Teriflunomide Neuraxpharm

Package Leaflet: Information for the Patient

Teriflunomide Neuraxpharm, 14 mg,

coated tablets
Teriflunomide

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

• 1. What is Teriflunomide Neuraxpharm and what is it used for
• 2. Important information 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 is Teriflunomide Neuraxpharm and what is it used for

What is Teriflunomide Neuraxpharm

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

What is Teriflunomide Neuraxpharm used for

Teriflunomide Neuraxpharm is used to treat adults and children and adolescents (aged 10 years and older) with multiple sclerosis with a relapsing-remitting course.

What is multiple sclerosis

Multiple sclerosis is a chronic disease that affects the central nervous system. The central nervous system consists of the brain and spinal cord. In multiple sclerosis, inflammation damages the protective covering (called myelin) that surrounds the nerves in the central nervous system. This process is called demyelination. It disrupts the normal functioning of the nerves.
People with multiple sclerosis with a relapsing-remitting course experience recurring attacks (relapses) of physical symptoms caused by the abnormal functioning of the nerves. These symptoms vary among patients but often include:

• difficulty walking,
• vision problems,
• balance problems.

These symptoms can completely disappear after a relapse, but over time, some problems may persist between relapses. This can lead to physical disability that interferes with daily activities.

How does Teriflunomide Neuraxpharm work

Teriflunomide Neuraxpharm helps protect the central nervous system from the effects of the immune system by reducing the increase in the number of certain white blood cells (lymphocytes). This reduces inflammation, which in people with multiple sclerosis leads to nerve damage.

2. Important information before taking Teriflunomide Neuraxpharm

When not to take Teriflunomide Neuraxpharm:

• if you are allergic to teriflunomide or any of the other ingredients of this medicine (listed in section 6);
• if you have ever experienced a severe skin rash or peeling, blisters, or mouth sores after taking teriflunomide or leflunomide;
• if you have severe liver disease;
• if you are pregnant, think you may be pregnant, or are breastfeeding;
• if you have any severe diseases that affect your immune system, such as acquired immune deficiency syndrome (AIDS);
• if you have any severe blood disorders or have a low number of red or white blood cells or platelets;
• if you have a severe infection;
• if you have severe kidney disease that requires dialysis;
• if you have very low protein levels in your blood (hypoproteinemia). If in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before starting treatment with Teriflunomide Neuraxpharm, discuss with your doctor or pharmacist if:

• you have liver function disorders and/or you drink large amounts of alcohol; your doctor may perform blood tests to check if your liver function is normal before and during treatment. If your test results show liver function disorders, your doctor may stop the use of Teriflunomide Neuraxpharm. Refer to section 4.
• you have high blood pressure, whether or not it is controlled with medication. Teriflunomide Neuraxpharm may increase blood pressure. Your doctor will check your blood pressure before starting treatment and regularly during treatment. Refer to section 4.
• you have an infection. Before taking Teriflunomide Neuraxpharm, your doctor will ensure that you have a sufficient number of white blood cells and platelets in your blood. Since Teriflunomide Neuraxpharm reduces the number of white blood cells in the blood, it may affect your ability to fight infections. Your doctor may perform a blood test to check the number of white blood cells if you think you have an infection. During treatment with teriflunomide, viral infections such as herpes simplex or shingles may occur. In some cases, serious complications have occurred. You should immediately inform your doctor if you suspect any symptoms of a viral infection. Refer to section 4.
• you have severe skin reactions.
• you have respiratory symptoms.
• you have weakness, numbness, and pain in your hands and feet.
• you plan to be vaccinated.
• you are taking leflunomide with Teriflunomide Neuraxpharm.
• you are switching from your current medicine to Teriflunomide Neuraxpharm or from Teriflunomide Neuraxpharm to another medicine.
• you need to have a specific blood test (calcium level measurement). The results of the calcium level measurement may be falsely lowered.

Respiratory reactions

Tell your doctor if you experience unexplained cough and shortness of breath (breathing difficulties). Your doctor may perform additional tests.

Children and adolescents

Teriflunomide Neuraxpharm is not intended for use in children under 10 years of age, as it has not been studied in this age group with multiple sclerosis.
The warnings and precautions mentioned above also apply to children. The following information is important for children and their caregivers:

• -cases of pancreatitis have been observed in patients taking teriflunomide. The doctor treating the child may perform blood tests if pancreatitis is suspected.

Teriflunomide Neuraxpharm and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained 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 immunosuppressive or immunomodulatory medicines);
• rifampicin (used to treat tuberculosis and other infections);
• carbamazepine, phenobarbital, phenytoin, used to treat epilepsy;
• St. John's Wort (a herbal medicine for depression);
• repaglinide, pioglitazone, nateglinide, or rosiglitazone used to treat diabetes;
• daunorubicin, doxorubicin, paclitaxel, or topotecan used to treat cancer;
• duloxetine used to treat depression, urinary incontinence, or diabetic neuropathy;
• alosetron used to treat severe diarrhea;
• theophylline used to treat asthma;
• tizanidine (a muscle relaxant);
• warfarin (an anticoagulant) used to thin the blood (i.e., make it more fluid) to prevent blood clots;
• oral contraceptives (containing ethinylestradiol and levonorgestrel);
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin, used to treat infections;
• indomethacin, ketoprofen, used to treat inflammation or pain;
• furosemide used to treat heart disease;
• cimetidine, used to reduce stomach acid production;
• zidovudine used to treat HIV infections;
• rosuvastatin, simvastatin, atorvastatin, pravastatin, medicines used to treat high cholesterol;
• sulfasalazine used to treat inflammatory bowel disease and rheumatoid arthritis;
• cholestyramine used to treat high cholesterol or itching in liver disease;
• activated charcoal used to reduce the absorption of medicines or other substances.

Pregnancy and breastfeeding

Do nottake Teriflunomide Neuraxpharm if you are pregnantor think you may be pregnant. In pregnant women or those who become pregnant while taking Teriflunomide Neuraxpharm, there is an increased risk of birth defects in the baby. Women of childbearing age who do not use effective contraception must not take this medicine.
If a girl starts menstruating while taking Teriflunomide Neuraxpharm, she should inform her doctor, who will provide specialized advice on contraception and potential risks in case of pregnancy.
If a woman plans to become pregnant after stopping Teriflunomide Neuraxpharm, she should inform her doctor, as it is essential to ensure that the medicine is no longer in the body before trying to conceive. The elimination of the active substance may take up to 2 years. This period can be shortened to a few weeks by taking certain medicines that accelerate the removal of Teriflunomide Neuraxpharm from the body.
In both cases, it should be confirmed by a blood test that the active substance has been sufficiently removed from the body. The treating doctor should confirm that the level of Teriflunomide Neuraxpharm in the blood is low enough for the woman to become pregnant.
More information on laboratory tests can be obtained from the treating doctor.
If there is a suspicion that a woman has become pregnant while taking Teriflunomide Neuraxpharm or within two years after stopping treatment, she should stop taking Teriflunomide Neuraxpharm and immediatelycontact her doctor to perform a pregnancy test.
If the test confirms pregnancy, the doctor may suggest using certain medicines to quickly and sufficiently remove Teriflunomide Neuraxpharm from the body.
Contraception
During treatment with Teriflunomide Neuraxpharm and after stopping it, women should use effective contraception. Teriflunomide remains in the blood for a long time after stopping treatment.
Therefore, effective contraception should still be used after stopping treatment.

• This method should be used until the level of Teriflunomide Neuraxpharm in the blood is low enough (checked by the doctor).
• You should discuss with your doctor the best contraceptive method for you and any need to change the contraceptive method. Do nottake Teriflunomide Neuraxpharm while breastfeeding, as teriflunomide passes into human milk.

Driving and using machines

Teriflunomide Neuraxpharm may cause dizziness, which can affect concentration and reaction time. Patients who experience these symptoms should not drive or operate machinery.

Teriflunomide Neuraxpharm contains lactose

Teriflunomide Neuraxpharm contains lactose (a type of sugar). If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

Teriflunomide Neuraxpharm contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Teriflunomide Neuraxpharm

Treatment with Teriflunomide Neuraxpharm will be supervised by a doctor experienced in the treatment of multiple sclerosis.
Always take this medicine exactly as your doctor has told you. If you are unsure, ask your doctor.

Adults

The recommended dose is one 14 mg tablet per day.

Children and adolescents (aged 10 years and older)

The dose depends on body weight:

• Children with a body weight over 40 kg: one 14 mg tablet per day.
• Children with a body weight of 40 kg or less: one 7 mg tablet per day (half of a 14 mg tablet).

Children and adolescents who reach a stable body weight above 40 kg will be informed by their doctor to change the dose to one 14 mg tablet per day.
Route and method of administration
Teriflunomide Neuraxpharm is taken orally. Teriflunomide Neuraxpharm is taken once daily at any time of day as a single daily dose.
Tablets should be swallowed whole with water.
Teriflunomide Neuraxpharm can be taken with or without food.

Taking more than the recommended dose of Teriflunomide Neuraxpharm

If you take more than the recommended dose of Teriflunomide Neuraxpharm, contact your doctor immediately. Side effects similar to those described in section 4 may occur.

Missing a dose of Teriflunomide Neuraxpharm

Do not take a double dose to make up for a forgotten tablet. Take the next dose as scheduled.

Stopping treatment with Teriflunomide Neuraxpharm

Do not stop taking Teriflunomide Neuraxpharm or change the dose without consulting your doctor first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur after taking this medicine.

Severe side effects

Some side effects can be serious or become serious if you experience any of these symptoms, contact your doctor immediately.
Common(may affect up to 1 in 10 people)

• pancreatitis, which may cause symptoms such as abdominal pain, nausea, or vomiting (common in children and adolescents and uncommon in adults).

Uncommon(may affect up to 1 in 100 people)

• allergic reactions, which may cause symptoms including rash, hives, swelling of the lips, tongue, or face, or sudden breathing difficulties;
• severe skin reactions, which may cause symptoms including skin rash, blisters, fever, or mouth sores;
• severe infections or sepsis (a life-threatening infection), which may cause symptoms including high fever, chills, reduced urine output, or disorientation;
• pneumonia, which may cause symptoms including shortness of breath or persistent cough.

Unknown(frequency cannot be estimated from the available data)

• serious liver disease, which may cause symptoms including yellowing of the skin or whites of the eyes, darker than usual urine, unexplained nausea and vomiting, or abdominal pain.

Other side effectsmay occur with the following frequency:
Very common(may affect more than 1 in 10 people)

• headache;
• diarrhea, nausea;
• increased liver enzyme activity (increased activity of certain liver enzymes in the blood) shown in 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 discomfort when swallowing, cystitis, viral gastroenteritis, tooth infection, laryngitis, fungal foot infection;
• herpes virus infections, including cold sores and 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 test results: reduced red blood cell count (anemia), changes in liver function and white blood cell count (see section 2), also increased muscle enzyme activity (creatine kinase);
• mild allergic reactions;
• feeling anxious;
• feeling of tingling, weakness, numbness, tingling, or pain in the lower back or leg (sciatica), feeling of numbness, burning, tingling, or pain in the hands and fingers (carpal tunnel syndrome);
• feeling of "heart pounding";
• increased blood pressure;
• vomiting, toothache, abdominal pain;
• rash, acne;
• tendon, joint, bone, or muscle pain (musculoskeletal pain);
• need to urinate more frequently than usual;
• heavy menstrual bleeding;
• pain;
• lack of energy or feeling weak (asthenia);
• weight loss.

Uncommon(may affect up to 1 in 100 people)

• reduced platelet count (mild thrombocytopenia);
• increased sensitivity (especially of the skin), stabbing or pulsating pain along one or more nerves, nerve disorders of the arms or legs (peripheral neuropathy);
• nail disorders, severe skin reactions;
• traumatic pain;
• psoriasis;
• mouth ulcers;
• abnormal blood lipid levels;
• colitis.

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

• liver inflammation or damage.

Unknown(frequency cannot be estimated from the available data)

• pulmonary hypertension.

Children (aged 10 years and older) and adolescents

The above 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 side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw; tel.: +48 22 49 21 301; fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Teriflunomide 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 refers to the last day of that month.
There are no special storage instructions for this medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Teriflunomide Neuraxpharm contains

The active substance is teriflunomide.
Teriflunomide Neuraxpharm 14 mg coated tablets

• Each tablet contains 14 mg of teriflunomide.
• The other ingredients are: lactose monohydrate, corn starch, microcrystalline cellulose, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E 171), talc, macrogol 8000, and indigo carmine, aluminum lake (E 132) (see section 2 “Teriflunomide Neuraxpharm contains lactose”).

What Teriflunomide Neuraxpharm looks like and contents of the pack

Teriflunomide Neuraxpharm 14 mg, coated tablets (tablets)
Light blue to pale blue, round, biconvex, film-coated tablet with a score line on both sides, with the numbers "I" and "2" embossed on either side of the score line on one side. The tablet diameter is approximately 7.50 mm. The tablet can be divided into equal doses.
Teriflunomide Neuraxpharm 14 mg coated tablets are available in cartons containing: 28, 28x1 (single dose), 56, 84, and 98 tablets in blisters.
Not all pack sizes may be marketed.

Marketing authorization holder:

neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert Str. 23
40764 Langenfeld
Germany

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona, 69
08970 Sant Joan Despí (Barcelona)
Spain

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

Czech Republic
Teriflunomide Neuraxpharm
Hungary
Teriflunomide Neuraxpharm 14 mg film-coated tablet
Poland
Teriflunomide Neuraxpharm
Slovakia
Teriflunomide Neuraxpharm 14 mg
Norway
Teriflunomide Neuraxpharm
Iceland
Teriflunomide Neuraxpharm
Germany
Teriflunomid neuraxpharm 14 mg film-coated tablets
France
TERIFLUNOMIDE NEURAXPHARM 14 mg, scored film-coated tablet
Spain
Teriflunomida Neuraxpharm 14 mg film-coated tablets EFG
Italy
Teriflunomide Neuraxpharm

For further information on this medicine, please contact the local representative of the marketing authorization holder:

Neuraxpharm Polska Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
info-poland@neuraxpharm.com

Date of last revision of the package leaflet: 03/2025