País: Malta
Língua: inglês
Origem: Medicines Authority
LEVETIRACETAM
FAIR-MED HEALTHCARE GmbH Planckstr. 13, 22765 Hamburg, Germany
N03AX14
LEVETIRACETAM 750 mg
FILM-COATED TABLET
LEVETIRACETAM 750 mg
POM
ANTIEPILEPTICS
Withdrawn
2011-09-12
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT _ _ LEVETIRACETAM FAIR-MED HEALTHCARE 250 MG FILM-COATED TABLETS LEVETIRACETAM FAIR-MED HEALTHCARE 500 MG FILM-COATED TABLETS LEVETIRACETAM FAIR-MED HEALTHCARE 750 MG FILM-COATED TABLETS LEVETIRACETAM FAIR-MED HEALTHCARE 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 Levetiracetam Fair-Med Healthcare is and what it is used for 2. What you need to know before you take Levetiracetam Fair-Med Healthcare 3. How to take Levetiracetam Fair-Med Healthcare 4. Possible side effects 5. How to store Levetiracetam Fair-Med Healthcare 6. Contents of the pack and other information 1. WHAT LEVETIRACETAM FAIR-MED HEALTHCARE IS AND WHAT IT IS USED FOR Levetiracetam Fair-Med Healthcare film-coated tabltes are an antiepileptic medicine (a medicine used to treat seizures in epilepsy). Levetiracetam Fair-Med Healthcare is used alone in the treatment of partial seizures in patients from 16 years of age. Levetiracetam Fair-Med Healthcare is used in patients who are already taking another antiepileptic medicine_ _ in the treatment of partial seizures in adults, children and infants from 1 month age in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy. in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age Page 2 of 7 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVETIRACETAM FAIR-MED HEA Leia o documento completo
Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Levetiracetam Fair-Med Healthcare 250 mg film-coated tablets. Levetiracetam Fair-Med Healthcare 500 mg film-coated tablets. Levetiracetam Fair-Med Healthcare 750 mg film-coated tablets. Levetiracetam Fair-Med Healthcare 1000 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250 mg levetiracetam. Each film-coated tablet contains 500 mg levetiracetam. Each film-coated tablet contains 750 mg levetiracetam. Each film-coated tablet contains 1000 mg levetiracetam. Excipients: 750 mg: Levetiracetam Fair-Med Healthcarefilm-coated tablets contains 0.375 mg Sunset Yellow Aluminium Lake (E110) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 250 mg: Blue, oval shaped film coated tablets with a break line on one side with dimensions 12.9 x 6.1 mm. The tablet can be divided into equal halves. 500 mg: Yellow, oval shaped film coated tablets with a break line on one side with dimensions 16.5 x 7.7 mm. The tablet can be divided into equal halves. 750 mg: Orange, oval shaped film coated tablets with a break line on one side with dimensions 18.8 x 8.9 mm. The tablet can be divided into equal halves. 1000 mg: White, oval shaped film coated tablets with a break line on one side with dimensions 19.2 x 10.2 mm. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levetiracetam Fair-Med Healthcare 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 Fair-Med Healthcare is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy. Page 2 of 19 in the treatment of myoclonic seizures in adults and adolescents from 12 years of age wi Leia o documento completo