In the U.S.—

In Canada—

• Antihyperlipidemic

Gemfibrozil (gem-FI-broe-zil) is used to lower cholesterol and triglyceride (fat-like substances) levels in the blood. This may help prevent medical problems caused by such substances clogging the blood vessels.

Gemfibrozil is available only with your doctor's prescription, in the following dosage forms:

Oral
• Capsules (Canada)
• Tablets (U.S. and Canada)

In addition to its helpful effects in treating your medical problem, this type of medicine may have some harmful effects.

Results of a large study using gemfibrozil seem to show that it may cause a higher rate of some cancers in humans. In addition, the action of gemfibrozil is similar to that of another medicine called clofibrate. Studies with clofibrate have suggested that it may increase the patient's risk of cancer, liver disease, pancreatitis (inflammation of the pancreas), gallstones and problems from gallbladder surgery, although it may also decrease the risk of heart attacks. Other studies have not found all of these effects.

Studies with gemfibrozil in rats found an increased risk of liver tumors when doses up to 10 times the human dose were given for a long time.

Be sure you have discussed this with your doctor before taking this medicine.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For gemfibrozil, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to gemfibrozil. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Diet—Before prescribing medicine for your condition, your doctor will probably try to control your condition by prescribing a personal diet for you. Such a diet may be low in fats, sugars, and/or cholesterol. Many people are able to control their condition by carefully following their doctor's orders for proper diet and exercise. Medicine is prescribed only when additional help is needed and is effective only when a schedule of diet and exercise is properly followed.

Also, this medicine is less effective if you are greatly overweight. It may be very important for you to go on a reducing diet. However, check with your doctor before going on any diet.

Make certain your health care professional knows if you are on a low-sodium, low-sugar, or any other special diet. Most medicines contain more than their active ingredient.

Pregnancy—Gemfibrozil has not been studied in pregnant women. However, studies in animals have shown that high doses of gemfibrozil may increase the number of fetal deaths, decrease birth weight, or cause some skeletal defects. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether gemfibrozil passes into breast milk. However, studies in animals have shown that high doses of gemfibrozil may increase the risk of some kinds of tumors. Therefore, you should consider this when deciding whether to breast-feed your baby while taking this medicine.

Children—There is no specific information about the use of gemfibrozil in children. However, use is not recommended in children under 2 years of age since cholesterol is needed for normal development.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of gemfibrozil in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking gemfibrozil it is especially important that your health care professional know if you are taking any of the following:

• Anticoagulants (blood thinners)—Use with gemfibrozil may increase the effect of the anticoagulant

• Lovastatin—Use with gemfibrozil may cause muscle or kidney problems or make them worse

• Gallbladder disease or
• Gallstones—Gemfibrozil may make these conditions worse

• Kidney disease or
• Liver disease—Higher blood levels of gemfibrozil may result, which may increase the chance of side effects; a decrease in the dose of gemfibrozil may be needed

Use this medicine only as directed by your doctor. Do not use more or less of it, and do not use it more often or for a longer time than your doctor ordered.

This medicine is usually taken twice a day. If you are taking 2 doses a day, it is best to take the medicine 30 minutes before your breakfast and evening meal.

Follow carefully the special diet your doctor gave you. This is the most important part of controlling your condition and is necessary if the medicine is to work properly.

Dosing—

The dose of gemfibrozil will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of gemfibrozil. If your dose is different, do not change it unless your doctor tells you to do so:

• For oral dosage forms (tablets):
  • Adults: 600 milligrams two times a day to be taken thirty minutes before the morning and evening meals.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol and triglyceride levels and to decide if you should continue to take it.

Do not stop taking this medication without first checking with your doctor. When you stop taking this medicine, your blood cholesterol levels may increase again. Your doctor may want you to follow a special diet to help prevent this from happening.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Rare
  • Cough or hoarseness;  fever or chills ;  lower back or side pain;  painful or difficult urination;  stomach pain (severe) with nausea and vomiting 
  
  

Check with your doctor as soon as possible if either of the following side effects occurs:

• Rare
  • Muscle pain;  unusual tiredness or weakness  
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Stomach pain, gas, or heartburn 
  
  

• Less common
  • Diarrhea;  nausea or vomiting;  skin rash 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.