What is the most important information I should know about omega-3 polyunsaturated fatty acids?

Use this medication exactly as it was prescribed for you. Do not use it in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

This medication 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 omega-3 polyunsaturated fatty acids. 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 this medication 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.

What is omega-3 polyunsaturated fatty acids?

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. Omega-3 polyunsaturated fatty acids work by lowering the body's production of triglycerides. High levels of triglycerides can lead to coronary artery disease, heart disease, and stroke.

Omega-3 polyunsaturated fatty acids are used together with diet and exercise to help lower triglyceride levels in the blood.

Omega-3 polyunsaturated fatty acids may also be used for other purposes not listed in this medication guide.

What should I discuss with my health care provider before taking omega-3 polyunsaturated fatty acids?

Do not use this medication 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 omega-3 polyunsaturated fatty acids, tell your doctor if you are allergic to any foods or drugs, or if you have:

• diabetes;
• liver disease;
• a pancreas disorder;
• underactive thyroid;
• 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 omega-3 polyunsaturated fatty acids, 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.

How should I take omega-3 polyunsaturated fatty acids?

Take this medication 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.

This medication works best if you take it with food.

To be sure this medication 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.

This medication 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 this medication at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

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.

What happens if I overdose?

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

An overdose of omega-3 polyunsaturated fatty acids is not expected to produce life-threatening symptoms.

What should I avoid while taking omega-3 polyunsaturated fatty acids?

Avoid eating foods that are high in fat or cholesterol. This medication 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.

What are the possible side effects of omega-3 polyunsaturated fatty acids?

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 this medication 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 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. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect omega-3 polyunsaturated fatty acids?

Before taking this medication, 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 omega-3 polyunsaturated fatty acids. 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.

Where can I get more information?

Your pharmacist can provide more information about omega-3 polyunsaturated fatty acids.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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