Teriflunomide Zentiva

Package Leaflet: Information for the Patient

Teriflunomide Zentiva, 14 mg, Film-Coated Tablets

Teriflunomide

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Teriflunomide Zentiva and what is it used for
• 2. Important information before taking 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 substance teriflunomide, which is an immunomodulatory and immunosuppressive agent, used to limit the immune system's attack on the nervous system.

What is Teriflunomide Zentiva used for

Teriflunomide Zentiva 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) of the nerves in the central nervous system. This process is called demyelination. It disrupts the normal flow of messages (nerve impulses) within the central nervous system. In people with relapsing-remitting multiple sclerosis, there are periods of relapses (exacerbations) of physical symptoms, followed by periods of partial or complete recovery.

• 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 interferes with daily activities.

How Teriflunomide Zentiva works

Teriflunomide Zentiva helps protect the central nervous system from the immune system's attack by reducing the increase in the number of certain white blood cells (lymphocytes). This reduces inflammation, which leads to nerve damage in people with multiple sclerosis.

2. Important information before taking Teriflunomide Zentiva

When not to 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 ever had a severe skin reaction or allergic reaction to teriflunomide or leflunomide,
• if you have severe liver disease,
• if you are pregnant, think you may be pregnant, or are breastfeeding,
• if you have any severe immune system disorders, such as AIDS,
• if you have any severe bone marrow disorders or have a low white blood cell or platelet count,
• if you have a severe infection,
• if you have severe kidney disease requiring dialysis,
• if you have very low blood protein levels (hypoproteinemia). If in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before starting treatment with Teriflunomide Zentiva, tell your doctor or pharmacist if:

• you have liver problems and/or drink large amounts of alcohol. Your doctor will perform blood tests before and during treatment to check if your liver is working properly. If your test results show liver problems, your doctor may stop Teriflunomide Zentiva treatment. See section 4.
• you have high blood pressure, whether or not it is controlled with medication. Teriflunomide Zentiva may increase blood pressure. Your doctor will check your blood pressure before starting treatment and regularly during treatment. See section 4.
• you have an infection. Before taking Teriflunomide Zentiva, your doctor will make sure you have enough white blood cells and platelets in your blood. Because Teriflunomide Zentiva reduces the number of white blood cells in your blood, it may affect your ability to fight infections. Your doctor may perform a blood test to check your white blood cell count if you think you have an infection. During treatment with teriflunomide, herpes virus infections (such as cold sores or shingles) may occur. In some cases, serious complications have occurred. You should immediately inform your doctor if you suspect any signs of a herpes virus infection. See section 4.
• you have severe skin reactions.
• you have respiratory symptoms.
• you have weakness, numbness, and pain in your hands and feet.
• you are planning to receive a vaccination.
• you are taking leflunomide with Teriflunomide Zentiva.
• you are switching from another medicine to Teriflunomide Zentiva or from Teriflunomide Zentiva to another medicine.
• you need to have a specific blood test (calcium level measurement). The results of the calcium level measurement may be falsely low.

Respiratory reactions

Tell your doctor if you experience unexplained coughing and shortness of breath (difficulty breathing). Your doctor may perform additional tests.

Children and adolescents

Teriflunomide Zentiva 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 and their caregivers:
­
in patients taking teriflunomide, cases of pancreatitis have been observed. Your child's doctor may perform blood tests if pancreatitis is suspected.

Teriflunomide Zentiva 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, tell your doctor or pharmacist if you are taking any of the following medicines:

• leflunomide, methotrexate, and other 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 (a blood thinner used 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 infection),
• rosuvastatin, simvastatin, atorvastatin, pravastatin (used to treat high cholesterol),
• sulfasalazine (used to treat inflammatory bowel disease or 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 Zentiva if you are pregnantor think you may be pregnant. In pregnant women or women who become pregnant while taking Teriflunomide Zentiva, there is an increased risk of birth defects in the baby. Women of childbearing potential must not take this medicine without using effective contraception. If a girl starts menstruating while taking Teriflunomide Zentiva, 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 Zentiva, she should inform her doctor, as it is necessary to ensure that the medicine is no longer in the body before trying to become pregnant. The 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 Zentiva from the body.
In both cases, it should be confirmed by a blood test that the active substance has been sufficiently removed from the body, and the doctor should confirm that the level of Teriflunomide Zentiva in the blood is low enough for the woman to become pregnant.
More information on laboratory tests can be obtained from the treating doctor.
If a woman suspects she is pregnant while taking Teriflunomide Zentiva or within 2 years after stopping treatment, she should stop taking Teriflunomide Zentiva 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 Zentiva from the body to reduce the risk to the baby.
Contraception
During treatment with Teriflunomide Zentiva and after stopping it, women should use effective contraception. Teriflunomide remains in the blood for a long time after stopping treatment. After stopping treatment, effective contraception should still be used.

• This method should be used until the level of Teriflunomide Zentiva in the blood is low enough - the doctor will check this.
• You should discuss with your doctor the best method of contraception and any need to change the method of contraception.

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

Driving and using machines

Teriflunomide Zentiva may cause dizziness, which may affect your ability to concentrate and react. Patients who experience such symptoms should not drive or operate machinery.

Teriflunomide Zentiva contains lactose

Teriflunomide Zentiva contains lactose (a type of sugar). If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

Teriflunomide Zentiva contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially 'sodium-free'.

3. How to take Teriflunomide Zentiva

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
Treatment with Teriflunomide Zentiva will be supervised by a doctor experienced in the treatment of multiple sclerosis.

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 above 40 kg: one 14 mg tablet per day.
• Children with a body weight of 40 kg or less: one 7 mg tablet per day.

Teriflunomide Zentiva 14 mg film-coated tablets are not suitable for children and adolescents with a body weight of 40 kg or less.
Other medicinal products containing teriflunomide are available in lower strengths (7 mg film-coated tablets).
Children and adolescents who reach a stable body weight above 40 kg will be informed by their doctor about switching to a 14 mg tablet per day.
Route of administration
Teriflunomide Zentiva is for oral use.
Teriflunomide Zentiva should be taken once daily at any time of day.
Swallow the tablets whole with water.
Teriflunomide Zentiva can be taken with or without food.

Take more than the recommended dose of Teriflunomide Zentiva

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

Miss a dose of Teriflunomide Zentiva

Do not take a double dose to make up for a forgotten tablet. Take the next dose at the scheduled time.

Stop taking Teriflunomide Zentiva

Do not stop taking Teriflunomide Zentiva or change the dose without consulting your doctor first.
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 during treatment with this medicine.

Severe side effects

Some side effects may be serious or become serious if you experience any of these symptoms, 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 (common in children and adolescents and uncommon in adults)

Uncommon(may affect up to 1 in 100 people)

• allergic reactions, which may include symptoms such as rash, hives, swelling of the lips, tongue, or face, or difficulty breathing
• severe skin reactions, which may cause symptoms such as skin rash, blisters, fever, or mouth ulcers
• severe infections or sepsis (a life-threatening infection), which may cause symptoms such as high fever, chills, shivering, reduced urine output, or confusion
• pneumonia, which may cause symptoms such as shortness of breath or persistent cough

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

• severe liver disease, which may cause symptoms such as yellowing of the skin or whites of the eyes, darker than usual urine, nausea, and vomiting of unknown origin, or abdominal pain

Other side effectsmay occur with the following frequencies:
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 blood 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, tooth infection, laryngitis, fungal foot infection
• herpes virus infections, including cold sores and shingles, with symptoms such as blisters, burning, itching, numbness, or pain on the skin, usually on one side of the upper body or face, and other symptoms such as fever and weakness
• 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 phosphokinase)
• mild allergic reactions
• feeling anxious
• tingling, feeling weak, numbness, tingling, or pain in the lower back or leg (sciatica), feeling numb, burning, tingling, or pain in the hands and fingers (carpal tunnel syndrome)
• feeling 'heart pounding'
• increased blood pressure
• vomiting, toothache, abdominal pain
• rash, acne
• tendon, joint, bone, or muscle pain (musculoskeletal pain)
• need to urinate more frequently 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 damage in the arms or legs (peripheral neuropathy)
• changes in nail condition, severe skin reactions
• post-traumatic pain
• psoriasis
• mouth ulcers
• abnormal blood lipid levels
• colitis

Rare(may affect up to 1 in 1,000 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 package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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
Side effects can also be reported to the marketing authorization holder or its representative. 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 carton 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Teriflunomide Zentiva contains

The active substance is teriflunomide. Each tablet contains 14 mg of teriflunomide.
The other ingredients are: lactose monohydrate, microcrystalline cellulose (PH-102), corn starch, sodium carboxymethylcellulose (type A), hydroxypropylcellulose (300-600 mPas), magnesium stearate, hypromellose (15 mPas), calcium carbonate, triacetin, indigo carmine, aluminum lake (E132).

What Teriflunomide Zentiva looks like and contents of the pack

Teriflunomide Zentiva 14 mg film-coated tablets (tablets) are round, blue, 7 mm in diameter, and marked with 'C14' on one side.
Pack sizes: 14, 28, or 84 film-coated tablets in a carton. Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva, k.s.
U kabelovny 130,
Dolní Měcholupy,
102 37 Prague 10, Czech Republic

Manufacturer

Coripharma ehf.
Reykjavikurvegur 78
Hafnarfjörður
IS-220, Iceland

This medicine is authorized in the Member States of the European Economic Area under the following names:

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 película
France:
Teriflunomide Zentiva 14 mg, comprimé pelliculé
Croatia:
Teriflunomid Zentiva 14 mg filmom obložene tablete
Hungary:
Teriflunomide Zentiva 14mg filmtabletta
Iceland:
Teriflunomid Zentiva
Italy:
Teriflunomide 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
To obtain more detailed information, please contact the local representative of the marketing authorization holder in Poland:
Zentiva Polska Sp. z.o.o.,
ul. Bonifraterska 17
00-203 Warsaw, Poland
tel.: +48 22 375 92 00
Date of last revision of the package leaflet:December 2024