Uses

This medication is used to treat heart failure. It is used by adults to help prevent the heart failure from getting worse and needing treatment in a hospital. It is also used by children who have heart failure due to an enlarged heart (dilated cardiomyopathy). Heart failure is a condition where your heart does not pump blood as well as it should. Ivabradine works by making your heart beat more slowly.

Other Uses

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for fast heartbeat.

How To Use

Read the Medication Guide provided by your pharmacist before you start taking ivabradine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with food as directed by your doctor, usually twice daily. The dosage is based on your medical condition and response to treatment. In children, the dosage is also based on the weight. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Other medications are usually used along with ivabradine to treat heart failure. Carefully follow your doctor's directions for taking all your medications.

If you are using the liquid form of this medication, read and follow the Instructions for Use from the manufacturer. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Tell your doctor if your condition does not improve or if it worsens.

Side Effects

Dizziness or tiredness may occur. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Ivabradine may rarely cause vision changes such as brief increased brightness, or seeing halos or colored bright lights. Sudden changes in light brightness may set off this effect. If vision changes happen, they usually start within the first 2 months and may go away during treatment or after stopping this medication.

Tell your doctor right away if you have any serious side effects, including:

• slow/fast/irregular heartbeat
• fainting

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking ivabradine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• low blood pressure
• liver problems
• other heart problems (such as sick sinus syndrome, heart block, slow/irregular heartbeat, pacemaker use)

This drug may make you dizzy or cause vision changes. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Be especially careful when driving at night because sudden changes in light brightness can happen, which may set off vision changes (see also Side Effects section). Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using ivabradine. Ivabradine may harm an unborn baby. Ask about reliable forms of birth control while using this medication. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

Drug Interactions

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of ivabradine from your body, which may affect how ivabradine works. Examples include azole antifungals (such as itraconazole, ketoconazole), macrolide antibiotics (such as clarithromycin, telithromycin), diltiazem, HIV protease inhibitors (such as nelfinavir), nefazodone, rifamycins (such as rifabutin, rifampin), ritonavir, St. John's wort, verapamil, drugs used to treat seizures (such as carbamazepine, phenobarbital, phenytoin), among others.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center. Symptoms of overdose may include: very slow heartbeat.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as pulse, blood pressure) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.