Avalide (as a combination product containing Hydrochlorothiazide, Irbesartan)

Irbesartan 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 irbesartan, take it at 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 irbesartan exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose of irbesartan and gradually increase your dose.

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

Before taking irbesartan,

• tell your doctor and pharmacist if you are allergic to irbesartan, any other medications, or any of the ingredients in irbesartan 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 irbesartan 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: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril (Capoten, in Capozide), enalapril (Vasotec), fosinopril, lisinopril (in Prinzide, in Zestoretic), moexipril (Univasc, in Uniretic), perindopril (Aceon), quinapril (Accupril, in Accuretic, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), and selective COX-2 inhibitors such as celecoxib (Celebrex); diuretics ('water pills'); 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 disease.
• tell your doctor if you are breastfeeding.
• you should know that irbesartan may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking irbesartan. To help avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• 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.

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.

Irbesartan may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• heartburn
• excessive tiredness

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately:

• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing

Irbesartan may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

• Avalide^® (containing Hydrochlorothiazide, Irbesartan)