Kraj: Szwecja
Język: szwedzki
Źródło: Läkemedelsverket (Medical Products Agency)
lakosamid
G.L. Pharma GmbH
N03AX18
lacosamide
50 mg + 100 mg + 150 mg + 200 mg
Filmdragerad tablett
lakosamid 200 mg Aktiv substans; lakosamid 150 mg Aktiv substans; lakosamid 50 mg Aktiv substans; lakosamid 100 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 14 +14 + 14 + 14 tabletter
Godkänd
2018-06-20
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TRELEMA 50 MG FILM-COATED TABLETS TRELEMA 100 MG FILM-COATED TABLETS TRELEMA 150 MG FILM-COATED TABLETS TRELEMA 200 MG FILM-COATED TABLETS lacosamide THE TREATMENT INITIATION PACK IS ONLY SUITABLE IN ADOLESCENTS AND CHILDREN WEIGHING 50 KG OR MORE AND IN ADULTS. 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 [Lacosamide] is and what it is used for 2. What you need to know before you take [Lacosamide] 3. How to take [Lacosamide] 4. Possible side effects 5. How to store [Lacosamide] 6. Contents of the pack and other information 1. WHAT [LACOSAMIDE] IS AND WHAT IT IS USED FOR WHAT [LACOSAMIDE] IS [Lacosamide] contains lacosamide. This belongs to a group of medicines called ‘antiepileptic medicines’. These medicines are used to treat epilepsy. You have been given this medicine to lower the number of fits (seizures) you have. WHAT [LACOSAMIDE] IS USED FOR - [Lacosamide] is used: - on its own and in association with other antiepileptic medicines in adults, adolescents and children aged 2 years and older to treat a certain type of epilepsy characterised by the occurrence of partial-onset seizure with or without secondary generalisation. In this type of epilepsy, fits first affect only one side of your brain. However, these may then spread to larger areas on both sides of your brain; - in association with other antiepileptic medicines in adults, adolescents and children aged 4 years and older to treat primary generalised tonic-clonic seizures (major fits, Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Trelema treatment initiation pack (in adolescent and children weighing 50 kg or more and adults only) Trelema 50 mg film-coated tablets Trelema 100 mg film-coated tablets Trelema 150 mg film-coated tablets Trelema 200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _[Lacosamide 50 mg film-coated tablets]_ Each film-coated tablet contains 50 mg lacosamide. _[Lacosamide 100 mg film-coated tablets]_ Each film-coated tablet contains 100 mg lacosamide. _[Lacosamide 150 mg film-coated tablets]_ Each film-coated tablet contains 150 mg lacosamide. _[Lacosamide 200 mg film-coated tablets]_ Each film-coated tablet contains 200 mg lacosamide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet _[Lacosamide 50 mg film-coated tablets]_ Pink coloured, oval and biconvex f/c tablets, with a break-score on both sides and with a length of about 10.3 mm. The tablet can be divided into equal doses. _[Lacosamide 100 mg film-coated tablets]_ Yellow coloured, oval and biconvex f/c tablets, with a break-score on both sides and with a length of about 13.1 mm. The tablet can be divided into equal doses. _[Lacosamide 150 mg film-coated tablets]_ Brown coloured, oval and biconvex f/c tablets, with a break-score on both sides and with a length of about 15.1 mm. The tablet can be divided into equal doses. _[Lacosamide 200 mg film-coated tablets]_ Blue coloured, oval and biconvex f/c tablets, with a break-score on both sides and with a length of about 16.5 mm. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [Lacosamide] is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. [Lacosamide] is indicated as adjunctive therapy • in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children fro Przeczytaj cały dokument