Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
dimethyl fumarate
Biogen Netherlands B.V.
L04AX07
dimethyl fumarate
Immunosuppressants
Multiple Sclerosis
Tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).
Revision: 28
Authorised
2014-01-30
43 B. PACKAGE LEAFLET 43 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TECFIDERA 120 MG GASTRO-RESISTANT HARD CAPSULES TECFIDERA 240 MG GASTRO-RESISTANT HARD CAPSULES dimethyl fumarate 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 1. What Tecfidera is and what it is used for 2. What you need to know before you take Tecfidera 3. How to take Tecfidera 4. Possible side effects 5. How to store Tecfidera 6. Contents of the pack and other information 1. WHAT TECFIDERA IS AND WHAT IT IS USED FOR WHAT TECFIDERA IS Tecfidera is a medicine that contains the active substance DIMETHYL FUMARATE . WHAT TECFIDERA IS USED FOR TECFIDERA IS USED TO TREAT RELAPSING-REMITTING MULTIPLE SCLEROSIS (MS) IN PATIENTS AGED 13 YEARS AND OLDER . MS is a long-term condition that affects the central nervous system (CNS), including the brain and the spinal cord. Relapsing-remitting MS is characterised by repeated attacks (relapses) of nervous system symptoms. Symptoms vary from patient to patient, but typically include walking difficulties, feeling off balance and visual difficulties (e.g. blurred or double vision). These symptoms may disappear completely when the relapse is over, but some problems may remain. HOW TECFIDERA WORKS Tecfidera seems to work by stopping the body’s defence system from damaging your brain and spinal cord. This may also help to delay future worsening of your MS. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TECFIDERA DO NOT TAKE TECFIDERA - IF YOU ARE ALLERGIC TO DIMETHYL FUMARATE or any of the other ingredient Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 43 1. NAME OF THE MEDICINAL PRODUCT Tecfidera 120 mg gastro-resistant hard capsules Tecfidera 240 mg gastro-resistant hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tecfidera 120 mg gastro-resistant hard capsules Each gastro-resistant hard capsule contains 120 mg dimethyl fumarate. Tecfidera 240 mg gastro-resistant hard capsules Each gastro-resistant hard capsule contains 240 mg dimethyl fumarate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant hard capsule Tecfidera 120 mg gastro-resistant hard capsules Green and white gastro-resistant hard capsules, size 0, printed with ‘BG-12 120 mg’ containing microtablets. Tecfidera 240 mg gastro-resistant hard capsules Green gastro-resistant hard capsules, size 0, printed with ‘BG-12 240 mg’ containing microtablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under supervision of a physician experienced in the treatment of multiple sclerosis. Posology The starting dose is 120 mg twice a day. After 7 days, the dose should be increased to the recommended maintenance dose of 240 mg twice a day (see section 4.4). If a patient misses a dose, a double dose should not be taken. The patient may take the missed dose only if they leave 4 hours between doses. Otherwise the patient should wait until the next scheduled dose. Temporary dose reduction to 120 mg twice a day may reduce the occurrence of flushing and gastrointestinal adverse reactions. Within 1 month, the recommended maintenance dose of 240 mg twice a day should be resumed. 43 Tecfidera should be taken with food (see section 5.2). For those patients who may experience flushing or gastrointestinal adverse reactions, taking Tecfidera with food may improve tolerability (see sections 4.4, 4.5 and 4. Прочетете целия документ