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 amlodipine, valsartan, hydrochlorothiazide, or sulfa drugs, or if you are pregnant.

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.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• 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.
• Some medicines can affect how this medicine works. Tell your doctor if you are using any of the following:
  
  • Atropine, biperiden, carbamazepine, clarithromycin, cyclophosphamide, cyclosporine, digoxin, heparin, itraconazole, ketoconazole, lithium, methotrexate, rifampin, ritonavir, simvastatin, sildenafil, tacrolimus, telithromycin
  • Diuretic (water pill)
  • Insulin or diabetes medicine that you take by mouth
  • NSAID pain or arthritis medicine (including aspirin, diclofenac, ibuprofen, naproxen)
  • Steroids (including hydrocortisone, methylprednisolone, prednisone, prednisolone, dexamethasone)
• Ask your doctor before you use any medicine, supplement, or salt substitute that contains potassium.
• If you also use cholestyramine or colestipol, take these at least 4 hours after you take this medicine.
• Alcohol, narcotic pain medicine, or sleeping pills may cause you to feel more lightheaded, dizzy, or faint when used with this 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, diabetes, gout, heart or blood vessel disease, heart failure, angina, high cholesterol, lupus, trouble urinating, or a history of allergies, asthma, or heart attack.
• This medicine may cause the following problems:
  
  • Worsening angina or risk of heart attack in people with heart problems
  • Kidney problems
  • Low potassium levels
  • Vision problems
• This medicine could lower your blood pressure too much, especially when you first use it or if you are dehydrated. Stand or sit up slowly if you feel dizzy or lightheaded.
• Drink plenty of fluids if you exercise, sweat more than usual, or have diarrhea or vomiting while you are using this medicine.
• 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
• Change in how much or how often you urinate, bloody or cloudy urine
• Chest pain that may spread, trouble breathing, unusual sweating
• Confusion, weakness, numbness in your hands, feet, or lips
• Dry mouth, increased thirst, muscle cramps, nausea, vomiting
• Eye pain, vision changes, seeing halos around lights
• Fast, slow, or uneven heartbeat
• Lightheadedness, dizziness, fainting
• Rapid weight gain, swelling in your hands, ankles, or feet

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