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AMLODIPINE AND ATORVASTATIN tablet, film coated


  1. Information For Patients:
  2. Muscle Pain:
  3. Liver Enzymes:
  4. Embryofetal Toxicity:
  5. Lactation:
  6. What Are Amlodipine And Atorvastatin Tablets?
  7. Norvasc Is Used To Treat:
  8. Lipitor Is Also Used To Lower The Risk For Heart Attack, Stroke, Certain Types Of Heart Surgery, And Chest Pain In Patients Who Have Heart Disease Or Risk Factors For Heart Disease Such As:
  9. Lipitor Can Lower The Risk For Heart Attack Or Stroke In Patients With Diabetes And Risk Factors Such As:
  10. Do Not Use Amlodipine And Atorvastatin Tablets If You:
  11. Tell Your Doctor About All The Medicines You Take Including Prescription And Nonprescription Medicines, Vitamins, And Herbal Supplements. Amlodipine And Atorvastatin Tablets And Some Other Medicines Can Interact, Causing Serious Side Effects. Especially Tell Your Doctor If You Take Medicines For:
  12. How Should I Take Amlodipine And Atorvastatin Tablets?
  13. What Should I Avoid While Taking Amlodipine And Atorvastatin Tablets?
  14. Amlodipine And Atorvastatin Tablets Can Cause Serious Side Effects. These Side Effects Happen Only To A Small Number Of People. Your Doctor Can Monitor You For Them. These Side Effects Usually Go Away If Your Dose Is Lowered Or Amlodipine And Atorvastatin Tablets Are Stopped. These Serious Side Effects Include:
  15. Common Side Effects Of Amlodipine And Atorvastatin Tablets Include:
  16. How Do I Store Amlodipine And Atorvastatin Tablets?
  17. What Is High Blood Pressure (hypertension)?
  18. What Is Angina (chest Pain)?
  19. What Is Cholesterol?
  20. What Is A Heart Attack?
  21. What Is A Stroke?
  22. Inactive Ingredients:
  23. Patient Information
  24. Amlodipine Besylate Is Used To Treat:
  25. Atorvastatin Calcium Is Also Used To Lower The Risk For Heart Attack, Stroke, Certain Types Of Heart Surgery, And Chest Pain In Patients Who Have Heart Disease Or Risk Factors For Heart Disease Such As:
  26. Tell Your Doctor About All Of Your Health Conditions, Including, If You Have:
  27. Amlodipine And Atorvastatin Tablets?
  28. Amlodipine And Atorvastatin Tablets Are Stopped. These Serious Side Effects Include:
  29. Call Your Doctor Right Away If:
  30. Active Ingredients:
  31. Manufactured By:
  32. Distributed By:

Information For Patients: 

Because of the risk of myopathy with statins, the drug class to which atorvastatin belongs, advise patients to report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.

Advise patients taking atorvastatin that cholesterol is a chronic condition and they should adhere to their medication along with their National Cholesterol Education Program (NCEP)-recommended diet, a regular exercise program as appropriate, and periodic testing of a fasting lipid panel to determine goal attainment.

Advise patients about substances they should not take concomitantly with atorvastatin[seeWarnings and Precautions (5.1)]. Patients should inform other healthcare professionals prescribing a new medication that they are taking amlodipine and atorvastatin tablets.

Muscle Pain: 

Advise patients starting therapy with amlodipine and atorvastatin tablets of the risk of myopathy and to report promptly any unexplained muscle pain, tenderness, or weakness particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing amlodipine and atorvastatin tablets. The risk of this occurring is increased when taking certain types of medication or consuming larger quantities (> 1 liter) of grapefruit juice. They should discuss all medication, both prescription and over the counter, with their healthcare professional.

Liver Enzymes: 

Advise patients treated with amlodipine and atorvastatin tablets to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.

Embryofetal Toxicity: 

Advise females of reproductive potential of the risk to a fetus, to use effective contraception during treatment and to inform their healthcare provider of a known or suspected pregnancy while using amlodipine and atorvastatin tablets[seeContraindications (4)andUse in Specific Populations (8.1,8.3)].

Lactation: 

Advise women not to breastfeed during treatment with amlodipine and atorvastatin tablets[seeContraindications (4)andUse in Specific Populations (8.2)].

What Are Amlodipine And Atorvastatin Tablets? 

Amlodipine and atorvastatin tablets are a prescription drug that combines Norvasc(amlodipine besylate) and Lipitor(atorvastatin calcium) in one pill.

Amlodipine and atorvastatin tablets are used in adults who need both Norvasc and Lipitor.

Norvasc Is Used To Treat: 

high blood pressure (hypertension) and
chest pain (angina) and
blocked arteries of the heart (coronary artery disease)

Lipitor is used to lower the levels of bad cholesterol and triglycerides in your blood. It can also raise the levels of good cholesterol.

Lipitor Is Also Used To Lower The Risk For Heart Attack, Stroke, Certain Types Of Heart Surgery, And Chest Pain In Patients Who Have Heart Disease Or Risk Factors For Heart Disease Such As: 

age, smoking, high blood pressure, low levels of good cholesterol, heart disease in the family.

Lipitor Can Lower The Risk For Heart Attack Or Stroke In Patients With Diabetes And Risk Factors Such As: 

diabetic eye or kidney problems, smoking, or high blood pressure.

Amlodipine and atorvastatin tablets have not been studied in children.

Do Not Use Amlodipine And Atorvastatin Tablets If You: 

Are pregnant or think you may be pregnant, or are planning to become pregnant. Amlodipine and atorvastatin tablets may harm your unborn baby. If you get pregnant, stop taking amlodipine and atorvastatin tablets and call your doctor right away.
Are breastfeeding. Amlodipine and atorvastatin can pass into your breast milk and may harm your baby. Do not breastfeed if you take amlodipine and atorvastatin tablets.
Have liver problems.
Are allergic to anything in amlodipine and atorvastatin tablets. The active ingredients are atorvastatin calcium and amlodipine besylate.

Tell Your Doctor About All The Medicines You Take Including Prescription And Nonprescription Medicines, Vitamins, And Herbal Supplements. Amlodipine And Atorvastatin Tablets And Some Other Medicines Can Interact, Causing Serious Side Effects. Especially Tell Your Doctor If You Take Medicines For: 

your immune system
infections
cholesterol
hepatitis C virus
birth control
heart failure
HIV (AIDS)

You can use nitroglycerin and amlodipine and atorvastatin tablets together. If you take nitroglycerin for chest pain (angina), do not stop taking it while taking amlodipine and atorvastatin tablets.

Know all the medicines you take. Keep a list of them with you to show your doctor and pharmacist.

How Should I Take Amlodipine And Atorvastatin Tablets? 

Take amlodipine and atorvastatin tablets once a day, exactly as your doctor tells you. Do not change your dose or stop amlodipine and atorvastatin tablets without talking to your doctor.
Take amlodipine and atorvastatin tablets each day at any time of day, at about the same time each day. Amlodipine and atorvastatin tablets can be taken with or without food.
Do not break the tablets before taking them. Talk to your doctor if you have a problem swallowing pills.
Your doctor should start you on a low-fat diet before giving you amlodipine and atorvastatin tablets. Stay on this low-fat diet when you take amlodipine and atorvastatin tablets.
If you miss a dose, take it as soon as you remember. Do not take amlodipine and atorvastatin tablets if it has been more than 12 hours since your missed dose. Just take the next dose at your regular time. Do not take 2 doses of amlodipine and atorvastatin tablets at the same time.
If too many amlodipine and atorvastatin tablets are taken by accident, call your doctor or poison control center, or go to the nearest emergency room.

What Should I Avoid While Taking Amlodipine And Atorvastatin Tablets? 

Avoid getting pregnant. If you get pregnant, stop taking amlodipine and atorvastatin tablets right away and call your doctor.
Do not breastfeed. Amlodipine and atorvastatin can pass into your breast milk and may harm your baby.

Amlodipine And Atorvastatin Tablets Can Cause Serious Side Effects. These Side Effects Happen Only To A Small Number Of People. Your Doctor Can Monitor You For Them. These Side Effects Usually Go Away If Your Dose Is Lowered Or Amlodipine And Atorvastatin Tablets Are Stopped. These Serious Side Effects Include: 

Muscle problems.Amlodipine and atorvastatin tablets can cause serious muscle problems that can lead to kidney problems, including kidney failure. You have a higher chance for muscle problems if you are taking certain other medicines with amlodipine and atorvastatin tablets.
Liver problems.Your doctor should do blood tests to check your liver before you start taking amlodipine and atorvastatin tablets and if you have symptoms of liver problems while you take amlodipine and atorvastatin tablets. Call your doctor right away if you have the following symptoms of liver problems:
feel tired or weak
loss of appetite
upper belly pain
dark amber colored urine
yellowing of your skin or the whites of your eyes
Low blood pressure or dizziness
Muscle rigidity, tremor and/or abnormal muscle movement

Common Side Effects Of Amlodipine And Atorvastatin Tablets Include: 

diarrhea
swelling of your legs or ankles
nausea
upset stomach
muscle and joint pain
alterations in some laboratory blood tests

Additional side effects have been reported: tiredness, tendon problems, memory loss, and confusion.

Talk to your doctor or pharmacist about side effects that bother you or do not go away. There are other side effects of amlodipine and atorvastatin tablets. Ask your doctor or pharmacist for a complete list.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How Do I Store Amlodipine And Atorvastatin Tablets? 

Store amlodipine and atorvastatin tablets at room temperature, 20 to 25 C (68 to 77 F).
Do not keep medicine that is out-of-date or that you no longer need.
Keep amlodipine and atorvastatin tablets and all medicines out of the reach of children.Keep medicines in places where children cannot get them.

General information about amlodipine and atorvastatin tablets

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use amlodipine and atorvastatin for a condition for which they were not prescribed. Do not give amlodipine and atorvastatin tablets to other people, even if they have the same problem you have. They may harm them. This leaflet summarizes the most important information about amlodipine and atorvastatin tablets. If you want more information, talk with your doctor. Ask your doctor or pharmacist for information about amlodipine and atorvastatin tablets written for health professionals. You can also call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).

What Is High Blood Pressure (hypertension)? 

You have high blood pressure when the force of blood against the walls of your arteries stays high. This can damage your heart and other parts of your body. Drugs that lower blood pressure lower your risk of having a stroke or heart attack.

What Is Angina (chest Pain)? 

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

What Is Cholesterol? 

Cholesterol is a fat-like substance made in your body. It is also found in foods. You need some cholesterol for good health, but too much is not good for you. Cholesterol can clog your blood vessels.

What Is A Heart Attack? 

A heart attack occurs when heart muscle does not get enough blood. Symptoms include chest pain, trouble breathing, nausea, and weakness. Heart muscle cells may be damaged or die. The heart cannot pump well or may stop beating.

What Is A Stroke? 

A stroke occurs when nerve cells in the brain do not get enough blood. The cells may be damaged or die. The damaged cells may cause weakness or problems speaking or thinking.

Inactive Ingredients: 

colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, L-arginine, lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, pregelatinized starch (corn), sodium carbonate anhydrous, talc, titanium dioxide and xanthan gum. The 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg tablets also contain FD&C Blue No. 2 Aluminum Lake.

The brands listed are trademarks of their respective owners.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Manufactured by:
Mylan Laboratories Limited
Hyderabad 500 096, India

75068359

Revised: 6/2019
MX:AMAT:R6

Patient Information 

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

Information for Patients

Because of the risk of myopathy with statins, the drug class to which atorvastatin belongs, advise patients to report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.

Advise patients taking atorvastatin that cholesterol is a chronic condition and they should adhere to their medication along with their National Cholesterol Education Program (NCEP)-recommended diet, a regular exercise program as appropriate, and periodic testing of a fasting lipid panel to determine goal attainment.

Advise patients about substances they should not take concomitantly with atorvastatin[

Amlodipine and atorvastatin tablets are a prescription drug that combines amlodipine besylate and atorvastatin calcium in one pill.

Amlodipine and atorvastatin tablets are used in adults who need both amlodipine besylate and atorvastatin calcium.

Amlodipine Besylate Is Used To Treat: 

  • High blood pressure (hypertension) and
  • Chest pain (angina) and
  • Blocked arteries of the heart (coronary artery disease)

Atorvastatin calcium is used to lower the levels of "bad" cholesterol and triglycerides in your blood. It can also raise the levels of "good" cholesterol.

Atorvastatin Calcium Is Also Used To Lower The Risk For Heart Attack, Stroke, Certain Types Of Heart Surgery, And Chest Pain In Patients Who Have Heart Disease Or Risk Factors For Heart Disease Such As: 

  • age, smoking, high blood pressure, low levels of "good" cholesterol, heart disease in the family.

Atorvastatin calcium can lower the risk for heart attack or stroke in patients with diabetes and risk factors such as:

  • diabetic eye or kidney problems, smoking, or high blood pressure.

Amlodipine and atorvastatin tablets have not been studied in children.

Who should not use

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

  • heart disease
  • muscle aches or weakness
  • diabetes
  • thyroid problems
  • kidney problems
  • or drink more than 2 glasses of alcohol daily

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Amlodipine and atorvastatin tablets and some other medicines can interact, causing serious side effects. Especially tell your doctor if you take medicines for:

  • your immune system
  • birth control
  • infections
  • heart failure
  • cholesterol
  • HIV (AIDS)
  • hepatitis C virus

You can use nitroglycerin and amlodipine and atorvastatin tablets together. If you take nitroglycerin for chest pain (angina), do not stop taking it while taking amlodipine and atorvastatin tablets.

Know all the medicines you take. Keep a list of them with you to show your doctor and pharmacist.

How should I take

Amlodipine And Atorvastatin Tablets? 

  • Take amlodipine and atorvastatin tablets once a day, exactly as your doctor tells you. Do not change your dose or stop amlodipine and atorvastatin tablets without talking to your doctor.
  • Take amlodipine and atorvastatin tablets each day at any time of day, at about the same time each day. Amlodipine and atorvastatin tablets can be taken with or without food.
  • Do not break the tablets before taking them. Talk to your doctor if you have a problem swallowing pills.
  • Your doctor should start you on a low-fat diet before giving you amlodipine and atorvastatin tablets. Stay on this low-fat diet when you take amlodipine and atorvastatin tablets.
  • If you miss a dose, take it as soon as you remember. Do not take amlodipine and atorvastatin tablets if it has been more than 12 hours since your missed dose. Just take the next dose at your regular time. Do not take 2 doses of amlodipine and atorvastatin tablets at the same time.
  • If too much amlodipine and atorvastatin tablets are taken by accident, call your doctor or poison control center, or go to the nearest emergency room.

What should I avoid while taking

Amlodipine And Atorvastatin Tablets Are Stopped. These Serious Side Effects Include: 

  • Muscle problems. Amlodipine and atorvastatin tablets can cause serious muscle problems that can lead to kidney problems, including kidney failure. You have a higher chance for muscle problems if you are taking certain other medicines with amlodipine and atorvastatin tablets.
  • Liver problems. Your doctor should do blood tests to check your liver before you start taking amlodipine and atorvastatin tablets and if you have symptoms of liver problems while you take amlodipine and atorvastatin tablets. Call your doctor right away if you have the following symptoms of liver problems:
  • feel tired or weak
  • loss of appetite
  • upper belly pain
  • dark amber colored urine
  • yellowing of your skin or the whites of your eyes
  • Low blood pressure or dizziness
  • Muscle rigidity, tremor and/or abnormal muscle movement

Call Your Doctor Right Away If: 

  • you have muscle problems like weakness, tenderness, or pain that happen without a good reason, especially if you also have a fever or feel more tired than usual. This may be an early sign of a rare muscle problem.
  • muscle problems that do not go away even after your doctor has advised you to stop taking amlodipine and atorvastatin tablets. Your doctor may do further tests to diagnose the cause of your muscle problems.
  • allergic reactions including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing which may require treatment right away
  • you have nausea and vomiting, stomach pain
  • you are passing brown or dark-colored urine
  • you feel more tired than usual
  • your skin and white of your eyes get yellow
  • you have allergic skin reactions
  • Chest pain that does not go away or gets worse. Sometimes when you start amlodipine and atorvastatin tablets or increase your dose, chest pain can get worse or a heart attack can happen. If this happens, call your doctor or go to the emergency room right away.

Active Ingredients: 

amlodipine besylate, USP and atorvastatin calcium, USP

Manufactured By: 

Cadila Healthcare Ltd.

Ahmedabad, India.

Distributed By: 

Zydus Pharmaceuticals (USA) Inc.

Pennington, NJ 08534

Rev.: 05/19



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