SINTHROME Tablet

Active ingredients: Acenocoumarol

Product name and form

Sinthrome Tablets 1mg.

Pharmaceutical Form

Tablets for oral administration.

White, round, flat tablets with slightly bevelled edges, with one side bearing the imprint “CG”, and the other the imprint “AA”.

Qualitative and quantitative composition

Acenocoumarol BP 1mg.

Excipient(s) with known effect: Lactose (20 mg).

For the full list of excipients, see Section 6.1.

Active Ingredient
Description

Acenocoumarol is a derivative of coumarin used as anticoagulant because acts as an antagonist of vitamin K. Vitamin K antagonists produce their anticoagulant effect by inhibition of the vitamin K-epoxide-reductase with a subsequent reduction of the gammacarboxylation of certain glutamic acid molecules which are located at several sites near the terminal end both of coagulation factors II (prothrombin), VII, IX, and X and of protein C or its cofactor protein S.

List of Excipients

Aerosil 200 (silica aerogel)
Hypromellose
Lactose
Magnesium stearate
Maize starch
Talc

Pack sizes and marketing

Blister packs of 100 tablets.

Marketing authorization holder

Norgine Pharmaceuticals Limited, Norgine House, Widewater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK

Marketing authorization dates and numbers

PL 20011/0068

Date of first authorisation: 08 August 1972
Date of latest renewal: 25 February 2005

Drugs

Drug
Countries
United Kingdom