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

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2021  Publisher: Aurogen South Africa (Pty) Ltd, Woodhill Office Park, Building 1, 53 Phillip Engelbrecht Avenue, Meyersdal, Ext. 12, 1448, Johannesburg, South Africa

Product name and form

PRIFET 5 mg TABLETS (Tablet).

PRIFET 10 mg TABLETS (Tablet).

Pharmaceutical Form

PRIFET 5 mg TABLETS: White to off-white, circular, biconvex, film-coated tablets debossed with 'X' on one side and '11' on the other side.

PRIFET 10 mg TABLETS: Yellow coloured, circular, biconvex, film-coated tablets debossed with 'X' on one side and '12' on the other side.

Qualitative and quantitative composition

PRIFET 5 mg TABLETS: Each film-coated tablet contains donepezil hydrochloride 5 mg. Contains lactose.

PRIFET 10 mg TABLETS: Each film-coated tablet contains donepezil hydrochloride 10 mg. Contains lactose.

Active Ingredient

Donepezil hydrochloride is a specific and reversible inhibitor of acetylcholinesterase, the predominant cholinesterase in the brain. Donepezil hydrochloride is in vitro over 1000 times more potent an inhibitor of this enzyme than of butyrylcholinesterase, an enzyme that is present mainly outside the central nervous system.

List of Excipients

Contains lactose.

The other excipients in the formulations are:

Pregelatinised starch
Microcrystalline cellulose
Hydroxypropylcellulose
Magnesium stearate
Hypromellose
Polyethylene glycol
Talc
Titanium dioxide

PRIFET 10 mg TABLETS also contains iron oxide yellow.

Pack sizes and marketing

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.

Marketing authorization holder

Aurogen South Africa (Pty) Ltd, Woodhill Office Park, Building 1, 53 Phillip Engelbrecht Avenue, Meyersdal, Ext. 12, 1448, Johannesburg, South Africa

Marketing authorization dates and numbers

PRIFET 5 mg TABLETS: 44/5.3/0946
PRIFET 10 mg TABLETS: 44/5.3/0947

Drugs

Drug Countries
PRIFET South Africa

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