Gavrila Warnings

Ivabradine is indicated only for symptomatic treatment of chronic stable angina pectoris because Ivabradine has no benefits on cardiovascular outcomes.
Measurement of Heart Rate: Given that the heart rate may fluctuate considerably over time, serial heart rate measurements, ECG or ambulatory 24-hr monitoring should be considered when determining resting heart rate before initiation of Ivabradine treatment and in patients on treatment with Ivabradine when titration is considered. This also applies to patients with a low heart rate, in particular when heart rate decreases <50 bpm or after dose reduction.
Cardiac Arrhythmias: Ivabradine is not recommended in patients with atrial fibrillation or other cardiac arrhythmias that interfere with sinus node function.
Use in Patients with AV-block of 2nd Degree: Ivabradine is not recommended in patients with AV-block of 2nd degree.
Use in Patients with a Low Heart Rate: Ivabradine must not be initiated in patients with a pre-treatment resting heart rate <70 bpm. If during treatment, resting heart rate decreases persistently <50 bpm or the patient experiences symptoms related to bradycardia e.g., dizziness, fatigue or hypotension, the dose must be titrated downward or treatment discontinued if heart rate is <50 bpm or symptoms of bradycardia persist.
Combination with Calcium Channel Blockers: Concomitant use of Ivabradine with heart rate-reducing calcium channel blockers e.g., Verapamil or Diltiazem is contraindicated. No safety issue has been raised on the combination of Ivabradine with nitrates and dihydropyridine calcium channel blockers e.g., Amlodipine.
Stroke: The use of Ivabradine is not recommended immediately after a stroke since no data is available in these situations.
Visual Function: Ivabradine influences on retinal function. To date, there is no evidence of a toxic effect of Ivabradine on the retina, but the effect of long-term Ivabradine treatment beyond 1 year on retinal function are currently not known. Cessation of treatment should be considered if any unexpected deterioration in visual function occurs. Caution should be exercised in patients with retinitis pigmentosa.
Excipients: Since tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Ivabradine.