Product Information

Ivabradine tablet

What is this medicine?

IVABRDINE works by affecting your heart's electrical activity in order to slow the heart rate. Ivabradine is used in certain people with chronic heart failure, to help lower the risk of needing to be hospitalized when symptoms get worse. Ivabradine is not for use if you already have heart failure symptoms that recently got worse before starting this medicine. Ivabradine may also be used for purposes not listed in this medication guide.

What should I tell my health care providers before I take this medicine?

You should not use ivabradine if you are allergic to it, or if you have:

• a serious heart condition such as "sick sinus syndrome" or "AV block" (unless you have a pacemaker);

• heart failure symptoms that recently got worse;

• severe liver disease;

• if your resting heart rate is less than 60 beats per minute;

• if your blood pressure is lower than 90 over 50; or

• if you depend on a pacemaker to regulate your heart rate.

Some medicines can cause unwanted or dangerous effects when used with ivabradine. Your doctor may need to change your treatment plan if you use any of the following drugs:

• imatinib;

• isoniazid;

• nefazodone;

• an antibiotic--clarithromycin, telithromycin;

• antifungal medicine--itraconazole, ketoconazole, posaconazole, voriconazole;

• heart medication--nicardipine, quinidine; or

• antiviral medicine to treat hepatitis C or HIV/AIDS--atazanavir, boceprevir, cobicistat, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, telaprevir.

To make sure ivabradine is safe for you, tell your doctor if you have:

• other heart problems not being treated with ivabradine;

• liver disease;

• high or low blood pressure;

• if you have a pacemaker; or

• if you take other heart medicine or blood pressure medication, such as amiodarone, digoxin, diltiazem, or verapamil.

Do not use ivabradine if you are pregnant. It could harm the unborn baby or lead to premature birth. In animal studies, ivabradine caused miscarriage, heart and blood vessel problems, and infant death. However, it is not known whether these effects would occur in humans. Use effective birth control to prevent pregnancy during treatment. Tell your doctor right away if you become pregnant while taking ivabradine. It is not known whether ivabradine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine. Do not use this medicine on a child without a doctor's advice. Children can absorb larger amounts of this medication through the skin and may be more likely to have side effects.

How should I use this medicine?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Ivabradine is usually taken 2 times per day with meals. Avoid eating grapefruit or drinking grapefruit juice with this medicine.

You may also need to take another medicine called a beta-blocker. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

Ivabradine can cause a temporary brightness in your vision, especially during the first 2 months of treatment. This can make you see halos around lights, see colors within lights, or see multiple images while looking at an object. You may also see kaleidoscope colors or flashes of movement in certain parts of your vision. Sudden bright light can make these vision changes more noticeable. These effects usually go away as you continue taking ivabradine or after you stop taking it.

While using ivabradine, you may need frequent medical tests. Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

What if I miss a dose?

Skip the missed dose and take the medicine when it is time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What may interact with this medicine?

Many drugs can interact with ivabradine, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with ivabradine. Give a list of all your medicines to any healthcare provider who treats you.

What side effects may I notice from this medicine?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• very slow heartbeats with dizziness, tiredness, or a lack of energy;

• a light-headed feeling, like you might pass out;

• shortness of breath that is worse than usual; or

• chest tightness, racing or pounding heartbeats, fluttering in your chest.

Common side effects may include:

• slow heart rate;

• high blood pressure (severe headache, blurred vision, pounding in your neck or ears); or

• your eyes may be more sensitive to light.

This is not a complete list of side effects and others may occur.

What should I watch for while using this medicine?

Avoid taking an herbal supplement containing St. John's wort at the same time you are taking ivabradine. Grapefruit and grapefruit juice may interact with ivabradine and lead to unwanted side effects. Avoid the use of grapefruit products while taking ivabradine. Avoid sudden changes in the intensity of light around you, such as going outside in sunlight after being in a dark place. Allow your eyes time to adjust slowly to the light. Ivabradine may cause dizziness or vision changes, which could impair your thinking or reactions. Be careful if you drive (especially at night) or do anything that requires you to be alert and able to see clearly.

Where should I keep this medicine?

Store at room temperature away from moisture and heat.