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Lovaza 1gm Capsules
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Product ID: **LOVAZA1
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Product Summary

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IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

OMEGA-3 ACID ETHYL ESTERS - ORAL

(oh-MAY-gah 3 AS-id ETH-il ES-ters)

COMMON BRAND NAME(S): Lovaza

USES: Omega-3 acid ethyl esters, a type of fat found in fish oil, is used along with diet and exercise to help lower levels of a certain blood fat (triglyceride). It may also raise "good" cholesterol (HDL). In general, this drug is used after your blood fat levels have not been fully controlled by non-drug treatments (e.g., diet changes, exercise, decreasing alcohol intake, weight loss if overweight, controlling blood sugar if diabetic, and regulating your thyroid hormone levels). Lowering triglycerides and increasing "good" cholesterol may help decrease the risk for strokes and heart attacks. Omega-3 acid ethyl esters are thought to work by decreasing the amount of triglyceride the body makes.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth, usually once or twice a day with a meal or as directed by your doctor. Swallow the capsules whole. Do not crush, chew, or dissolve the capsules. Do not substitute other omega-3 fatty acids or fish oil products (e.g., nonprescription products, vitamins, supplements) for this product without talking with your doctor first. They may not contain the same amount and type of fatty acids. Dosage is based on your medical condition and response to therapy. Use this medication regularly to get the most benefit from it. Remember to take it at the same time(s) each day. It is important to continue taking this medication even if you feel well. Most people with high triglycerides do not feel sick. It is very important to continue to follow your doctor's advice about diet and exercise. It may take up to 2 months to get the full benefits of this drug.

SIDE EFFECTS: Upset stomach, burping, and strange taste in mouth may occur. If these effects persist or worsen, notify your doctor promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, black/tarry stool, vomit that looks like coffee grounds. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking omega-3 acid ethyl esters, tell your doctor or pharmacist if you are allergic to it; or to fish or soy products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcohol use, diabetes, liver disease, underactive thyroid (hypothyroidism). This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially: anti-platelet drugs (e.g., clopidogrel, ticlopidine), "blood thinners" (e.g., warfarin, heparins), drugs which can increase triglycerides (e.g., beta blockers, estrogens, certain "water pills"/diuretics such as thiazides), other vitamins/supplements (e.g., fish/flaxseed/cod liver oils). This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., liver tests, triglyceride/lipid levels) may be performed to monitor your progress or check for side effects. Consult your doctor for more details. For best results, this medication should be used along with a doctor-approved diet, exercise, and weight control. Consult your doctor about other ways to lower your heart disease risk.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not freeze. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised August 2010. Copyright(c) 2010 First Databank, Inc.

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