Teriflunomide neuraxpharm

Package leaflet: Information for the patient

Teriflunomide Neuraxpharm, 14 mg,
film-coated tablets
Teriflunomidum
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

What is Teriflunomide Neuraxpharm
Teriflunomide Neuraxpharm contains the active substance teriflunomide, which is an immunomodulatory agent that regulates the immune system in order to reduce its attack on the nervous system.
What Teriflunomide Neuraxpharm is used for
Teriflunomide Neuraxpharm is used in the treatment of adults, children and adolescents (aged 10 years and older) with relapsing-remitting multiple sclerosis.
What is multiple sclerosis
Multiple sclerosis is a chronic disease that attacks 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) around the nerves in the central nervous system. This process is known as demyelination. It prevents nerves from functioning properly.
In people with relapsing-remitting multiple sclerosis, there are recurrent attacks (relapses) of physical symptoms caused by improper nerve function. These symptoms vary between patients but usually include:

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

These symptoms may completely disappear after a relapse ends, but over time some problems may persist between relapses. This may lead to physical disability that makes performing daily activities difficult.
How Teriflunomide Neuraxpharm works
Teriflunomide Neuraxpharm helps protect the central nervous system from the immune system by limiting the increase in number of certain white blood cells (lymphocytes). This reduces the inflammation that, in patients with multiple sclerosis, leads to nerve damage.

2. Important information before taking Teriflunomide Neuraxpharm

When not to take Teriflunomide Neuraxpharm:

• if the patient is allergic to teriflunomide or any of the other ingredients of this medicine (listed in section 6);
• if the patient has ever experienced severe skin rash, skin peeling, blisters and/or oral ulceration after taking teriflunomide or leflunomide;
• if the patient has severe liver disease;
• if the patient is pregnant, suspects she may be pregnant, or is breastfeeding;
• if the patient has any severe diseases affecting the immune system, e.g. acquired immunodeficiency syndrome (AIDS);
• if the patient has any severe bone marrow disorders or has low numbers of red or white blood cells or reduced platelet count;
• if the patient has a severe infection;
• if the patient has severe kidney disease requiring dialysis;
• if the patient has very low levels of protein in the blood (hypoproteinemia).
  If in doubt, consult a doctor or pharmacist before taking this medicine.

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

• the patient has impaired liver function and/or drinks large amounts of alcohol; the doctor may perform blood tests to check liver function before and during treatment. If test results indicate liver dysfunction, the doctor may discontinue Teriflunomide Neuraxpharm. Refer to section 4.
• the patient has high blood pressure (hypertension), regardless of whether it is controlled with medication or not. Teriflunomide Neuraxpharm may increase blood pressure. The doctor will check the patient's blood pressure before starting treatment and regularly thereafter. Refer to section 4.
• the patient has an infection. Before taking Teriflunomide Neuraxpharm, the doctor will ensure the patient has adequate levels of white blood cells and platelets in the blood. Since Teriflunomide Neuraxpharm reduces the number of white blood cells, it may impair the ability to fight infections. The doctor may perform blood tests to monitor white blood cell count if the patient suspects an infection. Viral infections such as herpes virus, including cold sores or shingles, may occur during treatment with teriflunomide. In some cases, serious complications have occurred. Inform the doctor immediately if any symptoms suggestive of herpes virus infection develop. Refer to section 4.
• the patient has severe skin reactions.
• the patient has respiratory symptoms.
• the patient experiences weakness, numbness, or pain in the hands and feet.
• the patient intends to receive vaccination.
• the patient is taking leflunomide together with Teriflunomide Neuraxpharm.
• the patient is switching from another medication to Teriflunomide Neuraxpharm or from Teriflunomide Neuraxpharm to another medicine.
• the patient is scheduled for a specific blood test (calcium level measurement). Test results for calcium levels may be falsely low.

Respiratory system reactions
Inform the doctor if the patient develops unexplained cough or shortness of breath (difficulty breathing). The 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 pediatric patients with multiple sclerosis.
The warnings and precautions listed above also apply to children. The following information is important for children and their caregivers:

• cases of pancreatitis have been observed in patients receiving teriflunomide. The child's doctor may perform blood tests if pancreatitis is suspected.

Teriflunomide Neuraxpharm and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including over-the-counter medicines, as well as any medicines the patient plans to take.
In particular, inform the doctor or pharmacist if the patient is taking any of the following medicines:

• leflunomide, methotrexate, and other medicines affecting the immune system (often called immunosuppressants or immunomodulators);
• rifampicin (used to treat tuberculosis and other infections);
• carbamazepine, phenobarbital, phenytoin, used to treat epilepsy;
• St. John's wort (herbal remedy 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 kidney disease in patients with diabetes;
• 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;
• indometacin, ketoprofen, used to treat inflammation or pain;
• furosemide, used to treat heart conditions;
• cimetidine, used to reduce gastric acid secretion;
• zidovudine, used to treat HIV infection;
• rosuvastatin, simvastatin, atorvastatin, pravastatin, medicines used to treat hypercholesterolemia (high blood cholesterol levels);
• sulfasalazine, used for inflammatory bowel disease and rheumatoid arthritis;
• cholestyramine, used in cases of high blood cholesterol or itching in liver diseases;
• activated charcoal, used to reduce absorption of medicines or other substances.

Pregnancy and breastfeeding
Do not take Teriflunomide Neuraxpharm if the patient is pregnant or suspects she may be pregnant.
Women who are pregnant or become pregnant while taking Teriflunomide Neuraxpharm have an increased risk of congenital malformations in the unborn child. Women of childbearing potential who do not use effective contraception must not take this medicine.
If a girl starts menstruating while taking Teriflunomide Neuraxpharm, inform the doctor, who will provide specialist advice regarding contraception and potential risks in case of pregnancy.
If a woman plans to become pregnant after stopping Teriflunomide Neuraxpharm, she must inform her doctor, as it is essential to confirm that the medicine has been eliminated from the body before attempting pregnancy. Elimination of the active substance may take up to 2 years. This period can be shortened to several weeks by taking certain medicines that accelerate the removal of Teriflunomide Neuraxpharm from the body.
In both cases, blood testing must confirm that the active substance has been sufficiently eliminated from the body. The treating doctor should confirm that the blood concentration of Teriflunomide Neuraxpharm is low enough to allow pregnancy.
More information about laboratory testing can be obtained from the treating doctor.
If pregnancy is suspected during treatment with Teriflunomide Neuraxpharm or within two years after stopping treatment, discontinue the medicine immediately and contact the doctor immediately to perform a pregnancy test.
If the test confirms pregnancy, the doctor may recommend certain treatments to rapidly and adequately eliminate Teriflunomide Neuraxpharm from the body to reduce the risk to the unborn child.

Contraception
Women must use an effective method of contraception during treatment with Teriflunomide Neuraxpharm and after stopping treatment. Teriflunomide remains in the blood for a long time after discontinuation.
For this reason, effective contraception must continue after stopping treatment.

• Contraception should be continued until blood levels of Teriflunomide Neuraxpharm are sufficiently low (as confirmed by the doctor).
• Discuss with the doctor the most suitable contraceptive method for the patient, and in case a change of contraceptive method is needed. Do not take Teriflunomide Neuraxpharm while breastfeeding, as teriflunomide passes into human milk.

Driving and operating machinery
Teriflunomide Neuraxpharm may cause dizziness, which may impair the ability to concentrate and react. Patients experiencing such symptoms should not drive or operate machinery.

Teriflunomide Neuraxpharm contains lactose
Teriflunomide Neuraxpharm contains lactose (a type of sugar). If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Teriflunomide Neuraxpharm contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Teriflunomide Neuraxpharm

Treatment with Teriflunomide Neuraxpharm will be supervised by a physician experienced in the
treatment of multiple sclerosis.
This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
physician.
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 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 (half of a 14 mg tablet).

Children and adolescents who reach a stable body weight above 40 kg will be informed by their physician
about changing the dose to one 14 mg tablet per day.
Route and method of administration
Teriflunomide Neuraxpharm is administered orally. Teriflunomide Neuraxpharm is taken daily at any
time as a single daily dose.
Tablets should be swallowed whole, with water.
Teriflunomide Neuraxpharm may be taken with food or independently of meals.
Taking more Teriflunomide Neuraxpharm than prescribed
If more Teriflunomide Neuraxpharm is taken than prescribed, contact your doctor immediately.
Adverse effects similar to those described in section 4 below may occur.
Missing a dose of Teriflunomide Neuraxpharm
Do not take a double dose to make up for a missed tablet. Take the next dose according to the prescribed
dosing schedule.
Stopping Teriflunomide Neuraxpharm
Do not stop taking Teriflunomide Neuraxpharm or change the dose without first consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur after using this medicine.
Serious adverse reactions
Some adverse reactions may be serious or may become serious. If any of the following symptoms occur, contact your doctor immediately.
Common (may occur in up to 1 in 10 people)

• Pancreatitis, which may cause symptoms such as abdominal pain, nausea or vomiting (frequency is common in children and adolescents and uncommon in adult patients).

Uncommon (may occur in 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 on the skin, fever or mouth ulcers;
• Severe infections or sepsis (a type of infection potentially life-threatening), which may cause symptoms such as high fever, seizures, chills, reduced urine flow or disorientation;
• Lung inflammation, which may cause symptoms such as shortness of breath or persistent cough.

Unknown frequency (frequency cannot be estimated from available data):

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

Other adverse reactions may occur with the following frequency:
Very common (may occur in more than 1 in 10 people)

• Headache;
• Diarrhoea, nausea;
• Increased AlAT activity (increase in certain liver enzyme activity in blood) observed in laboratory tests;
• Hair thinning.

Common (may occur in up to 1 in 10 people)

• Influenza, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and discomfort during swallowing, bladder inflammation, viral gastroenteritis, dental infection, laryngitis, fungal foot infection;
• Herpes virus infections, including cold sores and 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 fatigue;
• Laboratory test results: decreased number of red blood cells (anaemia), changes in liver and white blood cell test results (see section 2), increased activity of muscle enzymes (creatine kinase) has also been observed;
• Mild allergic reactions;
• Feeling of restlessness;
• Tingling sensation, feeling of weakness, numbness, tingling or pain in the lower back or leg (sciatica), tingling, burning, numbness or pain in hands and fingers (carpal tunnel syndrome);
• Sensation of "heart pounding";
• Increased blood pressure;
• Vomiting, toothache, upper abdominal pain;
• Rash, acne;
• Pain in tendons, joints, bones, muscle pain (musculoskeletal pain);
• Need to urinate more frequently than usual;
• Heavy menstrual bleeding;
• Pain;
• Lack of energy or feeling of weakness (asthenia);
• Weight loss.

Uncommon (may occur in up to 1 in 100 people)

• Decreased number of platelets (mild thrombocytopenia);
• Increased sensitivity (especially of the skin), stabbing or pulsating pain along one or more nerves, nerve disorders of arms or legs (peripheral neuropathy);
• Nail disorders, severe skin reactions;
• Traumatic pain;
• Psoriasis;
• Inflammation of the mouth/lips;
• Abnormal levels of fats (lipids) in the blood;
• Inflammation of the large intestine.

Rare (may occur in up to 1 in 1000 people)

• Inflammation or damage to the liver.

Unknown frequency (frequency cannot be estimated from available data)

• Pulmonary hypertension.

Children (aged 10 years and older) and adolescents
The adverse reactions listed above also apply to children and adolescents. The following additional information is important for children, adolescents and their caregivers:
Common (may occur in up to 1 in 10 people)

• Pancreatitis.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps 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 stated on the carton and blister after "EXP".
The expiry date refers to the last day of the mentioned month.
No special storage conditions are required for this medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Teriflunomide Neuraxpharm contains
The active substance is teriflunomide.
Teriflunomide Neuraxpharm 14 mg film-coated tablets

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

What Teriflunomide Neuraxpharm looks like and contents of the pack
Teriflunomide Neuraxpharm 14 mg, film-coated tablets (tablets)
Light blue to pastel blue, round, biconvex film-coated tablet with a division line on both sides and engraved with the numbers "I" and "2" on either side of the division line on one side. The diameter of the tablet is approximately 7.50 mm. The tablet may be divided into equal doses.
Teriflunomide Neuraxpharm 14 mg film-coated tablets are available in cardboard boxes containing: 28, 28x1 (unit dose), 56, 84 and 98 tablets in blister packs.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:
Czech Republic Teriflunomide Neuraxpharm
Hungary Teriflunomide Neuraxpharm 14 mg Filmtabletta
Poland Teriflunomide Neuraxpharm
Slovakia Teriflunomide Neuraxpharm 14 mg
Norway Teriflunomide Neuraxpharm
Iceland Teriflunomide Neuraxpharm
Germany Teriflunomid neuraxpharm 14 mg Filmtabletten
France TERIFLUNOMIDE NEURAXPHARM 14 mg, comprimé pelliculé sécable
Spain Teriflunomida Neuraxpharm 14 mg comprimidos recubiertos con película EFG
Italy Teriflunomide Neuraxpharm

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Neuraxpharm Polska Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
[email protected]