ARICEPT 5 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DONEPEZIL HYDROCHLORIDE

Available from:

PCO Manufacturing

INN (International Name):

DONEPEZIL HYDROCHLORIDE

Dosage:

5 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

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Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ARICEPT 5 mg film coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg donepezil hydrochloride.
Excipient with known effect: lactose monohydrate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from France, Greece and Spain:_
White, round, biconvex tablets with ‘ARICEPT’ on one side and ‘5’ on the other side.
_Product imported from Italy:_
White, round, biconvex tablets with ‘ARICEPT’ on one side and ‘5’ on the other side OR white, round, biconvex
tablets with no markings.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ARICEPT tablets are indicated for the symptomatic treatment of mild to moderately severe Alzheimer’s dementia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults/Elderly:
Treatment is initiated at 5 mg/day (once-a-day dosing). ARICEPT 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 ARICEPT 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