البلد: ماليزيا
اللغة: الإنجليزية
المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LEVETIRACETAM
HEALOL PHARMACEUTICALS SDN. BHD.
LEVETIRACETAM
3x10tablet Tablets
Aurobindo Pharma Limited (Unit III),
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ LEVAUR 250 (LEVETIRACETAM TABLETS 250MG) LEVAUR 500 (LEVETIRACETAM TABLETS 500MG) Levetiracetam (250mg, 500mg) 1 WHAT IS IN THIS LEAFLET 1. What LEVAUR is used for 2. How LEVAUR works 3. Before you use LEVAUR 4. How to use LEVAUR 5. While you are using it 6. Side effects 7. Storage and Disposal of LEVAUR 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT IS LEVAUR USED FOR LEVAUR is used to control epilepsy. Epilepsy is a condition where you have repeated seizures (fits). There are many different kinds of seizures that can be mild or severe in nature. LEVAUR can be used alone or in combination with other medicines to treat your condition. LEVAUR is used in patients who are already taking other anti-epileptic medicines: • For treating partial seizures in adults and children from 4 years of age. • For treating myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. • For treating primary generalized tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalized Epilepsy. HOW LEVAUR WORKS LEVAUR contains the active ingredient levetiracetam, which belongs to a group of medicines called anti-epileptics. It is thought to control brain chemicals which send signals to nerves, so that seizures do not occur. BEFORE YOU USE LEVAUR _-When you must not use it _ Do not use LEVAUR if you are allergic to: • Any medicine containing levetiracetam. • Medicines derived from a chemical called pyrrolidine (e.g. piracetam) or any of the ingredients that are listed here. If you are unsure about the use of LEVAUR, please consult your doctor or pharmacist for further advice. _-Before you start to use it _ Inform your doctor if you have any known allergies. It is important to inform your doctor if: • You suffer from any kidney or liver related health issues. Your doctor will adjust the dose of this medication for you accordingly. • You have any blood rel اقرأ الوثيقة كاملة
Pharmacode position may change as per Supplier’s m/c requirement & additional small pharma code may appear on the front / back panel SUMMARY OF PRODUCT CHARACTERISTICS LEVAUR LEVETIRACETAM TABLETS 250 MG, 500 MG NAME OF THE MEDICINAL PRODUCT : Levetiracetam Tablets 250 mg. Levetiracetam Tablets 500 mg. (TRADE) NAME OF PRODUCT : LEVAUR 250. LEVAUR 500. STRENGTH : 250 mg, 500 mg. QUALITATIVE AND QUANTITATIVE COMPOSITION Levetiracetam Tablets 250 mg: Each film-coated tablet contains 250 mg Levetiracetam. Levetiracetam Tablets 500 mg: Each film-coated tablet contains 500 mg Levetiracetam. PHARMACEUTICAL FORM _Levetiracetam Tablets 250 mg: _Blue oval shaped biconvex film -coated tablets debossed with a deep break line separating ‘E’ and ‘10’ on one side and plain on the other side. _Levetiracetam Tablets 500mg: _Yellow oval shaped biconvex film -coated tablets debossed with a deep break line separating ‘E’ and ‘11’ on one side and plain on the other side. CLINICAL PARTICULARS Therapeutic indications 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 and children from 4 years 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. POSOLOGY AND METHOD OF ADMINISTRATION 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. Adults • Monotherapy Adults and adolescents from 16 years of age The recommended starting dose is 250 mg tw اقرأ الوثيقة كاملة