Lescol XL extended-release tablets

Generic Name: fluvastatin (FLOO-va-STAT-in)
Brand Name: Lescol XL

Lescol XL extended-release tablets is used for:

Lowering high cholesterol and triglycerides in certain patients. It also increases high-density lipoprotein (HDL) ("good") cholesterol levels. It is used along with an appropriate diet. It is used in certain patients to slow blood vessel blockage and to reduce the need for medical procedures to open blocked heart blood vessels. It may also be used for other conditions as determined by your doctor.

Lescol XL extended-release tablets is an HMG-CoA reductase inhibitor, also known as a "statin." It works by reducing the production of certain fatty substances in the body, including cholesterol.

Do NOT use Lescol XL extended-release tablets if:

  • you are allergic to any ingredient in Lescol XL extended-release tablets
  • you have liver problems or unexplained abnormal liver function tests
  • you are pregnant, may become pregnant, or are breast-feeding
  • you are taking gemfibrozil

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Lescol XL extended-release tablets:

Some medical conditions may interact with Lescol XL extended-release tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have low blood pressure, a serious infection, kidney problems, diabetes, muscle problems (eg, pain weakness), thyroid problems, or a history of seizures
  • if you have metabolism, hormonal, or electrolyte problems
  • if you drink alcohol or have a history of liver problems or alcohol abuse
  • if you are scheduled for major surgery or if you have recently had major surgery or a serious injury
  • if you have a certain type of high cholesterol (homozygous familial hypercholesterolemia)
  • if you cannot swallow tablets whole

Some MEDICINES MAY INTERACT with Lescol XL extended-release tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Colchicine, cyclosporine, daptomycin, erythromycin, fibrates (eg, fenofibrate, gemfibrozil), fluconazole, mifepristone, niacin, omeprazole, or ranitidine because they may increase the risk of Lescol XL extended-release tablets's side effects, including muscle or kidney problems
  • Anticoagulants (eg, warfarin) because the risk of bleeding may be increased
  • Rifamycins (eg, rifampin) because they may decrease Lescol XL extended-release tablets's effectiveness
  • Cimetidine, glyburide, ketoconazole, phenytoin, or spironolactone because the risk of their side effects may be increased by Lescol XL extended-release tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lescol XL extended-release tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Lescol XL extended-release tablets:

Use Lescol XL extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Lescol XL extended-release tablets. Talk to your pharmacist if you have questions about this information.
  • Take Lescol XL extended-release tablets by mouth with or without food.
  • Swallow Lescol XL extended-release tablets whole. Do not break, crush, or chew before swallowing.
  • If you take cholestyramine or colestipol, ask your doctor or pharmacist how to take it with Lescol XL extended-release tablets.
  • Continue to take Lescol XL extended-release tablets even if you feel well. Do not miss any doses.
  • If you miss a dose of Lescol XL extended-release tablets, take it as soon as possible. If it has been more than 12 hours since the missed dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Lescol XL extended-release tablets.

Important safety information:

  • Lescol XL extended-release tablets may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Lescol XL extended-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Lescol XL extended-release tablets may cause liver problems. Rarely, severe and sometimes fatal liver failure has been reported in patients taking statin medicines, including Lescol XL extended-release tablets. Your risk of developing liver problems may be greater if you drink alcohol daily or in large amounts with Lescol XL extended-release tablets, or if you have a history of liver problems. Check with your doctor before drinking alcohol while you are taking Lescol XL extended-release tablets. Tell your doctor right away if you experience symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, loss of appetite, or stomach pain; unusual tiredness).
  • Follow the diet and exercise program given to you by your health care provider.
  • Tell your doctor or dentist that you take Lescol XL extended-release tablets before you receive any medical or dental care, emergency care, or surgery.
  • Women who may become pregnant should use effective birth control while taking Lescol XL extended-release tablets. Check with your doctor if you have questions about using birth control.
  • Do NOT take more than the recommended dose without checking with your doctor.
  • Muscle problems (myopathy) may occur with Lescol XL extended-release tablets. The risk of muscle problems may be greater in people older than 64 years old or in people who have kidney problems or low thyroid function. It may also be greater in those who take it with certain other medicines (eg, fibrates). Tell your doctor right away if you notice any unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or general body discomfort. Tell your doctor if you have muscle problems that persist even after your doctor has told you to stop taking Lescol XL extended-release tablets.
  • Diabetes patients - Lescol XL extended-release tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Lab tests, including blood cholesterol levels and liver function tests, may be performed while you use Lescol XL extended-release tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Lescol XL extended-release tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially muscle problems.
  • Lescol XL extended-release tablets should be used with extreme caution in CHILDREN younger than 9 years old and in those who have been having a menstrual period for less than 1 year; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use Lescol XL extended-release tablets if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Lescol XL extended-release tablets is found in breast milk. Do not breast-feed while you are taking Lescol XL extended-release tablets.

Possible side effects of Lescol XL extended-release tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache; mild stomach pain; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); burning, numbness, or tingling; change in the amount of urine produced; chest pain; confusion; decreased sexual desire or ability; fever, chills, or persistent sore throat; flu-like symptoms; joint pain; memory problems; mental or mood changes (eg, depression); muscle pain, tenderness, or weakness (with or without fever or fatigue); painful or frequent urination; red, swollen, blistered, or peeling skin; severe stomach or back pain (with or without nausea or vomiting); shortness of breath; symptoms of liver problems (eg, dark urine; pale stools; severe or persistent nausea, loss of appetite, or stomach pain; yellowing of the skin or eyes); tremors; unusual bruising or bleeding; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Lescol XL extended-release tablets:

Store Lescol XL extended-release tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lescol XL extended-release tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about Lescol XL extended-release tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Lescol XL extended-release tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Lescol XL extended-release tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Lescol XL extended-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Lescol XL extended-release tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Lescol XL extended-release tablets.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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