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EZETIMIBE tablet


  1. How Should I Take Ezetimibe?
  2. What Are Ezetimibe Tablets?
  3. How Should I Take Ezetimibe Tablets?
  4. Inactive Ingredients:
  5. Patient Information
  6. Manufactured By:
  7. Distributed By:
  8. Tell Your Doctor If You:
  9. Tablets?
  10. What Should I Know About High Cholesterol?

How Should I Take Ezetimibe? 

Take ezetimibe once a day, with or without food. It may be easier to remember to take your dose if you do it at the same time every day, such as with breakfast, dinner, or at bedtime. If you also take another medicine to reduce your cholesterol, ask your doctor if you can take them at the same time.
If you forget to take ezetimibe, take it as soon as you remember. However, do not take more than one dose of ezetimibe a day.
Continue to follow a cholesterol-lowering diet while taking ezetimibe. Ask your doctor if you need diet information.
Keep taking ezetimibe unless your doctor tells you to stop. It is important that you keep taking ezetimibe even if you do not feel sick.

In clinical studies patients reported few side effects while taking ezetimibe. These included diarrhea, joint pains, and feeling tired.

Patients have experienced severe muscle problems while taking ezetimibe. If you experience unexplained muscle pain, tenderness, or weakness while taking ezetimibe contact your doctor immediately. You need to do this promptly, because on rare occasions, these muscle problems can be serious, with muscle breakdown resulting in kidney damage.

Additionally, the following side effects have been reported in general use: allergic reactions (which may require treatment right away) including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing, rash, and hives; joint pain; muscle aches; alterations in some laboratory blood tests; liver problems; stomach pain; inflammation of the pancreas; nausea; dizziness; tingling sensation; depression; headache; gallstones; inflammation of the gallbladder.

Tell your doctor if you are having these or any other medical problems while on ezetimibe. For a complete list of side effects, ask your doctor or pharmacist.

What Are Ezetimibe Tablets? 

Ezetimibe tablets are a medicine used to lower levels of total cholesterol and LDL (bad) cholesterol in the blood. Ezetimibe tablets are for patients who cannot control their cholesterol levels by diet and exercise alone. It can be used by itself or with other medicines to treat high cholesterol. You should stay on a cholesterol-lowering diet while taking this medicine.

Ezetimibe tablets work to reduce the amount of cholesterol your body absorbs. Ezetimibe tablets do not help you lose weight. Ezetimibe tablets have not been shown to prevent heart disease or heart attacks.

For more information about cholesterol,

  • Do not take ezetimibe tablets if you are allergic to ezetimibe, the active ingredient in ezetimibe tablets, or to the inactive ingredients. For a list of inactive ingredients,

    Tell your doctor about any prescription and non-prescription medicines you are taking or plan to take, including natural or herbal remedies.

    Tell your doctor about all your medical conditions including allergies.

How Should I Take Ezetimibe Tablets? 

  • Take ezetimibe tablets once a day, with or without food. It may be easier to remember to take your dose if you do it at the same time every day, such as with breakfast, dinner, or at bedtime. If you also take another medicine to reduce your cholesterol, ask your doctor if you can take them at the same time.
  • If you forget to take ezetimibe tablets, take it as soon as you remember. However, do not take more than one dose of ezetimibe tablets a day.
  • Continue to follow a cholesterol-lowering diet while taking ezetimibe tablets. Ask your doctor if you need diet information.
  • Keep taking ezetimibe tablets unless your doctor tells you to stop. It is important that you keep taking ezetimibe tablets even if you do not feel sick.

In clinical studies, patients reported few side effects while taking ezetimibe tablets. These included diarrhea, joint pains, and feeling tired.

Patients have experienced severe muscle problems while taking ezetimibe tablets, usually when ezetimibe tablets were added to a statin drug. If you experience unexplained muscle pain, tenderness, or weakness while taking ezetimibe tablets, contact your doctor immediately. You need to do this promptly, because on rare occasions, these muscle problems can be serious, with muscle breakdown resulting in kidney damage.

Additionally, the following side effects have been reported in general use: allergic reactions (which may require treatment right away) including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing, rash, and hives; raised red rash, sometimes with target-shaped lesions; joint pain; muscle aches; alterations in some laboratory blood tests; liver problems; stomach pain; inflammation of the pancreas; nausea; dizziness; tingling sensation; depression; headache; gallstones; inflammation of the gallbladder.

Tell your doctor if you are having these or any other medical problems while on ezetimibe tablets. For a complete list of side effects, ask your doctor or pharmacist.

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

Inactive Ingredients: 

Croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, and sodium lauryl sulfate.

*All trademarks are property of their respective owners.

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

Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Oral Solid Dosage Unit

Ahmedabad, 382213 INDIA

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Rev. 05-2017-00

Patient Information 

See FDA-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.

17.1 Muscle Pain

All patients starting therapy with ezetimibe should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness. The risk of this occurring is increased when taking certain types of medication. Patients should discuss all medication, both prescription and over-the-counter, with their physician.

17.2 Liver Enzymes

Liver tests should be performed when Ezetimibe Tablet is added to statin therapy and according to statin recommendations.

17.3 Pregnancy

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

17.4 Breastfeeding

Women who are breastfeeding should be advised to not use Ezetimibe Tablets added to statin therapy. Patients who have a lipid disorder and are breastfeeding should be advised to discuss the options with their healthcare professionals.

Manufactured By: 

Alkem Laboratories Ltd.

Mumbai - 400 013, INDIA

Distributed By: 

Ascend Laboratories, LLC

Parsippany, NJ 07054


Revised: March,2017
PT 2508-01

Tell Your Doctor If You: 

ever had liver problems. Ezetimibe Tablets may not be right for you.

are pregnant or plan to become pregnant. Your doctor will discuss with you whether Ezetimibe Tablet is right for you.

are breast-feeding. We do not know if Ezetimibe Tablets can pass to your baby through your milk. Your doctor will discuss with you whether Ezetimibe Tablet is right for you.

experience unexplained muscle pain, tenderness, or weakness.

How should I take Ezetimibe

Tablets? 

Take Ezetimibe Tablets once a day, with or without food. It may be easier to remember to take your dose if you do it at the same time every day, such as with breakfast, dinner, or at bedtime. If you also take another medicine to reduce your cholesterol, ask your doctor if you can take them at the same time.

If you forget to take Ezetimibe Tablets, take it as soon as you remember. However, do not take more than one dose of Ezetimibe Tablets a day.

Continue to follow a cholesterol-lowering diet while taking Ezetimibe Tablets. Ask your doctor if you need diet information.

Keep taking Ezetimibe Tablets unless your doctor tells you to stop. It is important that you keep taking Ezetimibe Tablets even if you do not feel sick.

In clinical studies patients reported few side effects while taking Ezetimibe Tablets. These included diarrhea, joint pains, and feeling tired.

Patients have experienced severe muscle problems while taking Ezetimibe Tablets, usually when Ezetimibe Tablets was added to a statin drug. If you experience unexplained muscle pain, tenderness, or weakness while taking Ezetimibe Tablets, contact your doctor immediately. You need to do this promptly, because on rare occasions, these muscle problems can be serious, with muscle breakdown resulting in kidney damage.

Additionally, the following side effects have been reported in general use: allergic reactions (which may require treatment right away) including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing, rash, and hives; raised red rash, sometimes with target-shaped lesions; joint pain; muscle aches; alterations in some laboratory blood tests; liver problems; stomach pain; inflammation of the pancreas; nausea; dizziness; tingling sensation; depression; headache; gallstones; inflammation of the gallbladder.

Tell your doctor if you are having these or any other medical problems while on Ezetimibe Tablets. For a complete list of side effects, ask your doctor or pharmacist.

What Should I Know About High Cholesterol? 

Cholesterol is a type of fat found in your blood. Your total cholesterol is made up of LDL and HDL cholesterol.

LDL cholesterol is called bad cholesterol because it can build up in the wall of your arteries and form plaque. Over time, plaque build-up can cause a narrowing of the arteries. This narrowing can slow or block blood flow to your heart, brain, and other organs. High LDL cholesterol is a major cause of heart disease and one of the causes for stroke.

HDL cholesterol is called good cholesterol because it keeps the bad cholesterol from building up in the arteries.

Triglycerides also are fats found in your blood.

General information about EzetimibeTablets

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

This summarizes the most important information about Ezetimibe Tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Ezetimibe Tablets that is written for health professionals.



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