Pajjiż: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
Donepezil hydrochloride
Pfizer Australia Pty Ltd
Medicine Registered
ARICEPT ® _donepezil hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Aricept. 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 Aricept 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 ARICEPT IS USED FOR Aricept is used to treat mild, moderate and severe Alzheimer's disease, also called dementia of the Alzheimer's type. Aricept 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 Aricept in children has not been established. BEFORE YOU TAKE ARICEPT _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE ARICEPT 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 PACK OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. If it has expired or is damaged, return it to your pharmacist for disposal. IF YOU ARE NOT SU Aqra d-dokument sħiħ
Version: pfparict11112 Supersedes: pfparict10911 Page 1 of 31 PRODUCT INFORMATION ARICEPT , ARICEPT ® -D (DONEPEZIL HYDROCHLORIDE) NAME OF THE MEDICINE ARICEPT and ARICEPT-D contain the active ingredient donepezil hydrochloride (AAN). The structural formula of donepezil hydrochloride is shown below: . HCl CH 3 O CH 3 O O N CH 2 * CH 2 Chemical name: (RS)-1-benzyl-4-[5,6-dimethoxy-1-indanon)-2-yl] -methylpiperidine hydrochloride Molecular formula: C 24 H 29 NO 3 HCl Molecular weight: 415.96 CAS Registry Number: 120011-70-3 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. ARICEPT film-coated tablets for oral administration are supplied containing 5 mg or 10 mg donepezil hydrochloride equivalent to 4.56 mg or 9.12 mg donepezil free base, respectively. The inactive ingredients are lactose, starch-maize, microcrystalline cellulose, hydroxypropylcellulose and magnesium stearate. The film coating contains purified talc, macrogol 8000, hypromellose and titanium dioxide. Additionally, the 10 mg tablet contains iron oxide yellow as a colouring agent. ARICEPT-D orally disintegrating tablets are supplied containing 5 mg or 10 mg donepezil hydrochloride equivalent to 4.56 mg or 9.12 mg donepezil free base, respectively. The inactive ingredients are carrageenan, mannitol, silica colloidal anhydrous and polyvinyl alcohol. Additionally, the 10 mg tablet contains iron oxide yellow as a colouring agent. Version: pfparict11112 Supersedes: pfparict10911 Aqra d-dokument sħiħ