Country: মাল্যাশিয়া
ভাষা: ইংরেজি
সূত্র: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MEMANTINE HYDROCHLORIDE
SYNERRV SDN BHD
MEMANTINE HYDROCHLORIDE
4 x 14 Tablets
Macleods Pharmaceuticals Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 MACMENTA 10 (MEMANTINE HYDROCHLORIDE 10MG FILM-COATED TABLETS) MACMENTA 20 (MEMANTINE HYDROCHLORIDE 20 MG FILM-COATED TABLETS) Memantine hydrochloride tablets (10 mg, 20 mg) WHAT IS IN THIS LEAFLET 1. What _Macmenta _ is use for 2. How _Macmenta _ works _3._ _ _ Before you use _Macmenta _ _4._ _ _ How to use _Macmenta _ 5. While you are using it 6. Side effects _7._ _ _ Storage and Disposal of _Macmenta _ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _MACMENTA _IS USED FOR _Macmenta _ contains the active substance memantine hydrochloride. It belongs to a group of medicines known as anti- dementia medicines. _Macmenta _ is used for the treatment of patients with moderate to severe Alzheimer’s disease. HOW _MACMENTA _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. _Macmenta _ belongs to a group of medicines called NMDA-receptor antagonists. _Macmenta _ acts on these NMDA- receptors improving the transmission of nerve signals and the memory. BEFORE YOU USE _MACMENTA _ - _When you must not use it _ • if you are allergic to memantine or any of the other ingredients of this medicine. _Pregnancy and lactation _ Do not take _Macmenta _ if you are pregnant, trying to get pregnant or think you may be pregnant. If you get pregnant while taking _Macmenta_ , stop taking it immediately and contact your doctor. The use of memantine in pregnant women is not recommended. Do not take _Macmenta _ if you are breast- feeding. Women taking _Macmenta _ should not breast-feed. Ask your doctor or pharmacist for advice before taking any medicine. - _Before you start use it _ Talk to your doctor or pharmacist before taking _Macmenta_ : • if you have recently experienced a myocardial infarction (heart attack), or if you are suffering সম্পূর্ণ নথি পড়ুন
MACMENTA 10 (MEMANTINE HYDROCHLORIDE 10 MG FILM-COATED TABLETS) MACMENTA 20 (MEMANTINE HYDROCHLORIDE 20 MG FILM-COATED TABLETS) MACLEODS PHARMACEUTICALS LTD. FOR THE USE ONLY OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR A LABORATORY MACMENTA 10 (MEMANTINE HYDROCHLORIDE 10 MG FILM-COATED TABLETS) MACMENTA 20 (MEMANTINE HYDROCHLORIDE 20 MG FILM-COATED TABLETS) COMPOSITION: Each tablet contains: MACMENTA 10: Memantine hydrochloride ….…10mg (equivalent to 8.31mg Memantine) MACMENTA 20: Memantine hydrochloride ….…20mg (equivalent to 16.62mg Memantine) DESCRIPTION: MACMENTA 10: White to off white, capsule shape, film coated tablet debossed with “CL29” on one side and breakline on both sides (12.1 ± 0.3 x 5.1 ± 0.3) MACMENTA 20: Brown colour, capsule shape, film coated tablet debossed with “CL30” on one side and plain on both sides (14.6 ± 0.3 x 7.1± 0.3) PHARMACOLOGICAL ACTION: PHARMACOKINETICS: Absorption Memantine has an absolute bioavailability of approximately 100%. Tmax 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 to 150 ng/ml (0.5 - 1 µmol) with large interindividual variations. When daily doses of 5 to 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. MACMENTA 10 (MEMANTINE HYDROCHLORIDE 10 MG FILM-COATED TABLETS) MACMENTA 20 (MEMANTINE HYDROCHLORIDE 20 MG FILM-COATED TABLETS) MACLEODS PHARMACEUTICALS LTD. 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 catalysed metabolism has been detected in vi সম্পূর্ণ নথি পড়ুন