Valsts: Malaizija
Valoda: angļu
Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DONEPEZIL HCL
MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.
DONEPEZIL HCL
500tablet Tablets
MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 ALZHICEPT TABLETS 10MG Donepezil hydrochloride 10mg WHAT IS IN THIS LEAFLET What Alzhicept Tablets is used for How Alzhicept Tablets works Before you use Alzhicept Tablets How to use Alzhicept Tablets While you are using Alzhicept Tablets Side Effects Storage and Disposal of Alzhicept Tablets Product description Manufacturer and Product Registration Holder Date of Revision WHAT ALZHICEPT TABLETS IS USED FOR Donepezil Hydrochloride Tablets are used to treat the symptoms of mild, moderate and severe dementia in people diagnosed as having 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. This medicine is only available with a doctor’s prescription HOW ALZHICEPT TABLETS WORKS Donepezil belongs to a group of medicines called acetylcholinesterase inhibitors. 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 ALZHICEPT TABLETS - _When you must not use it _ Do not take Alzhicept Tablets if your have an allergy to: Any medicine containing donepezil hydrochloride. Piperidine derivatives Any of the ingredients listed at the end of this leaflet. Do not give Alzhicept Tablets to children. The safety and effectiveness of Alzhicept in children have not been establised. If you are not sure whether you should be taking Alzhicept Tablets, talk to your doctor. - _Before you start to use it _ Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes. Tell your doctor if you plan to go to hospital for surgery that requires a general anaesthetic. Tell your doctor if your have or have had any of the following medical conditions: stomach or duodenal ulcers seizures (fits) or convulsions a heart condit Izlasiet visu dokumentu
7196-00 ALZHICEPT TABLETS 10MG Alzhicept Tablets 10mg : A bluish green, scored, convex of diameter 8.5mm round tablet with “MPI” marking. PHARMACOLOGY: Donepezil is a piperidine derivative, chemically distinct from other agents in this class. Donepezil demonstrates relatively high selectivity for central nervous system acetylcholinesterase, with minimal peripheral activity. It reversibly and noncompetitively inhibits centrally-active acetylcholinesterase, the enzyme responsible for hydrolysis of acetylcholine. This is expected to result in increased concentrations of acetylcholine that are available for synaptic transmission. Alzheimer's’disease is characterized by cholinergic deficiency in the cortex and basal forebrain, which contributes to cognitive deficits. Donepezil does not alter the course of the underlying dementing process. PHARMACOKINETICS: _ABSORPTION _ Donepezil hydrochloride is well absorbed from the gastrointestinal tract, maximum plasma concentrations being achieved within 3 to 4 hours after ingestion. Food did not affect the absorption of donepezil hydrochloride. _ _ _DISTRIBUTION _ It is about 95% bound to human plasma proteins, mainly albumin. _ _ _METABOLISM _ Donepezil is metabolized in the liver. Donepezil undergoes partial metabolism via the cytochrome P450 isoenzyme CYP3A4, and to a lesser extent by CYP2D6, to 4 major metabolites. About 11% of a dose is present in plasma as 6-O-desmethyldonepezil, which has similar activity to the parent compound. _EXCRETION _ Over 10 days, about 57% of a dose is recovered from the urine as unchanged drug and metabolites, and about 15% from the faeces; 28% remains unrecovered suggesting accumulation. The elimination half-life is about 70 hours. Steady-state concentrations are achieved within 3 weeks of the start of therapy. _ _ * Sex, race and smoking history have no clinically significant influence on plasma concentrations of donepezil hydrochloride. COMPOSITION: Alzhicept Tablets 10mg : Each tablet contains 10mg of donepezil hydrochloride INDICATIO Izlasiet visu dokumentu