Land: Malaysia
Sprache: Englisch
Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LEVETIRACETAM
MEDISPEC (M) SDN.BHD
LEVETIRACETAM
3 x 10 Tablets; 6x10 Tablets; 10x10 Tablets
UNISON LABORATORIES CO.LTD
_CONSUMER MEDICATION INFORMATION LEAFLET _ _(RIMUP)_ 1 LECETAM FILM COATED TABLET Levetiracetam (250mg, 500mg) WHAT IS IN THIS LEAFLET 1. What LECETAM is used for 2. How LECETAM works 3. Before you use LECETAM 4. How to use LECETAM 5. While you are using it 6. Side effects 7. Storage and Disposal of LECETAM 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT LECETAM IS USED FOR LECETAM 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). LECETAM 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 LECETAM WORKS LECETAM is an antiepileptic medicine (a medicine used to treat seizures in epilepsy). BEFORE YOU USE LECETAM - _ When you must not use _ _it_ Do not take LECETAM • If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (see section PRODUCT DESCRIPTION ). _Pregnancy and _ _breastfeeding:_ 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. LECETAM should not be used during pregnancy unless clearly necessary Lesen Sie das vollständige Dokument
1 of 4 LECETAM 250 MG FILM COATED TABLET LECETAM 500 MG FILM COATED TABLET ANTIEPILEPTIC Each film coated tablet contains: LEVETIRACETAM 250 MG LEVETIRACETAM 500 MG PRODUCT DESCRIPTION: _250 MG_ : Light blue, oblong, biconvex, film coated tablet with engraved L-250 on one side and plain on the other _ _ _500 MG:_ Yellow, oblong, biconvex, film coated tablet with engraved L-500 on one side and plain on the other MECHANISM OF ACTION: Pharmacotherapeutic group: Antiepileptics; Other Antiepileptics ATC code: N03AX14 _Mechanism of action _ The active substance, Levetiracetam, is a pyrrolidone derivative (S-enantiomer of α-ethyl-2-oxo-1-pyrrolidine acetamide), chemically unrelated to existing antiepileptic active substances. The mechanism of action of Levetiracetam still remains to be fully elucidated. _In vitro_ and _in vivo_ experiments suggest that Levetiracetam does not alter basic cell characteristics and normal neurotransmission. _In vitro_ studies show that Levetiracetam affects intraneuronal Ca 2+ levels by partial inhibition of N-type Ca 2+ currents and by reducing the release of Ca 2+ from intraneuronal stores. In addition it partially reverses the reductions in GABA- and glycine-gated currents induced by Zinc and β-carbolines. Furthermore, Levetiracetam has been shown in _in vitro_ studies to bind to a specific site in rodent brain tissue. This binding site is the synaptic vesicle protein 2A, believed to be involved in vesicle fusion and neurotransmitter exocytosis. Levetiracetam and related analogs show a rank order of affinity for binding to the synaptic vesicle protein 2A which correlates with the potency of their anti-seizure protection in the mouse audiogenic model of epilepsy. This finding suggests that the interaction between Levetiracetam and the synaptic vesicle protein 2A seems to contribute to the antiepileptic mechanism of action of the medicinal product. Pharmacodynamic effects Levetiracetam induces seizure protection in a broad range of animal models of partial and primary generalized Lesen Sie das vollständige Dokument