Teriflunomide teva

Package leaflet: Information for the patient

Teriflunomide Teva, 14 mg, coated tablets
Teriflunomidum
Read the entire leaflet carefully before starting treatment, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of contents

1. What Teriflunomide Teva is and what it is used for
2. Important information before taking Teriflunomide Teva
3. How to take Teriflunomide Teva
4. Possible side effects
5. How to store Teriflunomide Teva
6. Contents of the pack and other information

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

What Teriflunomide Teva is
Teriflunomide Teva contains the active substance teriflunomide, which is an immunomodulatory agent that regulates the immune system in order to reduce its attack on the nervous system.

What Teriflunomide Teva is used for
Teriflunomide Teva is used to treat adults, children, and adolescents (aged 10 years and older) with relapsing-remitting multiple sclerosis.

What is multiple sclerosis
Multiple sclerosis is a chronic disease that attacks the central nervous system. The central nervous system consists of the brain and spinal cord. In multiple sclerosis, inflammation destroys the protective covering (called myelin) around the nerves in the central nervous system. This process is known as demyelination. It prevents nerves from functioning properly.

In people with relapsing-remitting multiple sclerosis, there are recurring attacks (relapses) of physical symptoms caused by improper nerve function. Symptoms vary between patients but usually include:

• difficulty walking,
• vision problems,
• balance problems.

These symptoms may completely disappear after a relapse ends, but over time, some problems may persist between relapses. This may lead to physical disability that interferes with daily activities.

How Teriflunomide Teva works
Teriflunomide Teva helps protect the central nervous system from immune system activity by reducing the increase in certain white blood cells (lymphocytes). This reduces the inflammation that, in patients with multiple sclerosis, leads to nerve damage.

2. Important information before taking Teriflunomide Teva

When not to take Teriflunomide Teva:

• if the patient is allergic to teriflunomide or any of the other ingredients of this medicine (listed in section 6);
• if the patient has ever experienced severe skin rash, skin peeling, blisters and/or oral ulceration after taking teriflunomide or leflunomide;
• if the patient has severe liver disease;
• if the patient is pregnant, suspects she may be pregnant, or is breastfeeding;
• if the patient has any severe diseases affecting the immune system, e.g. acquired immunodeficiency syndrome (AIDS);
• if the patient has any severe bone marrow disorders or has low numbers of red or white blood cells or reduced platelet count;
• if the patient has a severe infection;
• if the patient has severe kidney disease requiring dialysis;
• if the patient has very low levels of protein in the blood (hypoproteinemia).
  If in doubt, consult a doctor or pharmacist before taking this medicine.

Warnings and precautions
Before starting treatment with Teriflunomide Teva, discuss with your doctor or
pharmacist if:

• the patient has liver function disorders and/or drinks large amounts of alcohol; the doctor may perform blood tests to check liver function before and during treatment. If test results indicate impaired liver function, the doctor may discontinue treatment with Teriflunomide Teva. Please refer to section 4.
• the patient has high blood pressure (hypertension), regardless of whether it is controlled with medication or not. Teriflunomide Teva may increase blood pressure. The doctor will monitor the patient’s blood pressure before starting treatment and regularly thereafter. Please refer to section 4.
• the patient has an infection. Before the patient takes Teriflunomide Teva, the doctor will ensure the patient has adequate levels of white blood cells and platelets in the blood. Since Teriflunomide Teva reduces the number of white blood cells, it may impair the ability to fight infections. The doctor may perform blood tests to check white blood cell count if the patient suspects an infection. Please refer to section 4.
• the patient has experienced severe skin reactions.
• the patient has respiratory symptoms.
• the patient experiences weakness, numbness, or pain in the hands and feet.
• the patient intends to receive vaccination.
• the patient is taking leflunomide together with Teriflunomide Teva.
• the patient is switching from another medicine to Teriflunomide Teva or from Teriflunomide Teva to another medicine.
• the patient is scheduled for a specific blood test (calcium level measurement). Calcium levels may be falsely low.

Respiratory system reactions
Inform the doctor if the patient develops unexplained cough or shortness of breath (difficulty breathing). The doctor may perform additional tests.

Children and adolescents
Teriflunomide Teva is not intended for use in children under 10 years of age, as it has not been studied in patients with multiple sclerosis in this age group.
The warnings and precautions listed above also apply to children. The following information is important for children and their caregivers:

• cases of pancreatitis have been observed in patients receiving teriflunomide. The child’s doctor may perform blood tests if pancreatitis is suspected.

Teriflunomide Teva and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including those available without a prescription.
In particular, inform the doctor or pharmacist if the patient is taking any of the following medicines:

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

Pregnancy and breastfeeding
Do not take Teriflunomide Teva if the patient is pregnant or suspects she may be pregnant. There is an increased risk of congenital malformations in the unborn child in women who are pregnant or who become pregnant while taking Teriflunomide Teva. Women of childbearing potential who do not use effective contraception must not take this medicine.
If a girl starts menstruating while taking Teriflunomide Teva, inform the doctor, who will provide specialist advice regarding contraception and potential risks in case of pregnancy.
If a woman plans to become pregnant after stopping Teriflunomide Teva, she should inform her doctor, because it is essential to confirm that the medicine is no longer present in the body before attempting pregnancy. Elimination of the active substance may take up to 2 years. This period can be shortened to several weeks by taking appropriate medicines that accelerate the removal of Teriflunomide Teva from the body.
In both cases, blood testing must confirm that the active substance has been sufficiently eliminated from the body. The doctor should confirm that the blood concentration of Teriflunomide Teva is low enough to allow pregnancy.
More information about laboratory tests can be obtained from the doctor.
If a woman suspects she became pregnant while taking Teriflunomide Teva or within two years after stopping treatment, she must stop taking Teriflunomide Teva and immediately contact her doctor for a pregnancy test. If pregnancy is confirmed, the doctor may recommend appropriate treatment to rapidly and adequately eliminate Teriflunomide Teva from the body to reduce risk to the unborn child.

Contraception
During treatment with Teriflunomide Teva and after stopping it, women should use effective contraception. Teriflunomide remains in the blood for a long time after stopping treatment. Therefore, effective contraception must continue after stopping treatment.

• Contraception should be continued until the blood concentration of Teriflunomide Teva is sufficiently low (as confirmed by the doctor).
• Discuss with the doctor the best contraceptive method for the patient and whether a change in contraceptive method may be needed.

Do not take Teriflunomide Teva while breastfeeding, as teriflunomide passes into human milk.

Driving and operating machinery
Teriflunomide Teva may cause dizziness, which may impair concentration and reaction ability. Patients experiencing such symptoms should not drive or operate machinery.

Teriflunomide Teva contains lactose and sodium
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to take Teriflunomide Teva

The use of Teriflunomide Teva will be supervised by a physician experienced in the treatment of multiple sclerosis.
This medicine should always be taken exactly as prescribed by your doctor. In case of doubts, consult your doctor.
Adults
The recommended dose is one 14 mg tablet per day.
Children and adolescents (aged 10 years and older)
The dose depends on body weight:

• Children weighing more than 40 kg: one 14 mg tablet per day.
• Children weighing less than or equal to 40 kg: one 7 mg tablet per day. Teriflunomide Teva is available only as 14 mg coated tablets; therefore, for this group of patients, the doctor will recommend another available medicine containing teriflunomide.

Children and adolescents who reach a stable body weight above 40 kg will be informed by the doctor about changing the dose to one 14 mg tablet per day.
Route and method of administration
Teriflunomide Teva is administered orally. Teriflunomide Teva should be taken daily at any time of day as a single daily dose.
Tablets should be swallowed whole with water.
Teriflunomide Teva may be taken with food or independently of meals.
Taking more Teriflunomide Teva than prescribed
If more Teriflunomide Teva has been taken than prescribed, contact your doctor immediately. Adverse effects similar to those described in section 4 below may occur.
Missed dose of Teriflunomide Teva
Do not take a double dose to make up for a missed tablet. Take the next dose according to the prescribed dosing schedule.
Stopping Teriflunomide Teva
Do not stop taking Teriflunomide Teva or change the dose without first consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur after taking this medicine.
Serious adverse reactions
Some adverse reactions may be or may become serious. If any of the following symptoms occur, you should contact your doctor immediately.
Common (may affect up to 1 in 10 people)

• Pancreatitis, which may cause symptoms such as abdominal pain, nausea or vomiting (frequency is common in children and adolescents and uncommon in adult patients).

Uncommon (may affect up to 1 in 100 people)

• Allergic reactions, which may cause symptoms including rash, urticaria, swelling of the lips, tongue or face, or sudden breathing difficulties;
• Severe skin reactions, which may cause symptoms including skin rash, blisters, fever or mouth ulcers;
• Severe infections or sepsis (a type of infection potentially life-threatening to the patient), which may cause symptoms including high fever, seizures, chills, reduced urine output or confusion;
• Lung inflammation, which may cause symptoms including shortness of breath or persistent cough.

Frequency not known (frequency cannot be estimated from available data)

• Severe liver disease, which may cause symptoms including yellowing of the skin or whites of the eyes, darker than usual urine, unexplained nausea and vomiting, or abdominal pain.

Other adverse reactions may occur with the following frequency:
Very common (may affect more than 1 in 10 people)

• Headache;
• Diarrhoea, nausea;
• Increased AlAT activity (elevated activity of certain liver enzymes in blood) shown in laboratory 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 during swallowing, cystitis, viral gastroenteritis, cold sores, dental infection, laryngitis, fungal foot infection;
• Laboratory findings: decreased number of red blood cells (anaemia), changes in liver and white blood cell test results (see section 2), increased activity of muscle enzymes (creatine kinase) has also been observed;
• Mild allergic reactions;
• Feeling of anxiety;
• Tingling sensation, feeling of weakness, numbness, tingling or pain in the lower back or leg (sciatica), numbness, burning, tingling or pain in hands and fingers (carpal tunnel syndrome);
• Sensation of "pounding heartbeat";
• Increased blood pressure;
• Vomiting, toothache, epigastric pain;
• Rash, acne;
• Tendon, joint or bone pain, muscle pain (musculoskeletal pain);
• Need to urinate more often than usual;
• Heavy menstruation;
• Pain;
• Lack of energy or feeling of weakness (asthenia);
• Weight loss.

Uncommon (may affect up to 1 in 100 people)

• Decreased number of platelets (mild thrombocytopenia);
• Increased sensitivity (especially of the skin), stabbing or pulsating pain along one or more nerves, disorders of nerves in arms or legs (peripheral neuropathy);
• Nail changes, severe skin reactions;
• Injury-related pain;
• Psoriasis;
• Inflammation of the oral or lip mucosa;
• Abnormal levels of fats (lipids) in blood;
• Colitis.

Rare (may affect up to 1 in 1000 people)

• Inflammation or damage to the liver.

Frequency not known (frequency cannot be estimated from available data)

• Pulmonary hypertension.

Children (aged 10 years and older) and adolescents
The adverse reactions listed above also apply to children and adolescents. The following additional information is important for children, adolescents and their caregivers:
Common (may affect up to 1 in 10 people)

• Pancreatitis.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Teriflunomide Teva

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following:
"EXP". The expiry date refers to the last day of the specified month.
No special storage conditions apply for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Teriflunomide Teva contains

• The active substance is teriflunomide. Each film-coated tablet contains 14 mg of teriflunomide.
• The other ingredients are: monohydrate lactose, microcrystalline cellulose type 101, corn starch, sodium carboxymethyl starch (type A), hydroxypropylcellulose, colloidal anhydrous silica, sodium stearyl fumarate, hypromellose type 2910 - 6 mPas, titanium dioxide (E 171), talc, polyethylene glycol 8000, indigo carmine, aluminium lake (E 132).

What Teriflunomide Teva looks like and contents of the pack
Teriflunomide Teva is a blue, round, film-coated tablet with a diameter of approximately 6.6 mm and a thickness of 4.1 mm, marked with "TV" on one side and "Y12" on the other side of the tablet.
Teriflunomide Teva is available in:

• OPA/Aluminum/PVC/Aluminum foil blisters containing 10, 14, 28, 30 or 84 film-coated tablets in a cardboard box, or
• Unit dose blisters made of OPA/Aluminum/PVC/Aluminum foil containing 10x1, 28x1, 30x1 and 84x1 film-coated tablets in a cardboard box.

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Manufacturer
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Poland
Balkanpharma Dupnitsa AD
3 Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria: Teriflunomid ratiopharm 14 mg Filmtabletten
Belgium: Teriflunomide Teva 14 mg Filmomhulde tabletten/comprimés pelliculés/Filmtabletten
Czech Republic: Teriflunomide Teva
Germany: Teriflunomid-ratiopharm 14 mg Filmtabletten
Denmark: Teriflunomide Teva
Estonia: Teriflunomide Teva
Spain: Teriflunomida Teva 14 mg comprimidos recubiertos con película EFG
Finland: Teriflunomide ratiopharm 14 mg tabletti, kalvopäällysteinen
France: Tériflunomide Teva 14 mg, comprimé pelliculé
Croatia: Teriflunomid Teva 14 mg filmom obložene tablete
Hungary: Teriflunomide Teva 14 mg filmtabletta
Iceland: Teriflunomide Teva
Italy: Teriflunomide Teva
Lithuania: Teriflunomide 14 mg plėvele dengtos tabletės
Latvia: Teriflunomide Teva 14 mg apvalkotās tablets
The Netherlands: Teriflunomide Teva 14 mg, filmomhulde tabletten
Norway: Teriflunomide Teva
Poland: Teriflunomide Teva
Portugal: Teriflunomida Teva
Romania: Teriflunomidă Teva 14 mg comprimate filmate
Sweden: Teriflunomide Teva
Slovenia: Teriflunomid Teva 14 mg filmsko obložene tablete
Slovakia: Teriflunomid Teva 14 mg filmom obalené tablety
For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel.: +48 22 345 93 00
Other sources of information
The most up-to-date approved information (educational materials) about this medicinal product is available by scanning with a smartphone or another device the QR code located in the patient leaflet. The same information is also available at the following URL:
https://tevamed.pl/ae/attachments/TeriflunomideTeva.pdf
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