Chemical formula: C₁₀H₁₇NO₅S Molecular mass: 263.31 g/mol
There are limited amount of data from the use of etamsylate in pregnant women. Animal experiments have not revealed any direct or indirect toxicity affecting pregnancy, embryonic development, foetal development and/or post-natal development. As a precautionary measure, it is preferable to avoid the use of etamsylate during pregnancy.
In the absence of data concerning passage into breast milk, breast-feeding is inadvisable during treatment. Alternatively, the treatment should be stopped if breast-feeding is continued.
Etamsylate has no effect upon driving capacity and managing of machines.
The side effects are classified according to the MedDRA convention by system organ class and by frequency as follows: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1 000 to <1/100), Rare (≥1/10 000 to <1/1 000), Very rare (<1/10 000), not known (cannot be estimated from the available data).
Oral administration:
Common: nausea, diarrhoea, gastralgia, abdominal discomfort.
Common: rash.
Common: asthenia
Very rare: fever.
Common: headache.
Very rare: thromboembolism.
Very rare: agranulocytosis, neutropenia, thrombocytopenia.
Rare: arthralgia.
Very rare: hypersensitivity.
IV / IM administration:
Common: nausea, abdominal discomfort.
Common: rash.
Common: asthenia.
Very rare: fever.
Common: headache.
Very rare: thromboembolism, hypotension.
Very rare: agranulocytosis, neutropenia, thrombocytopenia.
Rare: arthralgia.
Very rare: hypersensitivity.
These reactions are generally reversible when stopping treatment course. In case of skin reactions or fever, the treatment must be stopped and the treating physician informed as this may constitute hypersensitivity reactions.
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