TERIFLUNOMIDE 14 mg Tabletki Powlekane

Treść ulotki

1. Teriflunomide Zentiva 14 mg film-coated tablets
   1. What is Teriflunomide Zentiva and what is it used for
   2. What you need to know before taking Teriflunomide Zentiva
   3. How to take Teriflunomide Zentiva
   4. Possible side effects
   5. How to store Teriflunomide Zentiva
   6. Package contents and other information

Teriflunomide Zentiva 14 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

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

Contents of this leaflet

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

1. What is Teriflunomide Zentiva and what is it used for

What is Teriflunomide Zentiva
Teriflunomide Zentiva contains the active ingredient teriflunomide, which is an immunomodulatory agent and
modulates the immune system to limit its attacks on the nervous system.

What is Teriflunomide Zentiva used for
Teriflunomide Zentiva is used in adults, children and adolescents (aged 10 years and over) for the treatment of relapsing-remitting multiple sclerosis (RRMS)

What is multiple sclerosis
MS is a long-term disease that affects the central nervous system (CNS), a system consisting of the brain and spinal cord. In multiple sclerosis, inflammation destroys the protective sheath (called myelin) that covers the nerves of the CNS. This loss of myelin is called demyelination. It prevents nerves from functioning properly.
People who suffer from a relapsing form of multiple sclerosis have repeated attacks (relapses) of physical symptoms caused by improper nerve function. These symptoms vary from patient to patient, but generally include:

• difficulty walking
• visual problems
• balance problems.

Symptoms may disappear completely at the end of the relapse, but over time some problems may persist even between relapses. This can cause physical disability that can interfere with daily activities.

How does Teriflunomide Zentiva work
Teriflunomide Zentiva helps to protect the central nervous system from attacks by the immune system, by limiting the increase of certain cells belonging to white blood cells (lymphocytes). This limits the inflammation that leads to nerve damage characteristic of MS.

2. What you need to know before taking Teriflunomide Zentiva

Do not take Teriflunomide Zentiva:

• if you are allergic to teriflunomide or any of the other ingredients of this medicine (listed in section 6),
• if you have developed a severe skin rash or peeling of the skin, blistering and/or sores in the mouth after taking teriflunomide or leflunomide,
• if you have severe liver problems,
• if you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
• if you have any serious condition that alters the immune system (e.g. acquired immunodeficiency syndrome (AIDS)),
• if you have any serious problems with your bone marrow or if you have low red blood cell or white blood cell counts in your blood or a reduced number of platelets,
• if you have a serious infection,
• if you have severe kidney problems, requiring dialysis,
• if you have very low levels of protein in your blood (hypoproteinaemia).

If you have any doubts, ask your doctor or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Teriflunomide Zentiva if:

• you have liver problems and/or consume large amounts of alcohol, your doctor will require blood tests before and during treatment to check your liver function. If the blood test results show a liver problem, your doctor may ask you to stop treatment with Teriflunomide Zentiva. Read section 4.
• you have high blood pressure (hypertension), whether controlled or not with medication. Teriflunomide Zentiva can cause an increase in blood pressure. Your doctor will check your blood pressure before starting treatment and regularly afterwards. Read section 4.
• you have an infection. Before taking Teriflunomide Zentiva, your doctor will check that your white blood cell and platelet count in your blood is sufficient. Because Teriflunomide Zentiva decreases the number of white blood cells in your blood, this may affect your ability to fight infection. If you believe you have any infection, your doctor may perform blood tests to check your white blood cells. Infections from the herpes virus, including oral herpes or shingles (herpes zoster) can occur with teriflunomide treatment. In some cases, serious complications have occurred. You should immediately inform your doctor if you suspect you have any symptoms of a herpes virus infection. Read section 4.
• you have severe skin reactions.
• you have respiratory symptoms.
• you have weakness, numbness and pain in your hands or feet.
• you are to undergo vaccination.
• you are taking leflunomide with Teriflunomide Zentiva.
• you are switching to or from treatment with Teriflunomide Zentiva. You will need to undergo a specific blood test (calcium level). Falsely low calcium levels may occur.

Respiratory reactions
Tell your doctor if you have unexplained cough and shortness of breath. Your doctor may perform further
checks.

Children and adolescents
Teriflunomide Zentiva is not indicated in children under 10 years of age, as it has not been studied in patients with MS in this age group.
The warnings and precautions listed above also apply to children. The following information
is important for children and those who care for them:

• inflammation of the pancreas has been observed in patients taking teriflunomide. Your child’s doctor may perform blood tests if pancreatic inflammation is suspected.

Other medicines and Teriflunomide Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without a prescription.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• leflunomide, methotrexate and other medicines that alter the immune system (commonly called immunosuppressants or immunomodulators)
• rifampicin (a medicine used to treat tuberculosis and other infections)
• carbamazepine, phenobarbital, phenytoin for epilepsy
• St John’s Wort (a herbal medicine for depression)
• repaglinide, pioglitazone, nateglinide or rosiglitazone for diabetes
• daunorubicin, doxorubicin, paclitaxel or topotecan for cancer
• duloxetine for depression, urinary incontinence or kidney problems in diabetics
• alosetron for managing severe diarrhoea
• theophylline for asthma
• tizanidine, a muscle relaxant
• warfarin, an anticoagulant used to thin the blood (i.e. make it more fluid) in order to prevent the formation of clots
• oral contraceptives (containing ethinylestradiol and levonorgestrel)
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections
• indometacin, ketoprofen for pain or inflammation
• furosemide for heart disease
• cimetidine for reducing stomach acid
• zidovudine for HIV infection
• rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolaemia (high cholesterol)
• sulfasalazine for inflammatory bowel disease or rheumatoid arthritis
• cholestyramine for high cholesterol or relief of itching in liver disease
• activated charcoal to reduce the absorption of medicines or other substances.

Pregnancy and breastfeeding
Donot take Teriflunomide Zentiva if you are pregnant or suspect you are pregnant. If you are
pregnant or become pregnant while taking Teriflunomide Zentiva, the risk
that your baby will have birth defects increases. Women of childbearing potential should not take this
medicine without using reliable contraceptive measures.
If your daughter has her first menstrual period during treatment with Teriflunomide Zentiva, you should inform the
doctor, who will provide specialist advice regarding contraception and potential risks in case of
pregnancy.
Tell your doctor if you intend to become pregnant after stopping treatment with Terifluno-
mide Zentiva, because before planning a pregnancy you must be sure that most of
this medicine has been eliminated from your body. Elimination of the active ingredient can take
up to 2 years to occur naturally. This period can be reduced to a few weeks
by taking certain medicines that accelerate the elimination of Teriflunomide Zentiva from the body.
In each case, it must be confirmed with a blood test that the active ingredient has been eliminated from the body to a sufficient extent and you must await confirmation from the doctor that the level of
Teriflunomide Zentiva in the blood is sufficiently low to allow the start of a pregnancy.
For further information on laboratory tests, consult your doctor.
If you suspect you are pregnant while taking Teriflunomide Zentiva or within two years of stopping treatment, you must stop Teriflunomide Zentiva and see your doctor immediately
for a pregnancy test. If the test confirms the pregnancy, your doctor may suggest treatment with certain medicines to eliminate Teriflunomide Zentiva quickly and sufficiently
from the body, as this can reduce the risk to the fetus.
Contraception
You must use an effective method of contraception during and after treatment with Teriflunomide
Zentiva. Teriflunomide remains in the blood for a long time after stopping treatment. Continue to
use effective contraception after stopping treatment.

• Continue until the levels of Teriflunomide Zentiva in your blood are sufficiently low. Your doctor will monitor them.
• Consult your doctor about the best method of contraception for you and if you need to change your contraception. Do not take Teriflunomide Zentiva if you are breastfeeding, as teriflunomide passes into breast milk.

Driving and using machines
Teriflunomide Zentiva can cause dizziness which may impair your ability to
concentrate and react. Do not drive vehicles or use machines if you experience this symptom.

Teriflunomide Zentiva contains lactose
Teriflunomide Zentiva contains lactose (a type of sugar). If you have been told you have an intolerance
to certain sugars, contact your doctor before taking this medicine.

Teriflunomide Zentiva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say essentially
‘sodium-free’.

3. How to take Teriflunomide Zentiva

Take this medicine exactly as your doctor has told you. If you have any doubts, ask your
doctor.
Treatment with Teriflunomide Zentiva must be supervised by a doctor experienced in the treat-
ment of multiple sclerosis.

Adults
The recommended dose is one 14 mg tablet a day.

Children and adolescents (10 years of age or older)
The dose depends on body weight:

• Children with a body weight greater than 40 kg: one 14 mg tablet a day.
• Children with a body weight less than or equal to 40 kg: one 7 mg tablet a day.

Teriflunomide Zentiva 14 mg film-coated tablets are not suitable for paediatric patients with a body
weight less than or equal to 40 kg.
There are other medicines containing teriflunomide with a lower dosage (such as 7 mg film-coated
tablets).
Children and adolescents who reach a stable body weight greater than 40 kg will be
advised by their doctor to switch to a 14 mg tablet a day.

Route/method of administration
Teriflunomide Zentiva is for oral use. Teriflunomide Zentiva is taken every day in a single
daily dose at any time of day.
The tablet must be swallowed whole with a little water.
Teriflunomide Zentiva can be taken with or without food.

If you take more Teriflunomide Zentiva than you should
If you have taken too much Teriflunomide Zentiva, call your doctor immediately. You may develop undesirable
effects similar to those described below in section 4.

If you forget to take Teriflunomide Zentiva
Do not take a double dose to make up for a missed tablet. Take the next dose
at the scheduled time.

If you stop taking Teriflunomide Zentiva
Do not stop using Teriflunomide Zentiva or change the dose without first talking to your
doctor.
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 everybody gets them.
The following side effects may occur with this medicine.

Serious side effects
Some side effects may be or may become serious. Tell your doctor immediately if you notice any of the following serious side effects.

Common (may affect up to 1 in 10 people)

• inflammation of the pancreas which may include symptoms of pain in the abdomen, nausea or vo- miting (the frequency is common in pediatric patients and uncommon in adult patients).

Uncommon(may affect up to 1 in 100)

• allergic reactions which may include symptoms of skin rash, hives, swelling of the lips, tongue or face or sudden difficulty in breathing
• severe skin reactions which may include symptoms of skin rash, blisters, fever, or ulcers in the mouth
• serious infections or sepsis (a type of infection with potentially life-threatening danger) which may include symptoms of high fever, shivering, chills, reduced urine flow, or confusion
• inflammation of the lungs which may include symptoms of shortness of breath or persistent cough

Not known(frequency cannot be estimated from available data)

• serious liver diseases which may include symptoms of yellowing of the skin or whites of the eyes, urine darker than usual, unexplained nausea and vomiting, or abdominal pains

Other side effectsmay occur with the following frequencies:

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

• headache
• diarrhea, feeling unwell
• increased ALT (increased levels of certain liver enzymes in the blood) found with tests
• hair thinning

Common(may affect up to 1 in 10 people):

• influenza, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and discomfort when swallowing, cystitis, viral gastroenteritis, oral herpes, dental infection, laryngitis, fungal foot infection
• herpes virus infections, including oral herpes and herpes zoster (shingles) with symptoms such as blisters, burning, itching, numbness or pain in the skin, usually on one side of the upper body or face, and other symptoms such as fever and weakness
• laboratory tests: decreases in the number of red blood cells (anemia), changes in test results relating to the liver and white blood cells (see section 2), and also increases in a muscle enzyme (creatine phosphokinase) have been observed
• mild allergic reactions
• feeling anxious
• tingling, feeling of weakness, numbness, tingling or pain in the lower back or legs (sciatica); feeling of numbness, tingling or pain in the hands and fingers (carpal tunnel syndrome)
• feeling your heartbeat
• increased blood pressure
• vomiting, toothache, upper abdominal pain
• skin rash, acne
• tendon, joint, bone pain, muscle pain (musculoskeletal pain)
• need to urinate more often than usual
• heavy menstrual bleeding
• pain
• lack of energy or feeling weak (asthenia)
• weight loss

Uncommon(may affect up to 1 in 100):

• decrease in the number of platelets (mild thrombocytopenia)
• increased sensitivity, especially of the skin; shooting or pulsating pain in one or more nerves, problems with the nerves in the arms or legs (peripheral neuropathy)
• nail disorders, severe skin reactions
• post-traumatic pain
• psoriasis
• inflammation of the mouth/lips
• abnormal levels of fats (lipids) in the blood
• inflammation of the colon (colitis)

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

• Inflammation or damage to the liver

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

• Pulmonary hypertension

Children (10 years of age and over) and adolescents
The side effects listed above also apply to children and adolescents. The following additional informa-
tion is important for children, adolescents and those who care for them:

Common(may affect up to 1 in 10)

• Pancreas inflammation

Reporting of suspected adverse reactions
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Teriflunomide Zentiva

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 pack after “Exp”. The expiry
date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dis-
pose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Teriflunomide Zentiva contains
The active ingredient is teriflunomide. Each tablet contains 14 mg of teriflunomide.
The other ingredients are lactose monohydrate, microcrystalline cellulose, corn starch, sodium starch
glycolate (type A), hydroxypropylcellulose, magnesium stearate, hypromellose, calcium carbonate, triacetin,
indigo carmine - aluminum lake (E132)

Description of Teriflunomide Zentiva and package contents
Teriflunomide Zentiva 14 mg film-coated tablets (tablets) are round, blue, 7 mm in
diameter and with the inscription “C14” imprinted on one side.
Packs: 14, 28, 84 or 98 film-coated tablets
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer
Marketing authorization holder
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milan

Manufacturer
Coripharma ehf.
Reykjavikurvegur 78
IS-220 Hafnarfjordur
Iceland

This medicinal product is authorized in the Member States of the European Economic Area under the
following denominations:
Austria: Teriflunomid Zentiva 14 mg Filmtabletten
Bulgaria: Терифлуномид Зентива
Czech Republic: Teriflunomid Zentiva
Germany: Teriflunomid Zentiva 14 mg Filmtabletten
Denmark: Teriflunomid Zentiva
Estonia: Teriflunomide Zentiva
Spain: Teriflunomida Zentiva 14 mg comprimidos recubiertos con pelicula EFG
France: Teriflunomide Zentiva 14 mg, comprimé pelliculé
Croatia: Teriflunomid Zentiva 14 mg filmom obložene tablete
Hungary: Teriflunomide Zentiva 14mg filmtabletta
Iceland: Teriflunomid Zentiva
Lithuania: Teriflunomide Zentiva 14 mg plėvele dengtos tabletės
Latvia: Teriflunomide Zentiva 14 mg apvalkotās tabletes
Norway: Teriflunomid Zentiva
Poland: Teriflunomide Zentiva
Portugal: Teriflunomida Zentiva
Romania: Teriflunomida Zentiva 14mg, comprimate filmate
Sweden: Teriflunomid Zentiva
Slovakia: Teriflunomide Zentiva

Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines
Agency.