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 (≥1/10000, <1/1000); very rare (< 1/10000), and not known (cannot be estimated from the available data).
Nervous system disorders: Rare: dizziness, headaches, malaise.
Gastrointestinal disorders: Common: diarrhoea, dyspepsia, nausea, vomiting.
Uncommon: colitis.
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 suspect ed adverse reactions via the national declaration system.
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