Land: Malaysia
Sprog: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DONEPEZIL HCL
HEALOL PHARMACEUTICALS SDN. BHD.
DONEPEZIL HCL
30tablet Tablets
Macleods Pharmaceuticals Limited
_Consumer Medication Information Leaflet (RiMUP) _ ARIMAC 5 (DONEPEZIL HCL TABLETS 5MG) ARIMAC 10 (DONEPEZIL HCL TABLETS 10MG) Donepezil Hydrochloride (5mg & 10mg) 1 WHAT IS IN THIS LEAFLET 1. What Arimac is used for 2. How Arimac works 3. Before you use Arimac 4. How to use Arimac 5. While you are using it 6. Side effects 7. Storage and Disposal of Arimac 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT IS ARIMAC USED FOR Arimac is used for the symptomatic treatment of mild, moderate & severe dementia in Alzheimer’s disease. HOW ARIMAC WORKS Arimac is one of a group of medicines called acetylcholinesterase inhibitor. It increases the levels of a substance (acetylcholine) in the brain involved in memory function by slowing down the breakdown of acetylcholine. BEFORE YOU USE ARIMAC -When you must not use it If you are allergic to donepezil hydrochloride or to piperidine derivatives, or any of the other ingredients of Arimac. If you are in any doubt at all, consult your doctor before taking donepezil. -Before you start to use it Talk to your doctor before taking Arimac if you: • Develop stomach or duodenal ulcers. • Seizures (fits) or convulsions. • A heart condition (irregular or very slow heart beat) • Asthma or other long term lung disease. • Liver problems or hepatitis. • Difficulty passing urine or mild kidney disease. • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine. • If you are taking Arimac, you should not breast-feed Children and Adolescents: Arimac is not recommended for use in children. 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 inter Læs hele dokumentet
ATC Code for Donepezil : N06DA02 Pharmacotherapeutic group : Acetylcholinesterase inhibitor MODE OF ACTION Donepezil hydrochloride is a specific and reversible inhibitor of acetylcholinesterase, the redominant 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. 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. Food does not influence the rate or extent of absorption of donepezil tablets. DISTRIBUTION: Donepezil hydrochloride is approximately 95% bound to human plasma proteins. The plasma protein binding of the active metabolite 6-O-desmethyldonepezil is not known. The distribution of donepezil hydrochloride in various body tissues has not been definitively studied. METABOLISM & EXCRETION: Donepezil hydrochloride is both excreted in the urine intact and metabolised by the cytochrome P450 system to multiple metabolites, not all of which have been identified. Following administration of a single 5 mg dose of 14C-labeled donepezil hydrochloride, plasma radioactivity, expressed as a percent of the administered dose, was present primarily as intact donepezil hydrochloride (30%), 6-O-desmethyl donepezil (11% - only metabolite that exhibits activity similar to donepezil hydrochloride), donepezil-cis-N-oxide (9%), 5-O-desmethyl donepezil (7%) and the glucuronide conjugate of 5-O-desmethyl donepezil (3%). Approximately 57% of the total administered radioactivity was recovered from the urine (17% as unchanged donepezil), and 14.5% was recovered from the faeces, suggesting biotra Læs hele dokumentet