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Ivabradine is a medicine used for treatment of angina (heart-related chest pain) and chronic (long-term) heart failure. It makes the heart work more efficiently by lowering the heart rate. This relieves chest pain and decreases the risk of hospitalization in heart failure patients. The dose will depend on what you are being treated for. Since the treatment for angina or heart failure is usually life-long, you should not stop using it without talking to your doctor. It should be taken with food at the same time each day. If you take too much in one go, your heart could slow down too much and make you feel breathless or tired. If this happens, call a doctor. The most common side effects are temporary brightness in your vision and changes to your heart function. You may also experience uncontrolled blood pressure, headache, dizziness and blurred vision. Some side effects such as fainting and significant changes to your heartbeat may be very serious and may need urgent medical attention. Avoid driving until you know how this medicine will affect you. Do not use Ivabradine if you have severe liver disease, have a low resting heart rate or a heart rhythm disorder. This medicine is also not suitable if you have very low blood pressure and heart failure that has recently become worse. This medicine interacts with certain other medicines used to treat high blood pressure, fungal infections and HIV. Do not take it if you are pregnant, trying to become pregnant, or breastfeeding. Ivabradine is a heart rate lowering medication. It works by reducing the heart rate which lowers the oxygen requirement of the heart. As a result, the heart works more efficiently.

• Angina (heart-related chest pain) • Heart failure

Ivabradine is a heart rate lowering agent that works through selective and specific inhibition of the cardiac pacemaker If current. If current controls the spontaneous diastolic depolarisation in the sinus node and regulate heart rate.

Adult Dose: Oral Heart Failure Initial: 5 mg PO BID with meals (all see Dosage Modifications) After 2 weeks, assess patient and adjust dose to achieve a resting heart rate of 50-60 bpm (see dose adjustment section below) Thereafter, adjust dose prn based on resting heart rate and tolerability; not to exceed 7.5 mg BID Dose adjustment HR >60 bpm: Increase dose by 2.5 mg (given twice daily) up to a maximum dose of 7.5 mg BID HR 50-60 bpm: Maintain dose HR 75 yr Initiate treatment at 2.5 mg bid. Titrate up if necessary. Hepatic impairment Mild or moderate (Child-Pugh A or B): No dose adjustment required Severe (Child-Pugh C): Contraindicated Child Dose: Safety and efficacy not established Renal Dose: Renal impairment: CrCl (ml/min) Dosage Recommendation <15 Use w/ caution.

Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Ivabradine is to be taken with food.

If you miss a dose of Ivabradine, skip it and continue with your normal schedule. Do not double the dose.

Common: • Slow heart rate • Headache • Luminous phenomena (Enhanced brightness) • High blood pressure

[UNSAFE] Ivabradine may cause side effects which could affect your ability to drive. Ivabradine may cause transient luminous phenomena consisting mainly of phosphenes. The possible occurrence of such luminous phenomena should be taken into account especially when driving at night. Ivabradine may cause dizziness or sleepiness. Do not drive or do anything requiring concentration until you know how it affects you. You may experience temporary changes in your vision such as enhanced visual brightness. These changes may occur within the initial 2 months of treatment and should gradually go away. Monitor your blood pressure when taking Ivabradine as it can increase your blood pressure. Monitor your heart rate when taking this medicine, as low heart rate is a common side effect. Inform your doctor if you experience symptoms of low heart rate such as dizziness, tiredness and low energy.

Pregnancy, lactation, resting heart rate <60 beats/min prior to treatment, cardiogenic shock, acute myocardial infarction, severe hypotension (<90/50 mmHg), severe hepatic insufficiency, sick sinus syndrome, sino-atrial block, heart failure patients with NYHA class III-IV, pacemaker dependent, unstable angina, 3rd degree AV-block, concurrent use with potent CYP3A4 inhibitors.

Concomitant use with QT-prolonging drugs (e.g. quinidine, disopyramide, bepridil, sotalol, ibutilide, amiodarone, pimozide, ziprasidone, sertinole, mefloquine, halofantrine, pentamide, cisapride, erythromycin IV) is not recommended as QT prolongation may be enhanced by heart rate reduction. Concentrations may increase when used with CYP3A4 inhibitors. Use with verapamil or diltiazem (moderate CYP3A4 inhibitors) is not recommended. If used with other moderate CYP3A4 inhibitors (e.g. fluconazole), may consider starting at lower dose and with heart rate monitoring if resting heart rate >60 beats/min. Concentration may be reduced with CYP3A4 inducers (e.g. rifampicin, barbiturates, phenytoin, St John's Wort) and may require Ivabradine dose adjustment. Potentially Fatal: Concurrent use with potent CYP3A4 inhibitors is contraindicated; e.g. azole antifungals (ketoconazole, itraconazole), macrolides (clarithromycin, erythromycin PO, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone.

[CONSULT YOUR DOCTOR] It is not known whether it is safe to consume alcohol with Ivabradine. Please consult your doctor.

[CONSULT YOUR DOCTOR] Ivabradine is unsafe to use during pregnancy as there is definite evidence of risk to the developing baby. However, the doctor may rarely prescribe it in some life-threatening situations if the benefits are more than the potential risks. Please consult your doctor.

[CONSULT YOUR DOCTOR] Information regarding the use of Ivabradine during breastfeeding is not available. Please consult your doctor.

[CAUTION] Ivabradine should be used with caution in patients with severe kidney disease. Dose adjustment of Ivabradine may be needed. Please consult your doctor. Limited information is available for use of Ivabradine in patients with severe kidney disease. [CAUTION] Ivabradine should be used with caution in patients with liver disease. Dose adjustment of Ivabradine may be needed. Please consult your doctor. Use of Ivabradine is not recommended in patients with severe liver disease.

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