Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LEVETIRACETAM
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
LEVETIRACETAM
30tablet Tablets; 60tablet Tablets; 100tablet Tablets
LEK PHARMACEUTICALS D.D.
LEVET ® 250MG & 500MG FILM-COATED TABLET Levetiracetam 250mg & 500mg 1 _Consumer Medication Information Leaflet (RiMUP) _ WHAT IS IN THIS LEAFLET: 1. What LEVET is used for 2. How LEVET works 3. Before you use LEVET 4. How to use LEVET 5. While you are using it 6. Side effects 7. Storage and Disposal of LEVET 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT LEVET IS USED FOR LEVET is used: • on its own in adults and adolescents from 16 years of age with a certain type of newly diagnosed 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 seizures with or without secondary generalization). Levet 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 secondary generalization in adults and children from 4 years of age with epilepsy. - 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 - primary generalized tonic-clonic seizures (major fits, including loss of consciousness) in adults and children from 12 years of age with Idiopathic Generalized Epilepsy. HOW LEVET WORKS Levet is an antiepileptic medicine (a medicine used to treat seizures in epilepsy). BEFORE YOU USE LEVET - _When you must not use it _ Do not take Levet • If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (see section PRODUCT DESCRIPTION ). _ _ _Pregnancy and _ _breast-feeding_ _ _ If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Levet should not be used during pregnancy unless clearly necessary. A ris Baca dokumen lengkap
Page 1 of 10 PACKAGE INSERT 1. NAME OF THE MEDICINAL PRODUCT Levet ® 250 mg Film-Coated Tablet Levet ® 500 mg Film-Coated Tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Levet ® 250 mg Film-Coated Tablet: Each film-coated tablet contains 250 mg levetiracetam. Levet ® 500 mg Film-Coated Tablet: Each film-coated tablet contains 500 mg levetiracetam. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Levet ® 250 mg Film-Coated Tablet: Light blue, oval, biconvex film-coated tablets, scored on both sides, debossed with LVT / 250 on one side. Levet ® 500 mg Film-Coated Tablet: Yellow, oval, biconvex film-coated tablets, scored on both sides, debossed with LVT / 500 on one side. The tablet can be divided into equal halves. 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 and children from 4 years of age with epilepsy. − myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. − 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 DOSAGE AND ADMINISTRATION Levetiracetam therapy can be initiated with either intravenous or oral administration. Conversion to or from oral to intravenous administration can be done directly without titration. The total daily dose and frequency of administration should be maintained. _Film-coated tablets _ The film-coated tablets must be taken orally, swallowed with a sufficient quantity of liquid and may be taken with or without food. The daily dose is administered in two equally divided doses. Page 2 of 10 ROUTE OF ADMINI Baca dokumen lengkap