What is LOVAZA?

LOVAZA is a prescription medicine for adults called a lipid-regulating medicine. LOVAZA is made of omega-3 fatty acids. Omega-3 fatty acids are natural substances that your body needs. They are found naturally in some plants and in the oil of certain fish, such as salmon and mackerel.

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:

• losing weight, if you are overweight
• increasing physical exercise
• lowering alcohol use
• treating diseases such as diabetes and low thyroid (hypothyroidism)
• adjusting the dose or changing other medicines that raise triglyceride levels such as certain blood pressure medicines and estrogens

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.

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Who should not take LOVAZA?

Do not take LOVAZA if you:

• are allergic to LOVAZA or any of its ingredients. See below for a complete list of ingredients in LOVAZA

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What should I tell my doctor before taking LOVAZA?

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

• drink more than 2 glasses of alcohol daily
• have diabetes
• have a thyroid problem called hypothyroidism
• have a liver problem
• have a pancreas problem
• are allergic to fish. LOVAZA may not be right for you
• are pregnant, or planning to become pregnant. It is not known if LOVAZA can harm your unborn baby
• are breastfeeding. It is not known if LOVAZA passes into your milk and if it can harm your baby

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 causing serious side effects. Especially tell your doctor if you take medicines:

• to reduce clotting – known as anticoagulants or blood thinners. These include aspirin, warfarin, coumarin and clopidogrel (PLAVIX)

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

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How should I take LOVAZA?

• Take LOVAZA exactly as prescribed. Do not change your dose or stop LOVAZA without talking to your doctor
• The usual dose of LOVAZA is 4 capsules:
• Take all 4 capsules at the same time, or
• Take 2 capsules two times a day
• Take LOVAZA at the same time or times each day
• Take LOVAZA with or without food. You may find it easier to take LOVAZA with food
• Do not take more than 4 capsules a day. Taking more than 4 capsules per day may increase the chance of side effects
• Your doctor should start you on a low-fat and low-cholesterol diet before giving you LOVAZA. Stay on this low-fat and low-cholesterol diet while taking LOVAZA
• Your doctor should do blood tests to check your triglyceride and cholesterol levels, and liver function during treatment with LOVAZA
• If you miss a dose of LOVAZA, take it as soon as you remember. However, if you miss one day of LOVAZA, do not double your dose when you next take it
• If you take too much LOVAZA or overdose, call your doctor or Poison Control Center right away

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What are the possible side effects of LOVAZA?

• The most common side effects with LOVAZA are burping, infection, flu symptoms, upset stomach, a change in your sense of taste, back pain, and skin rash.
• LOVAZA may affect certain blood tests. It may change:
  • one of the tests to check liver function (ALT)
  • one of the tests to measure cholesterol levels (LDL-C)

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. Ask your doctor or pharmacist for a complete list.

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How should I store LOVAZA?

• Store LOVAZA at room temperature, 59° to 86° F (15° to 30° C). Do not freeze.
• Do not keep medicine that is out of date or that you no longer need.
• Keep LOVAZA out of the reach of children. Be sure that if you throw medicines away, it is out of the reach of children.

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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

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What are the ingredients in LOVAZA?

Active Ingredient: Omega-3-acid ethyl esters

Inactive Ingredients: Gelatin, glycerol, purified water, alpha-tocopherol (in partially hydrogenated vegetable oils, including soybean oil)

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LOVAZA is a registered trademark of the GlaxoSmithKline group of companies.
PLAVIX is a registered trademark of Sanofi-Synthelabo.

Distributed by:

GlaxoSmithKline
Research Triangle Park, NC 27709

©2008 GlaxoSmithKline. All rights reserved.