$35.00

FENOFIBRATE

(Also Known As: LIPIDIL, TRICOR)

Use this medicine only as directed by your doctor. Take the medication at the same time each day to maintain the medication's effect. Do not use more or less of it, and do not use it more often than your doctor ordered.

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.

This medicine is usually taken once a day. This medicine works best if it is taken with a meal.

Dosing

The dose of fenofibrate 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 fenofibrate. If your dose is different, do not change it unless your doctor tells you to do so:

• For oral dosage form (capsules):
  • For hyperlipidemia (to lower triglycerides):
    • Adults At first, 67 milligrams (mg) once a day with a meal. Your doctor may increase your dose as needed.
    • Children Use and dose must be determined by your doctor.

• For oral dosage form (tablets):
  • For hyperlipidemia (to lower triglycerides):
    • Adults At first, 54 to 160 milligrams (mg) once daily. Your doctor may increase your dose as needed.
  • For hypercholesteremia (to lower cholesterol):
    • Adults 160 milligrams (mg) once daily.

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• Do not keep outdated medicine or medicine no longer needed.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.

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

Results of large studies using other agents that are similar to fenofibrate seem to suggest that fenofibrate may increase the patient's risk of cancer, pancreatitis (inflammation of the pancreas), gallstones, and problems from gallbladder surgery.

Studies with fenofibrate in rats found an increased risk of liver and pancreatic tumors when doses up to 6 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 fenofibrate, the following should be considered:

Allergies Tell your doctor if you have ever had any unusual or allergic reaction to fenofibrate. 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.

Pregnancy Fenofibrate has not been studied in pregnant women. However, studies in animals have shown that high doses of fenofibrate 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 fenofibrate passes into breast milk. Studies in animals have shown that high doses of fenofibrate may increase the risk of some kinds of tumors. Therefore, this medicine is not recommended for use during breast-feeding.

Children Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of fenofibrate in children with use in other age groups.

Older adults Although the effects of fenofibrate have not been fully tested in older people, this medicine has been tested in a limited number of patients 77 through 87 years of age and has not been shown to cause problems when given to older people.

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 fenofibrate, it is especially important that your health care professional know if you are taking any of the following:

• Anticoagulants (blood thinners) Use with fenofibrate may increase the effect of the anticoagulant and increase the risk of bleeding

• Carmustine (e.g., BiCNU) or
• Cisplatin (e.g., Platinol) or
• Combination pain medicine containing acetaminophen and aspirin (e.g., Excedrin) or other salicylates or
• Cyclosporine (e.g., Sandimmune) or
• Deferoxamine (e.g., Desferal) (with long-term use) or
• Gold salts (medicine for arthritis) or
• Inflammation or pain medicine, except narcotics, or
• Lithium (e.g., Lithane) or
• Methotrexate (Mexate) or
• Other medicine for infection or
• Penicillamine (e.g., Cuprimine) or
• Plicamycin (e.g., Mithracin) or
• Streptozocin (e.g., Zanosar) or
• Tiopronin (Thiola) Concurrent use of these medicines with fenofibrate may increase the chance for side effects, especially when kidney disease is present

• HMG-CoA reductase inhibitors (atorvastatin [e.g., Lipitor], cerivastatin [e.g., Baycol], fluvastatin [e.g., Lescol], lovastatin [e.g., Mevacor], pravastatin [e.g., Pravacol], simvastatin [e.g., Zocor]) Use with fenofibrate may cause muscle or kidney problems or make them worse

• Gallbladder disease or
• Gallstones or
• Liver disease Fenofibrate may make these conditions worse

• Kidney disease Higher blood levels of fenofibrate may result, which may increase the chance of side effects or make kidney problems worse