Uses of Ivabradine Oral Solution:

• It is used to treat heart failure (weak heart).
• It is used in certain patients with heart failure to lower the chance of having to go to the hospital for heart failure that gets worse.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Ivabradine Oral Solution?

• If you are allergic to ivabradine oral solution; any part of ivabradine oral solution; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Liver problems, low blood pressure, or slow heartbeat.
• If you have heart failure (weak heart) that is very bad or gets worse.
• If you have any of these health problems: Certain types of abnormal heartbeats (heart block, sick sinus syndrome) without a working pacemaker.
• If you have a defibrillator or pacemaker.
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with ivabradine oral solution, like certain drugs that are used for HIV, infections, or depression. There are many drugs that must not be taken with ivabradine oral solution. Your doctor or pharmacist can tell you if you are taking a drug that must not be taken with ivabradine oral solution.
• If you are taking St. John's wort. Do not take St. John's wort with ivabradine oral solution. This medicine may not work as well.
• If you are breast-feeding. Do not breast-feed while you take ivabradine oral solution.

This is not a list of all drugs or health problems that interact with ivabradine oral solution.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take ivabradine oral solution with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Ivabradine Oral Solution?

• Tell all of your health care providers that you take ivabradine oral solution. This includes your doctors, nurses, pharmacists, and dentists.
• Changes in eyesight may happen, including brightness caused by sudden changes in light. Use care when driving and doing other tasks or actions that call for clear eyesight. This includes driving at night. Talk with your doctor.
• Check blood pressure and heart rate as the doctor has told you.
• You may need to have your heart checked before starting ivabradine oral solution and while taking it. This includes an ECG.
• Avoid grapefruit and grapefruit juice.
• Use birth control that you can trust to prevent pregnancy while taking ivabradine oral solution.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking ivabradine oral solution, call your doctor right away.

How is this medicine (Ivabradine Oral Solution) best taken?

Use ivabradine oral solution as ordered by your doctor. Read all information given to you. Follow all instructions closely.

For all patients taking ivabradine oral solution:

• Take ivabradine oral solution with food.
• Keep taking ivabradine oral solution as you have been told by your doctor or other health care provider, even if you feel well.
• Do not stop taking ivabradine oral solution without calling the doctor who ordered it for you.
• Measure liquid doses carefully. Use the measuring device that comes with ivabradine oral solution. If there is none, ask the pharmacist for a device to measure ivabradine oral solution.
• Each container is for one use only. Use right after opening. Throw away any part of the opened container after the dose is given.

Children:

• If your child spits up a dose or if you are not sure your child got all of the drug, do not give another dose. Wait until your child's next dose to give again.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

For all patients taking ivabradine oral solution:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Slow heartbeat.
• A heartbeat that does not feel normal.
• Chest pain or pressure.
• Shortness of breath that is new or worse.
• Feeling tired or weak.
• Dizziness or passing out.

Children:

• In young children, signs of slow heartbeat may include poor feeding, trouble breathing, or turning a bluish color. If your child has any of these signs, call your child's doctor right away.

What are some other side effects of Ivabradine Oral Solution?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Ivabradine Oral Solution?

• Store at room temperature.
• Protect from light.
• Store unused containers in foil pouch until use.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time ivabradine oral solution is refilled. If you have any questions about ivabradine oral solution, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.