País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MEMANTINE HYDROCHLORIDE
MEDISPEC (M) SDN.BHD
MEMANTINE HYDROCHLORIDE
10 x 3tablet Tablets
UNISON LABORATORIES CO.LTD
MEMXA 10MG TABLET Memantine hydrochloride 10mg eq. to Memantine 8.31mg 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _MEMXA 10mg Tablet_ is used for 2. How _MEMXA 10mg Tablet_ works 3. Before you use _MEMXA _ _10mg _ _Tablet_ 4. How to use _MEMXA 10mg Tablet_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _MEMXA _ _10mg Tablet_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _MEMXA 10MG TABLET_ IS USED FOR _MEMXA _ _10 _ belongs to a group of medicines known as anti-dementia medicines. _MEMXA 10_ is used for the treatment of patients with moderate to severe Alzheimer’s disease. HOW _MEMXA 10MG TABLET_ WORKS Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA)- receptors that are involved in transmitting nerve signals important in learning and memory. _MEMXA _ _10_ belongs to a group of medicines called NMDA-receptor antagonists. _MEMXA _ _10_ acts on these NMDA-receptors improving the transmission of nerve signals and the memory. BEFORE YOU USE _MEMXA 10MG TABLET_ - _When you must not use it _ If you are allergic (Hypersensitive) to Memantine hydrochloride or any of the other ingredients of this medicine (listed in _Ingredients)._ _Pregnancy and breast-feeding _ Ask your doctor or pharmacist before taking any medicine. Tell your doctor if you are pregnant or planning to become pregnant. The use of Memantine in pregnant women is not recommended. Women taking _MEMXA _ _10mg _ _Tablet_ should not breast-feed. _Children and adolescents _ _MEMXA _ _10mg _ _Tablet_ is not recommended for children and adolescents under the age of 18 years. _ _ - _Before you start to use it _ Talk to your doctor or pharmacist before taking _MEMXA 10mg Tablet_ : • If you have a history of epileptic seizures • If you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart fai Llegiu el document complet
FRONT 28.5 cm. 16.5 cm. PRODUCT DESCRIPTION: White, centrally tapered, oblong, biconvex, film coated tablet with engraved MMT on one side and scored on the other MECHANISM OF ACTION: _PHARMACOLOGY_ There is increasing evidence that malfunctioning of glutamatergic neurotransmission, in particular at NMDA-receptors, contributes to both expression of symptoms and disease progression in neurodegenerative dementia. Memantine is a voltage-dependent, moderate-affinity uncompetitive NMDA-receptor antagonist. It modulates the effects of pathologically elevated tonic levels of glutamate that may lead to neuronal dysfunction. _PHARMACOKINETICS_ Absorption Memantine has an absolute bioavailability of approximately 100%. t max is between 3 and 8 hours. There is no indication that food influences the absorption of Memantine. Distribution Daily doses of 20 mg lead to steady-state plasma concentrations of Memantine ranging from 70-150 ng/mL (0.5-1 μmol) with large interindividual variations. When daily doses of 5-30 mg were administered, a mean cerebrospinal fluid (CSF)/serum ratio of 0.52 was calculated. The volume of distribution is around 10 L/Kg. About 45% of Memantine is bound to plasma-proteins. Biotransformation In man, about 80% of the circulating Memantine-related material is present as the parent compound. Main human metabolites are N-3,5-dimethyl-gludantan, the isomeric mixture of 4-and 6-hydroxy-memantine, and 1-nitroso-3,5-dimethyl-adamantane. None of these metabolites exhibit NMDA-antagonistic activity. No cytochrome P 450 catalyzed metabolism has been detected _in vitro._ _ _ Elimination Memantine is eliminated in a monoexponential manner with a terminal t½ of 60-100 hours. In volunteers with normal kidney function, total clearance (Cl tot ) amounts to 170 mL/min/1.73 m 2 and part of total renal clearance is achieved by tubular secretion. Renal handling also involves tubular reabsorption, probably mediated by cation transport proteins. The renal elimination rate of Memantine under alkaline urine conditions may b Llegiu el document complet