Valsartan and Sacubitril

Tell your doctor if you are pregnant or plan to become pregnant. Do not take the combination of valsartan and sacubitril if you are pregnant. If you become pregnant while you are taking valsartan and sacubitril, stop taking valsartan and sacubitril and call your doctor immediately. The combination of valsartan and sacubitril may cause death or serious injury to the fetus when taken in the last 6 months of pregnancy.

The combination of valsartan and sacubitril is usually used in combination with other medications to lower the risk of death and hospitalization in adults with certain types of heart failure. The combination of valsartan and sacubitril is also used to treat certain types of heart failure in children 1 year of age and older. Valsartan is in a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently. Sacubitril is in a class of medications called neprilysin inhibitors. It works to help control blood volume.

The combination of valsartan and sacubitril comes as a tablet and a sprinkle capsule (capsule that contains oral pellets, which are small beads of medication that can be sprinkled on food) to take by mouth. The tablets are usually taken twice a day with or without food. The sprinkle capsules are mixed with food and taken twice a day. To help you remember to take the combination of valsartan and sacubitril, take it at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take valsartan and sacubitril exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

To take the sprinkle capsules mixed with food, open the capsule and sprinkle the entire contents onto 1 or 2 teaspoonfuls of soft foods, such as applesauce, yogurt, or pudding. Swallow the mixture right after you mix it without chewing. Do not swallow the sprinkle capsules whole; do not chew or crush the oral pellets.

If you or your child cannot swallow the tablets, your pharmacist can prepare this medication as an oral suspension (liquid). Shake the bottle of suspension well before each dose.

Your doctor may start you on a low dose of valsartan and sacubitril and gradually increase your dose.

The combination of valsartan and sacubitril controls heart failure but does not cure it. Continue to take valsartan and sacubitril even if you feel well. Do not stop taking valsartan and sacubitril without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking valsartan and sacubitril,

• tell your doctor and pharmacist if you are allergic (swelling of your face, lips, tongue, or throat, or difficulty breathing) to valsartan, other angiotensin receptor blockers (ARB) such as azilsartan (Edarbi, in Edarbyclor), candesartan (Atacand, in Atacand HCT), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT); angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Epaned, Vasotec, in Vaseretic), fosinopril, lisinopril (Qbrelis, Zestril, in Zestoretic), moexipril, perindopril (in Prestalia), quinapril, ramipril (Altace), or trandolapril (Mavik, in Tarka); sacubitril; any other medications; or any of the ingredients in valsartan and sacubitril tablets and sprinkle capsules. Ask your pharmacist for a list of the ingredients.
• Some medications should not be taken with valsartan and sacubitril. Other medications may cause dosing changes or extra monitoring when taken with valsartan and sacubitril. Make sure you have discussed any medications you are currently taking or plan to take before starting valsartan and sacubitril with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking valsartan and sacubitril, please get the advice of your doctor or pharmacist.
• The following nonprescription or herbal products may interact with valsartan and sacubutril: ibuprofen (Advil, Motrin), naproxen (Aleve). Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking valsartan and sacubutril. Do not start any of these medications while taking valsartan and sacubutril without discussing with your healthcare provider.
• tell your doctor if you have or have ever had hereditary angioedema (inherited condition that causes episodes of swelling in the hands, feet, face, airway, or intestines); diabetes or kidney, or liver disease.
• tell your doctor if you are breastfeeding. Do not breastfeed while you are taking valsartan and sacubutril.
• you should know that valsartan and sacubutril may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking valsartan and sacubitril. To help avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• you should know that diarrhea, vomiting, not drinking enough fluids, and sweating a lot can cause a drop in blood pressure, which may cause lightheadedness and fainting. Tell your doctor if you have any of these problems or develop them during your treatment.

Do not use salt substitutes containing potassium without talking to your doctor. If your doctor prescribes a low-salt or low-sodium diet, follow these directions carefully.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Valsartan and sacubitril may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• cough
• extreme tiredness

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately:

• rash
• itching
• swelling of the lips, tongue, face, or throat
• difficulty breathing

The combination of valsartan and sacubitril may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets at room temperature and away from excess heat and moisture (not in the bathroom). Store the bottle of oral suspension at room temperature for up to 15 days; do not refrigerate it.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• dizziness
• fainting

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to valsartan and sacubitril.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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