Omega-3 polyunsaturated fatty acids are found in oil from certain types of fish, vegetables, and other plant sources. These fatty acids are not made by the body and must be consumed in the diet. Omacor works by lowering the body's production of triglycerides. High levels of triglycerides can lead to coronary artery disease, heart disease, and stroke.

Omacor is used together with diet and exercise to help lower triglyceride levels in the blood.

Omacor may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Omacor?

Take Omacor exactly as directed on the label, or as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended.

Swallow the Omacor capsule whole. Do not puncture or open the capsule.

Omacor is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

If you miss a dose, use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

There may be other drugs that can affect Omacor. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Stop using Omacor and get emergency medical help if you think you have used too much medicine, or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely, and you may have none at all. Talk to your doctor about any side effect that seems unusual or is especially bothersome.

Take Omacor exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Omacor works best if you take it with food.

To be sure Omacor is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

Omacor is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Store Omacor at room temperature away from moisture and heat. Do not freeze.

Do not use Omacor if you are allergic to fish or soybeans.

If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before you take Omacor, tell your doctor if you are allergic to any foods or drugs, or if you have:

• diabetes;

• liver disease;

• a pancreas disorder;

• an underactive thyroid; or

• if you drink more than 2 alcoholic beverages per day.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before you take Omacor, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether omega-3 polyunsaturated fatty acids pass into breast milk or if this could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to anyone under 18 years old.

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of Omacor is not expected to produce life-threatening symptoms.

Avoid eating foods that are high in fat or cholesterol. Omacor will not be as effective in lowering your triglycerides if you do not follow the diet plan recommended by your doctor.

Avoid drinking alcohol. It can increase triglycerides and may make your condition worse.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Omacor and call your doctor at once if you have any of these serious side effects:

• fever, chills, body aches, flu symptoms;

• chest pain; or

• uneven heartbeats.

Less serious Omacor side effects may include:

• back pain;

• unusual or unpleasant taste in your mouth;

• upset stomach, belching; or

• mild skin rash.

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

Before taking Omacor, tell your doctor if you are using any of the following drugs:

• estrogens (birth control pills or hormone replacement);

• a blood thinner such as warfarin (Coumadin);

• a beta-blocker such as atenolol (Tenormin), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), sotalol (Betapace), timolol (Blocadren), and others; or

• a diuretic (water pill) such as chlorothiazide (Diuril), hydrochlorothiazide (HydroDIURIL, Microzide), chlorthalidone (Hygroton, Thalitone), indapamide (Lozol), metolazone (Mykrox, Zaroxolyn), and others.

This list is not complete and there may be other drugs that can interact with Omacor. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.