500-mg: Summary of safety profile:
Side effects reported with DAFLON in clinical trials are of mild intensity. They consist mainly in gastro intestinal events (diarrhoea, dyspepsia, nausea, vomiting).
Tabulated list of adverse reactions: 500-mg:
The following adverse reactions have been reported and are ranked using the following frequency: 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). (See table.)
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The following undesirable effects have been reported and are ranked using the following frequency: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000), and not known (cannot be estimated from the available data).
Nervous system disorders:
Rare: dizziness, headaches, malaise.
Common: diarrhoea, dyspepsia, nausea, vomiting.
Frequency not known: abdominal pain.
Skin and subcutaneous tissue disorders:
Rare: rash, pruritus, urticaria.
Frequency not known: isolated face, eyelid and lip oedema. Exceptionally, Quincke's oedema.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.