Vascazen

You should not take this medicine if you are allergic to fish, shellfish, or soybeans.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have other medical conditions, especially:

• diabetes;

• liver disease;

• a heart rhythm disorder;

• a pancreas disorder;

• underactive thyroid;

• if you drink more than 2 alcoholic beverages per day.

It is not known whether omega-3 polyunsaturated fatty acids will harm an unborn baby. Ask a doctor before using this medicine if you are pregnant.

It is not known whether omega-3 polyunsaturated fatty acids pass into breast milk or if this could harm a nursing baby. Ask a doctor before using this medicine if you are breast-feeding a baby.

Do not give this medication to anyone under 18 years old.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• fever, chills, body aches, flu symptoms;

• chest pain; or

• uneven heartbeats.

Common side effects may include:

• upset stomach, belching;

• loss of appetite;

• diarrhea, constipation;

• back pain; or

• dry mouth, altered sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Applies to omega-3 polyunsaturated fatty acids: oral capsule liquid filled

Along with its needed effects, omega-3 polyunsaturated fatty acids (the active ingredient contained in Vascazen) 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 while taking omega-3 polyunsaturated fatty acids:

• 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 of omega-3 polyunsaturated fatty acids 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:

• 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

• Diarrhea
• difficulty having a bowel movement (stool)
• loss of appetite
• nausea or vomiting
• passing of gas
• stomach fullness