Ivabradine

WHY is this medicine prescribed?

Ivabradine is used to treat certain adults with heart failure (condition in which the heart is unable to pump enough blood to the other parts of the body) to decrease the risk that their condition will worsen and need to be treated in a hospital. It is also used to treat a certain type of heart failure in children 6 months of age and older due to cardiomyopathy (a condition in which the heart muscle becomes weakened and enlarged). Ivabradine is in a class of medications called hyperpolarization-activated cyclic nucleotide-gated (HCN) channel blockers. It works by slowing the heart rate so the heart can pump more blood through the body each time it beats.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Ivabradine comes as a tablet and as an oral solution (liquid) to take by mouth. It is usually taken with food twice a day. Take ivabradine at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ivabradine exactly as directed. Do not take more or less of it, or take it more often than prescribed by your doctor.

Some ivabradine tablets come with a line down the middle. If your doctor tells you to take half a tablet, break it carefully on the line. Take half the tablet as directed, and save the other half for your next dose.

Use an oral syringe (measuring device) and a medicine cup to accurately measure and take your dose of ivabradine solution. Ask your pharmacist for a medicine cup if one is not included with your medication. Your pharmacist will give you an oral syringe that works best to measure your dose. Empty all of the solution from the ampule(s) into the medication cup. Measure your dose of from the medication cup using the oral syringe. Follow the manufacturer's instructions about how to use and clean the oral syringe. Ask your doctor or pharmacist if you if you have any questions.

If you vomit or spit out after taking ivabradine, do not take another dose. Continue your regular dosing schedule.

Your doctor may increase or decrease your dose after 2 weeks depending on how well the medication works for you, and the side effects you experience. Be sure to tell your doctor how you are feeling during your treatment with ivabradine.

Ivabradine controls the symptoms of heart failure but does not cure it. Continue to take ivabradine even if you feel well. Do not stop taking ivabradine without talking to your doctor.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with ivabradine and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

What SPECIAL PRECAUTIONS should I follow?

Before taking ivabradine,

• tell your doctor and pharmacist if you are allergic to ivabradine, any other medications, or any of the ingredients in ivabradine tablets and oral solution. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor if you are taking certain antibiotics such as clarithromycin (Biaxin, in Prevpac) and telithromycin (Ketek), certain antifungals such as itraconazole (Onmel, Sporanox), certain HIV protease inhibitors such as nelfinavir (Viracept), and nefazodone. Your doctor will probably tell you not to take ivabradine if you are taking one or more of these medications.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: amiodarone (Nexterone, Pacerone); beta blockers such as atenolol (Tenormin, in Tenoretic), carteolol, labetalol (Trandate), metoprolol (Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, Corzide), propranolol (Inderal, InnoPran XL, Hemangeol, in Inderide), sotalol (Betapace, Sorine, Sotylize), and timolol; digoxin (Lanoxin); diltiazem (Cardizem, Cartia, Tiazac, others); phenobarbital; phenytoin (Dilantin, Phenytek); rifampin (Rifadin, Rifamate, Rifater, Rimactane); and verapamil (Calan, Verelan, in Tarka). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with ivabradine, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor what herbal products you are taking, especially St. John's wort.

• tell your doctor if you have an irregular or slow heartbeat, low blood pressure, a pacemaker, symptoms of heart failure that recently worsened, or liver disease. Your doctor will probably tell you not to take ivabradine.

• tell your doctor if you have or have ever had any other heart problems.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You should not become pregnant while you are taking ivabradine. Talk to your doctor about birth control methods that you can use during your treatment. If you become pregnant while taking ivabradine call your doctor.

• you should know that ivabradine may affect your vision, especially when the brightness of the light around you changes. This may include seeing bright spots, bright circles around lights, bright colored lights, seeing double, and other unusual problems with your vision. These vision problems are most common when you first start taking ivabradine and they usually go away after a few months of treatment with this medication. Do not drive a car, especially at night, or operate machinery until you know how this medication affects you.

What SPECIAL DIETARY instructions should I follow?

Do not eat grapefruit or drink grapefruit juice while taking this medication.

What should I do IF I FORGET to take a dose?

If you forget a dose of ivabradine, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately or get emergency medical treatment:

• fast, irregular, or pounding heartbeat
• slow or stopped heartbeat
• chest pain or pressure
• worsening shortness of breath
• dizziness
• excessive tiredness
• lack of energy
• swelling of the face, throat, tongue, lips, and eyes
• difficulty swallowing or breathing
• hoarseness

Ivabradine may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Discard any unused oral solution left in the medication cup or the ampule.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• slow heartbeat
• dizziness
• excessive tiredness
• lack of energy

What OTHER INFORMATION should I know?

Keep all appointments with your doctor. Your doctor will check your heartbeat and blood pressure from time to time to check your body's response to ivabradine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.