देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
DONEPEZIL HYDROCHLORIDE
Pfizer Healthcare Ireland
10 Milligram
Orodispersible Tablet
2011-10-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Donepezil Pfizer 10mg Orodispersible Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 10 mg donepezil hydrochloride, equivalent to 9.12 mg of donepezil free base. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet. Yellow orodispersible tablet embossed with ‘10’ on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Donepezil Pfizer orodispersible 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). Donepezil Pfizer 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 Pfizer 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 पूरा दस्तावेज़ पढ़ें