or other cancers may increase. In rare circumstances, a specific and serious type of lymphoma has been observed in patients treated with adalimumab. Some of these patients were also taking azathioprine or mercaptopurine. Tell your doctor if you are taking azathioprine or mercaptopurine with Hyrimoz.
• In addition, cases of non-melanoma skin cancer have been observed in patients taking adalimumab. If damaged areas of skin appear during or after treatment, or if the appearance of existing damaged areas changes, report it to your doctor.
• There have been cases of neoplasms, other than lymphoma, in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another anti-TNFα. If you suffer from COPD, or smoke heavily, you should discuss with your doctor whether treatment with an anti-TNFα is appropriate.

Autoimmune diseases

• Rarely, treatment with Hyrimoz can lead to the manifestation of a syndrome like lupus. Tell your doctor if you experience symptoms such as a persistent unexplained skin rash, fever, joint pain or fatigue.

Children and adolescents

• Do not give Hyrimoz to children with polyarticular juvenile idiopathic arthritis under the age of 2 years.
• Do not give Hyrimoz to children with pediatric plaque psoriasis or pediatric ulcerative colitis under the age of 4 years.
• Do not give Hyrimoz to children with pediatric Crohn's disease under the age of 6 years.
• Do not use the 80 mg pre-filled pen if doses other than 80 mg are recommended.

Other medicines and Hyrimoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Hyrimoz can be taken both with methotrexate and with other disease-modifying antirheumatic drugs
(sulfasalazine, hydroxychloroquine, leflunomide and parenteral gold salts), corticosteroids
or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Hyrimoz should not be taken in conjunction with medicines containing the active ingredients anakinra or
abatacept due to the increased risk of having serious infections. The combination of adalimumab and other
anti-TNF and anakinra or abatacept is not recommended due to the possible increase in the risk of
infections, including serious infections and other possible drug interactions. If you have doubts, consult
your doctor.

Pregnancy and breastfeeding

• You should consider using adequate contraceptive measures to prevent pregnancy and continue using them for at least 5 months after the last therapy with Hyrimoz.
• If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice on taking this medicine.
• Hyrimoz should only be used during pregnancy if necessary.
• According to a pregnancy study, no increased risk of birth defects was found when the mother had received adalimumab during pregnancy, compared to mothers who had the same condition but had not received adalimumab.
• Hyrimoz can be used during breastfeeding.
• If you take Hyrimoz during pregnancy, the child may be at increased risk of contracting an infection.
• It is important that you tell the pediatrician or other healthcare provider about your use of Hyrimoz during pregnancy, before the child receives any type of vaccination (for more information on vaccines, see “Warnings and precautions”).

Driving and using machines
Hyrimoz may affect, albeit only to a modest extent, your ability to drive, ride a bicycle or use
machinery. After taking Hyrimoz, you may experience vision disturbances and a feeling that the
environment around you is rotating (dizziness).

Hyrimoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 mL dose, i.e. essentially
‘sodium-free’.

3. How to use Hyrimoz

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended doses of Hyrimoz in each approved indication are listed in the following
table. Your doctor may prescribe a different concentration of Hyrimoz if the child needs a
different dose.

How and route of administration
Hyrimoz is administered by subcutaneous injection (subcutaneous injection).
Detailed instructions on how to inject Hyrimoz are provided in section 7, “Instructions for use”.

If you use more Hyrimoz than you should
If you accidentally inject Hyrimoz more frequently than you should, contact your doctor or
pharmacist explaining that you have taken more medicine than you should. Always keep the box of the
medicine, even if it is empty.

If you forget to use Hyrimoz
If you forget to make an injection, you should inject the next dose of Hyrimoz as soon as you
remember. Then resume the dose regularly according to the prescribed dosage schedule.

If you stop treatment with Hyrimoz
The decision to stop using Hyrimoz should be discussed with your doctor. Symptoms may
return after stopping treatment.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Most side effects are mild to moderate in form. However, some may be serious and require treatment. Side effects may occur
up to 4 months or more after the last injection of Hyrimoz.

Seek medical attention urgentlyif you notice any of the following signs of an allergic reaction or
heart failure

• severe skin rash, hives;
• swelling of the face, hands, feet;
• difficulty breathing, difficulty swallowing;
• shortness of breath during physical activity or when lying down or swollen feet.

Inform your doctor as soon as possibleif you notice any of the following reactions

• signs and symptoms of infection such as fever, feeling unwell, wounds, dental problems, burning when urinating; fatigue or weakness or cough;
• symptoms of nerve problems, such as tingling, numbness, double vision or weakness of the arms or legs;
• signs of skin cancer such as swelling or an open sore that does not heal;
• signs and symptoms suggesting the onset of blood system disorders, such as persistent fever, bruising, bleeding, paleness.

The following side effects have been observed with Hyrimoz

Very common(may affect more than 1 in 10 people)

• reactions at the injection site (including pain, swelling, redness or itching);
• respiratory tract infections (including cold, runny nose, sinusitis and pneumonia);
• headache;
• abdominal pain (stomach ache);
• nausea and vomiting;
• skin rash;
• muscle pain.

Common(may affect up to 1 in 10 people)

• serious infections (including sepsis and influenza);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes zoster infection);
• ear infections;
• mouth infections (including tooth infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• infections affecting the joints;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergy);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, pricking sensations or numbness;
• migraine;
• symptoms of nerve root compression (including back pain and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• dizziness (feeling of spinning);
• feeling of a fast heartbeat;
• high blood pressure;
• hot flashes;
• hematoma (solid swelling with coagulated blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, heartburn);
• acid reflux;
• dry syndrome (including dry eyes and dry mouth);
• itching;
• itchy skin rash;
• bruising;
• skin inflammation (such as eczema);
• breaking of fingernails and toenails;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in the urine;
• kidney problems;
• chest pain;
• edema (fluid retention in the body, causing swelling of the affected tissue);
• fever;
• reduced platelets in the blood, which increases the risk of bleeding or bruising;
• difficulty in wound healing.

Uncommon(may affect up to 1 in 100 people)

• unusual infections (including tuberculosis and other infections) that occur when defenses are lowered;
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumors, including tumors of the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• immune system disorders that can affect lungs, skin and lymph nodes (most commonly a condition called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor (shaking);
• neuropathy (nerve damage);
• stroke;
• hearing loss, ringing in the ears;
• feeling of irregular heartbeat such as palpitations;
• heart problems that can cause shortness of breath or swelling of the ankles;
• acute myocardial infarction (heart attack);
• formation of a sac in the wall of a major artery, inflammation and blood clot in a vein, blockage of a blood vessel;
• lung disease causing shortness of breath (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal collection of fluid in the pleural space);
• inflammation of the pancreas causing severe pain in the abdomen and back;
• difficulty swallowing;
• facial edema (swelling);
• inflammation of the gallbladder, gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scarring;
• abnormal muscle catabolism;
• systemic lupus erythematosus (immune system disorder, including inflammation of the skin, heart, lungs, joints and other organs);
• interrupted sleep;
• impotence;
• inflammations.

Rare(may affect up to 1 in 1,000 people)

• leukemia (a cancer that affects the blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as inflammation of the optic nerve in the eye and Guillain-Barré syndrome, a condition that can cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring of the lung);
• intestinal perforation (hole in the wall of the intestine);
• hepatitis (inflammation of the liver);
• reactivation of hepatitis B infection;
• autoimmune hepatitis (inflammation of the liver caused by your own immune system);
• cutaneous vasculitis (inflammation of the blood vessels in the skin);
• Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and skin rash with blisters);
• facial edema (swelling) associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (itchy red-purple rash).

Not known(frequency cannot be estimated from available data)

• T-cell hepatosplenic lymphoma (a rare blood cancer that is often fatal);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi's sarcoma, a rare cancer associated with human herpes virus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin;
• liver failure;
• worsening of a condition called dermatomyositis (which manifests as a skin rash accompanied by muscle weakness);
• weight gain (weight gain has been low for most patients).

Some of the side effects observed with adalimumab may be asymptomatic and can
only be detected through blood tests. These include:

Very common(may affect more than 1 in 10 people)

• low white blood cell count;
• low red blood cell count;
• increased lipids in the blood;
• increased liver enzymes.

Common(may affect up to 1 in 10 people)

• increased white blood cell count;
• reduced platelet count;
• increased uric acid in the blood;
• alteration of sodium in the blood;
• reduced calcium in the blood;
• reduced phosphorus in the blood;
• increased sugar in the blood;
• increased lactate dehydrogenase in the blood;
• presence of autoantibodies in the blood;
• reduced potassium in the blood.

Uncommon(may affect up to 1 in 100 people)

• high levels of bilirubin in the blood (liver blood test).

Rare(may affect up to 1 in 1,000 people)

• low white blood cell count, red blood cell count and platelet count.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system reported in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Hyrimoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label/blister/box after the
word Exp.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the pre-filled pen in the outer packaging to protect the medicine from light.
Alternative storage conditions:
When necessary (for example when travelling), Hyrimoz can be stored at room temperature (up to 25°C) for a maximum period of 42 days – ensure the medicine is
protected from light. Once it has been removed from the refrigerator to be stored at room temperature, the
pre-filled pen must be used within 42 days or discarded, even if it is subsequently
placed back in the refrigerator. You must record the date on which the pre-filled pen is removed from
the refrigerator for the first time and the date after which the pen must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Hyrimoz contains

• The active substance is adalimumab. Each pre-filled pen contains 80 mg of adalimumab in 0.8 mL of solution.
• The excipients are adipic acid, mannitol (E 421), polysorbate 80 (E 433), hydrochloric acid (E 507), sodium hydroxide (E 524) and water for injections.

Description of Hyrimoz and contents of the pack
Hyrimoz 80 mg solution for injection in pre-filled pen is supplied as 0.8 mL of solution that is
clear to slightly opalescent, colourless or slightly yellowish.
Hyrimoz is supplied in a single-use pre-filled syringe assembled in a triangular pen
with a transparent window and label. The syringe inside the pen is type I glass with a
29 gauge stainless steel needle, a rubber needle inner cap (thermoplastic elastomer)
and a rubber stopper, containing 0.8 mL of solution.
The packs contain 1, 2 and 3 pre-filled Hyrimoz pens.
Not all pack sizes may be marketed.
Hyrimoz is available in pre-filled syringe and in pre-filled pen.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestr. 10
6250 Kundl
Austria

Manufacturer
Sandoz GmbH Schaftenau
Biochemiestr. 10
6336 Langkampfen
Austria
Novartis Pharmaceutical Manufacturing GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Sandoz nv/sa
Tél/Tel: +32 2 722 97 97

Lietuva
Sandoz Pharmaceuticals d.d filialas
Tel: +370 5 2636 037

Luxembourg/Luxemburg
Sandoz nv/sa
Tél/Tel.: +32 2 722 97 97

Česká republika
Sandoz s.r.o.
Tel: +420 225 775 111

България
Сандоз България КЧТ
Тел.: +359 2 970 47 47

Magyarország
Sandoz Hungária Kft.
Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige
Sandoz A/S
Tlf: +45 63 95 10 00

Malta
Sandoz Pharmaceuticals d.d.
Tel: +356 99644126

Deutschland
Hexal AG
Tel: +49 8024 908 0

Nederland
Sandoz B.V.
Tel: +31 36 52 41 600

Eesti
Sandoz d.d. Eesti filiaal
Tel: +372 665 2400

Österreich
Sandoz GmbH
Tel: +43 5338 2000

Ελλάδα
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
Τηλ: +30 216 600 5000

Polska
Sandoz Polska Sp. z o.o.
Tel.: +48 22 209 70 00

España
Sandoz Farmacéutica, S.A.
Tel: +34 900 456 856

Portugal
Sandoz Farmacêutica Lda.
Tel: +351 21 000 86 00

France
Sandoz SAS
Tél: +33 1 49 64 48 00

România
Sandoz Pharmaceuticals SRL
Tel: +40 21 407 51 60

Hrvatska
Sandoz d.o.o.
Tel: +385 1 23 53 111

Slovenija
Sandoz farmacevtska družba d.d.
Tel: +386 1 580 29 02

Ireland
Rowex Ltd.
Tel: + 353 27 50077

Slovenská republika
Sandoz d.d. - organizačná zložka
Tel: +421 2 50 70 6111

Italia
Sandoz S.p.A.
Tel: +39 02 96541

Suomi/Finland
Sandoz A/S
Puh/Tel: +358 10 6133 400

Κύπρος
Sandoz Pharmaceuticals d.d.
Τηλ: +357 22 69 0690

United Kingdom (Northern Ireland)
Sandoz GmbH
Tel: +43 5338 2000

Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu.

7. Instructions for Use

To avoid possible infections and to ensure you use Hyrimoz correctly, it is important that you
follow these instructions.
Make sure you read, understand and follow these Instructions for Use before injecting Hyrimoz.
The healthcare professional must show you how to prepare and inject Hyrimoz correctly using the
Hyrimoz single-dose pre-filled pen before you use the medicine for the first time. If you have
any doubts, ask your healthcare professional.

Single-use pre-filled pen of Hyrimoz

Figure A:parts of the Hyrimoz pen
In Figure A, the pen is shown without the cap. Do not removethe cap until you are ready to administer
the injection.

It is important that you:

• do not usethe pen if the outer package seal or the pen safety seal is broken;
• keep the pen in the sealed outer packaging until you are ready to use it;
• never leavethe pen unattended where it could be tampered with by others;
• do not usethe pen if it has been dropped, appears damaged or if it has been dropped after you removed the cap;
• injectHyrimoz 15-30 minutes after taking it out of the refrigerator, for a more comfortable injection;
• dispose of the used pen immediately after use. Do not reuse the pen.See “4. Disposal of used pens”at the end of these Instructions for Use.

How should you store the pen?

• Store the pen in the refrigerator in its packaging, at a temperature between 2° and 8°C.
• When necessary, for example when travelling, Hyrimoz can be stored at room temperature (up to 25°C) for a maximum period of 42 days - make sure to protect the medicine from light. Once it is removed from the refrigerator to be stored at room temperature, the pre-filled pen must be used within 42 days or discarded, even if it is subsequently placed back in the refrigerator.
• You must record the date on which the pre-filled pen is removed from the refrigerator for the first time and the date after which it must be discarded.
• Store the pen in its original packaging until you are ready to use it, to protect the medicine from light.
• Do not store the pen at extremely high or low temperatures.
• Do not freeze the pen.

Keep Hyrimoz and all medicines out of the reach of children.
What is needed for the injection?
Place the following items on a clean, flat surface.
The package contains:

• Hyrimoz pre-filled pen/s (see Figure A). Each pen contains 80 mg/0.8 mL of adalimumab.

The pen package does not contain (see Figure B):

• Alcohol swab.
• Cotton ball or gauze.
• Sharps disposal container. See “8. Disposal of used pens”at the end of these Instructions for Use.
• Adhesive bandage.

Figure B:items not included in the package

Before the injection
Preparing the pen

• For a more comfortable injection, remove the pen from the refrigerator about 15-30 minutes before the injection to allow it to reach room temperature.
• Look through the window. The solution should be colourless or slightly yellowish and from clear to slightly opalescent. Do not usethe pen if you notice particles and/or colour changes. You may notice some air bubbles. This is normal. If you have any doubts about the appearance of the solution, ask your pharmacist for assistance.
• Check the expiry date (Exp.) on the pen (see Figure C). Do not use the pen if the expiry date has passed.
• Do not use the pen if the safety seal is broken.

Ask your pharmacist if the pen does not pass
any of the checks above.

Figure C:safety checks before
the injection

1. Choice of injection site:

• The recommended injection site is the front of the thighs. You can also use the lower abdomen, but not the area within 5 cm around the navel (see Figure D).
• Choose a different site each time you administer an injection.
• Do not inject the medicine into areas where the skin is painful, bruised, red, flaky, or hardened. Avoid areas with scars or stretch marks. If you suffer from psoriasis, DO NOTinject the medicine directly into areas with psoriasis plaques.

Figure D:how to choose the injection site

2. Injection site cleaning:

• Wash your hands thoroughly with water and soap.
• Using a circular motion, clean the injection site with a swab soaked in alcohol. Allow to dry before administering the injection (see Figure E).
• Do not touch the cleaned area before the injection.

Figure E:how to clean the injection site

3. Removing the pen cap:

• Remove the cap only when you are ready to use the pen.
• Rotate the cap in the direction of the arrows (see Figure F).
• Once the cap is removed, discard it. Do notattempt to replace the cap.
• Use the pen within 5 minutes of removing the cap.
• You may notice a few drops of liquid coming out of the needle. This is normal.

Figure F:how to remove the cap

4. How to hold the pen:

• Hold the pen at 90 degrees to the clean injection site (see Figure G).

CorrectIncorrect
Figure G:how to hold the pen

Injection
Read before performing the injection
During the injection you will feel 2 clicks:
o The first clickindicates that the injection has started.
o A moment later, a second clickindicates that the injection is almostfinished.
You must keep the pen pressed firmly against the skin until you see a green
indicatorfill the window and stop moving.

5. Start of injection:

• Press the pen firmly against the skin to start the injection (see Figure H).
• The first clickindicates that the injection has started.
• Keep pressingthe pen firmly against the skin.
• The green indicatorshows the progress of the injection.

Figure H:how to start the injection

6. Completion of the injection:

• Pay attention to the second clickwhich indicates that the injection is almostcomplete.
• Check that the green indicatorfills the window and has stopped moving (see Figure I).
• Now you can remove the pen.

Figure I:how to complete the injection

After the injection

7. Check that the green indicator

fills the window(see Figure J) :

• This means that the medicine has been administered. Contact your doctor if the green indicator is not visible.
• You may notice a small amount of blood at the injection site. You can press a cotton ball or gauze on the injection site and hold it for 10 seconds. Do not rub the injection site. If necessary, you can cover the injection site with a small adhesive bandage.

Figure J:how to check the green indicator

8. Disposal of used pens:

• Dispose of the used pen in a sharps container (a resealable, puncture-resistant container, see Figure K). For your safety and the safety of others, used pens must never be reused.
• Do not dispose of any medicine down the drain or with household waste. Ask your doctor or pharmacist how to dispose of medicines you no longer use. This will help protect the environment. Unused medicine and waste from that medicine must be disposed of in accordance with local regulations. Figure K:how to dispose of the used pen

If you have any doubts, please contact a doctor, pharmacist or nurse familiar with
Hyrimoz.