What is LOVAZA?

LOVAZA is a prescription medicine, called a lipid-regulating medicine, for adults. LOVAZA is made of omega-3 fatty acids from oils of fish, such as salmon and mackerel. Omega-3 fatty acids are substances that your body needs but cannot produce itself.

LOVAZA is used along with a low-fat and low-cholesterol diet to lower very high triglycerides (fats) in your blood. Before taking LOVAZA, talk to your healthcare provider about how you can lower high blood fats by:

Treatment with LOVAZA has not been shown to prevent heart attacks or strokes.

LOVAZA has not been studied in children under the age of 18 years.

Who should not take LOVAZA?

Do not take LOVAZA if you:

What should I tell my doctor before taking LOVAZA?

Tell your doctor about all of your medical conditions, including if you:

Tell your doctor about all the medicines you take, including prescription and non-prescription medicine, vitamins, and herbal supplements. LOVAZA and certain other medicines can interact. Especially tell your doctor if you take medicines that affect clotting such as anticoagulants or blood thinners. Examples of these medicines include aspirin, nonsteroidal anti-inflammatory agents (NSAIDS), warfarin, coumarin, and clopidogrel (PLAVIX).

Know all the medicines you take. Keep a list of them with you to show your doctor and pharmacist.

How should I take LOVAZA?

What are the possible side effects of LOVAZA?

The most common side effects with LOVAZA are burping, upset stomach, and a change in your sense of taste.

LOVAZA may affect certain blood tests. It may change:

Talk to your doctor if you have side effects that bother you or that will not go away. You may report side effects to FDA at 1-800-FDA-1088.

These are not all the side effects with LOVAZA. For more information, ask your doctor or pharmacist.

How should I store LOVAZA?

General information about LOVAZA

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use LOVAZA for a condition for which it was not prescribed. Do not give LOVAZA to other people, even if they have the same problem you have. It may harm them.

This leaflet summarizes the most important information about LOVAZA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about LOVAZA that is written for health professionals or go to www.LOVAZA.com.

What are the ingredients in LOVAZA?

Active Ingredient: Omega-3-acid ethyl esters

Inactive Ingredients: Gelatin, glycerol, purified water, alpha-tocopherol (in soybean oil)

LOVAZA is a registered trademark of the GlaxoSmithKline group of companies.

PLAVIX is a registered trademark of Sanofi-Synthelabo.

Manufactured for GlaxoSmithKline by:

Catalent Pharma Solutions

2725 Scherer Drive

St. Petersburg, FL 33716-1016

Accucaps Industries Limited

2125 Ambassador Drive

Windsor, Ontario, Canada N9B 3R5

Banner Pharmaceuticals Inc.

4125 Premier Drive

High Point, NC 27265

Distributed by:

GlaxoSmithKline

Research Triangle Park, NC 27709

©2010 GlaxoSmithKline. All rights reserved.

December 2010

LVZ:4PIL

PRINCIPAL DISPLAY PANEL

NDC 0173-0783-01

Lovaza

(omega-3-acid ethyl esters)

Capsules