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AMLODIPINE- amlodipine besylate tablet


  1. Patient Information
  2. What Is Amlodipine?
  3. Who Should Not Use Amlodipine?
  4. Tell Your Doctor About Any Prescription And Non-prescription Medicines You Are Taking, Including Natural Or Herbal Remedies. Tell Your Doctor If You:
  5. How Should I Take Amlodipine?
  6. Other Medicines:
  7. What Should I Avoid While Taking Amlodipine?
  8. Amlodipine May Cause The Following Side Effects. Most Side Effects Are Mild Or Moderate:
  9. Manufactured By:
  10. Revised: 12/2008document Id:
  11. How Do I Store Amlodipine?

Patient Information 

INFORMATION FOR PATIENTS TAKING AMLODIPINE BESYLATE TABLETS

Read this information carefully before you start amlodipine and each time you refill your prescription. There may be new information. This information does not replace talking with your doctor. If you have any questions about amlodipine, ask your doctor. Your doctor will know if amlodipine is right for you.

What Is Amlodipine? 

Amlodipine is a type of medicine known as a calcium channel blocker (CCB). It is used to treat high blood pressure (hypertension) and a type of chest pain called angina. It can be used by itself or with other medicines to treat these conditions.

High Blood Pressure (hypertension)

High blood pressure comes from blood pushing too hard against your blood vessels. Amlodipine relaxes your blood vessels which lets your blood flow more easily and helps lower your blood pressure. Drugs that lower blood pressure lower your risk of having a stroke or heart attack.

Angina

Angina is a pain or discomfort that keeps coming back when part of your heart does not get enough blood. Angina feels like a pressing or squeezing pain, usually in your chest under the breastbone. Sometimes you can feel it in your shoulders, arms, neck, jaws, or back. Amlodipine can relieve this pain.

Who Should Not Use Amlodipine? 

Do not use amlodipine if you are allergic to amlodipine, (the active ingredient in amlodipine), or to the inactive ingredients. Your doctor or pharmacist can give you a list of these ingredients.

Tell Your Doctor About Any Prescription And Non-prescription Medicines You Are Taking, Including Natural Or Herbal Remedies. Tell Your Doctor If You: 

  • ever had heart disease
  • ever had liver problems
  • are pregnant, or plan to become pregnant. Your doctor will decide if amlodipine is the best treatment for you.
  • are breastfeeding. Do not breast feed while taking amlodipine. You can stop breastfeeding or take a different medicine.

How Should I Take Amlodipine? 


  • Take amlodipine once a day, with or without food. You can take amlodipine with most drinks, including grapefruit juice.
  • It may be easier to take your dose if you do it at the same time every day, such as with breakfast, dinner, or at bedtime. Do not take more than one dose of amlodipine at a time.
  • If you miss a dose, take it as soon as you remember. Do not take amlodipine if it has been more than 12 hours since you missed your last dose. Wait and take the next dose at your regular time.

Other Medicines: 

You can use nitroglycerin and amlodipine together. If you take nitroglycerin for angina, don t stop taking it while you are taking amlodipine.
  • While you are taking amlodipine, do not stop taking your other prescription medicines, including any other blood pressure medicines, without talking to your doctor.
  • If you took too much amlodipine, call your doctor or Poison Control Center, or go to the nearest hospital emergency room right away.
  • What Should I Avoid While Taking Amlodipine? 


    • Do notbreastfeed. It is not known if amlodipine will pass through your milk.
    • Do notstart any new prescription or non-prescription medicines or supplements, unless you check with your doctor first.

    Amlodipine May Cause The Following Side Effects. Most Side Effects Are Mild Or Moderate: 

    • headache
    • swelling of your legs or ankles
    • tiredness, extreme sleepiness
    • stomach pain, nausea
    • dizziness
    • flushing (hot or warm feeling in your face)
    • arrhythmia (irregular heartbeat)
    • heart palpitations (very fast heartbeat)

    It is rare, but when you first start amlodipine or increase your dose, you may have a heart attack or your angina may get worse. If that happens, call your doctor right away or go directly to a hospital emergency room.

    Tell your doctor if you are concerned about any side effects you experience. These are not all the possible side effects of amlodipine. For a complete list, ask your doctor or pharmacist.

    Manufactured By: 

    CARACO PHARMACEUTICAL LABORATORIES, LTD.
    DETROIT, MI 48202

    AMLODIPINE
    amlodipine besylate tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57664-568
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Amlodipine besylate(UNII: 864V2Q084H) (Amlodipine - UNII:1J444QC288)2.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    dibasic calcium phosphate()
    butylated hydroxytoluene(UNII: 1P9D0Z171K)
    microcrystalline cellulose(UNII: OP1R32D61U)
    sodium starch glycolate()
    magnesium stearate(UNII: 70097M6I30)
    Product Characteristics
    Colorwhite (White to Off-White)Scoreno score
    ShapeDIAMOND (DIAMOND)Size7mm
    FlavorImprint Code568
    Contains
    CoatingfalseSymbolfalse
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57664-568-9990 in 1 BOTTLE
    2NDC:57664-568-88100 in 1 BOTTLE
    3NDC:57664-568-13500 in 1 BOTTLE
    4NDC:57664-568-181000 in 1 BOTTLE
    AMLODIPINE
    amlodipine besylate tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57664-569
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Amlodipine besylate(UNII: 864V2Q084H) (Amlodipine - UNII:1J444QC288)5 mg
    Inactive Ingredients
    Ingredient NameStrength
    dibasic calcium phosphate()
    butylated hydroxytoluene(UNII: 1P9D0Z171K)
    microcrystalline cellulose(UNII: OP1R32D61U)
    sodium starch glycolate()
    magnesium stearate(UNII: 70097M6I30)
    Product Characteristics
    Colorwhite (White to Off-White)Scoreno score
    ShapeOCTAGON (8 sided) (OCTAGON (8 sided))Size9mm
    FlavorImprint Code569
    Contains
    CoatingfalseSymbolfalse
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57664-569-9990 in 1 BOTTLE
    2NDC:57664-569-88100 in 1 BOTTLE
    3NDC:57664-569-13500 in 1 BOTTLE
    4NDC:57664-569-181000 in 1 BOTTLE
    AMLODIPINE
    amlodipine besylate tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57664-570
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Amlodipine besylate(UNII: 864V2Q084H) (Amlodipine - UNII:1J444QC288)10 mg
    Inactive Ingredients
    Ingredient NameStrength
    dibasic calcium phosphate()
    butylated hydroxytoluene(UNII: 1P9D0Z171K)
    microcrystalline cellulose(UNII: OP1R32D61U)
    sodium starch glycolate()
    magnesium stearate(UNII: 70097M6I30)
    Product Characteristics
    Colorwhite (White to Off-White)Scoreno score
    ShapeROUND (ROUND)Size10mm
    FlavorImprint Code570
    Contains
    CoatingfalseSymbolfalse
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57664-570-9990 in 1 BOTTLE
    2NDC:57664-570-88100 in 1 BOTTLE
    3NDC:57664-570-13500 in 1 BOTTLE
    4NDC:57664-570-181000 in 1 BOTTLE
    Labeler -CARACO PHARMACEUTICAL LABORATORIES, LTD.

    Revised: 12/2008document Id: 

    CB080F88-6B48-7021-8876-4F288E2998FDSet id: b52e2905-f906-4c46-bb24-2c7754c5d75bVersion: 1Effective Time: 20081215CARACO PHARMACEUTICAL LABORATORIES, LTD.

    How Do I Store Amlodipine? 

    Keep amlodipine away from children. Store amlodipine tablets at room temperature (between 59 and 86 degrees Fahrenheit). Keep amlodipine out of the light. Do not store in the bathroom. Keep amlodipine in a dry place.

    General advice about amlodipine

    Sometimes, doctors will prescribe a medicine for a condition that is not written in the patient information leaflets. Only use amlodipine the way your doctor told you to. Do not give amlodipine to other people, even if they have the same symptoms you have. It may harm them.

    You can ask your pharmacist or doctor for information about amlodipine.



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