WARFANT Tablet Ref.[49765] Active ingredients: Warfarin

Source: Health Products Regulatory Authority (IE)  Revision Year: 2018  Publisher: Mercury Pharmaceuticals (Ireland) Ltd, 4045 Kingswood Road, Citywest Business Park, Co Dublin, Ireland

Product name and form

Warfant 1 mg Tablets.

Pharmaceutical Form

Tablet.

Round brown uncoated tablet, scored and marked ‘W1’ on one side with company logo on reverse.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each tablet contains warfarin sodium clathrate equivalent to 1 mg warfarin sodium.

Excipients with known effect: each tablet contains 126.56 mg lactose monohydrate, tartrazine lake (E102) and amaranth lake (E123).

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 Monohydrate
Maize Starch
Sodium Starch glycollate (Type A)
Magnesium Stearate
Alumina
Tartrazine Lake (E102)
Amaranth Lake (E123)
Indigo Carmine Lake (E132)

Pack sizes and marketing

Polypropylene securitainer with tamper evident lid.

Pack size: 100 tablets, 500 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Mercury Pharmaceuticals (Ireland) Ltd, 4045 Kingswood Road, Citywest Business Park, Co Dublin, Ireland

Marketing authorization dates and numbers

PA 0073/139/001

Date of first authorisation: 17th October 1995
Date of last renewal: 17th October 2010

Drugs

Drug Countries
WARFANT Cyprus, Ireland

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