Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
levetiracetam
Actavis Group PTC ehf
N03AX14
levetiracetam
Antiepileptics,
Epilepsy
Levetiracetam Actavis 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.Levetiracetam Actavis is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;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 with idiopathic generalised epilepsy.
Revision: 19
Authorised
2011-10-03
53 B. PACKAGE LEAFLET 54 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT _ _ LEVETIRACETAM ACTAVIS 250 MG FILM-COATED TABLETS LEVETIRACETAM ACTAVIS 500 MG FILM-COATED TABLETS LEVETIRACETAM ACTAVIS 750 MG FILM-COATED TABLETS LEVETIRACETAM ACTAVIS 1000 MG FILM-COATED TABLETS 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 Actavis is and what it is used for 2. What you need to know before you take Levetiracetam Actavis 3. How to take Levetiracetam Actavis 4. Possible side effects 5. How to store Levetiracetam Actavis 6. Contents of the pack and other information 1. WHAT LEVETIRACETAM ACTAVIS IS AND WHAT IT IS USED FOR Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy). Levetiracetam Actavis 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 seizu Lue koko asiakirja
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Levetiracetam Actavis 250 mg film-coated tablets Levetiracetam Actavis 500 mg film-coated tablets Levetiracetam Actavis 750 mg film-coated tablets Levetiracetam Actavis 1000 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Levetiracetam Actavis 250 mg film-coated tablets Each film-coated tablet contains 250 mg levetiracetam. Levetiracetam Actavis 500 mg film-coated tablets Each film-coated tablet contains 500 mg levetiracetam. Levetiracetam Actavis 750 mg film-coated tablets Each film-coated tablet contains 750 mg levetiracetam. Excipient with known effect: Each film-coated tablet contains 0.156 mg sunset yellow E110. Levetiracetam Actavis 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 (tablet). Levetiracetam Actavis 250 mg film-coated tablets Oval, light blue, 13.6 x 6.4 mm marked with “L” on one side and “250” on the other side. Levetiracetam Actavis 500 mg film-coated tablets Oval, yellow, 17.1 x 8.1 mm marked with “L” on one side and “500” on the other side. Levetiracetam Actavis 750 mg film-coated tablets Oval, orange 19.0 x 9.3 mm marked with “L” on one side and “750” on the other side. Levetiracetam Actavis 1000 mg film-coated tablets Oval, white, 19.0 x 10.0 mm marked with “L” on one side and “1000” on the other side. 4. CLINICAL PARTICULARS 3 4.1 THERAPEUTIC INDICATIONS Levetiracetam Actavis 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 Actavis 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 Lue koko asiakirja