Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
levetiracetam
Accord Healthcare S.L.U.
N03AX14
levetiracetam
Antiepileptics,
Epilepsy
Levetiracetam 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 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: 16
Authorised
2011-10-03
36 B. PACKAGE LEAFLET 37 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LEVETIRACETAM ACCORD 250 MG FILM-COATED TABLETS LEVETIRACETAM ACCORD 500 MG FILM-COATED TABLETS LEVETIRACETAM ACCORD 750 MG FILM-COATED TABLETS LEVETIRACETAM ACCORD 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 Accord is and what it is used for 2. What you need to know before you take Levetiracetam Accord 3. How to take Levetiracetam Accord 4. Possible side effects 5. How to store Levetiracetam Accord 6. Contents of the pack and other information 1. WHAT LEVETIRACETAM ACCORD IS AND WHAT IT IS USED FOR Levetiracetam Accord is an antiepileptic medicine (a medicine used to treat seizures in epilepsy). Levetiracetam Accord 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, s Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Levetiracetam Accord 250 mg film-coated tablets Levetiracetam Accord 500 mg film-coated tablets Levetiracetam Accord 750 mg film-coated tablets Levetiracetam Accord 1000 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Levetiracetam Accord 250 mg film-coated tablets Each film-coated tablet contains 250 mg levetiracetam Levetiracetam Accord 500 mg film-coated tablets Each film-coated tablet contains 500 mg levetiracetam Levetiracetam Accord 750 mg film-coated tablets Each film-coated tablet contains 750 mg levetiracetam Excipient with known effect: Each film-coated tablet contains 0.013 mg of sunset yellow FCF (E110) Levetiracetam Accord 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. The tablet can be divided into equal halves Levetiracetam Accord 250 mg film-coated tablets White to off white, oval, biconvex, debossed ‘L 64’ and break line on one side and plain on the other side Levetiracetam Accord 500 mg film-coated tablets Yellow coloured, oval, biconvex, debossed ‘L 65’ and break line on one side and plain on the other side. Levetiracetam Accord 750 mg film-coated tablets Pink coloured, oval, biconvex, debossed ‘L 66’ and break line on one side and plain on the other side. Levetiracetam Accord 1000 mg film-coated tablets White to off white, oval, biconvex, debossed ‘L 67’ and break line on one side and plain on the other side. 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. 3 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 Pročitajte cijeli dokument