Country: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Donepezil Hydrochloride
MEDISPEC (M) SDN.BHD
Donepezil Hydrochloride
2 x 14 Tablets; 2 x 14 Tablets
GENEPHARM S.A
DONEPEZIL/GENEPHARM ORODISPERSIBLE TABLET Donepezil Hydrochloride (5mg & 10mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Donepezil/Genepharm is used for 2. How Donepezil/Genepharm works 3. Before you use Donepezil/Genepharm 4. How to use Donepezil/Genepharm 5. While you are using it 6. Side effects 7. Storage and Disposal of Donepezil/Genepharm 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT DONEPEZIL/GENEPHARM_ _IS USED FOR Donepezil/Genepharm (donepezil hydrochloride) belongs to a group of medicines called acetylcholinesterase inhibitors. It is used to treat dementia in people diagnosed as having mild, moderate and severe Alzheimer’s disease. The symptoms include increasing memory loss, confusion and behavioral changes. As a result, sufferers of Alzheimer’s disease find it more and more difficult to carry out their normal daily activities. Donepezil/Genepharm is for use in adult patients only. HOW DONEPEZIL/GENEPHARM_ _WORKS Donepezil increases the levels of a substance (acetylcholine) in the brain involved in memory function by slowing down the breakdown of acetylcholine. BEFORE YOU USE DONEPEZIL/GENEPHARM Tell the doctor about all your present or past health problems. Including: • 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 have ‘prolonged QT interval’. • Low levels of magnesium or potassium in your blood. - _When you must not use it _ • if you are allergic (hypersensitive) to donepezil hydrochloride, or to piperidine derivatives, or any of the other ingredients of Donepezil/Genepharm. _-Before you start to use it _ Tell your doctor or pharmacist before starting to take Donepezil/Genepharm if you have or have had: • stomach or duodenal ulcers • seizures (fits) or convulsions • a heart condition (irregular or ve Lestu allt skjalið
DONEPEZIL/GENEPHARM ORODISPERSIBLE TABLETS (5MG & 10MG) DONEPEZIL/GENEPHARM 5 MG ORODISPERSIBLE TABLET Each orodispersible tablet contains Donepezil HCl 5mg equivalent to Donepezil 4.56mg DONEPEZIL/GENEPHARM 10 MG ORODISPERSIBLE TABLET Each orodispersible tablet contains Donepezil HCl 10mg equivalent to Donepezil 9.12mg PRODUCT DESCRIPTION DONEPEZIL/GENEPHARM 5 MG ORODISPERSIBLE TABLET White to off-white round, flat tablets, with bevelled edges, embossed with ‘5’ on one side and plain on the other DONEPEZIL/GENEPHARM 10 MG ORODISPERSIBLE TABLET White to off-white round, flat tablets, with bevelled edges, embossed with ‘10’ on one side and plain on the other PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: anti-dementia drugs, anticholinesterases ATC code: N06DA02. 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 butyrylcholinesterase, an enzyme that is present mainly outside the central nervous system. In patients with 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 that 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. PHARMACOKINETIC PROPERTIES _ _ _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 dispositio Lestu allt skjalið