Coralan Adverse Reactions

Coralan has been studied in clinical trials involving nearly 45,000 participants. The most common undesirable effects with ivabradine are dose-dependent and related to the pharmacological effect of the medicinal product.
The following adverse effects or events have been reported during clinical trials.
Eye Disorders: Very Common (>1/10): 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. Phosphenes may also be described as a halo, image decomposition (stroboscopic or kaleidoscopic effects), coloured bright lights or multiple image (retinal persistency). 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 (>1/100, <1/10): Blurred vision. Uncommon (>1/1,000, <1/100): Diplopia, visual impairment.
Cardiovascular Disorders: Common (>1/100, <1/10): 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, atrial fibrillation. Uncommon (>1/1,000, <1/100): Palpitations, supraventricular extrasystoles. Very Rare (<1/10,000): AV 2nd degree block, 3rd degree block, sick sinus syndrome.
Gastrointestinal Disorders: Uncommon (>1/1,000, <1/100): Nausea, constipation, diarrhea and abdominal pain.
General Disorders: Common (>1/100, <1/10): Headache, generally during the 1st month of treatment; dizziness, possibly related to bradycardia, uncontrolled blood pressure. Uncommon (>1/1,000, <1/100): Vertigo, dyspnea, muscle cramps; syncope, possibly related to bradycardia; hypotension, possibly related to bradycardia; asthenia, possibly related to bradycardia; fatigue, possibly related to bradycardia. Rare (>1/10,000, <1/1,000): Malaise, possibly related to bradycardia.
Investigations: Uncommon (>1/1,000, <1/100): Hyperuricemia, eosinophilia, elevated creatinine in blood, ECG prolonged QT interval.
Skin and Subcutaneous Tissue Disorders: Uncommon (>1/1,000): Angioedema, rash. Rare (>1/10,000, <1/1,000): Erythema, pruritus, urticaria.