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What are omega-3-acid ethyl esters capsules?

Omega-3-acid ethyl esters capsules are a prescription medicine used along with a low fat and low cholesterol diet to lower very high triglyceride (fat) levels in adults.

It is not known if omega-3-acid ethyl esters capsules change your risk of having inflammation of your pancreas (pancreatitis).

It is not known if omega-3-acid ethyl esters capsules prevent you from having a heart attack or stroke.

It is not known if omega-3-acid ethyl esters capsules are safe and effective in children.

Who should not take omega-3-acid ethyl esters capsules?

Do not take omega-3-acid ethyl esters capsules if you are allergic to omega-3-acid ethyl esters or any of the ingredients in omega-3-acid ethyl esters capsules. See the end of this leaflet for a complete list of ingredients in omega-3-acid ethyl esters capsules.

Before taking omega-3-acid ethyl esters capsules, tell your healthcare provider about all of your medical conditions, including if you: ­

Tell your healthcare provider about all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements.

Omega-3-acid ethyl esters capsules can interact with certain other medicines that you are taking. Using omega-3-acid ethyl esters capsules with medicines that affect blood clotting (anticoagulants or blood thinners) may cause serious side effects. ­

Omega-3-acid ethyl esters capsules may cause serious side effects, including:

The most common side effects of omega-3-acid ethyl esters capsules include:

These are not all the possible side effects of omega-3-acid ethyl esters capsules.

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

General information about the safe and effective use of omega-3-acid ethyl esters capsules

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use omega-3-acid ethyl esters capsules for a condition for which it was not prescribed. Do not give omega-3-acid ethyl esters capsules to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about omega-3-acid ethyl esters capsules that is written for health professionals.

What are the ingredients in omega-3-acid ethyl esters capsules?

Active Ingredient: omega-3-acid ethyl esters, mostly EPA and DHA

Inactive Ingredients: alpha-tocopherol (in soybean oil), gelatin, glycerin, purified water and white ink. The capsule imprinting ink contains ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide.

­ This patient labeling has been approved by the U.S. Food and Drug Administration. ­