Coralan

Coralan Side Effects

ivabradine

Manufacturer:

Servier

Distributor:

Maxxcare
Full Prescribing Info
Side Effects
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.)

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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.
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