البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
donepezil hydrochloride
Teva Pharma Australia Pty Ltd
Donepezil hydrochloride
Registered
Donepezil-Teva Version 1.0 1 DONEPEZIL-TEVA _donepezil hydrochloride (as monohydrate)_ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about donepezil hydrochloride. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking donepezil against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DONEPEZIL HYDROCHLORIDE IS USED FOR Donepezil hydrochloride is used to treat mild, moderate and severe Alzheimer's disease, also called dementia of the Alzheimer's type. Donepezil hydrochloride 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. This medicine is not addictive. This medicine is only available with a doctor's prescription. _USE IN CHILDREN_ The safety and effectiveness of donepezil hydrochloride in children has not been established. BEFORE YOU TAKE DONEPEZIL HYDROCHLORIDE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE DONEPEZIL HYDROCHLORIDE IF YOU HAVE AN ALLERGY TO: • any medicine containing donepezil hydrochloride • 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 TAKE THIS MEDICINE AFTER THE EXPIRY DATE PRINTED ON THE PAC اقرأ الوثيقة كاملة
Product Information Donepezil-Teva 5 mg & 10 mg Film-coated Tablets Page 1 __________________________________________________________________________________ ___________________________________________________________________________ Teva Pharma Australia Pty Ltd Version 1.0 PRODUCT INFORMATION DONEPEZIL-TEVA [DONEPEZIL HYDROCHLORIDE (AS MONOHYDRATE)] NAME OF THE MEDICINE Donepezil-Teva 5 mg film-coated tablet Donepezil-Teva 10 mg film-coated tablet The structural formula of donepezil hydrochloride (as monohydrate) is shown below: Active ingredient: donepezil hydrochloride (as monohydrate) Chemical name: (±)-2-[(1-Benzyl-4-piperidyl)methyl]-5,6-dimethoxy-1- indanone hydrochloride monohydrate 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 (as 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. Donepezil-Teva film-coated tablets for oral administration are supplied containing 5 mg or 10 mg donepezil hydrochloride (as monohydrate) equivalent to 4.56 mg or 9.12 mg donepezil free base, respectively. The inactive ingredients are lactose, pregelatinised maize starch, microcrystalline cellulose, sodium starch glycollate (type A), colloidal anhydrous silica and magnesium stearate. The film coating for both 5 mg and 10 mg strengths contains macrogol 4000, hypromellose, titanium dioxide and lactose. Additionally, the 10 mg tablet contains iron oxide yellow. 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 accomplished by increasing the concentration of acetylch اقرأ الوثيقة كاملة