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EZETIMIBE AND SIMVASTATIN tablet, film coated


  1. Ezetimibe And Simvastatin Tablets Are A Prescription Medicine That Contain 2 Cholesterol Lowering Medicines, Ezetimibe And Simvastatin. Ezetimibe And Simvastatin Tablets Are Used Along With Diet To:
  2. Ezetimibe And Simvastatin Tablets 10 Mg/80 Mg Increases Your Chance Of Developing Muscle Damage. The 10 Mg/80 Mg Dose Should Only Be Used By People Who:
  3. Do Not Take Ezetimibe And Simvastatin Tablets If You Take:
  4. Also Do Not Take Ezetimibe And Simvastatin Tablets If You:
  5. Tell Your Doctor If You:
  6. Ezetimibe And Simvastatin Tablets May Cause Serious Side Effects, Including:
  7. Tell Your Doctor Right Away If:
  8. Your Chances Of Getting Muscle Problems Are Higher If You:
  9. The Most Common Side Effects Of Ezetimibe And Simvastatin Tablets Include:
  10. Additional Side Effects That Have Been Reported In General Use With Ezetimibe And Simvastatin Tablets Or With Ezetimibe Or Simvastatin Tablets (tablets That Contain The Active Ingredients Of Ezetimibe And Simvastatin Tablets) Include:
  11. How Should I Store Ezetimibe And Simvastatin Tablets?
  12. Active Ingredients:
  13. Inactive Ingredients:
  14. Patient Information

Ezetimibe And Simvastatin Tablets Are A Prescription Medicine That Contain 2 Cholesterol Lowering Medicines, Ezetimibe And Simvastatin. Ezetimibe And Simvastatin Tablets Are Used Along With Diet To: 

  • lower the level of your "bad" cholesterol (LDL)
  • increase the level of your "good" cholesterol (HDL)
  • lower the level of fat in your blood (triglycerides)

Ezetimibe and simvastatin tablets are for patients who cannot control their cholesterol levels by diet and exercise alone.

Ezetimibe and simvastatin tablets have not been shown to reduce heart attacks or strokes more than simvastatin alone.

It is not known if ezetimibe and simvastatin tablets are safe and effective in children under 10 years of age or in girls who have not started their period (menses). The usual dose of ezetimibe and simvastatin tablets is 10 mg/10 mg to 10 mg/40 mg 1 time each day.

Ezetimibe And Simvastatin Tablets 10 Mg/80 Mg Increases Your Chance Of Developing Muscle Damage. The 10 Mg/80 Mg Dose Should Only Be Used By People Who: 

  • have been taking ezetimibe and simvastatin tablets 10 mg/80 mg chronically (such as 12 months or more) without having muscle damage
  • do not need to take certain other medicines with ezetimibe and simvastatin tablets that would increase your chance of getting muscle damage.

If you are unable to reach your LDL-cholesterol goal using ezetimibe and simvastatin tablets 10 mg/40 mg, your doctor should switch you to another cholesterol-lowering medicine.

Do Not Take Ezetimibe And Simvastatin Tablets If You Take: 

  • Certain anti-fungal medicines including:
    • itraconazole
    • ketoconazole
    • posaconazole
    • voriconazole
  • HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir, tipranavir, or atazanavir)
  • Certain hepatitis C virus protease inhibitors (such as boceprevir or telaprevir)
  • Certain antibiotics, including:
    • erythromycin
    • clarithromycin
    • telithromycin
  • nefazodone
  • medicines containing cobicistat
  • A fibric acid medicine for lowering cholesterol called gemfibrozil
  • cyclosporine
  • danazol

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Also Do Not Take Ezetimibe And Simvastatin Tablets If You: 

  • are allergic to ezetimibe or simvastatin or any of the ingredients in ezetimibe and simvastatin tablets.

Tell Your Doctor If You: 

  • have unexplained muscle aches or weakness
  • have kidney problems
  • have or have had liver problems or drink more than 2 glasses of alcohol daily
  • have thyroid problems
  • are 65 years of age or older

Also

  • Take ezetimibe and simvastatin tablets exactly as your doctor tells you to take it.
  • Do not change your dose or stop taking ezetimibe and simvastatin tablets without talking to your doctor.
  • Take ezetimibe and simvastatin tablets 1 time each day in the evening.
  • Take ezetimibe and simvastatin tablets with or without food.
  • While taking ezetimibe and simvastatin tablets, continue to follow your cholesterol-lowering diet and to exercise as your doctor told you to.
  • If you miss a dose, do not take an extra dose. Just resume your usual schedule.
  • Your doctor should do fasting blood tests to check your cholesterol while you take ezetimibe and simvastatin tablets. Your doctor may change your dose of ezetimibe and simvastatin tablets if needed.
  • If you take too many ezetimibe and simvastatin tablets, call your doctor or Poison Control Center at 1-800-222-1222 or go to the nearest hospital emergency room right away.

Ezetimibe And Simvastatin Tablets May Cause Serious Side Effects, Including: 

  • Muscle pain, tenderness and weakness (myopathy).Muscle problems, including muscle breakdown, can be serious in some people and rarely cause kidney damage that can lead to death.

Tell Your Doctor Right Away If: 

  • you have unexplained muscle pain, tenderness, or weakness, especially if you have a fever or feel more tired than usual, while you take ezetimibe and simvastatin tablets.
  • you have muscle problems that do not go away even after your doctor has advised you to stop taking ezetimibe and simvastatin tablets. Your doctor may do further tests to diagnose the cause of your muscle problems.

Your Chances Of Getting Muscle Problems Are Higher If You: 

  • are taking certain other medicines while you take ezetimibe and simvastatin tablets
  • are 65 years of age or older
  • are female
  • have thyroid problems (hypothyroidism) that are not controlled
  • have kidney problems
  • are taking higher doses of ezetimibe and simvastatin tablets, particularly the 10/80 mg dose
  • Liver problems.Your doctor should do blood tests to check your liver before you start taking ezetimibe and simvastatin tablets and if you have any symptoms of liver problems while you take ezetimibe and simvastatin tablets. Call your doctor right away if you have the following symptoms of liver problems:
    • loss of appetite
    • upper belly pain
    • dark urine
    • yellowing of your skin or the whites of your eyes
    • feel tired or weak

The Most Common Side Effects Of Ezetimibe And Simvastatin Tablets Include: 

  • headache
  • increased liver enzyme levels
  • muscle pain
  • upper respiratory infection
  • diarrhea

Additional Side Effects That Have Been Reported In General Use With Ezetimibe And Simvastatin Tablets Or With Ezetimibe Or Simvastatin Tablets (tablets That Contain The Active Ingredients Of Ezetimibe And Simvastatin Tablets) Include: 

  • 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), rash, hives; joint pain; inflammation of the pancreas; nausea; dizziness; tingling sensation; depression; gallstones; trouble sleeping; poor memory; memory loss; confusion; erectile dysfunction; breathing problems including persistent cough and/or shortness of breath or fever.

Tell your doctor if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of ezetimibe and simvastatin tablets. For more information, ask your doctor or pharmacist.

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

How Should I Store Ezetimibe And Simvastatin Tablets? 

  • Store ezetimibe and simvastatin tablets at room temperature between 68 F to 77 F (20 C to 25 C).
  • Keep ezetimibe and simvastatin tablets in its original container until you use it.
  • Keep ezetimibe and simvastatin tablets in a tightly closed container, and keep ezetimibe or simvastatin tablets out of light.

Keep ezetimibe and simvastatin tablets and all medicines out of the reach of children.

General Information about the safe and effective use of ezetimibe and simvastatin tablets.

Ezetimibe and simvastatin tablets works to reduce your cholesterol in two ways. It reduces the cholesterol absorbed in your digestive tract, as well as the cholesterol your body makes by itself. Ezetimibe and simvastatin tablets do not help you lose weight.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use ezetimibe or simvastatin tablets for a condition for which they were not prescribed. Do not give ezetimibe and simvastatin tablets to other people, even if they have the same condition that you have. They may harm them.

This Patient Information summarizes the most important information about ezetimibe and simvastatin tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about ezetimibe and simvastatin tablets that is written for health professionals.

For more information, call Impax Laboratories, Inc. at 1-800-934-6729.

Active Ingredients: 

ezetimibe and simvastatin

Inactive Ingredients: 

microcrystalline cellulose, pregelatinized starch, lactose monohydrate, ascorbic acid, citric acid anhydrous, butylated hydroxyanisole, hypromellose type 2910, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, talc and titanium dioxide. In addition, the 10 mg/10 mg tablets contain FD&C Red No. 40 and FD&C Blue No. 2; the 10 mg/20 mg tablets contain iron oxide yellow; the 10 mg/40 mg tablets contain iron oxide yellow and iron oxide red.

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

Dist. by:
Impax Generics
Hayward, CA 94544

1152-04
Rev. 04/2018

Patient Information 

Advise the patient to read theFDA-Approved Patient Labeling (Patient Information)

Patients should be advised to adhere to their National Cholesterol Education Program (NCEP)-recommended diet, a regular exercise program, and periodic testing of a fasting lipid panel.

Patients should be advised about substances they should not take concomitantly with ezetimibe and simvastatin tablets[seeContraindications (4)andWarnings and Precautions (5.1)]. Patients should also be advised to inform other healthcare professionals prescribing a new medication or increasing the dose of an existing medication that they are taking ezetimibe and simvastatin tablets.

17.1 Muscle Pain

All patients starting therapy with ezetimibe and simvastatin tablets should be advised of the risk of myopathy, including rhabdomyolysis, and told 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 ezetimibe and simvastatin tablets.Patients using the 10 mg/80 mg dose should be informed that the risk of myopathy, including rhabdomyolysis, is increased with the use of the 10 mg/80 mg dose.The risk of myopathy, including rhabdomyolysis, occurring with use of ezetimibe and simvastatin tablets is increased when taking certain types of medication or consuming grapefruit juice. Patients should discuss all medication, both prescription and over the counter, with their healthcare professional.

17.2 Liver Enzymes

It is recommended that liver function tests be performed before the initiation of ezetimibe and simvastatin tablets, and thereafter when clinically indicated. All patients treated with ezetimibe and simvastatin tablets should be advised to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.

17.3 Pregnancy

Women of childbearing age should be advised to use an effective method of birth control to prevent pregnancy while using ezetimibe and simvastatin tablets. Discuss future pregnancy plans with your patients, and discuss when to stop taking ezetimibe and simvastatin tablets if they are trying to conceive. Patients should be advised that if they become pregnant they should stop taking ezetimibe and simvastatin tablets and call their healthcare professional.

17.4 Breastfeeding

Women who are breastfeeding should be advised to not use ezetimibe and simvastatin tablets. Patients who have a lipid disorder and are breastfeeding should be advised to discuss the options with their healthcare professional.



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