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AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE- amlodipine besylate valsartan hydrochlorothiazide tablet, film coated

  1. Patient Information
  2. What Is The Most Important Information I Should Know About Amlodipine/valsartan/hydrochlorothiazide?
  3. Amlodipine/valsartan/hydrochlorothiazide Contains Three Prescription Medicines:
  4. Who Should Not Take Amlodipine/valsartan/hydrochlorothiazide?
  5. Tell Your Doctor About All Of Your Medical Conditions, Including If You:
  6. Tell All Your Doctors And Dentist You Are Taking Amlodipine/valsartan/hydrochlorothiazide. This Is Especially Important If You:
  7. Amlodipine/valsartan/hydrochlorothiazide May Cause Serious Side Effects Including:
  8. What Are The Ingredients In Amlodipine/valsartan/hydrochlorothiazide?
  9. What Is High Blood Pressure (hypertension)?
  10. Manufactured By:
  11. Pregnancy:
  12. Potassium Supplements:

Patient Information 

Patient Information


(am-LOE-di-peen, val-SAR-tan, HYE-droe-klor-oh-THYE-a-zide) Tablets

Read the Patient Information that comes with amlodipine/valsartan/hydrochlorothiazide before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment.

What Is The Most Important Information I Should Know About Amlodipine/valsartan/hydrochlorothiazide? 

  • Amlodipine/valsartan/hydrochlorothiazide can cause harm or death to an unborn baby.
  • Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant.
  • If you get pregnant while taking amlodipine/valsartan/hydrochlorothiazide, tell your doctor right away.

Amlodipine/valsartan/hydrochlorothiazide Contains Three Prescription Medicines: 

  • amlodipine, a calcium channel blocker
  • valsartan, an angiotensin receptor blocker, and
  • hydrochlorothiazide, a diuretic (water pill)

Amlodipine/valsartan/hyddrochlorothiazide may be used to lower blood pressure in adults when two medicines to lower your high blood pressure are not enough.

Amlodipine/Valsartan/Hydrochlorothiazide has not been studied in children under 18 years of age.

Who Should Not Take Amlodipine/valsartan/hydrochlorothiazide? 

Do not take Amlodipine/Valsartan/Hydrochlorothiazide if you have low or no urine output (anuria).

Tell Your Doctor About All Of Your Medical Conditions, Including If You: 

  • are pregnant or plan to become pregnant.

    • Take amlodipine/valsartan/hydrochlorothiazide exactly as your doctor tells you.
    • Take amlodipine/valsartan/hydrochlorothiazide one time each day.
    • Amlodipine/valsartan/hydrochlorothiazide can be taken with or without food.
    • If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Just take the next dose at the regular time.
    • If you take too much amlodipine/valsartan/hydrochlorothiazide, call your doctor or Poison Control Center, or go to the emergency room.

Tell All Your Doctors And Dentist You Are Taking Amlodipine/valsartan/hydrochlorothiazide. This Is Especially Important If You: 

  • are going to have surgery
  • go for kidney dialysis

Amlodipine/valsartan/hydrochlorothiazide May Cause Serious Side Effects Including: 

  • harm to an unborn baby causing injury or death.

    • Store at 68 to 77 F (20 to 25 C)
    • Keep amlodipine/valsartan/hydrochlorothiazide dry (protect it from moisture).

    Keep Amlodipine/Valsartan/Hydrochlorothiazide and all medicines out of the reach of children.

    General Information about Amlodipine/Valsartan/Hydrochlorothiazide

    Medicines are sometimes prescribed for conditions that are not mentioned in the patient information leaflet. Do not use amlodipine/valsartan/hydrochlorothiazide for a condition for which it was not prescribed. Do not give amlodipine/valsartan/hydrochlorothiazide to other people, even if they have the same symptoms that you have. It may harm them.

    This patient information leaflet summarizes the most important information about amlodipine/valsartan/hydrochlorothiazide. If you would like more information about amlodipine/valsartan/hydrochlorothiazide, talk with your doctor. You can ask your doctor or pharmacist for information about amlodipine/valsartan/hydrochlorothiazide that is written for health professionals. For more information go to or call 1-800-828-9393.

What Are The Ingredients In Amlodipine/valsartan/hydrochlorothiazide? 

Active ingredients: amlodipine besylate, valsartan and hydrochlorothiazide

The inactive ingredients for all strengths of the tablets include microcrystalline cellulose, crospovidone, colloidal silicon dioxide, and magnesium stearate, Additionally, the 5/160/12.5 mg strength contains polyethylene glycol, polyvinyl alcohol, lactose monohydrate, triethyl citrate, hypromellose, titanium dioxide and talc; the 10/320/25 mg strength contains the same ingredients as the 5/160/12.5 mg strength with the exception of the talc; the 5/160/25 mg strength contains lactose monohydrate, hypromellose, triacetin, D&C Yellow #10, titanium dioxide, and FD&C Yellow #6; the 10/160/12.5 mg strength contains FD&C Yellow #6, triethyl citrate, yellow iron oxide, hypromellose and titanium dioxide; and the 10/160/25 mg strength contains hypromellose, titanium dioxide, D&C Yellow #10, macrogol and polysorbate.

What Is High Blood Pressure (hypertension)? 

Blood pressure is the force of blood in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too much. Amlodipine/valsartan/hydrochlorothiazide can help your blood vessels relax so your blood pressure is lower. Medicines that lower blood pressure lower your chance of having a stroke or heart attack.

High blood pressure makes the heart work harder to pump blood throughout the body and causes damage to blood vessels. If high blood pressure is not treated, it can lead to stroke, heart attack, heart failure, kidney failure and vision problems.

Revised: 03/16

Manufactured By: 

Par Pharmaceutical

Chestnut Ridge, NY 10977


Female patients of childbearing age should be told about the consequences of exposure to amlodipine/valsartan/hydrochlorothiazide during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physician as soon as possible.

Symptomatic Hypotension:A patient receiving amlodipine/valsartan/hydrochlorothiazide should be cautioned that lightheadedness can occur, especially during the first days of therapy, and that it should be reported to the prescribing physician. The patients should be told that if syncope occurs, amlodipine/valsartan/hydrochlorothiazide should be discontinued until the physician has been consulted.

All patients should be cautioned that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope.

Potassium Supplements: 

A patient receiving amlodipine/valsartan/hydrochlorothiazide should be told not to use potassium supplements or salt substitutes containing potassium without consulting the prescribing physician.

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