Uses

This product is used to treat certain types of heart failure. It may help you live longer and lower your chance of having to go to the hospital for heart failure. This product contains 2 medications: sacubitril and valsartan. Sacubitril belongs to a class of drugs called neprilysin inhibitors and valsartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). They work by relaxing blood vessels so that blood can flow more easily, which makes it easier for your heart to pump blood to your body.

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start taking this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this product by mouth with or without food as directed by your doctor, usually twice daily. The dosage is based on your medical condition and response to treatment. Children's dosage is also based on weight.

If you are using the suspension form of this medication, shake the bottle well before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

To reduce your risk of side effects, your doctor may direct you to start this product at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

This product should not be taken with ACE inhibitors (such as captopril, enalapril) since your risk of serious side effects may increase. Do not take this product for at least 36 hours before or after taking an ACE inhibitor. Consult your doctor or pharmacist for more details.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Tell your doctor if you do not get better or if you get worse.

Side Effects

Cough, dizziness, or lightheadedness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• signs of kidney problems (such as change in the amount of urine)
• symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat)
• fainting

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking this product, tell your doctor or pharmacist if you are allergic to sacubitril; or to valsartan; or to other ARBs (such as candesartan, losartan); or to ACE inhibitors (such as quinapril, ramipril); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver disease
• kidney disease
• dehydration
• high level of potassium in the blood
• serious allergic reaction conditions that included swelling of your face/lips/tongue/throat/trouble breathing (such as angioedema, hereditary angioedema)

This product may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Severe sweating, diarrhea, or vomiting may cause dehydration and cause you to feel lightheaded. Tell your doctor if you have severe diarrhea or vomiting. To prevent dehydration, drink plenty of fluids unless your doctor tells you not to.

This product may increase your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using sacubitril/valsartan. Valsartan may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. (See also Warning section.)

It is unknown if this product passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

See also How to Use and Precautions sections.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this medication include:

• aliskiren
• lithium
• drugs that may increase the level of potassium in the blood (such as sparsentan, ACE inhibitors including benazepril/lisinopril, birth control pills containing drospirenone)

Some products have ingredients that could worsen your heart failure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or NSAIDs such as ibuprofen/naproxen).

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness, fainting.

Notes

Do not share this product with others.

Lab and/or medical tests (such as kidney function tests, potassium levels) should be done while you are taking this product. Keep all medical and lab appointments.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Discard any unused suspension after 15 days. Do not store the suspension in the refrigerator. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.