Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Aurogen South Africa (Pty) Ltd, Woodhill Office Park, Building 1, 53 Phillip Engelbrecht Avenue, Meyersdal, Ext. 12, 1448, Johannesburg, South Africa
ROMIDAB 500 mg TABLETS (Tablet).
ROMIDAB 850 mg TABLETS (Tablet).
ROMIDAB 1000 mg TABLETS (Tablet).
| Pharmaceutical Form |
|---|
|
ROMIDAB 500 mg TABLETS: White, biconvex, circular shaped film-coated tablets with 'A' debossed on one side and '60' debossed on the other side. ROMIDAB 850 mg TABLETS: White, biconvex, circular shaped film-coated tablets with 'A' debossed on one side and '61' debossed on the other side. ROMIDAB 1000 mg TABLETS: White, biconvex, oval shaped film-coated tablets with a scoreline in between '6' and '2' on one side and 'A' debossed on the other side. |
ROMIDAB 500 TABLETS: Each film-coated tablet contains 500 mg metformin hydrochloride.
ROMIDAB 850 mg TABLETS: Each film-coated tablet contains 850 mg metformin hydrochloride.
ROMIDAB 1000 mg TABLETS: Each film-coated tablet contains 1 000 mg metformin hydrochloride.
| Active Ingredient |
|---|
|
Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycaemia. |
| List of Excipients |
|---|
|
Magnesium stearate |
1. Blister Pack:
Tablets are packed in clear PVC/PVdC aluminium blister packs:
ROMIDAB 500 mg TABLETS: 28's (2 x 14's), 56's (4 x 14's), 84's (6 x 14's), 100's (10 x 10's).
ROMIDAB 850 mg TABLETS: 28's (2 x 14's), 56's (4 x 14's), 60's (6 x 10's), 84's (6 x 14's).
ROMIDAB 1000 mg TABLETS: 28's (2 x 14's), 56's (4 x 14's), 60's (6 x 10's), 84's (6 x 14's).
The blister pack is packed in a cardboard carton.
2. HDPE Container:
Tablets are packed in a white opaque HDPE container with a white opaque stock ribbed closure and induction sealing wad. A 1 g active carbon sachet is included in each HDPE container. The exact amount of sachets per HDPE container is indicated in brackets in the following pack sizes:
ROMIDAB 500 mg TABLETS: 28's (1), 56's (1), 84's (2), 300's (3), 500's (5)
ROMIDAB 850 mg TABLETS: 28's (1), 56's (1), 84's (2), 300's (4), 500's (6)
ROMIDAB 1000 mg TABLETS: 28's (1), 56's (1), 84's (2), 300's (4), 500's (6)
The HDPE container is packed in a cardboard carton.
Aurogen South Africa (Pty) Ltd, Woodhill Office Park, Building 1, 53 Phillip Engelbrecht Avenue, Meyersdal, Ext. 12, 1448, Johannesburg, South Africa
ROMIDAB 500 mg TABLETS (Tablet): 45/21.2/0207
ROMIDAB 850 mg TABLETS (Tablet): 45/21.2/0208
ROMIDAB 1000 mg TABLETS (Tablet): 45/21.2/0209
| Drug | Countries | |
|---|---|---|
| ROMIDAB | South Africa |
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