Coralan has been studied in clinical trials involving nearly 14,000 participants.
The most common adverse reactions with ivabradine, luminous phenomena (phosphenes) and bradycardia, are dose-dependent and related to the pharmacological effect of the medicinal product.
The following adverse reactions have been reported during clinical trials and are ranked using the following frequency: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000); not known (cannot be estimated from the available data). (See Table 2.)
Click on icon to see table/diagram/image
Luminous phenomena (phosphenes) were 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.
Bradycardia was reported by 3.3% of patients particularly within the first 2-3 months of treatment initiation. 0.5% of patients experienced a severe bradycardia ≤40 bpm.