Sacubitril; Valsartan Oral Tablets

What is this medication?

SACUBITRIL; VALSARTAN (sak UE bi tril; val SAR tan) is a combination of a neprilysin inhibitor and a an angiotensin II receptor blocker. It treats heart failure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Entresto

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• diabetes and take a medicine that contains aliskiren
• high levels of potassium in the blood
• kidney disease
• liver disease
• low blood pressure
• an unusual or allergic reaction to sacubitril; valsartan, drugs called angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your health care provider tells you to stop.

Talk to your health care provider about the use of this drug in children. While it may be prescribed for children as young as 1 for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medicines:

• aliskiren if you have diabetes
• angiotensin-converting enzyme (ACE) inhibitors, like benazepril, captopril, enalapril, fosinopril, lisinopril, or ramipril
• tranylcypromine

This medicine may also interact with the following medicines:

• angiotensin II receptor blockers (ARBs) like azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, or valsartan
• celecoxib
• lithium
• NSAIDS, medicines for pain and inflammation, like ibuprofen or naproxen
• potassium-sparing diuretics like amiloride, spironolactone, and triamterene
• potassium supplements

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your doctor or health care provider if your symptoms do not start to get better or if they get worse.

Do not become pregnant while taking this medicine. Women should inform their health care provider if they wish to become pregnant or think they might be pregnant. There is a potential for serious harm to an unborn child. Talk to your health care provider for more information.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

Alcohol may interfere with the effects of this medicine. Avoid alcoholic drinks.

Avoid salt substitutes unless you are told otherwise by your health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care provider as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• high potassium levels (chest pain; fast, irregular heartbeat; muscle weakness)
• kidney injury (trouble passing urine or change in the amount of urine)
• low blood pressure (dizziness; feeling faint or lightheaded, falls; unusually weak or tired)

Side effects that usually do not require medical attention (report to your doctor or health care provider if they continue or are bothersome):

• cough

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from moisture. Keep the container tightly closed. Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, empty the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.