How does this medication work? What will it do for me?

Bezafibrate belongs to the class of medications known as fibrates. Bezafibrate is used in addition to diet and other measures to treat high cholesterol. It is especially useful in reducing triglycerides, a type of lipid (fat).

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each round, white, sustained-release, film-coated tablet, printed on one side with "D9", contains bezafibrate 400 mg. Nonmedicinal ingredients: colloidal silicon dioxide, hydroxypropyl methylcellulose 2208 & 2910, lactose, magnesium stearate, methyl methacrylate, polyethyl acrylate, polyethylene glycol 10,000, polysorbate 80, povidone K25, sodium citrate, sodium lauryl sulfate, talc, and titanium dioxide.

How should I use this medication?

The recommended adult dose of bezafibrate is one 400 mg sustained-release tablet daily. Swallow the tablet whole with plenty of fluid, with or after meals. Do not chew or crush the tablet.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

Store this medication at room temperature, protect it from moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to bezafibrate or any ingredients of this medication
  • are allergic to other "fibrate" medications (e.g., clofibrate, fenofibrate, gemfibrozil)
  • are breast-feeding
  • are pregnant
  • are taking a "statin" medication (e.g., atorvastatin, lovastatin, simvastatin, pravastatin) and have risk factors for muscle problems (e.g., reduced kidney function, severe infection, trauma, surgery, certain hormone or electrolyte imbalances)
  • have a disorder known as type 1 hyperlipoproteinemia
  • have gallbladder disease
  • have reduced kidney function
  • have reduced liver function or primary biliary cirrhosis (damage to the liver cause by inflammation of the bile ducts)

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • constipation
  • decreased appetite
  • diarrhea
  • difficulty sleeping
  • dry skin
  • gas
  • headache
  • heartburn

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • itching (generalized)
  • muscle pain, tenderness, or weakness, especially if accompanied by fever and feeling unwell
  • nausea
  • persistent and severe upper abdominal pain
  • small red or purple spots on the skin
  • symptoms of an infection (e.g., fever, chills, sore throat, cough, achy joints)
  • symptoms of liver problems (e.g., yellow eyes or skin, dark urine, loss of appetite)
  • unusual bleeding or bruising
  • unusual tiredness
  • vomiting

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • severe skin rash (e.g., blisters, peeling)
  • symptoms of a severe allergic reaction (e.g., hives; difficulty breathing; swelling of the face, mouth, tongue, or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood counts: This medication may decrease the amount of  hemoglobin (the part of red blood cells that carry oxygen), white blood cells (that help fight infection), and platelets (that help the blood to clot) during the first 12 months of treatment. Your doctor will monitor for these changes with blood tests during your first year of treatment.

Gallstones: Bezafibrate may increase the risk for gallstones. If you experience symptoms of gallstones (e.g., persistent and severe upper abdominal pain, pain in the back between the shoulder blades, pain under the right shoulder, nausea, vomiting), contact your doctor immediately.

Liver function: Bezafibrate may affect your liver function. You will have your liver function monitored regularly with blood tests while you are taking this medication. If you have had liver problems or jaundice (yellowing of the skin or eyes), discuss with your doctor how this medication may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Muscle problems: Very rarely, this medication can cause muscle problems such as myositis (inflammation of the muscles) or rhabdomyolysis (breakdown of muscle that can cause kidney damage). If you experience any unexplained muscle pain, tenderness or weakness, especially if you also have a fever and are not feeling well, contact your doctor immediately.

Pregnancy: Bezafibrate should not be taken during pregnancy. Women who could become pregnant while using this medication should use adequate birth control. If you become pregnant while taking this medication, stop taking it and contact your doctor immediately. If you are planning to become pregnant, you should stop this medication several months before trying to become pregnant.

Breast-feeding: Women taking this medication should not breastfeed.

Children: There is limited experience with the use of this medication by children.

What other drugs could interact with this medication?

There may be an interaction between bezafibrate and any of the following:

  • cholestyramine
  • colestipol
  • cyclosporine
  • estrogens
  • insulin
  • MAO inhibitors (e.g., phenelzine, tranylcypromine)
  • rosiglitazone
  • "statins" (e.g., atorvastatin, simvastatin, pravastatin, lovastatin)
  • sulfonylureas (e.g., glyburide, gliclazide)
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.