Amlodipine is a calcium channel blocker. Hydrochlorothiazide is a thiazide diuretic (water pill). Valsartan is an angiotensin II receptor blocker (sometimes called an ARB).

Amlodipine, hydrochlorothiazide, and valsartan is a combination medicine used to treat high blood pressure (hypertension).

This medicine is usually given after other blood pressure medication did not work.

Amlodipine, hydrochlorothiazide, and valsartan may also be used for purposes not listed in this medication guide.

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

• if you are allergic to any sulfa drug; or
• if you are unable to urinate.

If you have diabetes, do not use amlodipine, hydrochlorothiazide, and valsartan together with any medication that contains aliskiren (a blood pressure medicine).

You may also need to avoid taking this medicine with aliskiren if you have kidney disease.

Tell your doctor if you have ever had:

• heart problems;
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);
• high blood levels of calcium;
• kidney disease (or if you are on dialysis);
• liver disease;
• glaucoma;
• gout, or increased uric acid in your blood;
• lupus;
• gallstones; or
• a penicillin allergy.

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.

Use Amlodipine, Hydrochlorothiazide, And Valsartan (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• an unusual skin rash;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• high or low potassium levels--leg cramps, nausea, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;
• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
• low magnesium level--dizziness, feeling jittery, muscle cramps, muscle spasms, cough or choking feeling; or
• low sodium level --headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady.

Common side effects may include:

• dizziness;
• headache, tiredness;
• nausea, upset stomach;
• stuffy nose, sinus pain, sore throat;
• back pain, muscle spasms; or
• swelling in your hands, ankles, or feet.

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.

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

Drinking alcohol with this medicine can cause side effects.

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.

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