Land: Malaysia
Sprache: Englisch
Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DONEPEZIL HCL
EISAI (MALAYSIA) SDN BHD (18039-D)
DONEPEZIL HCL
28 Tablet Tablets
Bora Pharmaceuticals Co.,Ltd.
ARICEPT TABLET ® Donepezil Hydrochloride (5mg,10mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _ARICEPT® _ is used for 2. How _ARICEPT® _ works 3. Before you use _ARICEPT®_ 4. How to use _ARICEPT®_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _ARICEPT® _ _8. _ Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _ARICEPT® _IS USED FOR _ARICEPT® _ is a prescription medicine to treat dementia Alzheimer’s disease. The symptoms include increasing memory loss, confusion and behavioural changes. HOW _ARICEPT® _WORKS _ARICEPT® _ can help with mental function and with doing daily tasks. _ARICEPT® _ does not work the same in all people. 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. _ARICEPT® _ does not cure Alzheimer’s disease but helps to control your condition. BEFORE YOU USE _ARICEPT®_ - _ When you must not use it _ _ARICEPT®_ should be taken in the evening prior to retiring You should not take _ARICEPT®_ -if you are allergic to Donepezil or any of the ingredients in _ARICEPT® _ or to similar medicines that contain piperidines. -if you are not sure. See the end of this leaflet for a list of ingredients in _ARICEPT®_ . _Children _ Aricept is not recommended for use in children. _Pregnancy and lactation_ Do not take _ARICEPT® _ if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take _ARICEPT® _ if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. - _ Before you start to use it _ Tell the doctor about all your present or past health problems. Include: • Any heart problems including problems with irregular or slow heartbeats • Asthma or lung problems • Stomach ulcers • Difficulty passing urine or kidney problems • Liver problems • Trouble swallowing tablets - _ Taking other med Lesen Sie das vollständige Dokument
1. TRADE NAME OF THE MEDICINAL PRODUCT Aricept 5 mg Film-Coated tablet Aricept 10 mg Film-Coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 5 mg donepezil hydrochloride tablets each containing 4.56 mg donepezil f\ ree base 10 mg donepezil hydrochloride tablets each containing 9.12 mg donepezil \ free base For excipients, see 6.1 3. PHARMACEUTICAL FORM Aricept 5mg film coated tablets are white, round, biconvex and debossed. Aricept 10mg film coated tablets are yellow, round, biconvex and debossed. 4. CLINICAL PARTICULARS 4.1 Therapeutic indication Aricept tablets are indicated for the treatment of mild, moderate, and severe dementia in Alzheimer's Disease. 4.2 Posology and method of administration Adults/Elderly: Mild to Moderate Alzheimer's Disease Treatment is initiated at 5mg/day (once-a-day dosing). Aricept should be taken orally, in the evening, just prior to retiring. The tablet should be swallowed whole with water. The 5mg/day dose should be maintained for at least one month in order to allow the earliest clinical responses to treatment to be assessed and to allow steady-state concentrations of donepezil hydrochloride to be achieved. Following a one-month clinical assessment of treatment at 5mg/day, the dose of Aricept can be increased to 10mg/day (once-a-day dosing). The maximum recommended daily dose is 10mg. Doses greater than 10mg/day have not been studied in clinical trials. Upon discontinuation of treatment, a gradual abatement of the beneficial effects of Aricept is seen. Severe Alzheimer's Disease Aricept has been shown to be effective in controlled clinical trials at a dose of 10mg administered once daily. Evidence from the controlled trials in mild, moderate Alzheimer's Disease indicates that the 10mg dose, with one week titration, is likely to be associated with a higher incidence of cholinergic adverse events than the 5mg dose. In open label trials using a 6 week titration, the frequency of these same adverse events was similar between the 5mg and 10mg dose groups. Therefore, because ste Lesen Sie das vollständige Dokument