DONEPEZIL HYDROCHLORIDE RANBAXY
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
11-05-2024
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Active ingredient:
DONEPEZIL HYDROCHLORIDE
Available from:
Ranbaxy Ireland Limited
Dosage:
10 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 10 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg donepezil hydrochloride, equivalent to 9.12 mg donepezil.
Excipient:
Each film-coated 10 mg tablet also contains 166.29 mg Lactose
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Yellow coloured, capsule shaped, film-coated tablets debossed with ‘RC’ on one side of the score line and 26 on other
side
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
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 Hydrochlorideshould 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
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