Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
donepezil hydrochloride monohydrate, Quantity: 10.43 mg (Equivalent: donepezil hydrochloride, Qty 10 mg)
Dr Reddys Laboratories Australia Pty Ltd
donepezil hydrochloride monohydrate
Tablet, film coated
Excipient Ingredients: pregelatinised maize starch; hyprolose; lactose monohydrate; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; iron oxide yellow; macrogol 400
Oral
14, 28
(S4) Prescription Only Medicine
Treatment of mild, moderate and severe Alzheimer's disease.
Visual Identification: Yellow round, biconvex, bevel edged, film coated tablets debossed 'DNP' on one side and '10' on opposite side; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Registered
Consumer Medicine Information for Donepezil-DRLA V3 Page 1 of 11 DONEPEZIL-DRLA TABLETS _Donepezil hydrochloride monohydrate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Donepezil-DRLA. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicine have risks and benefits. Your doctor has weighed the risks of you taking Donepezil-DRLA against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERN ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DONEPEZIL-DRLA IS USED FOR Donepezil-DRLA Tablets are used to treat mild, moderate and severe Alzheimer’s disease, also called dementia of the Alzheimer’s type. Donepezil-DRLA will not cure this disease, but should help your memory and improve your ability to think more clearly. 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. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. Consumer Medicine Information for Donepezil-DRLA V3 Page 2 of 11 This medicine is not addictive. This medicine is only available with a doctor’s prescription. BEFORE YOU TAKE DONEPEZIL-DRLA _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE DONEPEZIL-DRLA IF YOU HAVE AN ALLERGY TO: Any medicine containing donepezil hydrochloride monohydrate Piperidine derivatives Any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. DO NOT GIVE DONEPEZIL-DRLA TO CHILDREN. The safety and effectiveness of Donepezil-DRLA in children have not been e Przeczytaj cały dokument
DONEPEZIL-DRLA TABLETS PRODUCT INFORMATION NAME OF THE MEDICINE Active: Donepezil hydrochloride monohydrate CAS Number: 120011-70-3 . HCl. . H 2 O DESCRIPTION Donepezil hydrochloride monohydrate 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. Chemical Name: (_RS_)-1-benzyl-4-[5,6-dimethoxy-1-indanon)-2-yl]- methylpiperidine hydrochloride monohydrate. Molecular formula: C 24 H 29 NO 3 HCl.H 2 O Molecular Weight: 433.97 Excipient: Lactose monohydrate, pregelatinised maize starch, microcrystalline cellulose, hyprolose, magnesium stearate. The film coating contains macrogol 400, hypromellose, titanium dioxide. Additionally, the 10 mg tablet contains yellow iron oxide as a colouring agent. ACTIONS Specific and reversible acetylcholinesterase inhibitor. 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 hydrochloride exerts its therapeutic effect by enhancing cholinergic function in the central nervous system. This is Product Information for Donepezil-DRLA V3 Product Information for Donepezil-DRLA –V3 2 of 34 accomplished by increasing the concentration of acetylcholine through reversible inhibition of acetylcholinesterase. PHARMACODYNAMICS Donepezil hydrochloride is a specific and reversible inhibitor of acetylcholinesterase, the predominant cholinesterase in the brain. Donepezil hydrochloride was found _in_ _ _ _vitro _ to be over 1,000 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 donepezil hydrochloride 5 or 10 mg produced steady-state inhibition of acetyl Przeczytaj cały dokument