TERIFLUNOMIDE NEURAXPHARM 14 mg FILM-COATED TABLETS

2. What you need to know before taking Teriflunomide Neuraxpharm

Do not takeTeriflunomide Neuraxpharm:

• if you are allergic to teriflunomide or any of the other ingredients of this medication (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 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 immune system problem, e.g., acquired immune deficiency syndrome (AIDS),
• if you have serious bone marrow problems or a low white blood cell count or red blood cell count or a reduced platelet count,
• if you have a serious infection,
• if you have severe kidney problems that require dialysis,
• if you have a low protein level in the blood (hypoproteinemia),

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take teriflunomide 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 and during treatment. If the test results indicate a liver problem, your doctor may interrupt 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 check your blood pressure before starting treatment and regularly during treatment. See section 4.
• you have an infection. Before you start taking teriflunomide, your doctor will make sure you have enough white blood cells and platelets in your blood. Since teriflunomide decreases the number of white blood cells in the blood, this may affect your ability to fight infection. Your doctor may perform blood tests to check your white blood cell count if they suspect you have an infection.

With teriflunomide treatment, viral infections such as oral or genital herpes (shingles) may occur. In some cases, serious complications have occurred. You should immediately inform your doctor if you suspect 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 hands and feet.
• you are going to be vaccinated.
• you are taking leflunomide with teriflunomide.
• you are being switched from or to teriflunomide.
• a specific blood test (calcium level) is scheduled. A false decrease in calcium levels may be detected.

Respiratory reactions

Inform your doctor if you have unexplained cough and 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 has been observed in patients receiving teriflunomide. Your child's doctor may perform blood tests if they suspect pancreatitis.

Other medications andTeriflunomide Neuraxpharm

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medications. This includes medications without a prescription.

In particular, inform your doctor or pharmacist if you are taking any of the following medications:

• leflunomide, methotrexate, and other medications that affect the immune system (often referred to as immunodepressants or immunomodulators)
• rifampicin (a medication 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
• 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
• sulfasalazine for inflammatory bowel disease or rheumatoid arthritis
• cholestyramine for high cholesterol or relief of itching in liver disease
• activated charcoal to reduce the absorption of medications or other substances.

Pregnancy and breastfeeding

Do nottake teriflunomide if you are pregnant or think you may be pregnant. If you are pregnant or become pregnant while taking teriflunomide, the risk of having a baby with birth defects will increase. Women of childbearing age must not take this medication if they are not using reliable contraceptive methods.

If your daughter has her first period while taking teriflunomide, she must inform her doctor, who will provide specialized advice on contraceptive methods and potential risks in case of pregnancy.

Inform your doctor if you plan to become pregnant after stopping treatment with teriflunomide, as you will need to make sure that most of this medication has been eliminated from your body before trying to become pregnant. The natural elimination of the active substance may take up to 2 years. This period can be reduced to a few weeks by taking certain medications to accelerate the elimination of teriflunomide from the body.

In any case, you need your doctor to confirm, based on a blood test, that the level of the active substance in your blood is low enough for you to become pregnant.

For more information on laboratory tests, contact your doctor.

If you suspect you are pregnant while taking teriflunomide or in the 2 years following the end of treatment, you must stop taking teriflunomide and contact your doctor immediatelyto perform a pregnancy test. If the test confirms pregnancy, your doctor may suggest treatment with certain medications to eliminate teriflunomide from the body quickly, 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 it. Continue to take contraceptive measures after stopping treatment.

• Continue to do so until the levels of teriflunomide in your blood are low enough (your doctor will check this).

• Consult your doctor about the best contraceptive method for you and in case 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 your ability to concentrate and react. If you are affected, do not drive or use machines.

Teriflunomide Neuraxpharmcontains lactose

Teriflunomide 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 medication.

Teriflunomide Neuraxpharm contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially "sodium-free".

3. How to take Teriflunomide Neuraxpharm

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

Follow the instructions for administration of this medication exactly 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 older)

The dose depends on body weight:

• children with a body weight over 40 kg: 14 mg once daily.
• children with a body weight of 40 kg or less: 7 mg once daily (half of a 14 mg tablet).

Your doctor will instruct children and adolescents who reach a stable body weight over 40 kg to switch to a 14 mg tablet per day.

Form/Route of Administration

This medication is administered orally. This medication is taken once daily, at any time of day.

Swallow the tablet with water.

This medication can be taken with or without food.

If you take moreTeriflunomide Neuraxpharmthan you should

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

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

If you forget to takeTeriflunomide Neuraxpharm

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

If you stop takingTeriflunomide Neuraxpharm

Do not stop treatment or change the dose of teriflunomide without consulting your doctor first.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everybody gets them.

The following side effects can occur with this medication.

Serious side effects

Some side effects can be or may become serious, if you experience any of these, 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 uncommon in adult patients).

Uncommon(may affect up to 1 in 100 people)

• allergic reactions that could include symptoms of rash, hives, swelling of lips, tongue, or face, or sudden difficulty breathing
• severe skin reactions that could include symptoms of skin rash, blisters, fever, or ulcers in the mouth
• serious infections or sepsis (a type of infection that can be life-threatening) that could include symptoms such as high fever, chills, shaking, decreased 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 side effectsmay occur with the following frequencies:

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

• headache
• diarrhea, feeling sick
• increased ALT (increase in certain liver enzymes in the blood) in blood tests
• hair loss

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, laryngitis, fungal infection of the foot
• viral infections, including oral and genital herpes (shingles), 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 liver and white blood cells in blood tests (see section 2), as well as elevations in a muscle enzyme (creatine phosphokinase)
• mild allergic reactions
• feeling anxious
• tingling, feeling weak, numbness, tingling, or pain in the lower back or leg (sciatica); feeling numb, burning, tingling, or pain in hands and fingers (carpal tunnel syndrome)
• palpitations
• increased blood pressure
• feeling sick (vomiting), toothache, pain in the upper abdominal region
• rash, acne
• pain in tendons, joints, bones, muscle pain (musculoskeletal pain)
• need to urinate more often than usual
• heavy periods
• pain
• lack of energy or weakness (asthenia)
• weight loss

Uncommon(may affect up to 1 in 100 people)

• mild decrease in platelet count (thrombocytopenia)
• increased sensitivity, especially in the skin; stabbing or pulsating pain in one or more nerves; problems in the nerves of arms and legs (peripheral neuropathy)
  • nail disorders, severe skin reactions

• post-traumatic pain
• psoriasis
• mouth/lip inflammation
• abnormal blood lipid levels
• inflammation of the colon (colitis)

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

• liver inflammation or damage

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

• pulmonary hypertension

Children (10 years of age and older) and adolescents

The side 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)

• pancreatitis

Reporting of side effects

If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Teriflunomida Neuraxpharm

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 after "EXP". The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Teriflunomida Neuraxpharm

The active ingredient is teriflunomide.

Teriflunomida Neuraxpharm 14 mg film-coated tablets EFG

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

Appearance and Package Contents of the Product

Teriflunomida Neuraxpharm 14 mg film-coated tablets EFG

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

The tablet can be divided into equal doses.

Teriflunomida 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 Authorization Holder and Manufacturer:

Marketing Authorization 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 medicine is authorized 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 last revision of this leaflet: September 2024

Other sources of information

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