Teriflunomide Neuraxpharm 14 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Teriflunomide Neuraxpharm 14 mg film-coated tablets EFG

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, because it may harm them.

  • If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Teriflunomide Neuraxpharm 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 Neuraxpharm 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 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 Neuraxpharm 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 Teriflunomide Neuraxpharm

Do not take Teriflunomide Neuraxpharm:

• 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 disorder affecting the immune system, for example, acquired immunodeficiency syndrome (AIDS),
• if you have severe bone marrow problems or have a low white blood cell or red blood cell count, 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 carry out 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, 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 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 planning to be vaccinated.
• you are taking leflunomide with teriflunomide.
• you are switching from or to teriflunomide treatment.
• 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 perform 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 Neuraxpharm

Inform 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,
• 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 if you are pregnant or think you might 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 menstruating while taking teriflunomide, inform the doctor, who will provide specific 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 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 your blood is low enough to allow pregnancy.

For further information on 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 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 period after stopping treatment. Continue using contraceptive measures 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 using machines

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

Teriflunomide Neuraxpharm contains lactose

Teriflunomide contains lactose (a type of sugar). If your doctor has informed you of an intolerance to certain sugars, consult them before taking this medicine.

Teriflunomide Neuraxpharm 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 Neuraxpharm

Treatment with teriflunomide will be supervised by a doctor experienced in the treatment of multiple sclerosis.

Always follow exactly the instructions for use of this medicine as 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 (half of a 14 mg tablet).

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

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

Swallow the tablet with water.

This medicine may be taken with or without food.

If you take more Teriflunomida Neuraxpharm 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, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Teriflunomida Neuraxpharm

Do not take a double dose to make up for forgotten doses.

If you stop taking Teriflunomida Neuraxpharm

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.

Common (may affect up to 1 in 10 people)

• Inflammation of the pancreas, which may include symptoms such as abdominal pain, nausea, or vomiting (common 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
• Serious 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 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

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, oral herpes, dental infection, fungal foot infection, laryngitis
• 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 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, bone, or 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 (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:

Common (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 Neuraxpharm

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

Do not use this medicine after the expiry date stated on the carton and 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 Point in your pharmacy. If you are 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 Neuraxpharm

The active substance is teriflunomide.

Teriflunomide Neuraxpharm 14 mg film-coated tablets EFG

• Each tablet contains 14 mg of teriflunomide.
• The other components are monohydrate lactose, corn starch, microcrystalline cellulose, sodium carboxymethyl starch (type A), hydroxypropylcellulose, anhydrous colloidal silica, magnesium stearate, hypromellose 2910, titanium dioxide (E171), talc, macrogol 8000, indigo carmine aluminium lake (E132) (see section 2 “Teriflunomide Neuraxpharm contains lactose”).

Nature of the product and pack contents

Teriflunomide Neuraxpharm 14 mg film-coated tablets EFG

The film-coated tablets are light blue or pastel blue in colour, round, biconvex, scored on both sides, and engraved with “I” and “2” on each side of the score line on one face. The diameter is approximately 7.50 mm.

The tablet can be divided into equal doses.

Teriflunomide Neuraxpharm 14 mg film-coated tablets EFG are available in cardboard boxes containing 28, 84 and 28x1 (unit dose) tablets in blisters.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

Sant Joan Despí – 08970

Barcelona

Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

Sant Joan Despí – 08970

Barcelona

Spain

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

Czech Republic: Teriflunomide Neuraxpharm

Germany: Teriflunomid neuraxpharm 14 mg Filmtabletten

France: Teriflunomide Neuraxpharm 14 mg, comprimé pelliculé sécable

Hungary: Teriflunomide Neuraxpharm 14 mg Filmtabletta

Iceland: Teriflunomide Neuraxpharm

Italy: Teriflunomide Neuraxpharm

Norway: Teriflunomide Neuraxpharm

Poland: Teriflunomide Neuraxpharm

Slovakia: Teriflunomide Neuraxpharm 14 mg

Date of the latest revision of this leaflet: September 2024

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.