Uses

Bezafibrate is used along with a proper diet to help lower "bad" cholesterol and fats (such as LDL, triglycerides) and raise "good" cholesterol (HDL) in the blood. It works by increasing the natural substance (enzyme) that breaks down fats in the blood. Bezafibrate belongs to a class of drugs known as "fibrates." Lowering triglycerides in people with very high triglyceride blood levels may decrease the risk of pancreas disease (pancreatitis). Reducing "bad" cholesterol and triglycerides lowers the risk of heart disease and helps prevent strokes and heart attacks.

In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or after a meal as directed by your doctor, usually once daily.

Swallow the tablets whole. Do not crush or chew the tablets. Doing so can release all of the drug at once, increasing the risk of side effects.

If you are also taking certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take bezafibrate at least 2 hours before or after taking these medications. These medications can bind to bezafibrate, preventing your body from fully absorbing the drug.

The dosage is based on your medical condition and response to treatment.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your cholesterol/triglyceride level will not lower faster and your risk of side effects will increase.

Keep taking this medication even if you feel well. Most people with high triglycerides/cholesterol do not feel sick.

It is very important to continue to follow your doctor's advice about diet and exercise. It may take up to 3 months to get the full benefit from this medication.

Side Effects

Stomach/abdominal upset, gas, or diarrhea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may rarely cause gallstones and liver problems. If you notice any of the following unlikely but serious side effects, tell your doctor right away:

• nausea/vomiting that doesn't stop
• loss of appetite
• stomach/abdominal pain
• yellowing eyes/skin
• dark urine

This medication may rarely cause muscle problems (which can rarely lead to a very serious condition called rhabdomyolysis). Tell your doctor right away if you develop any of these symptoms:

• muscle pain/tenderness/weakness (especially with fever or unusual tiredness)
• signs of kidney problems (such as change in the amount of urine)

Tell your doctor right away if you have any serious side effects, including:

• signs of infection (such as sore throat that doesn't go away, fever)
• easy bruising/bleeding
• unusual tiredness

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

See also Side Effects section.

Before taking bezafibrate, tell your doctor or pharmacist if you are allergic to it; or to other "fibrates" (such as fenofibrate, gemfibrozil); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver disease (such as biliary cholangitis, hepatitis)
• gallbladder disease
• kidney disease
• alcohol use

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Drug Interactions

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• "blood thinners" (such as warfarin)

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 9-1-1. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as triglyceride and cholesterol levels, liver/kidney function, complete blood count) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.