البلد: ماليزيا
اللغة: الإنجليزية
المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DONEPEZIL HCL
CIPLA MALAYSIA SDN BHD
DONEPEZIL HCL
30tablet Tablets
Cipla Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ DONECEPT-5 & DONECEPT-10 TABLETS Donepezil Hydrochloride (5mg,10mg) 1 WHAT IS IN THIS LEAFLET 1. What DONECEPT is used for 2. How DONECEPT works 3. Before you use DONECEPT 4. How to use DONECEPT 5. While you are using it 6. Side effects 7. Storage and Disposal of DONECEPT 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT DONECEPT_ _IS USED FOR DONECEPT _ _ 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 DONECEPT WORKS DONECEPT 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. DONECEPT _ _ has not been approved as a treatment for any medical condition in children. BEFORE YOU USE DONECEPT_ _ - _When you must not use it _ You should not take DONECEPT _ _ - if you are allergic to Donepezil Hydrochloride or any of the ingredients in DONECEPT or to medicines that contain piperidines. - if you are pregnant, trying to get pregnant or think you may be pregnant. - if you are breast- feeding. - _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, slow, or fast heartbeats • A heart condition called ‘prolonged QT interval’ or a history of certain abnormal heart rhythms called Torsade de Pointes or if anyone in your family has ‘prolonged QT interval’ • Low levels of magnesium or potassium in your blood • Asthma or lung problems • Other types of memory impairment • Any movement اقرأ الوثيقة كاملة
DONECEPT-5 (DONEPEZIL HYDROCHLORIDE TABLETS 5MG) DONECEPT-10 (DONEPEZIL HYDROCHLORIDE TABLETS 10MG) Donepezil Hydrochloride COMPOSITION DONECEPT-5 Each tablet contains Donepezil Hydrochloride 5mg. DONECEPT-10 Each tablet contains Donepezil Hydrochloride 10mg. DOSAGE FORM Film coated tablet DONECEPT-5 White, circular, biconvex film coated tablet with ‘5’ debossed on one side and ‘DPZ’ debossed on the other side. DONECEPT-10 Yellow, circular, biconvex film coated tablet with ‘10’ debossed on one side and ‘DPZ’ debossed on the other side. PHARMACOLOGY PHARMACODYNAMICS Pharmacotherapeutic group: anti-dementia drugs; anticholinesterase. ATC code: N06DA02 Donepezil hydrochloride is a specific and reversible inhibitor of acetyl cholinesterase, the predominant cholinesterase in the brain. Donepezil hydrochloride is in vitro over 1000 times more potent an inhibitor of this enzyme than of butyrylcholinesterase, an enzyme that is present mainly outside the central nervous system. Alzheimer's Dementia The inhibition of acetyl cholinesterase (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 studied. Thus donepezil cannot be considered to have any effect on the progress of the disease. PHARMACOKINETICS Absorption Maximum plasma levels are reached approximately 3 to 4 hours after oral administration. Plasma concentrations and area under the curve rise in proportion to the dose. The terminal disposition half-life is approximately 70 hours, thus, administration of multiple single daily doses results in gradual approach to steady-state. Approximate steady-state is achieved within 3 weeks after initiation of therapy. Once at steady-state, plasma donepezil hydrochloride concentrations and the related pharmacodynamic activity show little variability over the course of the day. Food did not affec اقرأ الوثيقة كاملة