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The following adverse effects or events have been reported during clinical trials and ranked using the following frequency: Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1000, <1/100); rare (>1/10,000, <1/1000); not known (cannot be estimated from the available data.
Eye Disorders: Very Common: Luminous Phenomena (Phosphenes): Reported by 14.5% of patients, described as a transient enhanced brightness in a limited area of the visual field. They are usually triggered by sudden variations in light intensity. The onset of phosphenes is generally within the first 2 months of treatment after which they may occur repeatedly. Phosphenes were generally reported to be of mild to moderate intensity. All phosphenes resolved during or after treatment, of which a majority (77.5%) resolved during treatment. Fewer than 1% of patients changed their daily routine or discontinued the treatment in relation with phosphenes. Common: Blurred vision.
Cardiovascular Disorders: Common: Bradycardia: 3.3% of patients particularly within the first 2-3 months of treatment initiation. 0.5% of patients experienced a severe bradycardia ≤40 bpm, AV 1st degree block, ventricular extrasystoles. Uncommon: Palpitations, supraventricular extrasystoles.
The following events reported during clinical trials were of similar incidence than comparators and/or possibly related to the underlying disease: Sinus arrhythmia, unstable angina, aggravated angina pectoris, atrial fibrillation, myocardial ischaemia, myocardial infarction and ventricular tachycardia.
Gastrointestinal Disorders: Uncommon: Nausea, constipation and diarrhea.
General Disorders: Common: Headache, generally during the 1st month of treatment, dizziness, possibly related to bradycardia. Uncommon: Vertigo, dyspnea, muscle cramps.
Investigations: Uncommon: Hyperuricaemia, eosinophilia, elevated creatinine in blood.
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