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 or valsartan, 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 foods and medicines can affect how amlodipine/valsartan works. Tell your doctor if you are using any of the following:
  
  • Clarithromycin, cyclosporine, itraconazole, ketoconazole, lithium, rifampin, ritonavir, sildenafil, tacrolimus, telithromycin
  • Medicine to lower cholesterol (including simvastatin)
  • Diuretic (water pill)
  • NSAID pain or arthritis medicine (including aspirin, celecoxib, diclofenac, ibuprofen, naproxen)
• Ask your doctor before you use any medicine, supplement, or salt substitute that contains potassium.

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 disease, liver disease, heart or blood vessel disease, angina, heart failure, or a history of heart attack.
• This medicine may cause the following problems:
  
  • Worsening angina or risk of heart attack in people with heart problems
  • Kidney problems
  • High potassium levels
• 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. Alcohol may make your symptoms worse.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Do not stop using this medicine without asking your doctor, even if you feel well. This medicine will not cure high blood pressure, but it will help keep it in normal range. You may have to take blood pressure medicine for the rest of your life.
• 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, nausea, unusual sweating
• Confusion, weakness, uneven heartbeat, numbness in your hands, feet, or lips
• 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