देश: यूरोपीय संघ
भाषा: अंग्रेज़ी
स्रोत: EMA (European Medicines Agency)
dimethyl fumarate
Accord Healthcare S.L.U.
L04AX07
dimethyl fumarate
Immunosuppressants
Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
Dimethyl fumarate Accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).
Authorised
2023-02-15
33 B. PACKAGE LEAFLET Medicinal product no longer authorised 34 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DIMETHYL FUMARATE ACCORD 120 MG GASTRO-RESISTANT HARD CAPSULES DIMETHYL FUMARATE ACCORD 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 Dimethyl fumarate Accord is and what it is used for 2. What you need to know before you take Dimethyl fumarate Accord 3. How to take Dimethyl fumarate Accord 4. Possible side effects 5. How to store Dimethyl fumarate Accord 6. Contents of the pack and other information 1. WHAT DIMETHYL FUMARATE ACCORD IS AND WHAT IT IS USED FOR WHAT DIMETHYL FUMARATE ACCORD IS Dimethyl fumarate Accord is a medicine that contains the active substance DIMETHYL FUMARATE . WHAT DIMETHYL FUMARATE ACCORD IS USED FOR DIMETHYL FUMARATE ACCORD 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 ACCORD WORKS Dimethyl fumarate Accord seems to work by stopping the body’s defence system from damagi पूरा दस्तावेज़ पढ़ें
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Dimethyl fumarate Accord 120 mg gastro-resistant hard capsules Dimethyl fumarate Accord 240 mg gastro-resistant hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Dimethyl fumarate Accord 120 mg gastro-resistant hard capsules Each gastro-resistant hard capsule contains 120 mg dimethyl fumarate Dimethyl fumarate Accord 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 (Gastro-resistant capsule) Dimethyl fumarate Accord 120 mg gastro-resistant hard capsules Size “0” (approximate 21.3 x 7.5 mm) hard gelatin capsules with green cap and white body, printed with “HR1” in black ink on capsule body containing white to off-white, round, biconvex enteric coated mini tablets plain on both the sides. Dimethyl fumarate Accord 240 mg gastro-resistant hard capsules Size “0” (approximate 21.3 x 7.5 mm) hard gelatin capsules with green cap and body, printed with “HR2” in black ink on capsule body containing white to off-white, round, biconvex enteric coated mini tablets plain on both the sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dimethyl fumarate Accord 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). Medicinal product no longer authorised 3 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 shou पूरा दस्तावेज़ पढ़ें