国: マレーシア
言語: 英語
ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Donepezil hydrochloride monohydrate
IMEKS PHARMA SDN. BHD.
Donepezil hydrochloride monohydrate
14x2 Tablets
T.O. CHEMICALS (1979) LTD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ TONIZEP ORALLY DISINTEGRATING TABLET 5MG Donepezil hydrochloride (5 mg Donepezil Hydrochloride tablets each containing 4.56 mg donepezil free base) _ _ 1 forodis WHAT IS IN THE LEAFLET 1. What _Tonizep Orally Disintegrating _ _Tablet 5mg_ is used for 2. How _Tonizep Orally Disintegrating _ _Tablet 5mg_ works 3. Before you use _Tonizep Orally _ _Disintegrating Tablet 5mg_ 4. How to use _Tonizep Orally _ _Disintegrating Tablet 5mg_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Tonizep Orally _ _Disintegrating Tablet 5mg_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT _TONIZEP ORALLY DISINTEGRATING TABLET _ _5MG_ IS USED FOR _Tonizep Orally Disintegrating Tablet 5mg _ is a prescription medicine to treat dementia in Alzheimer’s disease. The symptoms include increasing memory loss, confusion and behavioural changes. As a result, sufferers of Alzheimer’s disease find it more and more difficult to carry out their normal daily activities. HOW _TONIZEP ORALLY DISINTEGRATING TABLET _ _5MG_ WORKS _Tonizep Orally Disintegrating Tablet 5mg_ 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 levels of a substance (acetylcholine) in the brain involved in memory function by slowing down the breakdown of acetylcholine. _Tonizep Orally Disintegrating Tablet 5mg_ has not been approved as a treatment for any medical condition in children. BEFORE YOU USE _TONIZEP ORALLY _ _DISINTEGRATING TABLET 5MG _ - _When you must not use it _ Do not use _Tonizep Orally Disintegrating _ _Tablet 5mg_ if: • you are phenylketonurics • you are allergic to donepezil hydrochloride or any ingredients in _Tonizep Orally _ _Disintegrating Tablet 5mg_ or to medicines that contain piperidines. • you are pregnant or breast-feeding, think you may be 完全なドキュメントを読む
TONIZEP ® ORALLY DISINTEGRATING TABLET 5MG CONTENT Each 5 mg donepezil hydrochloride tablets each containing 4.56 mg donepezil free base. DESCRIPTION White, round tablets embossed with ‘5’ on one side and ‘ZD’ on another PHARMACODYNAMICS Donepezil hydrochloride is a specific and reversible inhibitor of acetylcholinesterase, the predominant cholinesterase in the brain. Donepezil hydrochloride is in vitro over 1000 times more potent an inhibitor of this enzyme than of butyryl cholinesterase, an enzyme which is present mainly outside the central nervous system. ALZHEIMER'S DEMENTIA Administration of single daily doses of 5 mg or 10 mg of donepezil hydrochloride produced steady-state inhibition of acetylcholinesterase activity (measured in erythrocyte membranes) of 63.6% and 77.3%, respectively when measured post dose. The inhibition of acetylcholinesterase (AChE) in red blood cells by donepezil hydrochloride has been shown to correlate to changes in ADAS-cog, a sensitive scale which examines selected aspects of cognition. The potential for donepezil hydrochloride to alter the course of the underlying neuropathology has not been known. Thus, donepezil hydrochloride cannot be considered to have any effect on the progress of the disease. An analysis was done at the conclusion of donepezil hydrochloride treatment using a combination of three efficacy criteria: the ADAS-Cog (a measure of cognitive performance), the Clinician Interview Based Impression of Change with Caregiver Input (a measure of global function) and the Activities of Daily Living Subscale of the Clinical Dementia Rating Scale (a measure of capabilities in community affairs, home and hobbies and personal care). Those fulfilled the criteria listed below were considered treatment responders. Response = Improvement of ADAS-Cog of at least 4 points No deterioration of CIBIC+ No Deterioration of Activities of Daily Living Subscale of the Clinical Dementia Rating Scale % Response Intent to Treat Population n = 365 Evaluable Population n = 352 Placebo G 完全なドキュメントを読む