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Risks and Side Effects

Read the Patient Information before you start taking LOVAZA, and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What Are the Possible Side Effects of LOVAZA?

LOVAZA may cause serious side effects, including:

  • increases in the results of blood tests used to check your liver function (ALT and AST) and your bad cholesterol levels (LDL-C)
  • increases in the frequency of a heart rhythm problem (atrial fibrillation or flutter) may especially happen in the first few months of taking LOVAZA if you already have that problem

The most common side effects of LOVAZA include:

  • burping
  • upset stomach
  • a change in your sense of taste

Talk to your doctor if you have a side effect that bothers you or does not go away.

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What is LOVAZA?

  • LOVAZA is a prescription medicine used along with a low fat and low cholesterol diet to lower very high triglyceride (fat) levels in adults.
  • It is not known if LOVAZA changes your risk of having inflammation of your pancreas (pancreatitis).
  • It is not known if LOVAZA prevents you from having a heart attack or stroke.
  • It is not known if LOVAZA is safe and effective in children.

Who should not take LOVAZA?

  • Do not take LOVAZA if you are allergic to omega-3-acid ethyl esters or any of the ingredients in LOVAZA. See the end of this page for a complete list of ingredients in LOVAZA.

What should I tell my doctor before taking LOVAZA?

  • Before you take LOVAZA, tell your doctor if you:
    • have diabetes.
    • have a low thyroid problem (hypothyroidism).
    • have a liver problem.
    • have a pancreas problem.
    • have a certain heart rhythm problem called atrial fibrillation or flutter.
    • are allergic to fish or shellfish. It is not known if people who are allergic to fish or shellfish are also allergic to LOVAZA.
    • are pregnant or plan to become pregnant. It is not known if LOVAZA will harm your unborn baby.
    • are breastfeeding or plan to breastfeed. LOVAZA can pass into your breast milk. You and your doctor should decide if you will take LOVAZA or breastfeed.
  • Tell your doctor about all the medicines you take, including prescription and non-prescription medicine, vitamins, and herbal supplements.
  • LOVAZA can interact with certain other medicines that you are taking. Using LOVAZA with medicines that affect blood clotting (anticoagulants or blood thinners) may cause serious side effects.
  • Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take LOVAZA?

  • Take LOVAZA exactly as your doctor tells you to take it.
  • You should not take more than 4 capsules of LOVAZA each day. Either take all 4 capsules at one time, or
    2 capsules two times a day.
  • Do not change your dose or stop LOVAZA without talking to your doctor.
  • Take LOVAZA with or without food.
  • Take LOVAZA capsules whole. Do not break, crush, dissolve, or chew LOVAZA capsules before swallowing. If you cannot swallow LOVAZA capsules whole, tell your doctor. You may need a different medicine.
  • Your doctor may start you on a diet that is low in saturated fat, cholesterol, carbohydrates, and low in added sugars before giving you LOVAZA. Stay on this diet while taking LOVAZA.
  • Your doctor should do blood tests to check your triglyceride, bad cholesterol and liver function levels while you take LOVAZA.

How should I store LOVAZA?

  • Store LOVAZA at room temperature between 68°F to 77°F (20°C to 25°C).
  • Do not freeze LOVAZA.
  • Safely throw away medicine that is out of date or no longer needed.
  • Keep LOVAZA and all medicines out of the reach of children.

General information about the safe and effective use of LOVAZA

  • Medicines are sometimes prescribed for purposes other than those listed in the Patient Information. 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 symptoms you have. It may harm them.
  • This Patient Information 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.
  • For more information, see the Patient Information or call 1-888-825-5249.

What are the ingredients in LOVAZA?

  • Active Ingredient: omega-3-acid ethyl esters, mostly EPA and DHA
  • Inactive Ingredients: alpha-tocopherol (in soybean oil), gelatin, glycerol, purified water.

IMPORTANT SAFETY INFORMATION

Do not take LOVAZA if you are allergic to omega-3-acid ethyl esters or any ingredient in LOVAZA.

Tell your doctor if you are allergic to fish or shellfish, or if you are pregnant, breastfeeding or plan to become pregnant or breastfeed as LOVAZA may not be right for you.

Talk to your doctor about any current medical conditions and any medications you are taking, especially those that may increase your risk of bleeding.

Take LOVAZA exactly as your doctor tells you to take it. You should not take more than 4 capsules of LOVAZA each day.

Your healthcare provider should do blood tests to check your triglyceride, bad cholesterol and liver function levels while you take LOVAZA.

LOVAZA may cause serious side effects including increases in:

  • results of blood tests to check your liver function (ALT and AST) and your bad cholesterol levels (LDL-C)
  • frequency of a heart rhythm problem (atrial fibrillation or flutter) that may especially happen in the first few months of taking LOVAZA if you already have that problem.

The most common side effects include burping, upset stomach, and change in sense of taste.

How supplied: 1-gram capsule

For more information about LOVAZA, click here to see the Patient Information or full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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