Negara: Malta
Bahasa: Inggris
Sumber: Medicines Authority
LEVETIRACETAM
Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom
N03AX14
LEVETIRACETAM 250 mg
FILM-COATED TABLET
LEVETIRACETAM 250 mg
POM
ANTIEPILEPTICS
Withdrawn
2013-06-03
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LEVETIRACETAM WOCKHARDT 250MG, 500MG, 750MG AND 1,000MG FILM-COATED TABLETS 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. The name of your medicine is Levetiracetam Wockhardt 250mg, 500mg, 750mg and 1,000mg Film-Coated Tablets. In the rest of the leaflet it is called Levetiracetam Tablets. WHAT IS IN THIS LEAFLET: 1. What Levetiracetam Tablets are and what they are used for 2. What you need to know before you take Levetiracetam Tablets 3. How to take Levetiracetam Tablets 4. Possible side effects 5. How to store Levetiracetam Tablets 6. Contents of the pack and other information 1. WHAT LEVETIRACETAM TABLETS ARE AND WHAT THEY ARE USED FOR Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy). Levetiracetam Tablets are used: • on their 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: o partial onset seizures with or without generalisation in adults, adolescents, children and infants from one Baca dokumen lengkapnya
Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levetiracetam Wockhardt 250mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250mg of levetiracetam. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Blue, film-coated, oval shaped tablets, debossed with “W532” on one side and a score line on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levetiracetam tablets are 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 tablets are 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_ Page 2 of 17 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 Baca dokumen lengkapnya