Brand Name(s):

• Edarbi®
• Edarbyclor®(as a combination product containing Azilsartan, Chlorthalidone)

IMPORTANT WARNING

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

WHY is this medicine prescribed?

Azilsartan is used alone or in combination with other medications to treat high blood pressure. Azilsartan 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.

HOW should this medicine be used?

Azilsartan comes as a tablet to take by mouth. It is usually taken once a day with or without food. To help you remember to take azilsartan, take it around the same time 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 azilsartan exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Azilsartan controls high blood pressure but does not cure it. It may take about 2 weeks for you to notice the full benefit of azilsartan. Continue to take azilsartan even if you feel well. Do not stop taking azilsartan without talking to your doctor.

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

Are there OTHER USES for this medicine?

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

What SPECIAL PRECAUTIONS should I follow?

Before taking azilsartan,

• tell your doctor and pharmacist if you are allergic to azilsartan, any other medications, or any of the ingredients in azilsartan tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor if you have diabetes (high blood sugar) and you are taking aliskiren (Tekturna, in Amturnide, Tekamlo, Tekturna HCT). Your doctor will probably tell you not to take azilsartan if you have diabetes and you are also taking aliskiren.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn) and selective COX-2 inhibitors such as celecoxib (Celebrex); diuretics ('water pills'); other medications to treat high blood pressure or heart problems; and potassium supplements. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had heart failure, or kidney or liver disease.
• tell your doctor if you are breast-feeding.
• 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.

What SPECIAL DIETARY instructions should I follow?

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.

What should I do IF I FORGET to take a dose?

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.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your blood pressure should be checked regularly to determine your response to azilsartan.

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

Azilsartan tablets have a noticeable odor. Ask your pharmacist if you have any questions regarding your medication.

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.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: January 15, 2013.