When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to irbesartan, hydrochlorothiazide, or a sulfa drug, or if you are pregnant or not able to urinate.

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.
• Drink plenty of fluids if you exercise, sweat more than usual, or have diarrhea or vomiting while you are using this medicine.
• 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 can affect how irbesartan/hydrochlorothiazide works. Tell your doctor if you are using aliskiren, carbamazepine, cholestyramine, colestipol, lithium, an NSAID pain or arthritis medicine (such as aspirin, celecoxib, diclofenac, ibuprofen, naproxen), insulin or diabetes medicine that you take by mouth, or steroids (such as hydrocortisone, methylprednisolone, prednisone, prednisolone, dexamethasone).
• Ask your doctor before you use any medicine, supplement, or salt substitute that contains potassium.
• This medicine can intensify the effects of alcohol or other medicine that makes you sleepy or dizzy, such as narcotic pain medicine.

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, or if you have kidney problems, liver disease, heart failure, diabetes, glaucoma, gout, high cholesterol, or lupus. Tell your doctor if you have a history of asthma or allergies.
• This medicine may cause the following problems:
  
  • Kidney problems
  • Vision problems or glaucoma
• 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 first use the medicine or if you become dehydrated. Stand or sit up slowly if you are dizzy.
• 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
• Blistering, peeling, red skin rash
• Confusion, weakness, muscle twitching
• Decrease in how much or how often you urinate
• Dry mouth, increased thirst, muscle cramps, nausea or vomiting, uneven heartbeat
• Lightheadedness, dizziness, fainting
• Rapid weight gain, swelling in your hands, ankles, or feet
• Vision changes or eye pain

If you notice these less serious side effects, talk with your doctor:

• Muscle or joint pain
• Tiredness

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