Omega-3-carboxylic acids (Oral)

Omega-3-carboxylic acids are a mixture of free fatty acids derived from fish oil. They are used along with a low fat and low cholesterol diet to help lower high triglyceride (fat) levels.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress during regular visits to ensure that this medicine is working properly. Blood tests may be necessary to look for any unwanted effects.

Do not take other medicines unless you have talked about them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of taking it against the benefits it will provide. For this medicine, please consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, inform your healthcare professional about any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to understand how age affects the effects of omega-3-carboxylic acids in children. Safety and effectiveness have not been established.

Geriatric

Studies so far have not shown any specific problems in older adults that would limit the usefulness of omega-3-carboxylic acids. However, older patients are more likely to have kidney, liver, or heart issues, which may require caution and possibly a dose adjustment for those taking this medicine.

Breast Feeding

Studies suggest that this medication may change milk production or its composition. If you are not given an alternative to this medication, you should watch the infant for side effects and ensure they are getting enough milk.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. If this is the case, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at the same time as eating food or specific types of food because interactions may occur. Drinking alcohol or using tobacco with certain medicines may also lead to interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems you have may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Allergy to fish or shellfish—Use with caution. May increase the risk of having an allergic reaction.

• Diabetes or
• Hypothyroidism (underactive thyroid)—May increase the risk for hypertriglyceridemia.

• Liver problems—Your doctor may want to monitor you more closely for unwanted effects.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Cough
• difficulty swallowing
• dizziness
• fast heartbeat
• hives, itching, or skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• tightness in the chest
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Change in taste
• diarrhea
• difficulty having a bowel movement (stool)
• difficulty with moving
• fever
• full or bloated feeling
• headache
• loss of taste
• muscle aches
• muscle pain or stiffness
• nausea
• pain in the joints
• pressure in the stomach
• sore throat
• stuffy or runny nose
• swelling of the abdominal or stomach area
• unusual tiredness or weakness
• vomiting

Less common

• Abdominal or stomach pain or discomfort
• belching
• bloated or full feeling
• excess air or gas in the stomach

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Epanova

Chemical Class: Omega-3 Fatty Acid

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Swallow the capsule whole. Do not crush, break, chew, or open it. If you cannot swallow the capsule whole, tell your doctor.

Take this medicine with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):For severe hypertriglyceridemia: Adults—2 grams (2 capsules) or 4 grams (4 capsules) once a day. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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