Leaflet: information for the patient

Teriflunomida Zentiva 14 mg film-coated tablets EFG

Read 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to take Teriflunomida Zentiva

3. How to take Teriflunomida Zentiva

4. Possible side effects

5. Storage of Teriflunomida Zentiva

6. Contents of the pack and additional information

What is Teriflunomida Zentiva

Teriflunomida Zentiva contains the active ingredient teriflunomida, which is an immunomodulator agent that adjusts the immune system to limit its attack on the nervous system.

What is Teriflunomida Zentiva used for

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

What is multiple sclerosis

MS is a long-term disease that affects the central nervous system (CNS). The CNS is made up of the brain and spinal cord. In MS, inflammation destroys the protective covering (myelin) that surrounds the nerves of the CNS. This loss of myelin is called demyelination. This makes the nerves stop functioning properly.

People with relapsing-remitting MS will have repeated attacks (recurrences) of physical symptoms caused by the improper functioning of the nerves. These symptoms vary from patient to patient, but usually include:

The symptoms may disappear completely after the recurrence but, over time, some problems may remain. This can cause physical disabilities that can interfere with daily activities.

How Teriflunomida Zentiva works

Teriflunomida helps to protect against attacks in the central nervous system by the immune system, limiting the growth of some white blood cells (lymphocytes). This limits the inflammation that causes nerve damage in MS.

Do not take Teriflunomida Zentiva

• if you are allergic to teriflunomida or any of the other ingredients of this medicine (listed in section 6),
• if you have ever developed a severe skin rash or peeling of the skin, blisters and/or ulcers in the mouth after taking teriflunomida or leflunomida,
• if you have severe liver problems,
• if you are pregnant, think you may be pregnant or are breastfeeding,
• if you have a serious condition that affects the immune system, for example, acquired immunodeficiency syndrome (AIDS),
• if you have severe bone marrow problems or if you have a low number of white blood cells, red blood cells in the blood or a reduced number of platelets,
• if you have a severe infection,
• if you have severe kidney problems that require dialysis,
• if you have too low levels of protein in the blood (hypoproteinemia),

In case of doubt, ask your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take teriflunomida if:

• you have liver problems and/or if you drink large amounts of alcohol. Your doctor may perform blood tests before treatment and during treatment to check the function of your liver. If the test results indicate a liver problem, your doctor may interrupt the treatment with teriflunomida. See section 4.
• you have high blood pressure (hypertension), whether or not you are being treated to control it. Teriflunomida may cause an increase in blood pressure. Your doctor will check your blood pressure before starting treatment and regularly during treatment. See section 4.
• you have an infection. Before you start taking teriflunomida, your doctor will ensure that you have enough white blood cells and platelets in your blood. Since teriflunomida reduces the number of white blood cells in the blood, this may affect your ability to fight the infection. Your doctor may perform blood tests to check your white blood cells if they suspect that you have an infection. With teriflunomida treatment, you may experience viral infections, including oral herpes or shingles (herpes zoster). In some cases, serious complications have occurred. You should inform your doctor immediately if you suspect that you have any symptoms of a viral herpes 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 going to be vaccinated.
• you are taking leflunomida with teriflunomida.
• you are changing your medication from or to teriflunomida.
• 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 perform additional tests.

Children and adolescents

Teriflunomida is not indicated for use in children under 10 years of age, as it has not been studied in patients with EM in this age group.

The warnings and precautions listed above also apply to children. The following information is important for children and their caregivers:

• inflammation of the pancreas has been observed in patients receiving teriflunomida. Your child's doctor may perform blood tests if they suspect pancreatitis.

Other medicines and Teriflunomida Zentiva

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine. This includes over-the-counter medicines.

Especially, inform your doctor or pharmacist if you are taking any of the following medicines:

• leflunomida, methotrexate and other medicines that affect the immune system (often referred to as immunodepressants 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 stomach acid,
• zidovudine for HIV infection,
• rosuvastatin, simvastatin, atorvastatin, pravastatin for high cholesterol (high cholesterol),
• sulfasalazine for inflammatory bowel disease or rheumatoid arthritis,
• cholestyramine for high cholesterol or itching in liver disease,
• activated charcoal to reduce the absorption of medicines or other substances.

Pregnancy and breastfeeding

Do not take teriflunomida if you arepregnantor think you may bepregnant. If you are pregnant or become pregnant while taking teriflunomida, you will have an increased risk of having a baby with birth defects. Women of childbearing age should not take this medicine unless they are using reliable contraceptive methods.

If your daughter starts menstruating while taking teriflunomida, she should inform her doctor, who will give her specialized advice on contraceptive methods and the possible risks in case of pregnancy.

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

In any case, you must confirm, through a blood test, that the active ingredient has been eliminated sufficiently from your body and need your doctor's confirmation that the level of teriflunomida in your blood is low enough to become pregnant.

For more information on laboratory tests, contact your doctor.

If you suspect you are pregnant while taking teriflunomida or in the two years after completing treatment, you must interrupt treatment with teriflunomida and contact your doctorimmediatelyto have a pregnancy test. If the test confirms pregnancy, your doctor may suggest a treatment with certain medicines to quickly and sufficiently eliminate teriflunomida from your body, as this may reduce the risk to your baby.

Contraception

You must use an effective contraceptive method during and after treatment with teriflunomida. Teriflunomida remains in the blood for a long time after stopping treatment. Continue taking contraceptive measures after interrupting treatment.

• Continue doing so until the levels of teriflunomida in your blood are low enough (your doctor will check).
• Consult your doctor about the best contraceptive method for you and if you need to change methods.

Do not take teriflunomida during breastfeeding as teriflunomida passes into breast milk.

Driving and operating machines

Teriflunomida may cause dizziness, which may affect your ability to concentrate and react. If you are affected, do not drive or operate machines.

Teriflunomida Zentiva contains lactose

Teriflunomida Zentiva contains lactose (a type of sugar). If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking thismedicine.

Teriflunomida Zentiva contains sodium

Thismedicinecontains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

A doctor with experience in the treatment of multiple sclerosis will supervise the treatment with teriflunomida.

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

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

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

Your doctor will instruct children and adolescents to switch to a 14 mg tablet per day once they reach a stable body weight greater than 40 kg.

Form/administration route

Teriflunomida is administered orally

Teriflunomida is taken once a day in a single daily dose at any time of the day.

The tablet should be swallowed whole with water.

Teriflunomida can be taken with or without food.

If you take more Teriflunomida Zentiva than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot 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 interrupt treatment with Teriflunomida Zentiva

Do not interrupt treatment or change the dose of teriflunomida without consulting your doctor first.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

This medicine may cause the following side effects.

Severe side effects

Some side effects can be serious, or even life-threatening. If you experience any of these, inform your doctor immediately.

Common(may affect up to 1 in 10 people)

• Pancreatitis, which may include symptoms of abdominal pain, nausea, or vomiting (common in pediatric patients and rare in adult patients).

Uncommon(may affect up to 1 in 100 people)

• Allergic reactions, which may include symptoms of rash, hives, swelling of lips, tongue, or face, or sudden difficulty breathing,
• Severe skin reactions, which may include symptoms of skin rash, blisters, fever, or ulcers in the mouth,
• Severe infections or sepsis (a type of infection that can be potentially life-threatening), which may include symptoms such as high fever, chills, decreased urine output, or confusion,
• Pneumonia, which may include symptoms of shortness of breath or persistent cough.

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

• Severe liver disease, which may include symptoms such as yellowing of the skin or eyes, dark urine, nausea, and vomiting without explanation, or abdominal pain.

Other side effectsmay occur with the following frequencies:

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

• Headache,
• Diarrhea, feeling of illness,
• Increased ALT (elevation of certain liver enzymes in the blood) in tests,
• Thinning of hair.

Common(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 infection of the foot,
• Herpes virus infections, including oral herpes and shingles (zoster) 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 values: a decrease in the number of red blood cells (anemia), changes in the liver and white blood cells in tests (see section 2), as well as elevations in a muscle enzyme (creatine phosphokinase),
• Mild allergic reactions,
• Feeling of anxiety,
• Tickling, feeling of weakness, numbness, tingling, or pain in the lower back or leg (sciatica); feeling of numbness, burning, tingling, or pain in hands and fingers (carpal tunnel syndrome),
• Palpitations,
• Increased blood pressure,
• Feeling of illness (vomiting), toothache, pain in the upper abdominal region,
• Rash, acne,
• Pain in tendons, joints, bones, muscle pain (musculoskeletal pain),
• Increased frequency of urination,
• Heavy periods,
• Pain,
• Lack of energy or feeling weak (asthenia),
• Weight loss,

Uncommon(may affect up to 1 in 100 people)

• Decrease in the number of platelets (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),
• Changes in nails, severe skin reactions,
• Post-traumatic pain,
• Psoriasis,
• Inflammation of the mouth/lips,
• Abnormal levels of fats (lipids) in the blood,
• Colitis (inflammation of the colon).

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

• Liver inflammation or damage.

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

• Pulmonary hypertension.

Children (10 years of age and older) and adolescents

The previously listed 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 of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box after “CAD”. The expiration date is thelast day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash..Deposit the packaging and medications you no longer need at the SIGRE point of your pharmacy. In case of doubtask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Teriflunomida Zentiva

The active ingredient isteriflunomida. Each film-coated tablet contains 14 mg ofteriflunomida.

The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, cornstarch, carboxymethylcellulose sodium (type A), hydroxypropylcellulose, magnesium stearate, hypromellose, calcium carbonate, triacetin, and Carmine (E132)

Appearance of the product and contents of the package

Teriflunomida Zentiva 14 mg film-coated tablets are round, blue, 7 mm in diameter, and printed with “C14” on one side.

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Zentiva, k.s.

U kabelovny 130,

Dolni Mecholupy, 102 37

Praga 10,

República Checa

Responsible for manufacturing

Coripharma ehf.

Reykjavikurvegur 78

IS-220 Hafnarfjordur

Islandia

For more information about this medication, please contact 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

España

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:December 2024

For more detailed information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/