Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
DONEPEZIL HYDROCHLORIDE
Niche Generics Limited
5 Milligram
Orodispersible Tablet
2012-01-20
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Donepezil Niche 5 mg orodispersible tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mg tablet contains: 5 mg donepezil hydrochloride, equivalent to 4.56 mg of donepezil free base. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet. Donepezil Niche 5 mg orodispersible tablets are white, round, flat faced, bevelled edged tablets debossed with ‘DO5’ on one side and plain on 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 ADULTS/ELDERY: Treatment is initiated at 5 mg/day (once-a-day dosing). Donepezil Niche should be taken orally, in the evening, just prior to retiring. The tablet should be placed on the tongue and allowed to disintegrate before swallowing with or without water, according to patient preference. 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 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 regul Read the complete document