Teriflunomide Zentiva 14 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Teriflunomide Zentiva 14 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as 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, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Teriflunomide Zentiva is and what it is 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. Contents of the pack and other information

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

What Teriflunomide Zentiva is

Teriflunomide Zentiva contains the active substance teriflunomide, which is an immunomodulatory agent that modulates the immune system to reduce its attack on the nervous system.

What Teriflunomide Zentiva is used for

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

What is multiple sclerosis

MS is a long-term disease affecting the central nervous system (CNS). The CNS consists of the brain and spinal cord. In multiple sclerosis, inflammation destroys the protective sheath (myelin) that surrounds the nerves of the CNS. This loss of myelin is called demyelination. This causes the nerves to malfunction.

People with the relapsing form of multiple sclerosis experience repeated episodes (relapses) of physical symptoms caused by improper nerve function. These symptoms vary between patients but typically include:

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

Symptoms may completely disappear after a relapse, but over time, some problems may persist. This can lead to physical disabilities that may interfere with daily activities.

How Teriflunomide Zentiva works

Teriflunomide helps protect against immune system attacks on the central nervous system by inhibiting the growth of certain white blood cells (lymphocytes). This reduces the inflammation that causes nerve damage in MS.

2. What you need to know before starting Teriflunomide Zentiva

Do not take Teriflunomide Zentiva

• if you are allergic to teriflunomide or to any of the other ingredients of this medicine (listed in section 6),
• if you have ever developed a severe skin rash, skin peeling, blisters and/or mouth ulcers after taking teriflunomide or leflunomide,
• if you have severe liver problems,
• if you are pregnant, think you may be pregnant, or are breastfeeding,
• if you have a serious condition affecting the immune system, for example, acquired immunodeficiency syndrome (AIDS),
• if you have serious bone marrow problems or have a low number of white blood cells or red blood cells 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 too low a level of proteins in your blood (hypoproteinemia),

If in doubt, ask your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting teriflunomide if:

• you have liver problems and/or drink large amounts of alcohol. Your doctor may carry out blood tests before and during treatment to monitor your liver function. If test results indicate a problem with your liver, your doctor may stop treatment with teriflunomide. See section 4.
• you have high blood pressure (hypertension), whether or not you are receiving treatment for it. Teriflunomide may cause an increase in blood pressure. Your doctor will monitor your blood pressure before starting treatment and regularly during treatment. See section 4.
• you have an infection. Before you start taking teriflunomide, your doctor will ensure you have adequate levels of white blood cells and platelets in your blood. Since teriflunomide reduces the number of white blood cells in the blood, this may affect your ability to fight infection. Your doctor may perform blood tests to check your white blood cell count if an infection is suspected. Infections with herpes viruses, including oral herpes or herpes zoster (shingles), may occur during treatment with teriflunomide. In some cases, serious complications have occurred. You must inform your doctor immediately if you suspect symptoms 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 due to be vaccinated.
• you are taking leflunomide together with teriflunomide.
• you are switching from or to teriflunomide treatment.
• you are scheduled to have a specific blood test (calcium level). A false decrease in calcium levels may be detected.

Respiratory reactions

Inform your doctor if you have unexplained cough and dyspnea (shortness of breath). Your doctor may carry out additional tests.

Children and adolescents

Teriflunomide is not indicated for use 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 their caregivers:

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

Other medicines and Teriflunomide Zentiva

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines 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 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 disease in diabetics,
• alosetron for severe diarrhea,
• theophylline for asthma,
• tizanidine, a muscle relaxant,
• warfarin, an anticoagulant to thin the blood (make it more fluid) and prevent clots,
• oral contraceptives (ethinylestradiol, levonorgestrel),
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections,
• indometacin, ketoprofen for pain or inflammation,
• furosemide for heart disease,
• cimetidine to reduce gastric acid,
• zidovudine for HIV infection,
• rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol),
• sulfasalazine for inflammatory bowel disease or rheumatoid arthritis,
• colestyramine for high cholesterol or relief of itching in liver disease,
• activated charcoal to reduce the absorption of medicines or other substances.

Pregnancy and breastfeeding

Do not take teriflunomide if you are pregnant or think you might be pregnant. If you become pregnant while taking teriflunomide, there is an increased risk of having a baby with birth defects. Women of childbearing potential must not take this medicine unless they are using reliable contraceptive methods.

If your daughter starts menstruating while taking teriflunomide, inform the doctor, who will provide specialized advice regarding contraception and potential risks in case of pregnancy.

Inform your doctor if you plan to become pregnant after stopping treatment with teriflunomide, as you must ensure that most of this medicine has been eliminated from your body before attempting pregnancy. Natural elimination of the active substance may take up to 2 years. This period can be reduced to a few weeks by taking certain medicines to accelerate the elimination of teriflunomide from your body.

In any case, blood testing must confirm that the active substance has been sufficiently eliminated from your body, and you need your doctor’s confirmation that the blood level of teriflunomide is low enough to allow pregnancy.

For further information about laboratory tests, please contact your doctor.

If you suspect you are pregnant while taking teriflunomide or within two years after stopping treatment, you must stop treatment with teriflunomide and contact your doctor immediately for a pregnancy test. If pregnancy is confirmed, your doctor may recommend treatment with certain medicines to rapidly and sufficiently eliminate teriflunomide from your body, as this may reduce the risk to your baby.

Contraception

You must use an effective method of contraception during and after treatment with teriflunomide. Teriflunomide remains in the blood for a long time after stopping treatment. Continue using contraceptive measures after stopping treatment.

• Continue until blood levels of teriflunomide are sufficiently low (your doctor will check this).
• Consult your doctor about the best contraceptive method for you and if you need to change methods.

Do not take teriflunomide during breastfeeding, as teriflunomide passes into breast milk.

Driving and use of machines

Teriflunomide may cause dizziness, which may affect concentration and reaction ability. If affected, do not drive or operate machinery.

Teriflunomide Zentiva contains lactose

Teriflunomide Zentiva contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Teriflunomide Zentiva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, essentially “sodium-free”.

3. How to take Teriflunomida Zentiva

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Treatment with teriflunomide 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 (10 years of age and older)

The dose depends on body weight:

• children with body weight greater than 40 kg: 14 mg once daily.
• children with body weight less than or equal to 40 kg: 7 mg once daily.

Teriflunomida Zentiva 14 mg film-coated tablets are not suitable for pediatric patients with a body weight ≤ 40 kg.

Other medicines containing teriflunomide are available in lower doses (such as 7 mg film-coated tablets).

Your doctor will instruct children and adolescents who reach a stable body weight above 40 kg to switch to one 14 mg tablet per day.

Form/route of administration

Teriflunomide is administered orally.

Teriflunomide is taken every day as a single daily dose at any time of day.

The tablet must be swallowed whole with water.

Teriflunomide may be taken with or without food.

If you take more Teriflunomida Zentiva than you should

If you have taken too much teriflunomide, contact your doctor immediately. You may experience side effects similar to those described below in section 4.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Poison Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Teriflunomida Zentiva

Do not take a double dose to make up for missed doses. Take the next dose at the usual time.

If you stop taking Teriflunomida Zentiva

Do not stop treatment or change the dose of teriflunomide without first consulting your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

The following adverse effects may occur with this medicine.

Serious adverse effects

Some adverse effects may be serious or may become serious. If you experience any of these, inform your doctor immediately.

Frequent (may affect up to 1 in 10 people)

• inflammation of the pancreas, which may include symptoms such as abdominal pain, nausea, or vomiting (frequent in pediatric patients and uncommon in adult patients).

Uncommon (may affect up to 1 in 100 people)

• allergic reactions that could include symptoms such as rash, hives, swelling of the lips, tongue, or face, or sudden difficulty breathing,
• severe skin reactions that could include symptoms such as skin rash, blisters, fever, or mouth ulcers,
• serious infections or sepsis (a type of infection that may be potentially life-threatening), which could include symptoms such as high fever, shaking, chills, reduced urine output, or confusion,
• inflammation of the lungs that could include symptoms such as shortness of breath or persistent cough.

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

• severe liver disease, which may include symptoms such as yellowing of the skin or whites of the eyes, unusually dark urine, unexplained nausea and vomiting, or abdominal pain.

Other adverse effects may occur with the following frequencies:

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

• headache,
• diarrhea, feeling unwell,
• increased ALT (elevation of certain liver enzymes in blood tests),
• finer hair.

Frequent (may affect up to 1 in 10 people)

• flu, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and difficulty swallowing, cystitis, viral gastroenteritis, 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 on the skin, usually on one side of the upper body or face, and other symptoms such as fever and weakness,
• laboratory findings: a decrease in red blood cell count (anemia), changes in liver function and white blood cells in blood tests (see section 2), as well as elevations in a muscle enzyme (creatine phosphokinase),
• mild allergic reactions,
• feeling anxious,
• tingling, weakness, numbness, prickling, or pain in the lower back or leg (sciatica); numbness, burning, tingling, or pain in hands and fingers (carpal tunnel syndrome),
• palpitations,
• increased blood pressure,
• feeling unwell (vomiting), toothache, upper abdominal pain,
• rash, acne,
• tendon, joint, bone, or muscle pain (musculoskeletal pain),
• need to urinate more often than normal,
• heavy menstrual periods,
• pain,
• lack of energy or feeling weak (asthenia),
• weight loss.

Uncommon (may affect up to 1 in 100 people)

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

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

• liver inflammation or damage.

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

• pulmonary hypertension.

Children (aged 10 years and older) and adolescents

The adverse effects listed above also apply to children and adolescents. The following additional information is important for children, adolescents, and their caregivers:

Frequent (may affect up to 1 in 10 people)

• inflammation of the pancreas.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Teriflunomide Zentiva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Instead, return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Teriflunomide Zentiva

The active substance is teriflunomide. Each film-coated tablet contains 14 mg of teriflunomide.

The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, maize starch, sodium carboxymethylstarch (type A), hydroxypropylcellulose, magnesium stearate, hypromellose, calcium carbonate, triacetin, indigo carmine (E132).

Appearance of the product and contents of the pack

Teriflunomide Zentiva 14 mg film-coated tablets are round, blue, 7 mm in diameter, printed with "C14" on one side.

Pack sizes: 14, 28, 84 or 98 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Zentiva, k.s.

U kabelovny 130,

Dolni Mecholupy, 102 37

Prague 10,

Czech Republic

Manufacturer

Coripharma ehf.

Reykjavikurvegur 78

IS-220 Hafnarfjordur

Iceland

More information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medicinal product is authorized in the European Economic Area Member States under the following names:

Date of the last revision of this leaflet: December 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/