País: Malta
Idioma: anglès
Font: Medicines Authority
LEVETIRACETAM
Cipla (EU) Limited Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom
N03AX14
LEVETIRACETAM 1000 mg
FILM-COATED TABLET
LEVETIRACETAM 1000 mg
POM
ANTIEPILEPTICS
Withdrawn
2015-02-27
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Levetiracetam 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 doctoror 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 pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Levetiracetam tablet is and what it is used for 2. What you need to know before you take Levetiracetam tablet 3. How to take Levetiracetam tablet 4. Possible side effects 5. How to store Levetiracetam tablet 6. Contents of the pack and other information 1. WHAT LEVETIRACETAM TABLET IS AND WHAT IT IS USED FOR Levetiracetam 1000 mg film-coated tablets are an antiepileptic medicine (a medicine used to treat seizures in epilepsy). Levetiracetam tablet is used: on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat partial onset seizures with or without secondary generalisation As an add-on to other antiepileptic medicines to treat: o partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age o myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy o 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 LEVETIRACETAM TABLET _ _ DO NOT TAKE LEVETIRACETAM TABLET 2 - If you are allergic (hypersensitive) to levetiracetam or any of the other ingredients of this medicine (listed in Section 6) WARNINGS AND PRECAUTIONS Talk to your doctor before taking Levetiracetam tablet If you suffer from kid Llegiu el document complet
1 1. NAME OF THE MEDICINAL PRODUCT Levetiracetam 250 mg film-coated tablet Levetiracetam 500 mg film-coated tablet Levetiracetam 750 mg film-coated tablet Levetiracetam 1000 mg film-coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250 mg levetiracetam, 500 mg levetiracetam, 750 mg levetiracetam or 1000 mg levetiracetam. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet 250 mg: Light blue, capsule shaped, biconvex, length: 12.9 mm to 13.3 mm, width: 5.9 mm to 6.3 mm and thickness: 4.2 mm to 4.8 mm, film-coated tablets plain on both sides. 500 mg: Yellow, capsule shaped, biconvex, length: 17.4 mm to 17.8 mm, width: 7.4 mm to 7.8 mm and thickness: 5.3 mm to 5.9 mm, film-coated tablets plain on both sides. 750 mg: Light pink, capsule shaped, biconvex, length: 19.4 mm to 19.8 mm, width: 8.0 mm to 8.4 mm and thickness: 6.3 mm to 6.9, mm, film-coated tablets plain on both sides. 1000 mg: White, capsule shaped, biconvex, length: 20.9 mm to 21.3 mm, width: 8.9 mm to 9.3 mm and thickness: 7.3 mm to 7.9 mm, film-coated tablets plain on both sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levetiracetam 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 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 in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy 2 in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Monotherapy for adults and adolescents from 16 years of age _ The recommended starting dose is 250 mg twice daily Llegiu el document complet