देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
DONEPEZIL HYDROCHLORIDE
Pliva Pharma Limited
5 Milligram
Film Coated Tablet
2009-11-27
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Donepezil Teva 5 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg donepezil hydrochloride. Excipient(s): Each 5 mg film-coated tablet contains 56.95mg of lactose (as monohydrate) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Donepezil Teva 5 mg film-coated tablets are white to off-white, round, biconvex film-coated tablets, with beveled edges and debossed 'TEVA' on one side and 738 on the other side 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Donepezil Teva film-coated tablets are indicated for the symptomatic treatment of mild to moderately severe Alzheimer's dementia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral use. For doses not realisable/practicable with this strength other strengths of this medicinal product are available. _ADULTS/ELDERLY:_ Treatment is initiated at 5 mg/day (once-a-day dosing). Donepezil hydrochloride 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 hydrochloride 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/day (once-a-day dosing). The maximum recommended daily dose is 10 mg. Doses greater than 10 mg/day have not been studied in clinical trials. 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 hydroch पूरा दस्तावेज़ पढ़ें