Teriflunomide Vivanta 14 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Teriflunomide Vivanta 14 mg film-coated tablets EFG teriflunomide

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet

1. What Teriflunomida Vivanta is and what it is used for
2. What you need to know before taking Teriflunomida Vivanta
3. How to take Teriflunomida Vivanta
4. Possible side effects
5. How to store Teriflunomida Vivanta
6. Contents of the pack and other information

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

What Teriflunomide Vivanta is

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

What Teriflunomide Vivanta is used for

This medicine 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 that affects 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 will experience repeated attacks (relapses) of physical symptoms caused by improper nerve function. These symptoms vary from patient to patient 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 Vivanta works

Teriflunomide helps protect against immune system attacks on the central nervous system by limiting 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 taking Teriflunomida Vivanta

Do not take Teriflunomida Vivanta:

• 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 your immune system, for example, acquired immunodeficiency syndrome (AIDS),
• if you have severe 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 very low levels of protein 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 perform blood tests to check your liver function before and during treatment. 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 being treated 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 starting 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 infections. Your doctor may perform blood tests to check your white blood cell count if they suspect you have an infection. Viral herpes infections, including oral herpes or herpes zoster (shingles), may occur during treatment with teriflunomide. In some cases, serious complications have occurred. You should inform your doctor immediately if you suspect you have symptoms of a herpes virus infection. See section 4.
• you have severe skin reactions.
• you have respiratory symptoms.
• you have weakness, numbness, or pain in your hands and feet.
• you are planning to be vaccinated.
• you are taking leflunomide with teriflunomide.
• you are switching from or to Teriflunomida Vivanta.
• you are scheduled for a specific blood test (calcium level). A falsely low calcium level may be detected.

Respiratory reactions

Inform your doctor if you experience unexplained cough or 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 Teriflunomida Vivanta

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 AIDS
• 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 absorption of medicines or other substances.

Pregnancy and breastfeeding

Do not take teriflunomide if you are pregnant or think you may be pregnant. If you are pregnant or 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 menstruation while taking teriflunomide, you must inform the doctor, who will provide expert advice on contraception and the potential risks in case of pregnancy.

Inform your doctor if you plan to become pregnant after stopping treatment with teriflunomide, as you must first ensure that most of the 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 the body.

In any case, your doctor must confirm, through a blood test, that the level of active substance in the blood is low enough to allow pregnancy.

For more information about laboratory tests, contact your doctor.

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

Contraception

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

• Continue until teriflunomide blood levels 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

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

Teriflunomida Vivanta contains lactose

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

Teriflunomida Vivanta contains sodium

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

3. How to take Teriflunomida Vivanta

Treatment with teriflunomide will be supervised by a physician experienced in the management of multiple sclerosis.

Follow exactly the instructions for use provided by your doctor. If in doubt, consult your doctor again.

Adults

The recommended dose is one 14 mg tablet daily.

Children and adolescents (10 years of age and above)

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.

This medicine is not suitable for pediatric patients with body weight ≤40 kg; other medicines are available at a lower concentration (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 daily.

Method/route of administration

Teriflunomida Vivanta is administered orally. Teriflunomide is taken daily as a single daily dose at any time of day. The tablet should be swallowed whole with water.

Teriflunomide may be taken with or without food.

If you take more Teriflunomida Vivanta than you should

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

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

If you forget to take Teriflunomida Vivanta

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

If you stop taking Teriflunomida Vivanta

Do not interrupt 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 can 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, contact 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
• Severe infections or sepsis (a type of infection that may be potentially life-threatening), which could include symptoms such as high fever, trembling, 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 the available data)

• Severe liver disease that may include symptoms such as yellowing of the skin or whites of the eyes, darker than normal urine, unexplained nausea and vomiting, or abdominal pain

Other adverse effects may occur with the following frequencies:

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

• Headache
• Diarrhea, feeling unwell
• Increased ALT (elevation of certain liver enzymes in blood tests)
• Thinner 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: decreased red blood cell count (anemia), changes in liver and white blood cells in blood tests (see section 2), and elevations in a muscle enzyme (creatine phosphokinase)
• Mild allergic reactions
• Feeling of anxiety
• Muscle soreness, feeling of weakness, numbness, tingling, or pain in the lower back or leg (sciatica); sensation of 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, or bone pain, muscle pain (musculoskeletal pain)
• Need to urinate more often than normal
• Heavy menstrual periods
• Pain
• Lack of energy or weakness (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 and 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 patients)

• Liver inflammation or liver damage

Frequency not known (frequency cannot be estimated from the 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 effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Teriflunomide Vivanta

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 pack after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Teriflunomide Vivanta

The active substance is teriflunomide.

• Each tablet contains 14 mg of teriflunomide.
  • The other components are:

Tablet core: Monohydrate lactose (see section 2 "Teriflunomide Vivanta contains lactose"), corn starch, sodium carboxymethylstarch type A, hydroxypropylcellulose, magnesium stearate, anhydrous colloidal silica.

Tablet coating: Hypromellose, titanium dioxide (E171), yellow iron oxide (E172), macrogol 6000 and indigo carmine (E132).

Appearance of Teriflunomide Vivanta and contents of the pack

Film-coated, biconvex, pentagon-shaped, blue tablets, marked with "14" on one side and "T" on the other.

Teriflunomide Vivanta 14 mg film-coated tablets EFG are available in cardboard boxes containing:

• 14, 28, 84 and 98 tablets in calendar blister packs;
• 10x1 tablet in single-dose blisters,
• 28x1 tablet in single-dose blisters.

Only some pack sizes may be marketed.

Marketing Authorization Holder:

Vivanta Generics s.r.o.

Trtinova 260/1, Cakovice,

196 00, Prague 9

Czech Republic

Manufacturer:

Pharmadox Healthcare Limited,

KW20A Corradino Park, Paola, PLA3000

Malta

MSN Labs Europe Limited,

KW20A Corradino Park, Paola, PLA3000

Malta

You can request further information about this medicinal product by contacting the local representative of the Marketing Authorization Holder:

Local Representative:

Vivanta Generics s.r.o. Spanish branch

C/Guzmán el Bueno 133, edificio Britannia

28003 Madrid

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

Date of the last revision of this leaflet: August 2024

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