IVABRADINE PHARMATHEN

5 mg ivabradine are available. Symptomatic treatment of chronic stable angina pectoris It is recommended that the decision to initiate or titrate treatment takes place with the availability of serial heart rate measurements, ECG or ambulatory 24 hour monitoring.

The starting dose of ivabradine should not exceed 5 mg twice daily in patients aged below 75 years. 5 mg twice daily or 5 mg twice daily. 5 mg twice daily. If there is no improvement in symptoms of angina within 3 months after start of treatment, treatment of ivabradine should be discontinued.

In addition, discontinuation of treatment should be considered if there is only limited symptomatic response and when there is no clinically relevant reduction in resting heart rate within three months. 5 mg twice daily (one half 5 mg tablet twice daily).

4). Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist despite dose reduction. Treatment of chronic heart failure The treatment has to be initiated only in patient with stable heart failure.

It is recommended that the treating physician should be experienced in the management of chronic heart failure. The usual recommended starting dose of ivabradine is 5 mg twice daily. 5 mg twice daily (one half 5 mg tablet twice daily) if resting heart rate is persistently below 50 bpm or in case of symptoms related to bradycardia such as dizziness, fatigue or hypotension.

If heart rate is between 50 and 60 bpm, the dose of 5 mg twice daily should be maintained. 5 mg twice daily or 5 mg twice daily. 5 mg twice daily or 5 mg twice daily. 4). e. one half 5 mg tablet twice daily) before up-titration if necessary.

2). No data are available in patients with creatinine clearance below 15 mL/min. Ivabradine should therefore be used with precaution in this population. Hepatic impairment No dose adjustment is required in patients with mild hepatic impairment.

Caution should be exercised when using ivabradine in patients with moderate hepatic impairment. 2). Paediatric population The safety and efficacy of ivabradine for the treatment of chronic heart failure in children aged below 18 years have not been established.

2 but no recommendation on a posology can be made. e. 2).

Summary of the safety profile Ivabradine has been studied in clinical trials involving nearly 45,000 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.

Tabulated list of adverse reactions 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 (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

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 two months of treatment after which they may occur repeatedly. Phosphenes were generally reported to be of mild to moderate intensity. 5%) resolved during treatment. Fewer than 1% of patients changed their daily routine or discontinued the treatment in relation with phosphenes.

3% of patients particularly within the first 2 to 3 months of treatment initiation. 5% of patients experienced a severe bradycardia below or equal to 40 bpm. 8% in the placebo group. 39]. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

g. 1). Measurement of heart rate Given that the heart rate may fluctuate considerably over time, serial heart rate measurements, ECG or ambulatory 24-hour 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.

2). Cardiac arrhythmias Ivabradine is not effective in the treatment or prevention of cardiac arrhythmias and likely loses its efficacy when a tachyarrhythmia occurs (eg. ventricular or supraventricular tachycardia). Ivabradine is therefore not recommended in patients with atrial fibrillation or other cardiac arrhythmias that interfere with sinus node function.

8). Atrial fibrillation has been more common in patients using concomitantly amiodarone or potent class I anti-arrhythmics. g. in case of exacerbated angina, palpitations, irregular pulse). Patients should be informed of signs and symptoms of atrial fibrillation and be advised to contact their physician if these occur.

If atrial fibrillation develops during treatment, the balance of benefits and risks of continued ivabradine treatment should be carefully reconsidered. Chronic heart failure patients with intraventricular conduction defects (bundle branch block left, bundle branch block right) and ventricular dyssynchrony should be monitored closely.

Use in patients with AV-block of 2nd degree Ivabradine is not recommended in patients with AV-block of 2nd degree. 3). 2). 5). No safety issue has been raised on the combination of ivabradine with nitrates and dihydropyridine calcium channel blockers such as amlodipine.

1). Chronic heart failure Heart failure must be stable before considering ivabradine treatment. Ivabradine should be used with caution in heart failure patients with NYHA functional classification IV due to limited amount of data in this population.

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