Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
donepezil hydrochloride
Apotex Pty Ltd
Donepezil hydrochloride
Registered
TERRY WHITE CHEMISTS DONEPEZIL TABLETS _Contains the active ingredient donepezil hydrochloride (as monohydrate)_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about donepezil. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is Terry White Chemists Donepezil. It contains the active ingredient donepezil hydrochloride (as monohydrate). It is used to treat mild, moderate and severe Alzheimer's disease, also called dementia of the Alzheimer's type. This medicine will not cure this disease, but it should help your memory and improve your ability to think more clearly. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. There is no evidence that this medicine is addictive. _HOW IT WORKS_ This medicine belongs to a group of medicines called acetylcholinesterase inhibitors. They are thought to work by increasing the level of a chemical called acetylcholine in the brain. _USE IN CHILDREN_ Do not give this medicine to children. Ther Přečtěte si celý dokument
Product Information – Australia Terry White Chemists Donepezil Tablets Page 1 TERRY WHITE CHEMISTS DONEPEZIL TABLETS NAME OF THE MEDICINE Donepezil hydrochloride monohydrate. Chemical Name: (_RS_)-2-[(1-Benzyl-4-piperidyl)methyl]-5,6-dimethoxyindan-1-one hydrochloride monohydrate. Structural Formula: Molecular Formula: C 24 H 29 NO 3. HCl.H 2 O Molecular Weight: 433.97 CAS Registry Number: 884740-09-4 DESCRIPTION Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile and practically insoluble in ethyl acetate and in n-hexane. Each tablet contains 5 mg or 10 mg donepezil hydrochloride (as monohydrate) as the active ingredient, equivalent to 4.56 mg or 9.12 mg donepezil free base, respectively. In addition, each tablet contains the following inactive ingredients: lactose, microcrystalline cellulose, maize starch, hydroxypropyl cellulose, sodium stearylfumarate, purified talc, macrogol 6000, hypromellose, iron oxide yellow (10 mg tablet only) and titanium dioxide. PHARMACOLOGY It has been demonstrated that Alzheimer's disease is associated with a relative decrease in the activity of the cholinergic system in the cerebral cortex and other areas of the brain. Studies suggest that donepezil exerts its therapeutic effect by enhancing cholinergic function in the central nervous system. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of acetylcholinesterase. PHARMACODYNAMICS Donepezil is a specific and reversible inhibitor of acetylcholinesterase, the predominant cholinesterase in the brain. Donepezil was found _in vitro_ to be over 1000 times more potent an inhibitor of this enzyme than of butyrylcholinesterase, an enzyme which is present mainly outside the central nervous system. In patients with Alzheimer’s Dementia participating in clinical trials, administration of single daily doses of 5 mg or 10 mg donepezil produced steady-state inh Přečtěte si celý dokument