Amlodipine and valsartan is a combination medicine used alone or together with other medicines to treat high blood pressure (hypertension) in adults.

Lowering blood pressure may lower your risk of a stroke or heart attack.

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

Do not use if you are pregnant. Stop taking this medicine and tell your doctor right away if you become pregnant.

Tell your doctor about all your other medicines. Some drugs should not be used with amlodipine and valsartan.

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.

Amlodipine and valsartan is usually taken once per day.

You may take this medication with or without food.

Your blood pressure will need to be checked often and you may need frequent blood tests. Your treatment may also include diet, exercise, lifestyle changes, and other medications. Follow your doctor's instructions very carefully.

Your blood pressure may get too low during prolonged illness. Call your doctor if you are sick with vomiting or diarrhea.

Tell your doctor if you have a planned surgery.

Keep using amlodipine and valsartan even if you feel well. High blood pressure often has no symptoms.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Hypertension:

Initial therapy: Amlodipine 5 mg-Valsartan 160 mg orally once a day

Add-on/Replacement therapy: Amlodipine 5 to 10 mg-Valsartan 160 to 320 mg orally once a day

Comments:
-May increase dose after 1 to 2 weeks of therapy.
-A patient who experiences dose-limiting adverse reactions on either component alone may be switched to this drug containing a lower dose of that component in combination with the other. If blood pressure remains uncontrolled after 3 to 4 weeks, may titrate up to a maximum of amlodipine 10 mg-valsartan 320 mg orally once a day.

You should not use amlodipine and valsartan if you are allergic to it.

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

Tell your doctor if you have ever had:

• heart problems or low blood pressure;

• a heart attack;

• a severe allergic reaction called angioedema to another blood pressure medicine;

• vomiting or having a lot of diarrhea;

• liver disease; or

• kidney disease (or if you are on dialysis).

You may also need to avoid taking amlodipine and valsartan with aliskiren if you have kidney disease.

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

Do not breastfeed.

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

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

Overdose symptoms may include rapid heartbeats, low blood pressure, redness or warmth in your arms or legs, or fainting.

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

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 amlodipine and valsartan will affect you. Your reactions could be impaired.

Drinking alcohol with this medicine can cause side effects.

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, when you first start taking amlodipine and valsartan, your chest pain may get worse or you could have a heart attack. Seek emergency medical attention or call your doctor right away if you have symptoms such as: chest pain or pressure, pain spreading to your jaw or shoulder, nausea, or sweating.

Amlodipine and valsartan may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• heart problems--swelling, rapid weight gain, feeling short of breath;

• kidney problems--swelling, urinating less, feeling tired or short of breath; or

• high blood potassium--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.

Common side effects include:

• swelling in your hands or feet;

• spinning sensation, dizziness; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

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.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Amlodipine and valsartan can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Tell your doctor about all your current medicines. Many drugs can affect amlodipine and valsartan, especially:

• cyclosporine;

• sildenafil;

• rifampin;

• ritonavir; or

• a heart or blood pressure medication, especially a diuretic ('water pill').

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