Source: Υπουργείο Υγείας (CY) Publisher: OM PHARMA S.A., R. da Indústria, 2 – Quinta Grande, 2610-088 Аmadora Portugal
Parenteral administration of Dicynone may induce a drop in blood pressure, but no data have been reported on such a risk during oral administration.
If Dicynone 500 is administered for a reduction of excessive and/or prolonged menstrual haemorrhages, and no improvement is observed, possible pathological causes should be looked for and excluded.
Dicynone 500 contains sodium sulfite as antioxidant, which may cause allergic reactions, nausea and diarrhoea in susceptible patients. The allergic reactions may go as far as anaphylactic shock and cause life-threatening asthma attacks.
The prevalence in the population is not known but is probably low. However, hypersensitivity to sulphites is observed more frequently in patient with asthma than in those without asthma (see section 4.3 “Contraindications”). If a hypersensitivity reaction occurs, the administration of Dicynone 500 must be stopped immediately
No interaction with other medicinal products is known.
At therapeutic doses, etamsylate may interfere with creatinine enzymatic assay by giving lower values than expected.
During the course of etamsylate treatment, sample collection (e.g. blood sampling) required for laboratory testing should be done before the first daily administration of the drug in order to minimise any potential interaction of etamsylate with laboratory testing
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.
Dicynone 500 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).
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.
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.
No known up to now.
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