Uses of Isosorbide Dinitrate and Hydralazine:

• It is used to treat heart failure (weak heart).

What do I need to tell my doctor BEFORE I take Isosorbide Dinitrate and Hydralazine?

• If you have an allergy to isosorbide dinitrate, hydralazine, or any other part of isosorbide dinitrate and hydralazine.
• If you are allergic to isosorbide dinitrate and hydralazine; any part of isosorbide dinitrate and hydralazine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are taking any of these drugs: Avanafil, riociguat, sildenafil, tadalafil, or vardenafil.

This is not a list of all drugs or health problems that interact with isosorbide dinitrate and hydralazine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take isosorbide dinitrate and hydralazine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Isosorbide Dinitrate and Hydralazine?

• Tell all of your health care providers that you take isosorbide dinitrate and hydralazine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how isosorbide dinitrate and hydralazine affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Check your blood pressure as you have been told.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• Tell your doctor if you have too much sweat, fluid loss, throwing up, or loose stools. This may lead to low blood pressure.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is this medicine (Isosorbide Dinitrate and Hydralazine) best taken?

Use isosorbide dinitrate and hydralazine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep taking isosorbide dinitrate and hydralazine as you have been told by your doctor or other health care provider, even if you feel well.
• Take isosorbide dinitrate and hydralazine at the same time of day.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
• Very bad dizziness or passing out.
• Chest pain or pressure or a fast heartbeat.
• Fever.
• A burning, numbness, or tingling feeling that is not normal.

What are some other side effects of Isosorbide Dinitrate and Hydralazine?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Dizziness.
• Feeling tired or weak.
• Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Isosorbide Dinitrate and Hydralazine?

• Store at room temperature.
• Keep lid tightly closed.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about isosorbide dinitrate and hydralazine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.