Țară: Uniunea Europeană
Limbă: engleză
Sursă: EMA (European Medicines Agency)
Brivaracetam
UCB Pharma SA
N03AX23
brivaracetam
Antiepileptics,
Epilepsy
Briviact is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent patients from 16 years of age with epilepsy.
Revision: 22
Authorised
2016-01-13
99 B. PACKAGE LEAFLET 100 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BRIVIACT 10 MG FILM-COATED TABLETS BRIVIACT 25 MG FILM-COATED TABLETS BRIVIACT 50 MG FILM-COATED TABLETS BRIVIACT 75 MG FILM-COATED TABLETS BRIVIACT 100 MG FILM-COATED TABLETS brivaracetam 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 Briviact is and what it is used for 2. What you need to know before you take Briviact 3. How to take Briviact 4. Possible side effects 5. How to store Briviact 6. Contents of the pack and other information 1. WHAT BRIVIACT IS AND WHAT IT IS USED FOR WHAT BRIVIACT IS Briviact contains the active substance brivaracetam. It belongs to a group of medicines called ‘anti-epileptics’. These medicines are used to treat epilepsy. WHAT BRIVIACT IS USED FOR • Briviact is used in adults, adolescents and children from 2 years of age. • It is used to treat a type of epilepsy that has partial seizures with or without a secondary generalisation. • Partial seizures are fits that start by only affecting one side of the brain. These partial seizures can spread and extend to larger areas on both sides of the brain – this is called a ‘secondary generalisation’. • You have been given this medicine to lower the number of fits (seizures) you have. • Briviact is used together with other medicines for epilepsy. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BRIVIACT DO NOT TAKE BRIVIACT IF: - you are allergic to brivaracetam, other similar chemical compounds as levetiracetam or piracetam or any of the oth Citiți documentul complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Briviact 10 mg film-coated tablets Briviact 25 mg film-coated tablets Briviact 50 mg film-coated tablets Briviact 75 mg film-coated tablets Briviact 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Briviact 10 mg film-coated tablets Each film-coated tablet contains 10 mg brivaracetam. Briviact 25 mg film-coated tablets Each film-coated tablet contains 25 mg brivaracetam. Briviact 50 mg film-coated tablets Each film-coated tablet contains 50 mg brivaracetam. Briviact 75 mg film-coated tablets Each film-coated tablet contains 75 mg brivaracetam. Briviact 100 mg film-coated tablets Each film-coated tablet contains 100 mg brivaracetam. Excipient(s) with known effect: Briviact 10 mg film-coated tablets Each 10 mg film-coated tablet contains 88 mg lactose. Briviact 25 mg film-coated tablets Each 25 mg film-coated tablet contains 94 mg lactose. Briviact 50 mg film-coated tablets Each 50 mg film-coated tablet contains 189 mg lactose. Briviact 75 mg film-coated tablets Each 75 mg film-coated tablet contains 283 mg lactose. Briviact 100 mg film-coated tablets Each 100 mg film-coated tablet contains 377 mg lactose. For the full list of excipients, see section 6.1. 3 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Briviact 10 mg film-coated tablets White to off-white, round film-coated tablets of 6.5 mm in diameter and debossed with ‘u10’ on one side. Briviact 25 mg film-coated tablets Grey, oval film-coated tablets with dimensions of 8.9 mm x 5.0 mm and debossed with ‘u25’ on one side. Briviact 50 mg film-coated tablets Yellow, oval film-coated tablets with dimensions of 11.7 mm x 6.6 mm and debossed with ‘u50’ on one side. Briviact 75 mg film-coated tablets Purple, oval film-coated tablets with dimensions of 13.0 mm x 7.3 mm debossed with ‘u75’ on one side. Briviact 100 mg film-coated tablets Green-grey, oval film-coated tablets with dimensions of 14.5 mm x 8.1 mm and debossed with ‘u100’ on one side Citiți documentul complet