Summary of the safety profile: The most commonly reported adverse reactions were dizziness and somnolence. Adverse reactions were usually mild to moderate in intensity.
The adverse reactions listed may also be associated with the underlying disease and/or concomitant medications. (See Table 2.)
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The following adverse events were reported during post-marketing surveillance: Immune system disorders: Uncommon: Hypersensitivity: Rare: Angioedema, allergic reaction.
Nervous system disorders: Very common: Headache; Uncommon: Loss of consciousness, mental impairment.
Eye disorders: Rare: Keratitis*.
Cardiac disorders: Rare: Congestive heart failure.
Respiratory and thoracic disorders: Rare: Pulmonary oedema*.
Gastrointestinal disorders: Common: nausea, diarrhea; Rare: Swollen tongue.
Skin and subcutaneous tissue disorders: Uncommon: Face swelling, pruritus.
Renal and urinary disorders: Rare: Urinary retention.
Reproductive system and breast tissue disorders: Rare: Gynecomastia*.
General disorders and administration site conditions: Uncommon: Malaise.
* Adverse drug reaction frequency estimated using "The Rule of 3".