Country: Европска Унија
Језик: Енглески
Извор: EMA (European Medicines Agency)
perampanel
Eisai GmbH
N03AX22
perampanel
Antiepileptics, , Other antiepileptics
Epilepsies, Partial
Fycompa is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in adult and adolescent patients from 12 years of age with epilepsy.Fycompa is indicated for the adjunctive treatment of primary generalised tonic-clonic seizures in adult and adolescent patients from 12 years of age with idiopathic generalised epilepsy.
Revision: 32
Authorised
2012-07-23
69 B. PACKAGE LEAFLET 70 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FYCOMPA 2 MG, 4 MG, 6 MG, 8 MG, 10 MG, AND 12 MG FILM-COATED TABLETS Perampanel 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 Fycompa is and what it is used for 2. What you need to know before you take Fycompa 3. How to take Fycompa 4. Possible side effects 5. How to store Fycompa 6. Contents of the pack and other information 1. WHAT FYCOMPA IS AND WHAT IT IS USED FOR Fycompa contains a medicine called perampanel. It belongs to a group of medicines called anti epileptics. These medicines are used to treat epilepsy - where someone has repeated fits (seizures). It has been given to you by your doctor to reduce the number of fits that you have. Fycompa is used in association with other antiepileptic drugs to treat certain forms of epilepsy: In adults, adolescents (aged 12 years and older), and children (from 4 to 11 years) - It is used to treat fits that affect one part of your brain (called a “partial seizure”). - These partial seizures may or may not then be followed by a fit affecting all of your brain (called a “secondary generalisation”). In adults and adolescents (aged 12 years and older), and children (from 7 to 11 years) - It is also used to treat certain fits that affect all of your brain from the start (called “generalised seizures”) and cause convulsions or staring spells. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FYCOMPA DO NOT TAKE FYCOMPA: - If you have ever developed a severe skin rash or skin peeling Прочитајте комплетан документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Fycompa 2 mg film-coated tablets Fycompa 4 mg film-coated tablets Fycompa 6 mg film-coated tablets Fycompa 8 mg film-coated tablets Fycompa 10 mg film-coated tablets Fycompa 12 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Fycompa 2 mg film-coated tablets Each film-coated tablet contains 2 mg perampanel. Excipient with known effect: Each 2 mg tablet contains 78.5 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. Fycompa 4 mg film-coated tablets Each film-coated tablet contains 4 mg perampanel. Excipient with known effect: Each 4 mg tablet contains 157.0 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. Fycompa 6 mg film-coated tablets Each film-coated tablet contains 6 mg perampanel. Excipient with known effect: Each 6 mg tablet contains 151.0 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. Fycompa 8 mg film-coated tablets Each film-coated tablet contains 8 mg perampanel. Excipient with known effect: Each 8 mg tablet contains 149.0 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. Fycompa 10 mg film-coated tablets Each film-coated tablet contains 10 mg perampanel. Excipient with known effect: Each 10 mg tablet contains 147.0 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. Fycompa 12 mg film-coated tablets Each film-coated tablet contains 12 mg perampanel. Excipient with known effect: Each 12 mg tablet contains 145.0 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Fycompa 2 mg film-coated tablets Orange, round, biconvex tablet, engraved with E275 on one side and ‘2’ on other side Fycompa 4 mg film-coated tablets Red, round, biconvex tablet, engraved with E277 on one side and ‘4’ on other side Fycompa 6 mg film-coated tablets Pink, round, biconvex tablet, engrav Прочитајте комплетан документ