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|Fluvastatin Immediate-Release Capsules

Fluvastatin Immediate-Release Capsules

Fluvastatin Immediate-Release Capsules 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, other heart procedures.

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

Do NOT use Fluvastatin Immediate-Release Capsules if:

• you are allergic to any ingredient in Fluvastatin Immediate-Release Capsules
• you have liver disease or repeated blood tests indicating possible liver problems of unknown cause
• you are currently 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 Immediate-Release Capsules:

Some medical conditions may interact with Fluvastatin Immediate-Release Capsules. 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 a liver disease, organ transplantation, recent trauma or major surgery, severe infection, severe kidney problems, or uncontrolled seizures

Some MEDICINES MAY INTERACT with Fluvastatin Immediate-Release Capsules. 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), or 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 Immediate-Release Capsules may be decreased
• Oral anticoagulants (eg, warfarin) because side effects, including increased risk of bleeding, may be increased by Fluvastatin Immediate-Release Capsules

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

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

• Fluvastatin Immediate-Release Capsules may be taken with or without food.
• If you are also taking cholestyramine, take Fluvastatin Immediate-Release Capsules at bedtime at least 2 hours after taking cholestyramine or other bile acid resins.
• If you miss a dose of Fluvastatin Immediate-Release Capsules, 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 Immediate-Release Capsules.

Important safety information:

• Fluvastatin Immediate-Release Capsules may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Fluvastatin Immediate-Release Capsules. Using Fluvastatin Immediate-Release Capsules 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 Immediate-Release Capsules to work. Do not stop using Fluvastatin Immediate-Release Capsules 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 Immediate-Release Capsules should be used along with exercise, a low-cholesterol/low-fat diet, and a weight loss program if you are overweight.
• 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 Immediate-Release Capsules is not recommended for use in CHILDREN; safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Fluvastatin Immediate-Release Capsules if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. Fluvastatin Immediate-Release Capsules is excreted in breast milk. Do not breast-feed while taking Fluvastatin Immediate-Release Capsules.

Possible side effects of Fluvastatin Immediate-Release Capsules:

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; diarrhea; dizziness; gas; general body discomfort; headache; indigestion; muscle aches; nausea; rash; sinus inflammation; sleeplessness; stomach pain; tiredness; tooth disorder.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); 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 Immediate-Release Capsules at room temperature 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Keep Fluvastatin Immediate-Release Capsules out of the reach of children and away from pets.

General information:

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