Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
LEVETIRACETAM
Cipla (EU) Limited
N03AX14
LEVETIRACETAM
500 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Other antiepileptics
Authorised
2015-01-30
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Levetiracetam Cipla 500 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 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 Cipla is and what it is used for 2. What you need to know before you take Levetiracetam Cipla 3. How to take Levetiracetam Cipla 4. Possible side effects 5. How to store Levetiracetam Cipla 6. Contents of the pack and other information 1. WHAT LEVETIRACETAM CIPLA IS AND WHAT IT IS USED FOR Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy). Levetiracetam Cipla 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 Cipla 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 Cipla has been given to you by your doctor to reduce the number of fits 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 (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy o primary generalised tonic-clonic sei read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levetiracetam Cipla 500mg film coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 500 mg levetiracetam. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet 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. 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 • 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 which should be increased to an initial therapeutic dose of 500 mg twice daily after two weeks. The dose can be further increased by 250 mg twice daily every two weeks depending upon the clinical response. The maximum dose is 1500 mg twice daily. _Add-on therapy for adults (_ _18 years) and adolescents (12 to 17 years) weighing 50 kg or more_ The initial therapeutic dose is 500 mg twice daily. This dose can be started on the first day of treatment. Depending upon the clinical response and tolerability, the daily dose can be increased up to 1,500 mg twice daily. Dose changes can be made in 500 mg twice daily increases or decreases every two to four weeks. H E A L T H P R read_full_document