Lescol XL is used together with diet to lower blood levels of "bad" cholesterol (low-density lipoprotein, or LDL), to increase levels of "good" cholesterol (high-density lipoprotein, or HDL), and to lower triglycerides (a type of fat in the blood).

Lescol XL is used to slow the build-up of plaque (fatty deposits) in your blood vessels.

Lescol XL is also used to lower the risk of heart complications in certain people with coronary heart disease.

Lescol XL is used in adults and children who are at least 10 years old.

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

You should not take Lescol XL if you have liver disease, or if you are breastfeeding a baby.

Do not use if you are pregnant or breastfeeding.

Some medicines can cause unwanted or dangerous effects when used with Lescol XL. Tell your doctor about all other medicines you use.

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.

Take this medicine with a full glass of water, with or without food.

Take the regular tablet or capsule at the same time(s) each day.

You can take an extended-release tablet at any time of day.

Follow your doctor's dosing instructions very carefully.

Swallow the pill whole and do not crush, chew, break, or open it. Tell your doctor if you have trouble swallowing the pill.

You will need frequent medical tests.

It may take up to 4 weeks before your cholesterol levels improve. Keep using this medicine as directed, even if you feel well. High cholesterol usually has no symptoms.

Lescol XL is only part of a complete treatment program that may also include diet, exercise, and weight control. Follow your doctor's instructions very closely.

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

You should not take Lescol XL if you are allergic to it, or if:

• you have active liver disease; or

• you are pregnant or breastfeeding.

Do not use if you are pregnant. Lescol XL can harm an unborn baby. Use effective birth control to prevent pregnancy. Stop taking this medicine and tell your doctor at once if you become pregnant.

Do not breastfeed while using this medicine.

Tell your doctor if you have ever had:

• liver disease;

• muscle pain or weakness;

• kidney disease;

• diabetes;

• a thyroid disorder; or

• if you drink more than 2 alcoholic beverages daily.

Lescol XL can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

Lescol XL is not approved for use by anyone younger than 10 years old.

Use the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use 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 Lescol XL 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; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, Lescol XL 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:

• muscle weakness in your hips, shoulders, neck, and back;

• trouble lifting your arms, trouble climbing or standing;

• signs of a kidney problem--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath; or

• liver problems--upper stomach pain, loss of appetite, tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of Lescol XL may include:

• muscle pain;

• headache; or

• stomach pain, nausea, or indigestion.

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 drugs can increase your risk of serious muscle problems if you take them together with Lescol XL. Your doctor may need to change your treatment plan if you use any of the following drugs:

• gemfibrozil, fenofibric acid, fenofibrate; or

• medicines that contain niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others).

Tell your doctor about all your current medicines. Many drugs can affect Lescol XL, especially:

• other cholesterol medications;

• an antibiotic or antifungal medicine;

• diabetes medicine;

• heart medication;

• seizure medication; or

• medicine to treat excess stomach acid or stomach ulcer.

This list is not complete and many other drugs can interact with Lescol XL. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.