This drug can cause serious (possibly fatal) harm to an unborn baby if used during pregnancy. Therefore, it is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss the use of reliable forms of birth control while taking this medication. If you are planning pregnancy, become pregnant, or think you may be pregnant, contact your doctor immediately.

This drug is used to treat high blood pressure (hypertension). This medication is a combination of two drugs (an angiotensin receptor blocker and a thiazide "water pill"/diuretic). Valsartan blocks the hormone angiotensin thereby relaxing blood vessels, causing them to widen. The thiazide diuretic increases the amount of urine you make, therefore decreasing excess water and salt in your body. High blood pressure reduction helps prevent strokes, heart attacks, and kidney problems.

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.

This drug may also be used to treat heart failure and to help protect the kidneys from damage due to diabetes.

Read the Patient Information Leaflet available from your pharmacist before you start taking this medication and each time you get a refill. If you have any questions regarding this information, consult your doctor or pharmacist.

Take this medication by mouth, usually once daily or as directed by your doctor. You may take this drug with or without food. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day.

Drink adequate fluids to prevent from becoming dehydrated. If you are on restricted fluid intake, consult your doctor for further instructions.

Do not take potassium supplements or salt substitutes containing potassium without talking to your doctor or pharmacist first. This medicine can infrequently raise or lower your potassium blood levels, which rarely can cause serious side effects such as muscle weakness/cramping or very slow heartbeats. Tell your doctor immediately if these effects occur.

The dosage is based on your medical condition and response to therapy. For the treatment of high blood pressure, it may take 4 weeks before the full benefit of this drug occurs.

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 are also taking cholestyramine or colestipol, take valsartan/hydrochlorothiazide at least 2 hours before either of these drugs.

You may experience dizziness, lightheadedness, blurred vision, or tiredness as your body adjusts to the medication. You may also experience diarrhea, dry mouth, nausea, vomiting, or cough. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual thirst, weakness, confusion, fainting, fast heartbeat, decreased sexual ability.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: unusual change in the amount of urine (not including the normal increase in urine when you first start this drug), signs of infection (e.g., fever, chills, persistent sore throat), seizures, yellowing eyes or skin, stomach/abdominal pain, dark urine, unusual fatigue.

An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: 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 medication, tell your doctor or pharmacist if you are allergic to it; or to ACE inhibitors (e.g., benazepril, captopril); or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: urinary problems (inability to make urine or anuria).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, severe loss of body fluids (dehydration through excessive sweating, vomiting, or diarrhea), mineral/electrolyte problems (e.g., imbalance of sodium, potassium, magnesium, calcium), gout, lupus, high levels of fats in the blood (high cholesterol or triglycerides), asthma.

If you have diabetes, this medication may affect your blood sugar levels. Your doctor may need to adjust the dosage of your medications used to treat diabetes (e.g., insulin, glipizide). Monitor your blood sugar levels as instructed and tell your doctor immediately if you develop signs of high blood sugar (e.g., increased thirst, unusual tiredness, vision changes, fruity breath odor).

This drug 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.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Hydrochlorothiazide may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially the dizziness effect.

This medication is not recommended for use during pregnancy due to the risk for harm to an unborn baby. Consult your doctor for more details. (See also Warning section.)

Hydrochlorothiazide passes into breast milk. Breast-feeding is not recommended due to the potential harm to the nursing infant. Consult your doctor before breast-feeding.

See also How to Use section.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medication because very serious interactions may occur: dofetilide.

If you are currently using this medication, tell your doctor or pharmacist before starting valsartan/hydrochlorothiazide.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: cisapride, corticosteroids (e.g., prednisone), diazoxide, drugs which can increase dizziness (e.g., phenobarbital, narcotic analgesics), drugs which are affected by the acid level in the urine (e.g., amphetamine, methenamine, quinidine), lithium, probenecid.

Check the labels on all your medicines (e.g., cough-and-cold products, diet aids, nonsteroidal anti-inflammatory drugs - NSAIDs such as ibuprofen and naproxen for pain/fever reduction) because they may contain ingredients that could increase your blood pressure. Ask your pharmacist about the safe use of those products. Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day), should be continued. Consult your doctor or pharmacist for more details.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include unusually fast or slow heartbeat, severe dizziness or fainting.

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 (e.g., kidney function, potassium blood level) 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. Discuss this with your doctor.

If you miss a dose, use 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.

Store at room temperature (77 degrees F or 25 degrees C) away from light and moisture. Brief storage between 59 and 86 degrees F (15 to 30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines 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 for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).

Information last revised July 2009 Copyright(c) 2009 First DataBank, Inc.