Teriflunomide Tarbis 7 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Teriflunomide Tarbis 7 mg film-coated tablets EFG

Teriflunomide Tarbis 14 mg film-coated tablets EFG

Read the entire 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 must not be given to other people, even if they have the same symptoms as you, because it may 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.

Leaflet contents

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

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

What Teriflunomide Tarbis is

Teriflunomide Tarbis 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 Tarbis is used for

Teriflunomide 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 affecting the central nervous system (CNS). The CNS consists of the brain and spinal cord. In multiple sclerosis, inflammation destroys the protective sheath (myelin) surrounding 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 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 Tarbis 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 taking Teriflunomide Tarbis

Do not take Teriflunomide Tarbis:

• 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 severe bone marrow problems or if you have a low white blood cell or red blood cell count, or a reduced platelet count,
• if you have a serious infection,
• if you have severe kidney problems requiring dialysis,
• if you have very low levels of protein in the 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 liver problem, 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, this may affect your ability to fight infections. Your doctor may perform blood tests to monitor your white blood cell count if an infection is suspected. Herpes virus infections, including oral herpes or herpes zoster (shingles), may occur during treatment with teriflunomide. In some cases, serious complications may arise. 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 experience weakness, numbness, or pain in your hands and feet.
• you are due to be vaccinated.
• you are taking leflunomide together with Teriflunomide.
• you are switching medication to or from Teriflunomide.
• 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 develop unexplained cough or dyspnea (shortness of breath). Your doctor may carry out additional tests.

Children and adolescents

Teriflunomide Tarbis 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 Tarbis

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those not requiring 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
• cholestyramine 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 Tarbis 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 birth defects in the baby. Women of childbearing potential must not take this medicine unless they are using reliable contraceptive methods.

If your daughter begins menstruation while taking Teriflunomide, inform the doctor, who will provide specialized advice regarding contraception and potential pregnancy risks.

Inform your doctor if you plan to become pregnant after stopping treatment with Teriflunomide, as you must 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 further 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 Teriflunomide and contact your doctor immediately for a pregnancy test. If pregnancy is confirmed, your doctor may recommend treatment with specific medicines to rapidly and sufficiently eliminate this medicine 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 Teriflunomide. Teriflunomide remains in the blood for a long time after stopping treatment. Continue contraceptive measures after stopping treatment.

• Continue until Teriflunomide blood levels are sufficiently low (your doctor will confirm this).
• Consult your doctor about the most suitable 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

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

Teriflunomide Tarbis contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

Teriflunomide Tarbis contains sodium

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

3. How to take Teriflunomide Tarbis

A doctor experienced in the treatment of multiple sclerosis will supervise treatment with Teriflunomide.

Always follow exactly the instructions for taking this medicine as indicated by your doctor. If in doubt, consult your doctor again.

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: one 14 mg tablet per day.
• children with body weight less than or equal to 40 kg: one 7 mg tablet per day.

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.

Method/Route of administration

Teriflunomide is administered orally. This medicine is taken every day as a single daily dose at any time of day.

The tablet should be swallowed whole with water.

Teriflunomide Tarbis may be taken with or without food.

If you take more Teriflunomide Tarbis than you should

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

In case of overdose or accidental ingestion, contact your doctor 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 Teriflunomide Tarbis

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

If you stop taking Teriflunomide Tarbis

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 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 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, 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 the 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 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
• Laboratory findings: a decrease in red blood cell count (anemia), changes in liver and white blood cell counts in blood tests (see section 2), as well as elevations in a muscle enzyme (creatine phosphokinase)
• Mild allergic reactions
• Feeling of anxiety
• Muscle cramps, weakness, numbness, tingling, 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, or bone pain, muscle pain (musculoskeletal pain)
• Need to urinate more often than usual
• Heavy menstrual periods
• Pain
• Lack of energy or weakness (asthenia)
• Weight loss
• Herpes virus infections, including oral herpes and herpes zoster (shingles), with symptoms such as blisters, burning, itching, numbness, or pain on the skin, typically on one side of the upper body or face, and other symptoms such as fever and weakness.

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)

• Inflammation or liver damage

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

• Pulmonary hypertension

Children (10 years of age 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, pharmacist, or nurse, 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 Tarbis

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

Do not use this medicine after the expiry date stated on the packaging and on the blister 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. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Teriflunomide Tarbis

The active substance is teriflunomide.

Teriflunomide Tarbis 7 mg film-coated tablets EFG

Each tablet contains 7 mg of teriflunomide.

Teriflunomide Tarbis 14 mg film-coated tablets EFG

Each tablet contains 14 mg of teriflunomide.

Other ingredients are:

Tablet core: Lactose monohydrate, corn starch, Sodium carboxymethyl starch type A from potato, hydroxypropylcellulose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.

Tablet coating: Hypromellose, titanium dioxide (E171), macrogol 400, talc, yellow iron oxide (E172) (for 7 mg).

Nature and contents of the container

Teriflunomide Tarbis 7 mg film-coated tablets EFG

Film-coated tablets, biconvex, round, pale yellow to yellow in colour, approximately 5.2 mm in diameter, marked with "H" on one side and "T19" on the other.

Teriflunomide Tarbis 14 mg film-coated tablets EFG

Film-coated tablets, biconvex, round, white to off-white in colour, approximately 7.3 mm in diameter, marked with "H" on one side and "T41" on the other.

Containers containing 28 and 84 film-coated tablets.

Unit-dose containers containing 28 and 84 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

The Netherlands

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

Germany: Teriflunomid Amarox 7 mg/14 mg Filmtabletten

Spain: Teriflunomida Tarbis 7 mg/14 mg comprimidos recubiertos con película EFG

The Netherlands: Teriflunomid Amarox 7 mg/14 mg, filmomhulde tabletten

Date of the most recent revision of this leaflet: 08/2024

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/