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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Donepezil Krka 10mg Orodispersible tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains donepezil hydrochloride monohydrate equivalent to 10 mg donepezil hydrochloride.
Excipient:
Each orodispersible tablet contains 1.50 mg aspartame (E951), 0.60 mg glucose, 0.50 mg sucrose and 0.04 mg sorbitol
(E420).
For a full list of excipients,see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablet.
White round orodispersible tablets, bevel-edged.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Donepezil Krka 10mg Orodispersible tablets is 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). Donepezil Krka 10mg Orodispersible tablets 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 Krka 10mg Orodispersible 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, IC
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