DONEPEZIL HYDROCHLORIDE RANBAXY
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
12-05-2024
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Active ingredient:
DONEPEZIL HYDROCHLORIDE
Available from:
Ranbaxy Ireland Limited
Dosage:
5 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2009-11-13
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Donepezil hydrochloride Ranbaxy 5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg donepezil hydrochloride, equivalent to 4.56mg of donepezil.
Excipient:
Each film-coated 5 mg tablet also contains 83.14 mg Lactose.
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
Yellow coloured, circular, biconvex film coated tablets debossed with ‘RC25’ on one side
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Donepezil tablets are indicated for the symptomatic treatment of mild to moderately severe Alzheimer's dementia
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral use
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 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 patient
exists. Therefore,
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