IMPORTANT SAFETY INFORMATION

INDICATION

EPANED® (enalapril maleate) Oral Solution, 1 mg/mL

EPANED is a prescription medicine that contains enalapril maleate, used to treat:

• High blood pressure (hypertension) in adults and children older than 1 month, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
• When the heart cannot pump blood effectively for the body’s needs (symptomatic heart failure).
• When the left ventricle of the heart is not functioning properly, but there are no symptoms of heart failure, to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure.

ADDITIONAL IMPORTANT SAFETY INFORMATION:

Do not receive EPANED if you are:

• Allergic to EPANED, or any of the ingredients in EPANED.
• Allergic to any ACE inhibitors, the class of medication that EPANED is in.
• Patients with inherited or unknown cause of swelling of skin, caused by build-up of fluid (hereditary or idiopathic angioedema).
• Do not take EPANED in combination with Aliskiren for diabetes.
• Do not take EPANED in combination with a type of medication class called neprilysin inhibitors.
• Do not take EPANED within 36 hours of switching to or from sacubitril/valsartan.

What are the possible side effects of EPANED?

EPANED can cause serious side effects, including:

• Swelling of the head and neck (Head and Neck Angioedema). EPANED should be promptly discontinued and appropriate therapy and monitoring provided until complete and sustained resolution of signs and symptoms of angioedema has occurred. Patients with a history of angioedema may be at increased risk of angioedema while receiving an ACE inhibitor. ACE inhibitors have been associated with a higher rate of angioedema in Black than in non-Black patients.
• Serious or mild allergic reactions. Some people who take EPANED may develop serious or mild allergic reactions. Call your doctor right away if you experience rash, swelling, or difficulty breathing during or soon after treatment with dialysis.
• Low blood pressure (hypotension). EPANED can cause symptoms of low pressure. Call your doctor right away if you experience symptoms that may include faintness or dizziness.
• If you are undergoing major surgery or during anesthesia. EPANED may cause complications, please tell your doctor about all medicines you take.
• A type of liver disease (hepatotoxicity). Rarely, some people who take medications containing enalapril, including EPANED, may develop fatal and serious cases of liver injury. Call your doctor right away if signs of liver failure occur, including jaundice, anorexia, bleeding or bruising.
• Weakened kidney function. EPANED may cause a weakened kidney function. Call your doctor right away if you are having problem with urination.
• High potassium levels (Hyperkalemia). EPANED may cause high levels of potassium in people taking EPANED. Tell your doctor about all medicines you take, especially prior to using salt substitutes containing potassium.

Before taking EPANED, tell your doctor about all your medical conditions, including:

• Are pregnant or plan to become pregnant.
• Are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using EPANED with certain other medicines can affect each other. Keep a list of your medicines and show them to your healthcare provider and pharmacist when you get a new medicine.

The most common side effects of EPANED:

• For high blood pressure was tiredness or fatigue.
• For heart failure was low blood pressure or dizziness.

These are not all the possible side effects of EPANED. Please see Full Prescribing Information for a full list.

To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.

EPANED® is a trademark of Azurity Pharmaceuticals, Inc.

©2025 Azurity Pharmaceuticals, Inc.

PP-EPN-US-0031