Source: Health Products Regulatory Authority (ZA) Revision Year: 2024 Publisher: Aurogen South Africa (Pty) Ltd, Woodhill Office Park, Building 1, First floor, 53 Phillip Engelbrecht Avenue, Meyersdal, Ext. 12, 1448, Johannesburg, South Africa
PRESESE 5 mg TABLETS (tablet).
PRESESE 10 mg TABLETS (tablet).
| Pharmaceutical Form |
|---|
|
PRESESE 5 mg TABLETS: Yellow coloured, circular, biconvex, film-coated tablets, debossed with 'I and break line' on one side and '11' on the other side. PRESESE 10 mg TABLETS: Yellow coloured, circular, biconvex, film-coated tablets, debossed with 'I and break line' on one side and '13' on the other side. |
PRESESE 5 mg TABLETS: Each film-coated tablet contains bisoprolol fumarate (2:1) 5 mg. Sugar free.
PRESESE 10 mg TABLETS: Each film-coated tablet contains bisoprolol fumarate (2:1) 10 mg. Sugar free.
For full list of excipients, see section 6.1.
| Active Ingredient |
|---|
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Bisoprolol is a potent highly beta1-selective-adrenoceptor blocking agent, lacking intrinsic stimulating and without relevant membrane stabilising activity. |
| List of Excipients |
|---|
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Calcium hydrogen phosphate The coating material of PRESESE contains: Hypromellose |
Blister pack:
Tablets are packed in printed peelable lidding silver foil (50 g/m² paper/12 micron polyster/20 micron Aluminium foil/7 g/m² HSL) and cold form film (25 micron polyamide/45 micron Aluminium foil/60 micron PVC film). One blister contains 10 tablets.
Pack size: 30's: Each carton contains 3 blisters of 10 tablets each.
HDPE Container Pack:
Tablets are packed in white opaque round 40 ml HDPE container with a white opaque ribbed stock (RS) HDPE closure, with induction sealing wad containing one silica gel sachet. Each container which is enclosed in an outer cardboard carton contains 30 tablets.
Pack size: 30's - One HDPE container contains 30 tablets.
Aurogen South Africa (Pty) Ltd, Woodhill Office Park, Building 1, First floor, 53 Phillip Engelbrecht Avenue, Meyersdal, Ext. 12, 1448, Johannesburg, South Africa
PRESESE 5 mg TABLETS: 45/5.2/0866
PRESESE 10 mg TABLETS: 45/5.2/0867
11 June 2018
| Drug | Countries | |
|---|---|---|
| PRESESE | South Africa |
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