Patient Information Leaflet

Teriflunomida Neuraxpharm 14 mg Film-Coated Tablets

Read this 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. Do not give it to others even if they have similar symptoms, 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 Neuraxpharm and what it is used for

2.What you need to know before taking Teriflunomida Neuraxpharm

3.How to take Teriflunomida Neuraxpharm

4.Possible side effects

5.Storage of Teriflunomida Neuraxpharm

6. Contents of the pack and additional information

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

What is it used forTeriflunomida Neuraxpharm

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 formed by the brain and spinal cord. In MS, inflammation destroys the protective sheath (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 the physical symptoms caused by the improper functioning of the nerves. These symptoms vary from patient to patient, but usually include:

•difficulty walking

•vision problems

•balance problems.

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 it worksTeriflunomida Neuraxpharm

Teriflunomidahelps 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 takeTeriflunomida Neuraxpharm:

• 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 skin peeling, blisters, and/or mouth ulcers 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 severe condition that affects your 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, or platelets in your 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 a very low level of proteins in your 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 to check your liver function before treatment and during treatment. 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 your 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 immediately inform your doctor if you suspect that you have any symptoms of a viral 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 being switched 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 cough and shortness of breath without explanation. 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:

-pancreatitis has been observed in patients receiving teriflunomida. Your child's doctor may perform blood tests if they suspect pancreatitis.

Other medicines andTeriflunomida Neuraxpharm

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 immunosuppressants or immunomodulators)
• rifampicin (a medicine used to treat tuberculosis and other infections)
• carbamazepine, phenobarbital, phenytoin for epilepsy
• hypericum (a plant-based medicine for depression)
• repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes
• daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer
• duloxetine for depression, 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
• indomethacin, ketoprofen for pain or inflammation
• furosemide for heart disease
• cimetidine to reduce stomach acid
• zidovudine for AIDS
• 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 lactation

Do nottake teriflunomida if you are pregnant or think you may be pregnant. 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 need to ensure that most of this medicine has been eliminated from your body before trying to become pregnant. The elimination of the active ingredient naturally may take up to 2 years. This time period may be reduced to a few weeks by taking certain medicines to accelerate the elimination of teriflunomida from your body.

Regardless, you need your doctor to confirm, from a blood test, that the level of active ingredient in your blood is low enough for you to become pregnant.

For more information on laboratory tests, contact your doctor.

If you suspect that you are pregnant while taking teriflunomida or in the two years following the end of treatment, you should interrupt teriflunomida and contact your doctor immediately to perform a pregnancy test. If the test confirms pregnancy, your doctor may suggest a treatment with certain medicines to eliminate teriflunomida from your body quickly and sufficiently, as this may reduce the risk to your baby.

Contraception

You should use an effective contraceptive method during and after treatment with teriflunomida. Teriflunomida remains in your blood for a long time after you stop taking it. Continue to take contraceptive measures after interrupting treatment.

• Skip doing it 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 Neuraxpharm contains lactose

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

Teriflunomida Neuraxpharm contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

A healthcare professional with experience in treating multiple sclerosis will supervise the treatment with teriflunomida.

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

Adults

The recommended dose is one 14 mg tablet per day.

Children and adolescents (10 years of age and above)

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 (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 per day.

Form/Via of Administration

This medication is administered orally. This medication is taken once a day in a single daily dose at any time of the day.

Swallow the tablet with water.

This medication can be taken with or without food.

If you take more Teriflunomida Neuraxpharm than you should

If you have taken too much teriflunomida, call 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, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Teriflunomida Neuraxpharm

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Teriflunomida Neuraxpharm

Do not interrupt the 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.

With this medicine, the following side effects may occur.

Severe side effects

Some side effects may be severe, if you experience any of these, inform your doctor immediately.Inform your doctor immediately.

Common(may affect up to 1 in 10 people)

• pancreatitis that 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 that may include symptoms of rash, hives, swelling of lips, tongue, or face, or sudden difficulty breathing
• severe skin reactions that may include symptoms of skin rash, blisters, fever, or ulcers in your mouth
• serious infections or sepsis (a type of infection that can be potentially fatal) that may include symptoms such as high fever, chills, decreased urine flow, or confusion
• lung inflammation that may include symptoms such as shortness of breath or persistent cough

Frequency unknown(the frequency cannot be estimated with the available data)

• serious liver disease that may include symptoms such as yellowing of the skin or eyes, darker urine than normal, 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
• increase in ALT (increase in certain liver enzymes in the blood) in tests
• finer hair

Common(may affect up to 1 in 10 people)

-flu, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat, and swallowing difficulties, cystitis, viral gastroenteritis, oral herpes, dental infection, laryngitis, fungal infection of the foot

-herpes virus infections, including oral herpes and shingles (herpes 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.

- Changes in 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

-tingling, feeling of weakness, numbness, 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)

-need to urinate more frequently than normal

-heavy periods

-pain

-lack of energy or weakness (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; sharp, stabbing, or pulsating pain in one or more nerves; nerve problems in arms and 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

- inflammation of the colon (colitis)

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

• inflammation or liver damage

Frequency unknown(the frequency cannot be estimated with the available data)

-respiratory 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 side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines 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 and the blister pack after "CAD". The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the Sigre Point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Teriflunomide Neuraxpharm

The active ingredient is teriflunomide.

Teriflunomide Neuraxpharm 14 mg film-coated tablets EFG

• Each tablet contains14mg of teriflunomide.
• The other components are lactose monohydrate, maize starch, microcrystalline cellulose, carboxymethyl starch sodium (type A), hydroxypropyl cellulose, colloidal anhydrous silica, magnesium stearate, hypromellose 2910, titanium dioxide (E171), talc, macrogol 8000, aluminium lake carmine (E132) (see section 2 “Teriflunomide Neuraxpharm contains lactose”).

Appearance of the product and contents of the pack

Teriflunomide Neuraxpharm 14 mg film-coated tablets EFG

The film-coated tablets are light blue or pale blue in colour, round, biconvex, scored on both sides and engraved with “I” and “2” on each side of the score 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 cartons containing 28, 84 and 28x1 (unit dose) tablets in blisters.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Responsible for Manufacturing:

Marketing Authorisation Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

Sant Joan Despí – 08970

Barcelona

Spain

Responsible for Manufacturing:

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 with the following names:

Republic of CzechiaTeriflunomide 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

Last date of revision of this leaflet: September 2024

Other sources of information

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