国: 欧州連合
言語: 英語
ソース: EMA (European Medicines Agency)
Rufinamide
Eisai GmbH
N03AF03
rufinamide
Antiepileptics,
Epilepsy
Inovelon is indicated as adjunctive therapy in the treatment of seizures associated with Lennox Gastaut syndrome in patients 4 years of age and older.
Revision: 23
Authorised
2007-01-16
46 B. PACKAGE LEAFLET 47 PACKAGE LEAFLET: INFORMATION FOR THE USER INOVELON 100 MG FILM-COATED TABLETS INOVELON 200 MG FILM-COATED TABLETS INOVELON 400 MG FILM-COATED TABLETS Rufinamide 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 the 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 the doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Inovelon is and what it is used for 2. What you need to know before you take Inovelon 3. How to use Inovelon 4. Possible side effects 5. How to store Inovelon 6. Contents of the pack and other information 1. WHAT INOVELON IS AND WHAT IT IS USED FOR Inovelon contains a medicine called rufinamide. It belongs to a group of medicines called antiepileptics, which are used to treat epilepsy (a condition where someone has seizures or fits). Inovelon is used with other medicines to treat seizures associated with Lennox-Gastaut syndrome in adults, adolescents and children from 1 year of age. Lennox-Gastaut syndrome is the name given to a group of severe epilepsies in which you may experience repeated seizures of various types. Inovelon has been given to you by your doctor to reduce the number of your seizures or fits. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE INOVELON DO NOT TAKE INOVELON: - if you are allergic to rufinamide or triazole derivatives or any of the other ingredients of Inovelon (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist if: - you have Congenital Short QT Syndrome or a family history of such a syndrome (electrical disturbance of the heart), as taking rufinamide could make it worse. - you suffer from liver problems. There is l 完全なドキュメントを読む
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Inovelon 100 mg film-coated tablets Inovelon 200 mg film-coated tablets Inovelon 400 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Oral Tablet Each film-coated tablet contains 100 mg rufinamide. Each film-coated tablet contains 200 mg rufinamide. Each film-coated tablet contains 400 mg rufinamide. Excipients with known effect: Each 100 mg film-coated tablet contains 20 mg lactose (as monohydrate). Each 200 mg film-coated tablet contains 40 mg lactose (as monohydrate). Each 400 mg film-coated tablet contains 80 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 100 mg: Pink, ‘ovaloid’, slightly convex, approximately 10.2 mm in length, scored on both sides, embossed ‘Є261’ on one side and blank on the other side. The tablet can be divided into equal halves. 200 mg: Pink, ‘ovaloid’, slightly convex, approximately 15.2 mm in length, scored on both sides, embossed ‘Є262’ on one side and blank on the other side. The tablet can be divided into equal halves. 400 mg: Pink, ‘ovaloid’, slightly convex, approximately 18.2 mm in length, scored on both sides, embossed ‘Є263’ on one side and blank on the other side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Inovelon is indicated as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 1 year of age and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with rufinamide should be initiated by a physician specialised in paediatrics or neurology with experience in the treatment of epilepsy. Inovelon oral suspension and Inovelon film-coated tablets may be interchanged at equal doses. Patients should be monitored during the switch over period. 3 Posology _USE IN CHILDREN FROM 1 YEAR TO LESS THAN 4 YEARS OF AGE_ _Patients not receiving valproate:_ Treatment should be initiated 完全なドキュメントを読む