Teriflunomid beta 7 mg Filmtabletten - Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete

Package leaflet: Information for the patient

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this 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 signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

Do not take

Warnings and precautions

Talk to your doctor or pharmacist before taking <Invented name> if:

• – you have liver problems and/or if you drink large amounts of alcohol. Your doctor will carry out blood tests before and during treatment to check how well your liver is working. If your test results show a problem with your liver, your doctor may stop your treatment with <Invented name>. Please read section 4.

• – you have high blood pressure (hypertension) whether it is controlled with medicines or not. <Invented name> can cause an increase in blood pressure. Your doctor will check your blood pressure before the start of treatment and regularly thereafter. Please read section 4.

• – you have an infection. Before you take <Invented name>, your doctor will make sure you have enough white blood cells and platelets in your blood. As <Invented name> decreases the number of white cells in the blood this may affect your ability to fight the infection. Your doctor may do blood tests to check your white blood cells if you think you have an infection. Please read section 4.

• – you have severe skin reactions.

• – you have respiratory symptoms.

• – you have weakness, numbness and pain in the hands and feet.

• – you are going to have a vaccination.

• – you take leflunomide with <Invented name>.

• – you are switching to or from <Invented name>.

• – you are due to have a specific blood test (calcium level). Falsely low levels of calcium can be detected.

Respiratory reactions

Tell your doctor if you have unexplained cough and dyspnoea (shortness of breath). Your doctor may perform additional tests.

Children and adolescents

<Invented name> is not intended for use in children under 10 years of age, as it has not been studied in MS patients in this age group.

The warnings and precautions listed above also apply to children. The following information is important for children and their caregivers:

• – inflammation of the pancreas has been observed in patients receiving teriflunomide. Your child’s doctor may carry out blood tests if an inflammation to the pancreas is suspected.

Other medicines and <Invented name>

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

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

• – 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 in kidney disease in diabetics

• – alosetron for the management of severe diarrhoea

• – theophylline for asthma

• – tizanidine, a muscle relaxant

• – warfarin, an anticoagulant used to make the blood thinner (i.e. more fluid) in order to avoid blood clots

• – oral contraceptives (containing ethinylestradiol and levonorgestrel)

• – cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections

• – indomethacin, ketoprofen for pain or inflammation

• – furosemide for heart disease

• – cimetidine for reducing gastric acid

• – zidovudine for HIV infection

• – rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholeste­rolemia (high cholesterol)

• – sulfasalazine for inflammatory bowel disease or rheumatoid arthritis

• – cholestyramine for high cholesterol or relief from itching in liver disease

• – activated charcoal to reduce absorption of medicines or other substances

Pregnancy and breast-feeding

Do not take when you are breast-feeding, as teriflunomide passes into the breast milk.

Driving and using machines

contains lactose

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

• 5. How to store <Invented name>

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 after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

• 6. Contents of the pack and other information

This leaflet was last revised in {MM/YYYY}

Other sources of information

Detailed information on this medicine is available on the website of {name of Member State Agency (link)}

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