Država: Nizozemska
Jezik: nizozemščina
Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
LEVETIRACETAM 250 mg/stuk
LEVETIRACETAM 250 mg/stuk
Filmomhulde tablet
INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)
Oraal gebruik
1900-01-01
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LEVETIRACETAM AMETAS 250 MG, FILMOMHULDE TABLETTEN LEVETIRACETAM AMETAS 500 MG, FILMOMHULDE TABLETTEN LEVETIRACETAM AMETAS 750 MG, FILMOMHULDE TABLETTEN LEVETIRACETAM AMETAS 1000 MG, FILMOMHULDE TABLETTEN Levetiracetam READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD 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 Levetiracetam AMETAS is and what it is used for 2. What you need to know before you take Levetiracetam AMETAS 3. How to take Levetiracetam AMETAS 4. Possible side effects 5. How to store Levetiracetam AMETAS 6. Contents of the pack and other information 1. WHAT LEVETIRACETAM AMETAS IS AND WHAT IT IS USED FOR Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy). Levetiracetam AMETAS is used: • on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition where the patients have repeated fits (seizures). Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation). Levetiracetam has been given to you by your doctor to reduce the number of fits. • 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 (short, shock-like jerk Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAAM VAN HET GENEESMIDDEL Levetiracetam AMETAS 250 mg, filmomhulde tabletten Levetiracetam AMETAS 500 mg, filmomhulde tabletten Levetiracetam AMETAS 750 mg, filmomhulde tabletten Levetiracetam AMETAS 1000 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Levetiracetam AMETAS 250 mg film-coated tablets _ Each film-coated tablet contains 250 mg levetiracetam. _Levetiracetam AMETAS 500 mg film-coated tablets _ Each film-coated tablet contains 500 mg levetiracetam. _Levetiracetam AMETAS 750 mg film-coated tablets _ Each film-coated tablet contains 750 mg levetiracetam. Excipient with known effect: Each film-coated tablet contains 0.17 mg of sunset yellow FCF (E110). _Levetiracetam AMETAS 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. _Levetiracetam AMETAS 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 halves. _Levetiracetam AMETAS 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 halves. _Levetiracetam AMETAS 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 halves. _Levetiracetam AMETAS 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 halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levetiracetam AMETAS is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Levetiracetam AMETAS is indicated as adjunctive therapy • in the treatment of partial onset seizures with or without secondary Preberite celoten dokument