Azilsartan Medoxomil (ay-zil-SAR-tan me-DOX-oh-mil), Chlorthalidone (klor-THAL-i-done)

Treats high blood pressure. This medicine contains an angiotensin II receptor blocker (ARB) and a diuretic (water pill).

Brand Name(s):

Edarbyclor

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with aliskiren if you have diabetes.
• Some medicines and foods can affect how azilsartan/chlorthalidone works. Tell your doctor if you are taking any of the following:
  • A diuretic (water pill), such as furosemide, hydrochlorothiazide, torsemide
  • An NSAID pain or arthritis medicine, such as aspirin, diclofenac, ibuprofen, naproxen
  • Digoxin
  • Lithium

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding, are on a low-sodium diet, or you have kidney problems, liver disease, heart failure, gout, or low potassium or sodium levels.
• This medicine could lower your blood pressure too much and cause you to feel dizzy or lightheaded. This is more likely to happen when you begin to use the medicine or if you become dehydrated. Stand or sit up slowly if you are dizzy. Drink more liquids if you exercise, sweat more than usual, or have diarrhea or are vomiting.
• This medicine may cause the following problems:
  • Low potassium levels
  • Worsening kidney problems
  • Worsening symptoms of gout
• Do not stop using this medicine without asking your doctor, even if you feel well. This medicine will not cure your high blood pressure, but it will help keep it in the normal range. You may have to take blood pressure medicine for the rest of your life.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate
• Confusion, weakness in your hands and feet, uneven heartbeat, trouble breathing
• Dry mouth, increased thirst, muscle cramps, nausea or vomiting
• Joint pain or swelling
• Lightheadedness, dizziness, fainting
• Unusual tiredness or weakness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088