Section 4.2 - many changes
section 4.4 - many changes
Section 4.5 - many changes
Section 4.6 - now reads
Pregnancy
Sinthrome, like other coumarin derivatives, may be associated with congenital malformations of the embryo, therefore Sinthrome is contra-indicated for use in pregnancy. Women of child-bearing potential should take contraceptive measures during treatment with Sinthrome.
Lactation
Acenocoumarol passes into the breast milk of lactating mothers, but in quantities so small that no undesirable effects on the infant are to be expected. However, as a precaution, the infant should be given 1mg vitamin K1 per week as a prophylactic measure.
The decision to breast-feed should be carefully considered and may include coagulation tests and vitamin K status evaluation in infants before advising women to breast-feed. Women who are breast-feeding and treated with Sinthrome should be carefully monitored to ensure that recommended PT/INR values are not exceeded.
Section 4.8- the following has been added
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Immune system disorders
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Rare:
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Allergic reactions (e.g. urticaria, rash)
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Vascular disorders
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Very rare:
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Vasculitis
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Gastrointestinal disorders
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Rare
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Loss of appetite, nausea, vomiting
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Hepatobiliary disorders
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Very rare:
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Liver damage
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Skin and subcutaneous tissue disorders
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Rare:
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Alopecia
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Very rare:
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Skin necrosis haemorrhagic (usually associated with congenital deficiency of protein C or its cofactor protein S)
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Section 4.9 - many changes
Section 5.1 - now reads
Pharmacotherapeutic group: Antithrombotic, vitamin K antagonists. ATC code: B01AA07
To initiate blood clotting, Vitamin K causes gamma-carboxylation of certain glutamic acid molecules on the coagulation factors II, VII, IX and X, and of protein C and its cofactor protein S. Coumarin derivatives, such as Sinthrome, prevent gamma-carboxylation of these proteins by Vitamin K, although the precise nature of this antagonism has yet to be established.
Depending on the initial dosage, Sinthrome prolongs the thromboplastin time within approximately 36 to 72 hours. Following withdrawal of Sinthrome, the thromboplastin time usually reverts to normal after a few days.
Section 6.1- hydroxypropylmethylcellulose has been replaced by hypromellose
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