Gemfibrozil (Oral Route)

This may help prevent medical problems caused by such substances clogging the blood vessels .

Gemfibrozil is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Capsule


• Tablet

Before Using

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 this medicine, the following should be considered:

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.

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

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 .

Geriatric

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.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is not recommended . Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Repaglinide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atorvastatin


• Bexarotene


• Cerivastatin


• Colchicine


• Eltrombopag


• Ezetimibe


• Fluvastatin


• Lovastatin


• Pitavastatin


• Pravastatin


• Rosuvastatin


• Simvastatin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Dicumarol


• Glyburide


• Loperamide


• Pioglitazone


• Rosiglitazone


• Warfarin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Gallbladder disease or


• Gallstonesa€”Gemfibrozil may make these conditions worse

• Kidney disease or


• Liver diseasea€”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

Proper Use

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.

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 this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions

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.

Side Effects

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 any of the following side effects occur:

Rare

• Muscle pain


• Unusual tiredness or weakness

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Stomach pain, gas, or heartburn

Less common

• Diarrhea


• Nausea or vomiting


• Skin rash

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.