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

The usual dosage is 2 grams (2 capsules) or 4 grams (4 capsules) once daily without regard to meals.

You should take the exact dose your doctor prescribes.

Do not change your dose or stop treatment without talking to your doctor.

If you miss a dose, take it as soon as you remember. However, if you miss one whole day of dosing, do not double your catch up dose.

Swallow capsules whole. Do not break open, crush, dissolve, or chew capsules before swallowing. If you cannot swallow the 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. You should start this diet before your treatment, and continue during your treatment.

Your doctor should do blood tests to check your triglycerides, bad cholesterol and liver function levels during your treatment.

You should not take this medicine if you are allergic to omega-3-carboxylic acids or any of the other ingredients.

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
• are pregnant or plan to become pregnant, as it is not known if Epanova will harm your unborn baby
• are breastfeeding or plan to breastfeed, as Epanova can pass into your breast milk.

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

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 include:

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

This is not a complete list of possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.