Lovaza (Omega-3-Acid Ethyl Esters) Drug Information: Medication Guide and Patient Information

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May 27, 2012

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PATIENT INFORMATION

LOVAZA®
(lo-va-za)
(omega-3-acid ethyl esters) Capsules

Read the Patient Information that comes with LOVAZA (omega-3-acid ethyl esters) before you start taking it, and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.

What is LOVAZA (omega-3-acid ethyl esters) ?

LOVAZA (omega-3-acid ethyl esters) is a prescription medicine, called a lipid-regulating medicine, for adults. LOVAZA (omega-3-acid ethyl esters) 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 (omega-3-acid ethyl esters) is used along with a low-fat and low-cholesterol diet to lower very high triglycerides (fats) in your blood. Before taking LOVAZA (omega-3-acid ethyl esters) , 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 (omega-3-acid ethyl esters) has not been shown to prevent heart attacks or strokes. LOVAZA (omega-3-acid ethyl esters) has not been studied in children under the age of 18 years.

Who should not take LOVAZA (omega-3-acid ethyl esters) ?

Do not take LOVAZA (omega-3-acid ethyl esters) if you:

are allergic to LOVAZA (omega-3-acid ethyl esters) or any of its ingredients. See the end of this leaflet for a complete list of ingredients in LOVAZA (omega-3-acid ethyl esters) .

What should I tell my doctor before taking LOVAZA (omega-3-acid ethyl esters) ?

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 and/or shellfish. LOVAZA (omega-3-acid ethyl esters) may not be right for you.
are pregnant, or planning to become pregnant. It is not known if LOVAZA (omega-3-acid ethyl esters) can harm your unborn baby.
are breastfeeding. It is not known if LOVAZA (omega-3-acid ethyl esters) 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 (omega-3-acid ethyl esters) 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 (omega-3-acid ethyl esters) ?

Take LOVAZA (omega-3-acid ethyl esters) exactly as prescribed. Do not change your dose or stop LOVAZA (omega-3-acid ethyl esters) without talking to your doctor.
The usual dose of LOVAZA (omega-3-acid ethyl esters) is 4 capsules:
- Take all 4 capsules at the same time, or
- Take 2 capsules two times a day
Take LOVAZA (omega-3-acid ethyl esters) at the same time or times each day.
Take LOVAZA (omega-3-acid ethyl esters) with or without food. You may find it easier to take LOVAZA (omega-3-acid ethyl esters) 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.
Take LOVAZA (omega-3-acid ethyl esters) capsules whole. Do not break, crush, dissolve, or chew LOVAZA (omega-3-acid ethyl esters) capsules before swallowing. If you cannot swallow LOVAZA (omega-3-acid ethyl esters) capsules whole, tell your doctor. You may need a different medicine.
Your doctor should start you on a low-fat and low-cholesterol diet before giving you LOVAZA (omega-3-acid ethyl esters) . Stay on this low-fat and low-cholesterol diet while taking LOVAZA (omega-3-acid ethyl esters) .
Your doctor should do blood tests to check your triglyceride and cholesterol levels during treatment with LOVAZA (omega-3-acid ethyl esters) .
If you have liver disease, your doctor should do blood tests to check your liver function during treatment with LOVAZA (omega-3-acid ethyl esters) .
If you miss a dose of LOVAZA (omega-3-acid ethyl esters) , take it as soon as you remember. However, if you miss one day of LOVAZA (omega-3-acid ethyl esters) , do not double your dose when you next take it.
If you take too much LOVAZA (omega-3-acid ethyl esters) or overdose, call your doctor or Poison Control Center right away.

What are the possible side effects of LOVAZA (omega-3-acid ethyl esters) ?

The most common side effects with LOVAZA (omega-3-acid ethyl esters) are burping, upset stomach, a change in your sense of taste, and skin rash.

LOVAZA (omega-3-acid ethyl esters) 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 (omega-3-acid ethyl esters) . For more information, ask your doctor or pharmacist.

How should I store LOVAZA (omega-3-acid ethyl esters) ?

Store LOVAZA (omega-3-acid ethyl esters) 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 (omega-3-acid ethyl esters) out of the reach of children. Be sure that if you throw medicines away, it is out of the reach of children.

General information about LOVAZA (omega-3-acid ethyl esters)

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use LOVAZA (omega-3-acid ethyl esters) for a condition for which it was not prescribed. Do not give LOVAZA (omega-3-acid ethyl esters) 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 (omega-3-acid ethyl esters) . If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about LOVAZA (omega-3-acid ethyl esters) that is written for health professionals or go to www.LOVAZA (omega-3-acid ethyl esters) .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)

Last reviewed on RxList: 2/10/2011
This monograph has been modified to include the generic and brand name in many instances.