PRIFET Film-coated tablet Ref.[115309] Active ingredients: Donepezil

Adults/Elderly

The recommended dosages of PRIFET TABLETS are 5 mg and 10 mg administered once daily. Although there is no statistically significant evidence that a greater treatment effect is obtained from the use of the 10 mg dose, there is a suggestion, based on analysis of group data that some additional benefits may accrue to some patients from the use of the higher dose.

Treatment is initiated at 5 mg/day (once-a-day dosing).

The 5 mg/day dose should be maintained for at least 4–6 weeks 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 PRIFET 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. Upon discontinuation of treatment, a gradual abatement of the beneficial effects of PRIFET TABLETS is seen. After abrupt discontinuation of therapy, there is no evidence of a rebound effect.

Renal and Hepatic Impairment

A similar dose schedule can be followed for patients with renal or mild to moderate hepatic impairment as clearance of donepezil hydrochloride is not affected by these conditions.

Dose-related signs of cholinergic stimulation were observed in animals and included reduced spontaneous movement, prone position, staggering gait, lacrimation, clonic convulsions, depressed respiration, salivation, miosis, fasciculation and lower body surface temperature.

Overdosage with PRIFET TABLETS can result in cholinergic crisis characterised by severe nausea, vomiting, salivation, sweating, bradycardia, hypotension, respiratory depression, collapse and convulsions. Increasing muscle weakness is a possibility and may result in death if respiratory muscles are involved.

General supportive measures should be utilised. Tertiary anticholinergics such as atropine may be used as an antidote for PRIFET TABLETS overdosage. Intravenous atropine sulphate titrated to effect is recommended: an initial dose of 1,0 to 2,0 mg IV with subsequent doses based upon clinical response. Atypical responses in blood pressure and heart rate have been reported with other cholinomimetics when co-administered with quaternary anticholinergics such as glycopyrrolate. It is not known whether donepezil hydrochloride and/or its metabolites can be removed by dialysis (hemodialysis, peritoneal dialysis, or hemofiltration).

Store at or below 25°C. Protect from light. Do not remove blisters from carton until required for use. Keep securitainer well-closed after use.

KEEP OUT OF REACH OF CHILDREN.

PRIFET 5 mg TABLETS

1) Blister Pack:

Tablets are packed in 250 micron clear PVC/25 micron PE/90 gsm PVdC and silver coloured printed 25 micron aluminium foil with 7 gsm heat seal lacquer.

Each blister contains 10 tablets.

Pack size: 30's – Each carton contains 3 blisters of 10 tablets each.

2) HDPE Container Pack:

Tablets are packed in 40 ml HDPE white container with white closure with induction sealing wad containing 1 no. of 1 gm silica gel sachet.

Each container contains 30 tablets.

Pack size: 30's - One HDPE container contains 30 tablets.

PRIFET 10 mg TABLETS

1) Blister Pack:

Tablets are packed in 250 micron clear PVC/25 micron PE/90 gsm PVdC and silver coloured printed 25 micron aluminium foil with 7 gsm heat seal lacquer.

Each blister contains 10 tablets.

Pack size: 30's – Each carton contains 3 blisters of 10 tablets each.

2) HDPE Container Pack:

Tablets are packed in 40 ml HDPE white container with white closure with induction sealing wad containing 1 no. of 1 gm silica gel sachet.

Each container contains 30 tablets.

Pack size: 30's - One HDPE container contains 30 tablets.