Epanova

PATIENT INFORMATION

EPANOVA
(EPP-ah-no-vah)
(omega-3-carboxylic acids) Soft-gelatin Capsules

What is EPANOVA?

EPANOVA is 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 EPANOVA changes your risk of having inflammation of your pancreas (pancreatitis).
  • It is not known if EPANOVA prevents you from having a heart attack or stroke.
  • It is not known if EPANOVA is safe and effective in children.

Who should not take EPANOVA?

Do not take EPANOVA if you are allergic to omega-3-carboxylic acids or any of the ingredients in EPANOVA. See the end of this leaflet for a complete list of ingredients in EPANOVA.

Before taking EPANOVA, tell your doctor about all your medical conditions, including if you:

  • have diabetes
  • have a low thyroid problem (hypothyroidism)
  • have a liver problem
  • have a pancreas problem
  • are allergic to fish or shellfish. It is not known if people who are allergic to fish or shellfish are also allergic to EPANOVA.
  • are pregnant or plan to become pregnant. It is not known if EPANOVA will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. EPANOVA can pass into your breast milk. You and your doctor should decide if you will take EPANOVA or breastfeed.

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

How should I take EPANOVA?

  • Take EPANOVA exactly as your doctor tells you to take it.
  • Do not change your dose or stop taking EPANOVA without talking to your doctor.
  • If you miss a dose of EPANOVA, take it as soon as you remember. However, if you miss 1 day of EPANOVA, do not double your dose when you take it.
  • Take EPANOVA capsules whole. Do not break open, crush, dissolve, or chew EPANOVA capsules before swallowing. If you cannot swallow EPANOVA capsules whole, tell your doctor. You may need a different medicine.
  • Your doctor should start you on a diet that is low in saturated fat, cholesterol, carbohydrates, and low in added sugars before giving you EPANOVA. Stay on this diet while taking EPANOVA.
  • Your doctor should do blood tests to check your triglycerides, bad cholesterol and liver function levels while you take EPANOVA.

What are the possible side effects of EPANOVA?

EPANOVA 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)
  • possible allergic reactions if you are also allergic to fish or shellfish

The most common side effects of EPANOVA include:

  • diarrhea
  • upset stomach
  • abdominal pain or discomfort
  • burping

These are not all the possible side effects of EPANOVA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store EPANOVA?

  • Store EPANOVA at room temperature between 68°F to 77°F (20°C to 25°C).
  • Do not freeze EPANOVA.
  • Keep EPANOVA and all medicines out of the reach of children.

General information about the safe and effective use of EPANOVA.

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

What are the ingredients in EPANOVA?

Active Ingredient: omega-3-carboxylic acids

Inactive Ingredients: α-tocopherol (in a carrier of vegetable oil), gelatin, glycerol, sorbitol, and purified water (components of the capsule shell). Coating and ink components to the EPANOVA capsules also contain ethyl acrylate and methyl methacrylate copolymer dispersion, talc, titanium dioxide, iron oxide red, polysorbate 80, and carboxymethylcellulose sodium (coating components), pharmaceutical glaze, titanium dioxide, n-butyl alcohol, propylene glycol and isopropanol (ink components) Manufactured by: Catalent Germany GmbH, Eberbach and Schorndorf, Germany For more information, go to www.epanova.com or call 1-800-236-9933.

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

Last reviewed on RxList: 5/20/2014
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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