מדינה: האיחוד האירופי
שפה: אנגלית
מקור: EMA (European Medicines Agency)
dimethyl fumarate
Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A.
L04AX07
dimethyl fumarate
Immunosuppressants
Multiple Sclerosis, Relapsing-Remitting
Dimethyl fumarate Polpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.
Revision: 4
Authorised
2022-05-13
30 B. PACKAGE LEAFLET ema-combined-h-5955-en Pg. 30 Medicinal product no longer authorised 31 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DIMETHYL FUMARATE POLPHARMA 120 MG GASTRO-RESISTANT CAPSULES, HARD DIMETHYL FUMARATE POLPHARMA 240 MG GASTRO-RESISTANT CAPSULES, HARD _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 Dimethyl fumarate Polpharma is and what it is used for 2. What you need to know before you take Dimethyl fumarate Polpharma 3. How to take Dimethyl fumarate Polpharma 4. Possible side effects 5. How to store Dimethyl fumarate Polpharma 6. Contents of the pack and other information 1. WHAT DIMETHYL FUMARATE POLPHARMA IS AND WHAT IT IS USED FOR WHAT DIMETHYL FUMARATE POLPHARMA IS Dimethyl fumarate Polpharma is a medicine that contains the active substance DIMETHYL FUMARATE . WHAT DIMETHYL FUMARATE POLPHARMA IS USED FOR DIMETHYL FUMARATE POLPHARMA 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 DIMETHYL FUMARATE POLPHARMA WORKS Dimethyl fum קרא את המסמך השלם
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ema-combined-h-5955-en Pg. 1 Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Dimethyl fumarate Polpharma 120 mg gastro-resistant capsules, hard Dimethyl fumarate Polpharma 240 mg gastro-resistant capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Dimethyl fumarate Polpharma 120 mg: Each capsule contains 120 mg dimethyl fumarate. Dimethyl fumarate Polpharma 240 mg: Each capsule contains 240 mg dimethyl fumarate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant hard capsule Dimethyl fumarate Polpharma 120 mg: hard gelatin capsules, length: 19 mm, with white body and light-green cap, with overprint on the body 120 mg. Dimethyl fumarate Polpharma 240 mg: hard gelatin capsules, length: 23 mm, light-green, with overprint on the body 240 mg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dimethyl fumarate Polpharma 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. ema-combined-h-5955-en Pg. 2 Medicinal product no longer authorised 3 Dimethyl fumarate Polpharma should be taken with food (see section 5.2). For those patients who may experience flushing or gastrointestinal adve קרא את המסמך השלם