Omega-3-acid ethyl esters capsules, USP

This product has the same...

  • Active ingredient
  • Dosage strength
  • FDA standards of quality and performance

... as Lovaza® Capsules

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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.

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IMPORTANT SAFETY INFORMATION

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 Patient Information leaflet for a complete list of ingredients in omega-3-acid ethyl esters capsules.

What should I tell my doctor before taking omega-3-acid ethyl esters capsules?

Before you take omega-3-acid ethyl esters capsules, tell your doctor if you:

  • have diabetes.
  • have a low thyroid problem (hypothyroidism).
  • have a liver problem.
  • have a pancreas problem.
  • have a certain heart rhythm problem called atrial fibrillation or flutter.
  • are allergic to fish or shellfish. It is not known if people who are allergic to fish or shellfish are also allergic to omega-3-acid ethyl esters capsules.
  • are pregnant, or plan to become pregnant. It is not known if omega-3-acid ethyl esters capsules will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. Omega-3-acid ethyl esters can pass into your breast milk. You and your doctor should decide if you will take omega-3-acid ethyl esters capsules or breastfeed.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicine, 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. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

What are the possible side effects of omega-3-acid ethyl esters capsules?

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

  • increases in the results of blood tests used to check your liver function (ALT and AST) and your bad cholesterol levels (LDL-C).
  • increases in the frequency of a heart rhythm problem (atrial fibrillation or flutter) may especially happen in the first few months of taking omega-3-acid ethyl esters capsules if you already have that problem.

The most common side effects of omega-3-acid ethyl esters capsules include: burping, upset stomach, and a change in your sense of taste.

Talk to your doctor if you have a side effect that bothers you or does not go away. These are not all the possible side effects of omega-3-acid ethyl esters capsules. For more information, 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.

Please read the Patient Information in the accompanying full Prescribing Information.

 

TG-40799 October 2016

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* Lovaza® is a registered trademark of GlaxoSmithKline LLC.

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