Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
DONEPEZIL HYDROCHLORIDE
Teva Pharma B.V.
5 Milligram
Orodispersible Tablet
2010-09-10
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aripez 5 mg Orodispersible Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mg orodispersible tablet contains 5 mg donepezil hydrochloride equivalent to 4.56 mg donepezil. Excipients: Each 5 mg orodispersible tablet contains 183.82 mg lactose anhydrous and 0.14 mg aspartame. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet White, flat bevelled edge, round tablet, engraved with “L 5” on one side and plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Donepezil hydrochloride is indicated for the symptomatic treatment of mild to moderately severe Alzheimer's dementia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral use. For doses not realisable/practicable with this strength, other strengths of this medicinal product are available. Adults/Elderly: Treatment is initiated at 5 mg/day (once-a-day dosing). The orodispersible tablet should be taken orally, in the evening, just prior to retiring. It 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 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 Read the complete document