Երկիր: Մալթա
Լեզու: անգլերեն
Աղբյուրը: Medicines Authority
Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
L04AX07
DIMETHYL FUMARATE 240 mg
GASTRO-RESISTANT HARD CAPSULE
DIMETHYL FUMARATE 240 mg
POM
IMMUNOSUPPRESSANTS
Authorised
2023-11-14
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SCLERYDA 120 MG GASTRO-RESISTANT HARD CAPSULES SCLERYDA 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 Scleryda is and what it is used for 2. What you need to know before you take Scleryda 3. How to take Scleryda 4. Possible side effects 5. How to store Scleryda 6. Contents of the pack and other information 1. WHAT SCLERYDA IS AND WHAT IT IS USED FOR WHAT SCLERYDA IS Scleryda is a medicine that contains the active substance dimethyl fumarate WHAT SCLERYDA IS USED FOR Scleryda 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 SCLERYDA WORKS Scleryda 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 SCLERYDA _ _ DO NOT TAKE SCLERYDA - IF YOU ARE ALLERGIC TO DIMETHYL FUMARATE or any of the other ingredients of this medicine Կարդացեք ամբողջական փաստաթուղթը
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Scleryda 120 mg gastro-resistant hard capsules Scleryda 240 mg gastro-resistant hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Scleryda 120 mg gastro-resistant hard capsules Each gastro-resistant hard capsule contains 120 mg dimethyl fumarate Scleryda 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) Scleryda 120 mg gastro-resistant hard capsules Blue-green and white gastro-resistant hard capsules, 21.7 mm in length, printed with ‘MYLAN’ over ‘DF-120’ containing white to off-white enteric coated pellets. Scleryda 240 mg gastro-resistant hard capsules Blue-green gastro-resistant hard capsules, 21.7 mm in length, printed with ‘MYLAN’ over ‘DF-240’ containing white to off-white enteric coated pellets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Scleryda 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. 3 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. _ _ Scleryda should be taken with food (see section 5.2). For those patients who may experience flushi Կարդացեք ամբողջական փաստաթուղթը