Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
memantine hydrochloride
Sun Pharma ANZ Pty Ltd
memantine hydrochloride
MEMANTINE RBX _MEMANTINE HYDROCHLORIDE 10 & 20 MG TABLETS_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet contains answers to some common questions about MEMANTINE RBX. It does not contain all the information that is known about MEMANTINE RBX. It does not take the place of talking to your doctor or pharmacist. This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from https://www.ebs.tga.gov.au/ and may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT MEMANTINE RBX IS USED FOR MEMANTINE RBX is used to treat moderately severe to severe Alzheimer's disease (AD). AD can be described as a general decline in all areas of mental ability. MEMANTINE RBX belongs to a group of medicines called N- methyl-Daspartate (NMDA) receptor antagonists. It is thought to work by protecting NMDA receptors in the brain against high levels of the chemical glutamate, which could be the cause of brain degeneration. NMDA receptors are involved in the transmission of nerve signals within the brain, e.g. in learning and memory. MEMANTINE RBX should improve your thinking capacity and your ability to remember. Your doctor, however, may prescribe MEMANTINE RBX for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. This medicine is only available with a doctor's prescription. MEMANTINE RBX is not addictive. BEFORE YOU TAKE IT _ _ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE MEMANTINE RBX IF YOU ARE ALLERGIC TO IT OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction may include shortn Přečtěte si celý dokument
MEMANTINE RBX PI Version 0.005 Page 1 of 13 PRODUCT INFORMATION MEMANTINE RBX MEMANTINE HYDROCHLORIDE 10 & 20 MG FILM-COATED TABLETS NAME OF THE MEDICINE Memantine hydrochloride Structural formula: Molecular formula: C 12 H 21 N.HCl Chemical name: 1-amino-3, 5-dimethyl-adamantane hydrochloride Molecular weight: 215.76 CAS number: 19982-08-2 (free base); 4110-52-1 (hydrochloride salt) DESCRIPTION Memantine hydrochloride is a white to off-white crystalline powder. It is soluble in water and methanol, and insoluble in petroleum ether. Its pKa is 10.27. No polymorphic forms have been detected. Each MEMANTINE RBX tablet contains 10 mg or 20 mg of memantine hydrochloride. The inactive ingredients are: microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, purified talc and magnesium stearate. In addition, the 10 mg tablet contains OPADRY complete film coating system OY-S-58910 WHITE (hypromellose, titanium dioxide, macrogol 400 and purified talc; Proprietary ingredient # 11503), and the 20 mg tablet contains OPADRY complete film coating system 03B540015 PINK (hypromellose, titanium dioxide, macrogol 400, iron oxide red and iron oxide yellow; Proprietary ingredient # 108462). PHARMACOLOGY Pharmacological actions There is increasing evidence that malfunctioning of glutamatergic neurotransmission, in particular at N-methyl-D-aspartate (NMDA) receptors, contributes to both expression of symptoms and disease progression in neurodegenerative dementia. MEMANTINE RBX PI Version 0.005 Page 2 of 13 Memantine is a rapid, strongly voltage-dependent, uncompetitive NMDA receptor antagonist. Prolonged increased levels of glutamate in the brain of demented patients are sufficient to counter the voltage-dependent block of NMDA receptors by Mg 2+ ions and allow continuous influx of Ca 2+ ions into cells and ultimately neuronal degeneration. Studies suggest that memantine binds more effectively than Mg 2+ ions at the NMDA receptor, and thereby effectively blocks this prolonged influx of Ca 2+ ions through the NMDA Přečtěte si celý dokument