OLUMIANT 2 mg Tabletki Powlekane

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1. Olumiant 1 mg film-coated tablets, 2 mg film-coated tablets, 4 mg film-coated tablets
   1. What is Olumiant and what is it used for
   2. What you need to know before you take Olumiant
2. Olumiant in the blood. If you are taking probenecid, the recommended dose of Olumiant for
   1. How to take Olumiant
   2. Possible side effects
   3. How to store Olumiant
   4. Package contents and other information

Olumiant 1 mg film-coated tablets, 2 mg film-coated tablets, 4 mg film-coated tablets

baricitinib

Read this leaflet carefully before you are given this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• 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 you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What is Olumiant and what is it used for

Olumiant contains the active substance baricitinib and belongs to a group of medicines called
Janus kinase inhibitors, which help to reduce inflammation.

Rheumatoid arthritis
Olumiant is used to treat adults with moderate to severe rheumatoid arthritis, an
inflammatory joint disease, when previous therapy has not worked well enough
or has not been tolerated. Olumiant can be used alone or with other medicines, such as
methotrexate.
Olumiant works by reducing the activity of an enzyme present in the body called 'Janus kinase',
which is involved in the inflammatory process. By reducing the activity of this enzyme, Olumiant helps to
reduce pain, stiffness and swelling of the joints, fatigue, and helps to slow down damage
to the bones and cartilage of the joints. These effects can help to perform normal
daily activities and thus improve the quality of life related to health for patients with rheumatoid
arthritis.

Atopic dermatitis
Olumiant is used to treat children from 2 years of age, adolescents and adults with
moderate to severe atopic dermatitis, also known as atopic eczema. Olumiant can be used
with medicines that are applied to the skin for eczema or can be used alone.
Olumiant works by reducing the activity of an enzyme present in the body called 'Janus kinase',
which is involved in the inflammatory process. By reducing the activity of this enzyme, Olumiant helps to
improve the condition of the skin and reduce itching. In addition, Olumiant helps to improve sleep disturbances
(due to itching) and overall quality of life. Olumiant has been shown to improve
symptoms of skin pain, anxiety and depression associated with atopic dermatitis.

Alopecia areata
Olumiant is used to treat adults with severe alopecia areata, an autoimmune disease
characterized by inflammation, non-scarring hair loss on the scalp, face and
sometimes on other areas of the body and which can be recurrent and progressive.
Olumiant works by reducing the activity of an enzyme present in the body called 'Janus kinase',
which is involved in the inflammatory process. By reducing the activity of this enzyme, Olumiant helps to make
hair regrow on the scalp, face and other areas of the body affected by the disease.

Polyarticular juvenile idiopathic arthritis, arthritis associated with enthesitis and juvenile psoriatic arthritis

Olumiant is used for the treatment of active polyarticular juvenile idiopathic arthritis, an inflammatory disease
of the joints, in children aged 2 years and older.
Olumiant is also used for the treatment of active arthritis related to enthesitis, an inflammatory disease
of the joints and the points where tendons attach to bone, in children aged 2 years and older.
Olumiant is also used for the treatment of active juvenile psoriatic arthritis, a condition that is
an inflammatory joint disease often accompanied by psoriasis, in children aged 2 years and older.
Olumiant can be used alone or with methotrexate.

2. What you need to know before you take Olumiant

Do not take Olumiant

• if you are allergic to baricitinib or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or suspect you may be pregnant.

Warnings and precautions
Talk to your doctor or pharmacist before and during treatment with Olumiant if:

• you are over 65 years old. Patients aged 65 years or older may be at increased risk of infections, including heart problems such as heart attack and certain types of cancer. Your doctor will discuss with you whether Olumiant is appropriate for you
• you have an infection, or if you frequently get infections. Tell your doctor if you have symptoms such as fever, wounds, feel more tired than usual or have dental problems as these can be signs of infection. Olumiant may reduce the body's ability to fight infections and may worsen an existing infection or increase the likelihood of getting a new infection. If you have diabetes or are over 65 years old you may have a greater chance of getting infections
• you have, or have had in the past, tuberculosis. You may need to have tests for tuberculosis before taking Olumiant. Tell your doctor if you develop a persistent cough, fever, night sweats and weight loss during treatment with Olumiant, as these can be signs of tuberculosis
• you have had a herpes infection (herpes zoster - shingles), because Olumiant may cause it to reappear. Tell your doctor if you develop a painful rash with blisters during treatment with Olumiant, as these can be signs of herpes zoster
• you have, or have had in the past, hepatitis B or C
• you are due to receive a vaccination. During the use of Olumiant you should not be given any (live) vaccine
• you have or have had cancer, smoke or have smoked in the past, because your doctor will discuss with you whether Olumiant is appropriate for you
• you have liver problems
• you have or have had heart problems, because your doctor will discuss with you whether Olumiant is appropriate for you
• you have previously had blood clots in the veins of the legs (deep vein thrombosis) or the lungs (pulmonary embolism), or if you are at increased risk of developing them (for example: if you have recently had major surgery, if you use hormonal contraceptives/hormone replacement therapy or if a clotting disorder has been diagnosed in you or your close relatives). Your doctor will discuss with you whether Olumiant is appropriate for you. Tell your doctor if you experience sudden shortness of breath or difficulty breathing, chest pain or pain in the upper back, swelling of the leg or arm, pain or tenderness in the legs or redness or discoloration of the leg or arm as these can be signs of blood clots in the veins
• you have had diverticulitis (a type of inflammation of the large intestine) or ulcers of the stomach or intestine (see section 4)
• a different type of skin cancer other than melanoma has been observed in patients taking Olumiant. Your doctor may recommend that you have regular skin exams while taking Olumiant. If new skin lesions appear during or after therapy or if existing lesions change in appearance, tell your doctor.

You should immediately tell a doctor if you notice any of the following serious adverse events:

• wheezing
• severe dizziness or mild confusion
• swelling of lips, tongue or throat
• urticaria (itchy, raised rash)
• severe abdominal pain accompanied in particular by fever, nausea and vomiting
• severe chest pain or tightness (which may spread to arms, jaw, neck, back)
• shortness of breath
• cold sweats
• one-sided weakness in the arm and/or leg
• slurred speech

Before starting to take Olumiant, or during treatment, it may be necessary to perform blood tests to check if you have a low number of red blood cells (anemia), a low number of white blood cells (neutropenia or lymphopenia), a high fat content in the blood (cholesterol) or high levels of liver enzymes, in order to ensure that treatment with Olumiant does not cause problems.

Children and adolescents
If possible, children and adolescents should be up to date with all vaccinations before using Olumiant.
Do not give this medicine to children under 2 years of age.
Do not give this medicine to children and adolescents with alopecia areata under 18 years of age, because there is no information on how it works in this disease.

Other medicines and Olumiant
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, before taking Olumiant tell your doctor or pharmacist if you are taking any other medicine such as:

• probenecid (for gout), as this medicine may increase the levels of

Olumiant in the blood. If you are taking probenecid, the recommended dose of Olumiant for

adults is 2 mg once a day and for children and adolescents the dose should be reduced by
half.

• rheumatic disease-modifying injectable medications.
• injectable medications that suppress the immune system, including so-called biological target (antibody) therapies
• medications that are used to control the body's immune response, such as azathioprine, tacrolimus or cyclosporine.
• other medications that belong to the group of Janus kinase inhibitors.
• medications that may increase the risk of diverticulitis such as non-steroidal anti-inflammatory drugs (usually used in the treatment of painful and/or inflammatory conditions at the muscle or joint level) and/or opioids (used in the treatment of severe pain), and/or corticosteroids (usually used in the treatment of inflammatory conditions) (see section 4)
• medications for the treatment of diabetes or if you have diabetes. Your doctor may decide if you need to reduce the dose of antidiabetic medications while taking Olumiant.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect or are planning a
pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Use an effective method of contraception to avoid pregnancy during treatment with
Olumiant and for at least one week after the last treatment with Olumiant. You must inform
your doctor if you become pregnant as Olumiant should not be used during
pregnancy.
Do not take Olumiant during breastfeeding as it is not known whether this medicine
passes into breast milk. Together with your doctor, you must decide whether to breastfeed or use Olumiant. You cannot
do both.

Driving and using machines
Olumiant does not affect the ability to drive vehicles and use machines.

Olumiant contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially
“sodium-free”.

3. How to take Olumiant

Treatment must be started by a doctor experienced in the diagnosis and treatment of your
condition. Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you have any doubts.

Adults with rheumatoid arthritis, atopic dermatitis and alopecia areata
The recommended dose is 4 mg once a day. Your doctor may prescribe a lower dose,
i.e. 2 mg once a day, especially if you are over 65 years of age or if you have an increased risk
of developing infections, blood clots, major cardiovascular events or cancer.
If the medicine is working well, your doctor may decide to reduce the dose.
If you have reduced kidney function, the recommended dose of Olumiant is 2 mg once a day.

Use in children and adolescents
The recommended dose is 4 mg once a day for patients weighing ≥ 30 kg. For patients weighing
between 10 kg and < 30 kg the recommended dose is 2 mg once a day.
If you have reduced kidney function, the recommended dose of Olumiant should be halved.
For pediatric patients who are unable to swallow whole tablets, the tablets may
be dispersed in water:

• Place the whole tablet in a container with 5-10 ml of water at room temperature and gently stir to disperse (break up) the tablet. It may take up to 10 minutes before the tablet disperses into a cloudy pale pink suspension. Some sediment may form.
• After the tablet has dispersed, stir gently again and then immediately swallow the mixture
• Rinse the container with 5-10 ml of water at room temperature, stirring and immediately swallow the mixture to ensure the full dose is taken.

Only water should be used to disperse the tablet.
After the tablet has been dispersed in water, it can be used for up to 4 hours if kept at
room temperature.
If a tablet is dispersed in water and only part of the dispersed dose is taken, wait
until the next day to take the next scheduled dose.

Method of administration
Olumiant is taken orally. Swallow the tablet with the help of a glass of water.
You can take the tablets with or without food. To help you remember to take Olumiant, you may find
it easier to take it at the same time each day.

If you take more Olumiant than you should
If you take more Olumiant than you should, contact your doctor. You may experience some of the side
effects described in section 4.

If you forget to take Olumiant

• If you forget a dose, take it as soon as you remember.
• If you forget a dose for a whole day, skip the missed dose and only take a single dose the next day as scheduled.
• Do not take a double dose to make up for a missed dose.

If you stop taking Olumiant
Do not stop taking Olumiant unless your doctor tells you to do so.
If you have any further questions on 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 gets them.

Serious adverse events
Infection, such as Herpes Zoster (shingles) and pulmonary infection, which may occur in up to 1 in 10 patients:
Inform your doctor or seek immediate medical attention if you have the following symptoms, which may
be manifestations of:

• shingles (herpes zoster): painful rash with blistering and fever (very rare in atopic dermatitis and uncommon in alopecia areata)
• pulmonary infection: persistent cough, fever, shortness of breath and fatigue (uncommon in atopic dermatitis and alopecia areata) Serious pulmonary infection and severe herpes zoster have been uncommon

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

• throat and nose infections
• high levels of fats in the blood (cholesterol) detected by blood tests

Common(may affect up to 1 in 10 people)

• cold sores (herpes simplex)
• infection causing stomach upset or diarrhea (gastroenteritis)
• urinary infection
• increased number of platelets (cells involved in blood clotting), detected by blood tests (uncommon in atopic dermatitis and alopecia areata)
• headache
• feeling unwell in the stomach (nausea, uncommon in atopic dermatitis)
• stomach pain (uncommon in alopecia areata)
• increased liver enzymes, detected by blood tests (uncommon in atopic dermatitis)
• skin rash
• acne (uncommon in rheumatoid arthritis)
• increased enzyme called creatine kinase, detected by blood test (uncommon in rheumatoid arthritis)
• inflammation (swelling) of hair follicles, particularly in the scalp region associated with hair regrowth (observed in alopecia areata)

Uncommon(may affect up to 1 in 100 people)

• low number of white blood cells (neutrophils) in the blood, detected by blood tests
• high levels of fats in the blood (triglycerides) detected by blood tests
• high levels of liver enzymes, detected by blood tests (common in alopecia areata)
• weight gain
• facial swelling
• hives
• blood clots in the lungs
• blood clot in the veins of the legs or pelvis, called deep vein thrombosis (DVT)
• diverticulitis (inflammation of small pouches that form in the wall of the intestine)

Children and adolescents

• Juvenile idiopathic polyarticular arthritis, enthesitis-associated arthritis and juvenile psoriatic arthritis: in a study of children aged 2 years and older with juvenile idiopathic polyarticular arthritis, enthesitis-associated arthritis and juvenile psoriatic arthritis, headache was very common, low number of white blood cells and blood clots in the lungs were common (1 in 82 children).
• Pediatric atopic dermatitis:in a study of children aged 2 years and older with atopic dermatitis, side effects were consistent with those seen in adult patients with the exception of low number of white blood cells (neutrophils) which was more common compared to adults.

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

5. How to store Olumiant

Keep this medicine out of the sight and reach of children.
This medicine does not require special storage conditions.
Do not use this medicine after the expiry date which is stated on the blister and the carton after
‘EXP’/’Scad.’. The expiry date refers to the last day of that month.
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 Olumiant contains

• The active ingredient is baricitinib. Each tablet contains 1, 2 or 4 milligrams of baricitinib.
• The other ingredients are microcrystalline cellulose, sodium croscarmellose (see section 2 “Olumiant contains sodium”), magnesium stearate, mannitol, red iron oxide (E172), lecithin (soy) (E322), macrogol, polyvinyl alcohol, talc and titanium dioxide (E171).

Description of Olumiant and package contents
Olumiant 1 mg film-coated tablets are light pink in colour, 6.75 mm in size
round in shape, with "Lilly" imprinted on one side and "1" on the other side.
Olumiant 2 mg film-coated tablets are light pink in colour, 9 x 7.5 mm in shape
oblong, with "Lilly" imprinted on one side and "2" on the other side.
Olumiant 4 mg film-coated tablets are pink in colour, 8.5 mm in size, round in shape,
with "Lilly" imprinted on one side and "4" on the other side.
The tablets are rounded and have a recess on the sides to facilitate gripping.
Olumiant 1 mg is available in packs of 14 and 28 tablets in blister packs with a calendar and in
28 x 1 tablet blister packs divisible for a single dose. Olumiant 2 mg and 4 mg are available in
packs of 14, 28, 35, 56, 84 and 98 tablets in blister packs with a calendar and in 28 x 1 and
84 x 1 tablet blister packs divisible for a single dose. Not all pack sizes may be
marketed.

Marketing Authorisation Holder
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ, Utrecht, Netherlands

Manufacturer
Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600

България
ТП "Ели Лили Недерланд" Б.В. - България
тел. + 359 2 491 41 40

Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111

Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100

Danmark
Eli Lilly Danmark A/S
Tlf: +45 45 26 60 00

Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500

Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222

Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800

Eesti
Eli Lilly Nederland B.V.
Tel: +372 6 817 280

Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00

Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600

Österreich
Eli Lilly Ges.m.b.H.
Tel: + 43-(0) 1 711 780

España
Lilly S.A.
Tel: + 34-91 663 50 00

Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00

France
Lilly France
Tél: +33-(0) 1 55 49 34 34

Portugal
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600

Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999

România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000

Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377

Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10

Ísland
Icepharma hf.
Sími + 354 540 8000

Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111

Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571

Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000

Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā
Tel: +371 67364000

United Kingdom (Northern Ireland)
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377

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.
Insert QR code + www.olumiant.eu
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