When This Medicine Should Not Be Used:
Do not use this medicine if you have had an allergic reaction to fluvastatin. Do not use this medicine if you have active liver disease or if you are pregnant or breastfeeding.

How to Use This Medicine:
Capsule, Long Acting Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take the capsule at the same time every evening. If you take this medicine twice a day, take it at the same time every morning and every evening. You may take the extended-release tablet at any time of the day.
• Swallow the extended-release tablet whole. Do not crush, break, or chew it. Do not open the capsule before you take it.
• Carefully follow your doctor's instructions about diet and exercise. This medicine is part of a complete plan for lowering cholesterol and triglyceride levels in your blood.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you also use cimetidine (Tagamet®), colchicine (Colcrys®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), diclofenac (Cataflam®, Voltaren®), erythromycin (Ery-Tab®), glyburide (Diabeta®, Micronase®), niacin (Vitamin B3), phenytoin (Dilantin®), rifampicin (Rifadin®, Rimactane®), or spironolactone (Aldactone®). Tell your doctor if you also use a blood thinner (such as warfarin, Coumadin®, Jantoven®), medicine to treat a fungus infection (such as fluconazole, ketoconazole, Diflucan®, Nizoral®), or other medicine for lowering cholesterol (such as fenofibrate, gemfibrozil, Lopid®, Tricor®).
• Tell your doctor if you usually drink more than 2 glasses of alcohol per day.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Make sure your doctor knows if you have kidney disease, diabetes, muscle pain or weakness, or an underactive thyroid. Tell your doctor if you have a history of liver disease or if you drink alcohol regularly.
• Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness. These could be symptoms of a serious muscle problem called myopathy.
• Check with your doctor right away if you have dark-colored urine, fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness or weakness. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.
• Make sure any doctor or dentist who treats you knows that you use this medicine. You may need to stop using this medicine if you have major surgery, a major injury, or you develop other serious health problems.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, yellow skin or eyes
• Fever
• Muscle pain, tenderness, or weakness
• Unusual tiredness

If you notice these less serious side effects, talk with your doctor:

• Confusion or problems with memory
• Headache
• Mild nausea, upset stomach

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088