Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
DONEPEZIL HYDROCHLORIDE
EGIS Pharmaceuticals PLC
5 Milligram
Film Coated Tablet
2009-04-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Donepezil hydrochloride 5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mg film-coated tablet contains 5 mg donepezil hydrochloride (as monohydrate), equivalent to 4.56 mg of donepezil For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet White or almost white, odourless or almost odourless, round, biconvex film-coated tablets with stylized E 381 on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Donepezil hydrochloride is indicated for the symptomatic treatment of mild to moderately severe Alzheimer’s dementia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults/Elderly_ Treatment is initiated at 5 mg donepezil hydrochloride once a day. It should be taken orally in the evening, just prior to retiring. The 5 mg/day dose should be maintained for at least one month in order to allow the earliest clinical responses to treatment to be assessed and to allow steady- state concentrations of donepezil to be achieved. Following a one- month clinical assessment of treatment at 5 mg/day, the dose of donepezil hydrochloride can be increased to 10 mg once a day. The maximum recommended daily dose is 10 mg. Doses greater than 10 mg /day have not been studied in clinical trials. For doses not realisable/practicable with this strength other strengths of this medicinal product are available. Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’s dementia. Diagnosis should be made according to accepted guidelines (e.g. DSM IV, ICD 10). Therapy with donepezil should only be started if a caregiver is available who will regularly monitor drug intake for the patient. Maintenance treatment c Read the complete document