Sacubitril; Valsartan oral tablet

What is this medicine?

SACUBITRIL; VALSARTAN (sak UE bi tril; val SAR tan) is a combination of 2 drugs used to reduce the risk of death and hospitalizations in people with long-lasting heart failure. It is usually used with other medicines to treat heart failure.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Do not take this medicine for at least 36 hours before or after you take an ACE inhibitor medicine. Talk to your health care provider if you are not sure if you take an ACE inhibitor.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

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

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• signs and symptoms of increased potassium like muscle weakness; chest pain; or fast, irregular heartbeat

• signs and symptoms of kidney injury like trouble passing urine or change in the amount of urine

• signs and symptoms of low blood pressure like feeling dizzy or lightheaded, or if you develop extreme fatigue

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

• cough

What may interact with this medicine?

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

This medicine may also interact with the following medicines:

• angiotensin II receptor blockers (ARBs) like azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, or valsartan

• lithium

• NSAIDS, medicines for pain and inflammation, like ibuprofen or naproxen

• potassium-sparing diuretics like amiloride, spironolactone, and triamterene

• potassium supplements

What if I miss a dose?

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

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

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

• diabetes and take a medicine that contains aliskiren

• kidney disease

• liver disease

• 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

What should I watch for while using this medicine?

Tell your doctor or healthcare professional 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 doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

You may get 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. Avoid alcoholic drinks; they can make you more dizzy.