Lipofen helps reduce cholesterol and triglycerides (fatty acids) in the blood. High levels of these types of fat in the blood are associated with an increased risk of atherosclerosis (clogged arteries).

Lipofen may also be used for purposes not listed in this medication guide.

You should not take Lipofen if you have liver disease, gallbladder disease, severe kidney disease, or if you are breast-feeding a baby.

Lipofen can cause the breakdown of muscle tissue, which can lead to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark urine.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Some brands of fenofibrate should be taken with meals to help your body better absorb the medicine. Other brands may be taken with or without food. Follow the directions on your medicine label.

Swallow the tablet or capsule whole and do not crush, chew, dissolve, or open it.

You may need frequent medical tests. Even if you have no symptoms, tests can help your doctor determine if Lipofen is effective.

Lipofen is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture, heat, and light.

You should not take Lipofen if you are allergic to it, or if you have:

• severe kidney disease (or if you are on dialysis);

• liver disease; or

• gallbladder disease.

Do not breast-feed while using this medicine, and for at least 5 days after your last dose.

Tell your doctor if you have ever had:

• kidney disease;

• liver disease; or

• gallbladder problems.

Lipofen can cause the breakdown of muscle tissue, which can lead to kidney failure. This happens more often in women, in older adults, or people who have kidney disease, diabetes, or poorly controlled hypothyroidism (underactive thyroid).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Lipofen is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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

Avoid eating foods high in fat or cholesterol, or Lipofen will not be as effective.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

In rare cases, Lipofen can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark colored urine.

Also call your doctor at once if you have:

• sharp stomach pain spreading to your back or shoulder blade;

• loss of appetite, stomach pain just after eating a meal;

• jaundice (yellowing of the skin or eyes);

• fever, chills, weakness, sore throat, mouth sores, unusual bruising or bleeding;

• chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

• swelling, warmth, or redness in an arm or leg.

Common side effects of Lipofen may include:

• runny nose, sneezing; or

• abnormal laboratory tests.

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.

Some medicines can make Lipofen much less effective when taken at the same time. If you take any of the following medicines, take your this medicine dose 1 hour before or 4 to 6 hours after you take the other medicine.

• cholestyramine;

• colesevelam; or

• colestipol.

Tell your doctor about all your other medicines, especially:

• other cholesterol lowering medicines;

• colchicine;

• a blood thinner such as warfarin, Coumadin, Jantoven; or

• drugs that weaken the immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection.

This list is not complete. Other drugs may affect Lipofen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.