Teriflunomide Teva

Leaflet accompanying the packaging: patient information

Teriflunomide Teva, 14 mg, film-coated tablets

Teriflunomide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Teriflunomide Teva and what is it 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 packaging and other information

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

What is Teriflunomide Teva

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

What is Teriflunomide Teva used for

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

What is multiple sclerosis

Multiple sclerosis is a chronic disease that affects the central nervous system. The central nervous system consists of the brain and spinal cord. In multiple sclerosis, inflammation damages the protective covering (called myelin) around the nerves in the central nervous system. This process is called demyelination. It disrupts the normal functioning of the nerves. In people with relapsing-remitting multiple sclerosis, there are recurring attacks (relapses) of physical symptoms caused by the abnormal functioning of the nerves. These symptoms vary from person to person but usually include:

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

These symptoms can completely disappear after a relapse, but over time, some problems may persist between relapses. This can lead to physical disability that makes it difficult to perform daily activities.

How does Teriflunomide Teva work

Teriflunomide Teva helps protect the central nervous system from the effects of the immune system by reducing the increase in the number of certain white blood cells (lymphocytes). This reduces inflammation, which 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 had a severe skin rash or peeling, blisters, or mouth sores after taking teriflunomide or leflunomide;
• if the patient has severe liver disease;
• if the patient is pregnant, thinks they may be pregnant, or is breastfeeding;
• if the patient has any severe immune system disorders, such as acquired immune deficiency syndrome (AIDS);
• if the patient has any severe bone marrow disorders or has a low number of red or white blood cells or platelets;
• if the patient has a severe infection;
• if the patient has severe kidney disease that requires dialysis;
• if the patient has very low protein levels in the blood (hypoproteinemia). If in doubt, consult your 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 the patient drinks large amounts of alcohol; the doctor may perform blood tests to check if liver function is normal before and during treatment. If the patient's test results show liver function disorders, the doctor may stop the use of Teriflunomide Teva. Refer to section 4.
• the patient has high blood pressure, whether controlled with medication or not. Teriflunomide Teva may increase blood pressure. The doctor will check the patient's blood pressure before starting treatment and then regularly during treatment. Refer to section 4.
• the patient has an infection. Before taking Teriflunomide Teva, the doctor will ensure that the patient has a sufficient number of white blood cells and platelets in the blood. Since Teriflunomide Teva reduces the number of white blood cells in the blood, it may affect the ability to fight infections. The doctor may perform a blood test to check the number of white blood cells if the patient suspects an infection. Refer to section 4.
• the patient has severe skin reactions.
• the patient has respiratory symptoms.
• the patient has weakness, numbness, and pain in the hands and feet.
• the patient is going to be vaccinated.
• the patient is taking leflunomide with Teriflunomide Teva.
• the patient is switching from their current medicine to Teriflunomide Teva or from Teriflunomide Teva to another medicine.
• the patient is going to have a specific blood test (calcium level measurement). The results of the calcium level measurement may be falsely lowered.

Respiratory reactions

Tell your doctor if you experience unexplained cough and 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 this age group with multiple sclerosis. The warnings and precautions mentioned above also apply to children. The following information is important for children, adolescents, and their caregivers:

• -pancreatitis has been observed in patients taking teriflunomide. The doctor may perform blood tests if pancreatitis is suspected.

Teriflunomide Teva and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained 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 affect the immune system (often called immunosuppressive or immunomodulatory medicines);
• rifampicin (used to treat tuberculosis and other infections);
• carbamazepine, phenobarbital, phenytoin, used to treat epilepsy;
• St. John's Wort (a herbal medicine 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 diabetic neuropathy;
• alosetron used to treat severe diarrhea;
• 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 blood clots;
• oral contraceptives (containing ethinylestradiol and levonorgestrel);
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin, used to treat infections;
• indomethacin, ketoprofen, used to treat inflammation or pain;
• furosemide used to treat heart disease;
• cimetidine, used to reduce stomach acid production;
• zidovudine used to treat HIV infections;
• rosuvastatin, simvastatin, atorvastatin, pravastatin, medicines used to treat high cholesterol;
• sulfasalazine used to treat inflammatory bowel disease and rheumatoid arthritis;
• cholestyramine used to treat high cholesterol or itching in liver disease;
• activated charcoal used to reduce the absorption of medicines or other substances.

Pregnancy and breastfeeding

Do nottake Teriflunomide Teva if you are pregnantor think you may be pregnant. In pregnant women or those who become pregnant while taking Teriflunomide Teva, there is an increased risk of birth defects in the baby. Women of childbearing age who are not using effective contraception must not take this medicine.
If a girl starts menstruating while taking Teriflunomide Teva, she should inform her doctor, who will provide specialized advice on contraception and potential risks in case of pregnancy.
If a woman plans to become pregnant after stopping Teriflunomide Teva, she should inform her doctor, as it is essential to ensure that the medicine is no longer in the body before trying to become pregnant. Elimination of the active substance may take up to 2 years. This period can be shortened to a few weeks by taking certain medicines that accelerate the removal of Teriflunomide Teva from the body.
In both cases, it is necessary to confirm through a blood test that the active substance has been sufficiently removed from the body. The doctor should confirm that the level of Teriflunomide Teva in the blood is low enough for the woman to become pregnant.
More information about laboratory tests can be obtained from your doctor.
If a woman suspects she has become pregnant while taking Teriflunomide Teva or within two years after stopping treatment, she should stop taking Teriflunomide Teva and immediatelycontact her doctor to perform a pregnancy test. If the test confirms pregnancy, the doctor may suggest using certain medicines to quickly and sufficiently remove Teriflunomide Teva from the body to reduce the risk to the baby.
Contraception
During and after treatment with Teriflunomide Teva, women should use effective contraception. Teriflunomide remains in the blood for a long time after stopping treatment. Therefore, effective contraception should still be used after stopping treatment.

• This method should be used until the level of Teriflunomide Teva in the blood is low enough (checked by the doctor).
• Discuss with your doctor the best contraception method for you and any need to change the contraception method.

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

Driving and using machines

Teriflunomide Teva may cause dizziness, which can affect concentration and reaction time. Patients who experience these symptoms should not drive or operate machinery.

Teriflunomide Teva contains lactose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Teriflunomide Teva

Treatment with Teriflunomide Teva will be supervised by a doctor experienced in treating multiple sclerosis.
Always take this medicine exactly as your doctor has told you. If you are not sure, ask 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 with a body weight over 40 kg: one 14 mg tablet per day.
• Children with a body weight of 40 kg or less: one 7 mg tablet per day. Since Teriflunomide Teva is only available in 14 mg film-coated tablets, the doctor will prescribe another teriflunomide-containing medicine for this group of patients.

Children and adolescents who reach a stable body weight above 40 kg will be informed by their doctor to switch to one 14 mg tablet per day.
Route and method of administration
Teriflunomide Teva is taken orally. Teriflunomide Teva should be taken once daily at any time of day as a single daily dose.
Swallow the tablets whole with water.
Teriflunomide Teva can be taken with or without food.

Taking more than the recommended dose of Teriflunomide Teva

If you take more than the recommended dose of Teriflunomide Teva, contact your doctor immediately. Side effects similar to those described in section 4 may occur.

Missing a dose of Teriflunomide Teva

Do not take a double dose to make up for a missed tablet. Take the next dose as scheduled.

Stopping treatment with Teriflunomide Teva

Do not stop taking Teriflunomide Teva or change the dose without first consulting 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 after taking this medicine.

Severe side effects

Some side effects can be severe or become severe if you experience any of these symptoms, contact your doctor immediately.

Very common (may affect up to 1 in 10 people)

• pancreatitis, which may cause symptoms such as abdominal pain, nausea, or vomiting (very 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, hives, swelling of the lips, tongue, or face, or sudden difficulty breathing;
• severe skin reactions, which may cause symptoms including skin rash, blisters, fever, or mouth sores;
• severe infections or sepsis (a life-threatening infection), which may cause symptoms including high fever, chills, shivering, reduced urine output, or disorientation;
• pneumonia, which may cause symptoms including shortness of breath or persistent cough.

Frequency not known (frequency cannot be estimated from the 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 side effectsmay occur with the following frequency:

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

• headache;
• diarrhea, nausea;
• increased liver enzyme activity (increased activity of certain liver enzymes in the blood) shown in tests;
• hair loss.

Common (may affect up to 1 in 10 people)

• flu, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and discomfort when swallowing, cystitis, viral gastroenteritis, herpes simplex, tooth infection, laryngitis, fungal foot infection;
• laboratory test results: reduced red blood cell count (anemia), changes in liver function and white blood cell count (see section 2), also increased muscle enzyme activity (creatine kinase);
• mild allergic reactions;
• feeling anxious;
• feeling of tingling, weakness, numbness, tingling, or pain in the lower back or leg (sciatica), feeling of numbness, burning, tingling, or pain in the hands and fingers (carpal tunnel syndrome);
• feeling of "heart pounding";
• increased blood pressure;
• vomiting, toothache, abdominal pain;
• rash, acne;
• tendon, joint, bone, or 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 people)

• reduced platelet count (mild thrombocytopenia);
• increased sensitivity (especially of the skin), stabbing or pulsating pain along one or more nerves, nerve disorders of the arms or legs (peripheral neuropathy);
• changes in nail condition, severe skin reactions;
• traumatic pain;
• psoriasis;
• mouth ulcers;
• abnormal blood lipid levels;
• colitis.

Rare (may affect up to 1 in 1000 people)

• liver inflammation or damage.

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

• pulmonary hypertension.

Children (aged 10 years and older) and adolescents

The above side effects 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 side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Teriflunomide Teva

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 carton and blister after "EXP". The expiry date refers to the last day of that month.
There are no special storage instructions 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. This will help protect the environment.

6. Contents of the packaging 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: lactose monohydrate, microcrystalline cellulose type 101, corn starch, sodium carboxymethylcellulose (type A), hydroxypropylcellulose, colloidal anhydrous silica, sodium stearyl fumarate, hypromellose type 2910 - 6mPas, titanium dioxide (E 171), talc, macrogol 8000, indigo carmine, aluminum lake (E 132).

What Teriflunomide Teva looks like and contents of the pack

Teriflunomide Teva is blue, round, film-coated tablets with a diameter of about 6.6 mm and a thickness of 4.1 mm with the imprint "TV" on one side of the tablet and "Y12" on the other side of the tablet.
Teriflunomide Teva is available in:

• blister packs of 10, 14, 28, 30, or 84 film-coated tablets in a cardboard box or
• single-dose blister packs of 10x1, 28x1, 30x1, and 84x1 film-coated tablets in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder

Teva B.V.
Swensweg 5
2031 GA Haarlem
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 medicine is authorized 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
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 tablet
To obtain more detailed information on this medicine, contact the representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
phone: +48 22 345 93 00

Date of last revision of the leaflet:

Other sources of information

The latest approved information (educational materials) about this medicine is available by scanning the QR code in the patient leaflet with your smartphone or other device. The same information is also available at the following URL:
https://tevamed.pl/ae/attachments/TeriflunomideTeva.pdf
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