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AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE tablet


  1. Patient Information
  2. Pregnancy:
  3. Symptomatic Hypotension:
  4. Potassium Supplements:
  5. Manufactured By:
  6. Manufactured For:
  7. What Is The Most Important Information I Should Know About Amlodipine, Valsartan And Hydrochlorothiazide Tablets?
  8. Amlodipine, Valsartan And Hydrochlorothiazide Tablets Contain 3 Prescription Medicines:
  9. Who Should Not Take Amlodipine, Valsartan And Hydrochlorothiazide Tablets?
  10. Tell Your Doctor About All Of Your Medical Conditions, Including If You:
  11. Tell All Your Doctors And Dentist You Are Taking Amlodipine, Valsartan And Hydrochlorothiazide Tablets. This Is Especially Important If You:
  12. What Are The Possible Side Effects Of Amlodipine, Valsartan And Hydrochlorothiazide Tablets?
  13. What Are The Ingredients In Amlodipine, Valsartan And Hydrochlorothiazide Tablets?
  14. What Is High Blood Pressure (hypertension)?
  15. Active Ingredient(s):
  16. Inactive Ingredient(s):
  17. Revised: 8/2019document Id:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Pregnancy: 

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

Symptomatic Hypotension: 

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

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Manufactured By: 

TORRENT PHARMACEUTICALS LTD., Indrad-382 721, INDIA.

Manufactured For: 

TORRENT PHARMA INC., Basking Ridge, NJ 07920.

8061141 Revised June 2016

Information for Patients

Patient Information

Amlodipine, Valsartan and Hydrochlorothiazide (am-LOE-di-peen, val-SAR-tan andhye-droe klor-oh-THYE-a-zide) Tablets, USP

Read the Patient Information that comes with amlodipine, valsartan and hydrochlorothiazide tablets before you start taking them 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 And Hydrochlorothiazide Tablets? 

  • Amlodipine, valsartan and hydrochlorothiazide tablets 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 and hydrochlorothiazide tablets, tell your doctor right away.

Amlodipine, Valsartan And Hydrochlorothiazide Tablets Contain 3 Prescription Medicines: 

1. amlodipine, a calcium channel blocker

2. valsartan, an angiotensin receptor blocker, and

3. hydrochlorothiazide, a diuretic (water pill)

Amlodipine, valsartan and hydrochlorothiazide tablets may be used to lower blood pressure in adults when 2 medicines to lower your high blood pressure are not enough.

Amlodipine, valsartan and hydrochlorothiazide tablets have not been studied in children under 18 years of age.

Who Should Not Take Amlodipine, Valsartan And Hydrochlorothiazide Tablets? 

Do not take amlodipine, valsartan and hydrochlorothiazide tablets 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 and hydrochlorothiazide tablets exactly as your doctor tells you.
  • Take amlodipine, valsartan and hydrochlorothiazide tablets one time each day.
  • Amlodipine, valsartan and hydrochlorothiazide tablets 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 many amlodipine, valsartan and hydrochlorothiazide tablets, call your doctor or Poison Control Center, or go to the emergency room.

Tell All Your Doctors And Dentist You Are Taking Amlodipine, Valsartan And Hydrochlorothiazide Tablets. This Is Especially Important If You: 

  • are going to have surgery
  • go for kidney dialysis
  • What Are The Possible Side Effects Of Amlodipine, Valsartan And Hydrochlorothiazide Tablets? 

    Amlodipine, valsartan and hydrochlorothiazide tablets may causeserious side effectsincluding:

    • harm to an unborn baby causing injury or death.

      • Store amlodipine, valsartan, and hydrochlorothiazide tablets at room temperature between 59 F to 86 F (15 C to 30 C).
      • Keep amlodipine, valsartan and hydrochlorothiazide tablets dry (protect it from moisture).

      Keep amlodipine, valsartan and hydrochlorothiazide tablets and all medicines out of the reach of children.

      General Information about amlodipine, valsartan and hydrochlorothiazide tablets

      Medicines are sometimes prescribed for conditions that are not mentioned in the patient information leaflet. Do not use amlodipine, valsartan and hydrochlorothiazide tablets for a condition for which it was not prescribed. Do not give amlodipine, valsartan and hydrochlorothiazide tablets 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 and hydrochlorothiazide tablets. If you would like more information about amlodipine, valsartan and hydrochlorothiazide tablets, talk with your doctor. You can ask your doctor or pharmacist for information about amlodipine, valsartan and hydrochlorothiazide tablets that is written for health professionals. For more information call at 1-269-544-2299.

    What Are The Ingredients In Amlodipine, Valsartan And Hydrochlorothiazide Tablets? 

    Active ingredients: amlodipine besylate, USP, valsartan, USP and hydrochlorothiazide, USP.

    The inactive ingredients for all strengths of the tablets are croscarmellose sodium, hypromellose, magnesium stearate, mannitol, polyethylene glycol, povidone, talc and titanium dioxide. Additionally, the 5 mg/160 mg/25 mg, 10 mg/160 mg/12.5 mg, 10 mg/160 mg/25 mg and 10 mg/320 mg/25 mg strengths contain ferric oxide yellow.

    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 and hydrochlorothiazide tablets 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.

    Trademarks are the property of their respective owners.

    This Patient Information has been approved by the U.S. Food and Drug Administration.

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    Active Ingredient(s): 

    • AMLODIPINE BESYLATE 10mg in 1
    • HYDROCHLOROTHIAZIDE 25mg in 1
    • VALSARTAN 320mg in 1

    Inactive Ingredient(s): 

    • CROSCARMELLOSE SODIUM
    • POVIDONE K30
    • POLYETHYLENE GLYCOL 400
    • TALC
    • MANNITOL
    • FERRIC OXIDE YELLOW
    • HYPROMELLOSE 2910 (6 MPA.S)
    • MAGNESIUM STEARATE
    • TITANIUM DIOXIDE

    Remedy_Label

    AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE
    amlodipine, valsartan and hydrochlorothiazide tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70518-1220(NDC:13668-325)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMLODIPINE BESYLATE(UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)AMLODIPINE10 mg
    VALSARTAN(UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)VALSARTAN320 mg
    HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)HYDROCHLOROTHIAZIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
    FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
    HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
    MAGNESIUM STEARATE(UNII: 70097M6I30)
    MANNITOL(UNII: 3OWL53L36A)
    POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
    POVIDONE K30(UNII: U725QWY32X)
    TALC(UNII: 7SEV7J4R1U)
    TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
    Product Characteristics
    Coloryellow (Brown Yellow)Scoreno score
    ShapeCAPSULE (Biconvex)Size21mm
    FlavorImprint Code1325
    Contains
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70518-1220-090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20159305/21/2018
    Labeler -REMEDYREPACK INC. (829572556)

    Revised: 8/2019document Id: 

    90b09e14-1325-a70f-e053-2995a90a71dfSet id: c469ee49-3698-4063-8663-1d307fa9ccedVersion: 3Effective Time: 20190822REMEDYREPACK INC.



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