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|Fluvastatin Extended-Release Tablets

Fluvastatin Extended-Release Tablets

Fluvastatin Extended-Release Tablets is used for:

Treating elevated blood lipid levels including high blood cholesterol and triglycerides in patients who are not controlled with diet or other measures. It is also used to slow the progression of hardening of the coronary arteries and to reduce the risk in patients with coronary heart disease who are undergoing angioplasty, bypass surgery, or other heart procedures.

Fluvastatin Extended-Release Tablets is "statin". It works by blocking a certain chemical that is necessary for your body to manufacture.

Do NOT use Fluvastatin Extended-Release Tablets if:

• you are allergic to any ingredient in Fluvastatin Extended-Release Tablets
• you have active liver disease or repeated blood tests indicating possible liver problems of unknown cause
• you are presently taking a fibrate (eg, clofibrate, gemfibrozil)

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

Before using Fluvastatin Extended-Release Tablets:

Some medical conditions may interact with Fluvastatin 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, plan to become pregnant, or are breast-feeding
• 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 endocrine, electrolyte, or metabolic disease, or low blood pressure
• if you abuse alcohol, have a history of alcohol abuse, or if you consume more than 3 alcoholic beverages per day
• if you have liver disease, organ transplantation, recent trauma or major surgery, severe infection, severe kidney problems, or uncontrolled seizures

Some MEDICINES MAY INTERACT with Fluvastatin Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), cyclosporine, fibrates (eg, clofibrate, gemfibrozil), of fluconazole because side effects including severe abnormal weakness of the muscles, muscle destruction (causing dark colored urine and muscle weakness, aching, and tenderness) may occur
• Rifampin because the effectiveness of Fluvastatin Extended-Release Tablets may be decreased
• Oral anticoagulants (eg, warfarin) because side effects, including increased risk of bleeding, may be increased by Fluvastatin Extended-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fluvastatin 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 Fluvastatin Extended-Release Tablets:

Use Fluvastatin Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Fluvastatin Extended-Release Tablets may be taken with or without food.
• Swallow Fluvastatin Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.
• Take Fluvastatin Extended-Release Tablets in the evening or at bedtime as directed by your doctor. Dosage is based on your medical condition, response to therapy, and use of certain interacting medicines.
• If you are also taking cholestyramine, take Fluvastatin Extended-Release Tablets at bedtime at least 2 hours after taking cholestyramine or other bile acid resins.
• If you miss a dose of Fluvastatin Extended-Release Tablets, take it as soon as possible. If it is almost time for your next 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 Fluvastatin Extended-Release Tablets.

Important safety information:

• Fluvastatin Extended-Release Tablets may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Fluvastatin Extended-Release Tablets. Using Fluvastatin Extended-Release Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• It may take several weeks for Fluvastatin Extended-Release Tablets to work. Do not stop using Fluvastatin Extended-Release Tablets without checking with your doctor.
• Contact your health care provider if unexplained muscle pain, tenderness, or weakness occurs, especially if accompanied by general body discomfort or fever.
• For best results, Fluvastatin Extended-Release Tablets should be used along with exercise, a low-cholesterol/low-fat diet, and a weight loss program if you are overweight.
• Do not drink alcohol while you are using Fluvastatin Extended-Release Tablets.
• LAB TESTS, including liver function and blood cholesterol, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Fluvastatin Extended-Release Tablets is not recommended for use in CHILDREN; safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Fluvastatin Extended-Release Tablets if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. Fluvastatin Extended-Release Tablets is excreted in breast milk. Do not breast-feed while taking Fluvastatin Extended-Release Tablets.

Possible side effects of Fluvastatin 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:

Allergies; bronchitis; diarrhea; dizziness; gas; general body discomfort; headache; indigestion; nausea; rash; sinus inflammation; sleeplessness; stomach pain; tiredness; tooth disorder; urinary tract infections.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; dark colored urine; difficulty swallowing or breathing; fever; general body discomfort; hoarseness; muscle pain, tenderness, or weakness; unusual bleeding or bruising; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Fluvastatin Extended-Release Tablets at room temperature 77 degrees F (25 degrees C). Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Keep Fluvastatin Extended-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Fluvastatin Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Fluvastatin 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.

This information is a summary only. It does not contain all information about Fluvastatin Extended-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.