DICYNONE 250 Solution for injection Ref.[28188] Active ingredients: Etamsylate

As parenteral administration of Dicynone 250 for injection may induce a drop in blood pressure, it is advised to carefully monitor patients suffering from blood pressure instability or hypotension (see section 4.8 “Undesirable effects” ).

Dicynone 250 contains sodium metabisulfite (E223) 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 250 must be stopped immediately.

Thiamine (vitamin B₁) is inactivated by the sulphite contained in Dicynone 250 for injection. If a perfusion with Dextran is necessary, Dicynone 250 must be injected first. 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.

In adults, Dicynone 250 for injection 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).

Gastrointestinal disorders

Common: nausea, abdominal discomfort.

Skin and subcutaneous tissue disorders

Common: rash.

General disorders and administration site conditions

Common: asthenia.

Very rare: fever.

Nervous System disorders

Common: headache.

Vascular disorders

Very rare: thromboembolism, hypotension.

Blood and lymphatic system disorders

Very rare: agranulocytosis, neutropenia, thrombocytopenia.

Musculoskeletal and connective tissue disorders

Rare: arthralgia.

Immune System Disorders

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.