Diovan HCT

Hydrochlorothiazide is a water pill (diuretic). Valsartan is a type of medicine called an angiotensin II receptor blocker (sometimes known as an ARB blocker).

Diovan HCT is a combination medicine used to treat high blood pressure (hypertension). Reducing blood pressure may decrease your chances of having a stroke or heart attack.

Diovan HCT is prescribed when other blood pressure medicines have not worked or have stopped working.

Diovan HCT may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take Diovan HCT with or without food.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medication, which can lead to severely low blood pressure or a serious electrolyte imbalance.

Your blood pressure will need to be checked often. Your blood and urine may also be tested if you have been vomiting or are dehydrated.

If you need surgery, tell the surgeon ahead of time that you are using Diovan HCT.

It may take up to 4 weeks for this medication to control your blood pressure. Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture and heat.

You should not use Diovan HCT if you cannot urinate, or if you are allergic to sulfa drugs.

Do not use if you are pregnant. Stop using the medicine and contact your doctor immediately if you become pregnant.

If you have diabetes, do not use Diovan HCT with any medication that contains aliskiren (a blood pressure medicine).

You should not use this medicine if you are allergic to valsartan or hydrochlorothiazide, or if you have:

• decreased urination or are unable to urinate; or
• an allergy to sulfa drugs.

If you have diabetes, do not use Diovan HCT together with any medication that contains aliskiren (a blood pressure medicine).

You may also need to avoid taking Diovan HCT with aliskiren if you have kidney disease.

Tell your doctor if you have ever had:

• an electrolyte imbalance (such as low levels of potassium or magnesium, or high levels of calcium in your blood);
• liver disease;
• kidney disease;
• gallstones;
• lupus;
• congestive heart failure;
• gout, or high levels of uric acid in your blood;
• asthma or allergies;
• high cholesterol or triglyceride levels;
• an allergy to penicillin;
• glaucoma; or
• if you are on a low-salt diet.

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant. Valsartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

You should not breastfeed while using this medicine.

Diovan HCT is not approved for use by anyone younger than 18 years old.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, Diovan HCT can cause a condition that breaks down skeletal muscle tissue, which can lead to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have fever, unusual tiredness, or dark colored urine.

Diovan HCT may cause serious side effects. Call your doctor immediately if you have:

• a light-headed feeling, like you might pass out;
• eye pain or vision problems;
• an unusual skin rash;
• little or no urinating;
• jaundice (yellowing of the skin or eyes);
• easy bruising or unusual bleeding;
• a seizure;
• kidney problems--little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or
• signs of an electrolyte imbalance--dry mouth, increased thirst, confusion, feeling restless, vomiting, muscle pain or weakness, drowsiness, lack of energy, fast heartbeats, decreased urination.

Common side effects include:

• cold symptoms such as stuffy nose, sneezing, sore throat;
• dizziness; or
• headache.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Take the medicine as soon as you remember, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Hydrochlorothiazide may increase your risk of skin cancer. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Your doctor may want you to have skin examinations on a regular basis.

Do not use potassium supplements or salt substitutes, unless your doctor has told you to.

Drinking alcohol can further lower your blood pressure and may cause side effects.

Avoid driving or doing hazardous activities until you know how Diovan HCT will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

If you take cholestyramine or colestipol, take your Diovan HCT dose 4 hours before or 4 hours after taking the other medicine.

Tell your doctor about all the medicines you are currently taking. Many drugs can affect Diovan HCT, especially:

• cyclosporine, digoxin, digitalis, lithium, or ritonavir;
• all your heart or blood pressure medicines;
• insulin or oral diabetes medicine;
• a diuretic or "water pill";
• opioid pain medicine;
• a sleeping pill;
• a muscle relaxer;
• an antibiotic--rifabutin, rifampin, rifamycin, rifapentine;
• cancer medicine--cyclophosphamide, methotrexate; or
• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete, and many other drugs may affect Diovan HCT. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.