Edarbyclor Oral

This product is used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This product contains two medications: azilsartan and chlorthalidone. Azilsartan is an angiotensin receptor blocker (ARB) that works by relaxing blood vessels so blood can flow more easily. Chlorthalidone is a \"water pill\" (diuretic) that helps your body get rid of extra salt and water so there is less pressure in the blood vessels. This effect may increase the amount of urine you make when you first start taking this product.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
The azilsartan in this product may also be used to help protect the kidneys from damage due to diabetes.

How to use Edarbyclor Oral
Read the Patient Information Leaflet provided by your pharmacist before you start taking this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth as directed by your doctor, usually once daily with or without food. If you take this medication too close to bedtime, you may need to wake up to urinate. Therefore, it is best to take this medication at least 4 hours before your bedtime. Consult your doctor or pharmacist if you have questions about your dosing schedule.
The dosage is based on your medical condition and response to treatment.
It may several weeks before you get the full benefit of this product. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick.
If you also take certain drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take this product at least 2 hours before or at least 4 hours after these medications.
Tell your doctor if your condition does not improve or if it worsens (for example, your blood pressure readings remain high or increase).

Dizziness, lightheadedness, tiredness, diarrhea may occur as your body adjusts to the medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This product may cause a loss of too much body water (dehydration) and salt/minerals. Tell your doctor right away if you have any symptoms of dehydration or mineral loss, including: extreme thirst, very dry mouth, muscle cramps/weakness, fast/slow/irregular heartbeat, confusion, decreased urination.
Tell your doctor right away if you have any serious side effects, including: fainting, toe/joint pain, unexpected change in the amount of urine, symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this product, tell your doctor or pharmacist if you are allergic to azilsartan or chlorthalidone; or if you have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease (such as inability to make urine, renal artery stenosis), liver disease, lupus, gout or high uric acid levels, dehydration, untreated mineral imbalance (such as low/high potassium, low sodium).
This product may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Too much sweating, diarrhea, or vomiting may cause dehydration and increase your risk of dizziness or lightheadedness. Report prolonged diarrhea or vomiting to your doctor. Be sure to drink enough fluids to prevent dehydration unless your doctor directs you otherwise.
If you have diabetes, this product may affect your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst and urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.
This product may affect the potassium levels in your blood. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.
This product may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the side effects of this product, especially dizziness and kidney effects.
This product is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details. (See also Warning section.)
This product passes into breast milk. Consult your doctor before breast-feeding.

See also Precautions section.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval.
Some products that may interact with this drug include: lithium, cisapride, aliskiren, drugs that may increase the level of potassium in the blood (such as birth control pills containing drospirenone).
Check the labels on all your medicines (such as cough-and-cold products, diet aids, or NSAIDs such as ibuprofen, naproxen) because they may contain ingredients that could increase your blood pressure. Ask your pharmacist for more details.
This product may interfere with certain laboratory tests (including parathyroid, protein-bound iodide), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this product.

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fainting, severe weakness/dizziness.

NOTES:
Do not share this medication with others.
Lifestyle changes such as stress reduction programs, exercise and dietary changes may increase the effectiveness of this medicine. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.
Laboratory and/or medical tests (such as kidney function, blood potassium levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
Have your blood pressure checked regularly while taking this medication. Learn how to monitor your own blood pressure at home, and share the results with your doctor.

MISSED DOSE:
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE:
Store at room temperature, in the original container from your pharmacist/doctor, away from light and moisture. Do not put this medication in a different container. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised August 2012. Copyright(c) 2012 First Databank, Inc.