Sacubitril; Valsartan Tablets

SACUBITRIL; VALSARTAN (sak UE bi tril; val SAR tan) treats heart failure. It works by relaxing blood vessels, which decreases the amount of work the heart has to do. It also helps your kidneys remove more fluid and salt from your blood through the urine. It is a combination of a neprilysin inhibitor and an ARB.

Take this medication 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 care team tells you to stop.

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

Side effects that you should report to your care team as soon as possible:

• Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
• High potassium level—muscle weakness, fast or irregular heartbeat
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision

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

• Cough

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 medication after the expiration date.

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

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

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

• Diabetes
• Hereditary angioedema (HAE)
• High levels of potassium in the blood
• Kidney disease
• Liver disease
• Low blood pressure
• An unusual or allergic reaction to sacubitril, valsartan, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

Do not take this medication with any of the following:

• Aliskiren (if you have diabetes)
• ACE inhibitors, such as benazepril, captopril, enalapril, lisinopril
• Tranylcypromine

This medication may also interact with the following:

• ARBs, such as azilsartan, losartan, valsartan
• Lithium
• NSAIDS, medications for pain and inflammation, such as ibuprofen or naproxen
• Potassium-sparing diuretics, such as amiloride, spironolactone, triamterene
• Potassium supplements

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.

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

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

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy.

Talk to your care team before breastfeeding. Changes to your treatment plan may be needed.