Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LEVETIRACETAM
HOVID BERHAD
LEVETIRACETAM
3x10 Tablets; 6x10 Tablets
Jubilant Generics Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ HOVID-LEVETIRACETAM TABLETS 500 MG _ _ Levetiracetam Tablet 500 mg 1 WHAT IS IN THIS LEAFLET 1. What hovid-Levetiracetam Tablets 500 mg is used for 2. How hovid-Levetiracetam Tablets 500 mg works 3. Before you use hovid- Levetiracetam Tablets 500 mg 4. How to use hovid-Levetiracetam Tablets 500 mg 5. While you are using hovid- Levetiracetam Tablets 500 mg 6. Side effects 7. Storage and disposal of hovid- Levetiracetam Tablets 500 mg 8. Product description 9. Manufacturer and product registration holder 10. Date of revision 11. Serial Number WHAT HOVID-LEVETIRACETAM TABLETS 500 MG IS USED FOR hovid-Levetiracetam Tablets 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). hovid-Levetiracetam Tablets has been given to you by your doctor to reduce the number of fits. hovid-Levetiracetam Tablets is also used 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 HOVID-LEVETIRACETAM TABLETS 500 MG WORKS hovid-Levetiracetam Tablets contains Levetiracetam as active substance, which treats seizure in epilepsy. BEFORE YOU USE HOVID- LEVETIRACETAM TABLETS 500 MG _- When you must not use it_ Do not take hovid-Levetiracetam Tablets if you Lue koko asiakirja
x x x D E S C R I P T I O N hovid-Levetiracetam Tablet 500 mg is a yellow coloured, oblong shaped film-coated tablet, with a scoreline on one side and debossed with “500” on the other side of tablet. C O M P O S I T I O N Each film coated tablet consists of 500 mg Levetiracetam Ph. Eur. P H A R M A C O D Y N A M I C S Levetiracetam is a pyrrolidone derivative (S-enantiomer of α-ethyl-2-oxo-1-pyrrolidine acetamide). In man, an activity in both partial and generalised epilepsy conditions (epileptiform discharge/photoparoxysmal response) has confirmed the broad spectrum pharmacological profile of levetiracetam. The primary metabolite of levetiracetam is inactive. P H A R M A C O K I N E T I C S Levetiracetam is a highly soluble and permeable compound. Due to its complete and linear absorption, plasma levels can be predicted from the oral dose of levetiracetam expressed as mg/kg bodyweight. Therefore, there is no need for plasma level monitoring of levetiracetam. ABSORPTION Levetiracetam is rapidly absorbed after oral administration. Oral absolute bioavailability is close to 100 %. The extent of absorption is dose-independent and is not altered by food. DISTRIBUTION Neither levetiracetam nor its primary metabolite are significantly bound to plasma proteins. The volume of distribution of levetiracetam is close to the total body water volume. BIOTRANSFORMATION Levetiracetam is not extensively metabolised in humans. The major metabolic pathway is an enzymatic hydrolysis of the acetamide group. Production of the primary metabolite, ucb L057, is not supported by liver cytochrome P 450 isoforms. Hydrolysis of the acetamide group was measurable in a large number of tissues including blood cells. The metabolite ucb L057 is pharmacologically inactive. Levetiracetam had little or no effect on CYP1A2, SULT1E1 or UGT1A1. Levetiracetam caused mild induction of CYP2B6 and CYP3A4. ELIMINATION The plasma half life in adults does not vary with dose, route of administration or repeated administration. Levetiracetam is excreted ma Lue koko asiakirja