Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, The Netherlands
Warfarin 0.5 mg Tablets.
| Pharmaceutical Form |
|---|
|
Tablet. Warfarin 0.5 mg Tablets are white, flat round tablets, with a 7.0 mm diameter, plain on one side and scored on the other, engraved with “W” above the score and “0.5” underneath. The tablet can be divided into equal halves. |
Each tablet contains Warfarin Sodium 0.5 mg.
Excipient with known effect: 98.25 mg lactose anhydrous per tablet.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Warfarin |
Warfarin is a synthetic 4-Hydroxycoumarin derivative which acts by preventing the formation of active procoagulation factors II, VII, IX and X in the liver by inhibiting the vitamin K – mediated gammacarboxylation of precursor proteins. Full therapeutic activity is not achieved until circulating coagulation factors have been removed by normal catabolism. This occurs at different rates for each factor, with factor VII having the shortest half-life. Warfarin has no direct thrombolytic effect, though it may limit the extension of existing thrombi. |
| List of Excipients |
|---|
|
Lactose anhydrous |
HDPE bottle with polyester wad and child resistant polypropylene cap.
Contents: 21, 28, 50, 56, 100, 112, 200 or 500 tablets.
PVC/PVDC-aluminium foil or Aclar/aluminium foil blisters.
Contents: 21, 28, 50, 56, 100, 112, 200 or 500 tablets.
Not all pack sizes may be marketed.
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, The Netherlands
PL 31750/0092
07/01/2002
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