Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill Ext.1, Roodepoort, Johannesburg
MEDABON CO oral and vaginal tablets.
| Pharmaceutical Form |
|---|
|
Mifepristone: Tablet (for oral use). Light yellow, circular, biconvex, uncoated tablet, debossed with “S” on one side and plain on the other side. Diameter: 11,0 mm. Misoprostol: Vaginal tablet. White to off-white, rectangular shaped, uncoated tablet, debossed with a square on either side of the break line on one side and plain on the other side. Diameter: 11,6 mm x 6,3 mm. |
Each combipack of MEDABON CO contains one mifepristone oral tablet and four misoprostol vaginal tablets.
Each mifepristone oral tablet contains 200 mg mifepristone.
Each misoprostol vaginal tablet contains 0,2 mg misoprostol.
Sugar free.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Mifepristone |
Mifepristone is a synthetic steroid with an antiprogestational action as a result of competition with progesterone at the progesterone receptors. |
|
| Misoprostol |
Misoprostol is an analogue of naturally occurring prostaglandin E1 which promotes peptic ulcer healing and symptomatic relief. Misoprostol protects the gastroduodenal mucosa by inhibiting basal, stimulated and nocturnal acid secretion and by reducing the volume of gastric secretions, the proteolytic activity of the gastric fluid, and increasing bicarbonate and mucus secretion. |
| List of Excipients |
|---|
|
Mifepristone: Colloidal anhydrous silica Misoprostol: Hydrogenated castor oil |
Silver aluminium blister strip with a peelable paper backed aluminium lid, containing 1 oral tablet of mifepristone 200 mg and 4 vaginal tablets of misoprostol 0,2 mg. Each blister strip is packed together with a silica gel sachet in a sealed aluminium pouch and placed in an outer carton.
Pack sizes:
1 combipack (containing 1 blister strip with 1 mifepristone tablet and 4 misoprostol vaginal tablets),
or
30 × 1 combipacks.
Not all pack sizes may be marketed.
Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill Ext.1, Roodepoort, Johannesburg
54/21.12/0619
07 September 2021
| Drug | Countries | |
|---|---|---|
| MEDABON | Estonia, Hong Kong, Romania, United Kingdom, South Africa |
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