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
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. |
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 PRIFET 10 mg TABLETS also contains iron oxide yellow. |
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.
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.
Aurogen South Africa (Pty) Ltd, Woodhill Office Park, Building 1, 53 Phillip Engelbrecht Avenue, Meyersdal, Ext. 12, 1448, Johannesburg, South Africa
PRIFET 5 mg TABLETS: 44/5.3/0946
PRIFET 10 mg TABLETS: 44/5.3/0947
| Drug | Countries | |
|---|---|---|
| PRIFET | South Africa |
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