Description
Omega-3-acid ethyl esters are used together with a proper diet to lower very high triglyceride (fat-like substance) levels in the blood. This medicine may help prevent medical problems caused by clogged blood vessels such as heart attacks and strokes.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule, Liquid Filled
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of omega-3-acid ethyl esters in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of omega-3-acid ethyl esters in the elderly.
Breastfeeding
Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Allergy to fish or shellfish, history of—Use with caution. May increase risk of having an allergic reaction.
- Atrial fibrillation or flutter (heart rhythm problem), or history of—Use with caution. May cause this condition to occur again.
- Diabetes or
- Hypothyroidism (underactive thyroid)—May increase risk for hypertriglyceridemia.
- Liver problems—Your doctor may want to monitor you more closely for unwanted effects.
Proper Use
Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, or do not use it for a longer time than your doctor ordered. Also, do not stop or change your dose without checking first with your doctor.
This medicine comes with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
Remember that this medicine will not cure your condition but it does help control it. Therefore, you must continue to take it as directed if you expect to keep your triglyceride (fats) levels down.
Before prescribing medicine for your condition your doctor will probably try to control your condition prescribing a personal diet for you. Carefully follow the special diet your doctor gave you. Such a diet may be low in fats, sugars, and/or cholesterol. Many people are able to control their condition by carefully following their doctor's orders for proper diet and exercise. Medicine is prescribed only when additional help is needed and is effective only when a schedule of diet and exercise is properly followed. Also, this medicine is less effective if you are greatly overweight. It may be very important for you to go on a weight-reducing diet. However, check with your doctor before going on any diet.
This medicine may be taken with meals.
Swallow the capsule whole. Do not break, crush, chew, dissolve, or open the capsule. If you are using a disposable foam plastic cup (Styrofoam cup), do not puncture the capsule and do not let its contents contact the foam plastic cup.
Take this medicine at the same time each day.
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 high triglycerides or fats in the blood:
- Adults—4 capsules per day, either taken as a single dose once per day, or 2 capsules two times a day.
- Children—Use and dose must be determined by your doctor.
- For high triglycerides or fats in the blood:
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.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Incidence not known
- Bleeding gums
- cough
- coughing up blood
- difficulty with breathing or swallowing
- dizziness
- fast or irregular heartbeat
- headache
- hives, itching, or skin rash
- increased menstrual flow or vaginal bleeding
- nosebleeds
- paralysis
- prolonged bleeding from cuts
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red or black, tarry stools
- red or dark brown urine
- sweating
- 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:
Less common
- Acid or sour stomach
- bad, unusual, or unpleasant (after) taste
- belching
- bloated or full feeling
- change in taste
- excess air or gas in the stomach
- heartburn
- indigestion
- stomach discomfort, upset, or pain
Incidence not known
- Diarrhea
- difficulty having a bowel movement (stool)
- loss of appetite
- nausea or vomiting
- passing of gas
- stomach fullness
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.
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