País: Suécia
Língua: sueco
Origem: Läkemedelsverket (Medical Products Agency)
levetiracetam
G.L. Pharma GmbH
N03AX14
levetiracetam
1000 mg
Filmdragerad tablett
levetiracetam 1000 mg Aktiv substans
Apotek
Receptbelagt
Levetiracetam
Förpacknings: Blister, 10 tabletter; Blister, 20 tabletter; Blister, 30 tabletter; Blister, 50 tabletter; Blister, 60 tabletter; Blister, 90 tabletter; Blister, 100 tabletter; Blister, 120 tabletter; Blister, 200 tabletter; Burk, 10 tabletter; Burk, 20 tabletter; Burk, 30 tabletter; Burk, 50 tabletter; Burk, 60 tabletter; Burk, 90 tabletter; Burk, 100 tabletter; Burk, 120 tabletter; Burk, 200 tabletter
Godkänd
2012-02-10
PACKAGE LEAFLET: INFORMATION FOR THE USER250 MG FILM-COATED TABLETS. Leia o documento completo500 MG FILM-COATED TABLETS. 750 MG FILM-COATED TABLETS. 1000 MG FILM-COATED TABLETS. Levetiracetam 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 is and what it is used for 2. What you need to know before you take 3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR film-coated tablets are an antiepileptic medicine (a medicine used to treat seizures in epilepsy). is used: on its own in patients from 16 years of age with newly diagnised epilepsy, to treat partial onset seizures with or without secondary generalisation. as an add-on to other antiepileptic medicines to treat: partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age myoclonic seizures in patients from 12 years of age with juvenile myoclonic epilepsy. primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DO NOT TAKE if you are allergic to levetiracetam or any of the other ingredients of this medicine (listed in Section 6). WARNINGS AND PRECAUTIONS Talk to your doctor before taking PDF rendering: Titel 00421076, Version 5.4, Namn Levebon fi
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT250 mg film-coated tablets. Leia o documento completo500 mg film-coated tablets. 750 mg film-coated tablets. 1000 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ 250 mg film-coated tablets_ Each film-coated tablet contains 250 mg levetiracetam. _ 500 mg film-coated tablets_ Each film-coated tablet contains 500 mg levetiracetam. _ 750 mg film-coated tablets_ Each film-coated tablet contains 750 mg levetiracetam. Excipient: Each film-coated tablet contains 0.17 mg of sunset yellow FCF (E110). _ 1000 mg film-coated tablets_ Each film-coated tablet contains 1000 mg levetiracetam. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. _ 250 mg film-coated tablets_ Blue coloured, capsule shaped tablets (12,7 x 5,9 mm) with deep notch on one side. The tablets can be divided into equal doses. _ 500 mg film-coated tablets_ Yellow coloured, capsule shaped tablets (16,3 x 7,6 mm)with deep notch on one side. The tablets can be divided into equal doses. _ 750 mg film-coated tablets_ Orange coloured, capsule shaped tablets (18,6 x 8,65 mm) with deep notch on one side. The tablets can be divided into equal doses. _ 1000 mg film-coated tablets_ White coloured, capsule shaped tablets (19,1 x 10,2 mm) with deep notch on one side. The tablets can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, children and infants from 1 month of age with epilepsy. in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epil