Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
DONEPEZIL HYDROCHLORIDE
Niche Generics Limited
5 Milligram
Film Coated Tablet
2010-11-19
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Donepezil Niche 5mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mg tablet contains: 5 mg donepezil hydrochloride, equivalent to 4.56 mg of donepezil free base. Excipient: 96.0 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Donepezil Niche 5 mg film coated tablets are white, round, biconvex tablets debossed ‘D5’ on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Donepezil Niche Tablets are indicated for the symptomatic treatment of mild to moderately severe Alzheimer’s dementia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment is initiated at 5 mg/day (once-a-day dosing). Donepezil Niche tablets 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 Niche tablets 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 should only be started if a caregiver is available who will regularly monitor drug intake for the patient. Maintenance treatment can be continued for as long as a therapeutic benefit for the patie Pročitajte cijeli dokument