Sacubitril and valsartan is a combination medicine that is used in adults with chronic heart failure. sacubitril and valsartan helps lower the risk of needing to be hospitalized when symptoms get worse, and helps lower the risk of death from heart failure.

Sacubitril and valsartan is also used to treat heart failure in children who are at least 1 year old.

Sacubitril and valsartan is usually given together with other heart medications.

Sacubitril and valsartan may also be used for purposes not listed in this medication guide.

Do not use if you are pregnant, and tell your doctor right away if you become pregnant.

If you have diabetes, do not use sacubitril and valsartan together with any medication that contains aliskiren (a blood pressure medicine).

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take this medicine with or without food.

Sacubitril and valsartan doses are based on weight in children. Your child's dose needs may change if the child gains or loses weight.

If you cannot swallow a tablet whole, a pharmacist can make an oral suspension (liquid). Tell the doctor if the person taking this medicine has trouble swallowing the tablet.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Your blood pressure will need to be checked often. Your kidney function may also need to be checked.

Store at room temperature away from moisture and heat. Throw away any oral suspension not used within 15 days after it was mixed. Do not keep the oral suspension in a refrigerator.

You should not use sacubitril and valsartan if you are allergic to sacubitril or valsartan (Diovan), or if you have ever had a severe allergic reaction to a blood pressure medication such as:

• an ACE inhibitor--benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, trandolapril (Lotensin, Vasotec, Prinivil, Accupril, Mavik, and others); or

• an ARB--azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan (Atacand, Avapro, Benicar, Diovan, Edarbi, Micardis, Teveten, and others).

You should not take sacubitril and valsartan within 36 hours before or after you have taken any ACE inhibitor medication.

If you have diabetes, do not use sacubitril and valsartan together with any medication that contains aliskiren (a blood pressure medicine).

You may also need to avoid taking sacubitril and valsartan with aliskiren if you have kidney disease.

Tell your doctor if you have ever had:

• liver disease;

• hereditary angioedema; or

• if you are on a low-salt-diet.

Do not use if you are pregnant, and tell your doctor right away if you become pregnant. Sacubitril and valsartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

You should not breastfeed while using this medicine.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not use potassium supplements or salt substitutes, unless your doctor has told you to.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. You may be more likely to have an allergic reaction if you are African-American.

Also call your doctor at once if you have:

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

• extreme tiredness;

• high potassium--slow heart rate, weak pulse, muscle weakness, tingly feeling; or

• kidney problems--little or no urination, rapid weight gain, painful or difficult urination, swelling in your hands, feet, or ankles.

Common side effects of sacubitril and valsartan may include:

• kidney problems;

• high potassium;

• dizziness, feeling light-headed; or

• cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• aliskiren;

• lithium;

• any other heart or blood pressure medicines;

• a diuretic or "water pill";

• medicine or mineral supplements that contain potassium; or

• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may affect sacubitril and valsartan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.