Fenofibric Acid (Oral Route)

This may help prevent the development of pancreatitis (inflammation of the pancreas) caused by high levels of triglycerides in the blood .

Fenofibric acid may also be used together with cholesterol-lowering medicines called "statins" to prevent certain types of heart problems in patients with risk factors for heart problems .

This medicine is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Tablet


• Capsule, Delayed Release

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:

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

Appropriate studies have not been performed on the relationship of age to the effects of fenofibric acid in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fenofibric acid in the elderly. However, elderly patients are more likely to have kidney problems, which may require caution in patients receiving fenofibric acid .

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 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.

• 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:

• Blood clotting disorders or


• Blood disorders or


• Gallstonesa€”Use with caution. May make these conditions worse.

• Diabetes or


• Kidney problems or


• Underactive thyroida€”May increase chance of having serious side effects.

• Gallbladder disease, history of or


• Kidney disease, severe or


• Liver disease, activea€”Should not be used in patients with these conditions.

Proper Use

Before prescribing medicine for your high cholesterol, your doctor will probably try to control your cholesterol with a special diet. Such a diet may be low in fats, sugars, and/or cholesterol. Many people are able to control their cholesterol by carefully following their doctor`s orders for a proper diet and exercise. Medicine is prescribed only when additional help is needed, and is effective only when used together with a special diet and exercise.

This medicine will not cure your high cholesterol problem, but it does help control it. You must continue to take it as directed if you expect to keep your cholesterol levels down .

Swallow the delayed-release capsule whole. Do not crush, break, or chew it.

You may take this medicine with or without food.

If you also take another medicine called a statin, you may take fenofibric acid and the statin at the same time each day.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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 form (delayed-release capsules):
  
  
  
  • For hypertriglyceridemia (to lower triglycerides):
    
    
    
    • Adultsa€”At first, 45 to 135 milligrams (mg) once a day. Your doctor may adjust your dose if needed.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  • For primary hyperlipidemia:
    
    
    
    • Adultsa€”135 milligrams (mg) once a day.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  • For mixed dyslipidemia:
    
    
    
    • Adultsa€”135 milligrams (mg) once a day, taken with or without another medicine called a statin.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Check with your doctor right away if you experience unexplained muscle pain, tenderness, or weakness, especially if it is accompanied by unusual tiredness or fever. These may be symptoms of a muscle condition called rhabdomyolysis, which can lead to serious kidney problems .

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.

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

Avoid large amounts of grapefruit juice (more than 1 quart each day) while you are taking this medicine. Grapefruit juice can increase the amount of fenofibric acid in the body, which may increase your chance of having muscle problems .

Do not take other medicines unless they have been discussed with your doctor . This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

More common

• Body aches or pain


• Chills


• Cough


• Difficulty with breathing


• Ear congestion


• Fever


• Headache


• Loss of voice


• Nasal congestion


• Runny nose


• Sneezing


• Sore throat


• Unusual tiredness or weakness

Less common

• Bladder pain


• Bloody or cloudy urine


• Blurred vision


• Cough producing mucus


• Diarrhea


• Difficult, burning, or painful urination


• Difficulty with moving


• Dizziness


• Frequent urge to urinate


• General feeling of discomfort or illness


• Joint pain


• Loss of appetite


• Lower back or side pain


• Muscle aching or cramping


• Muscle or bone pain


• Muscle pain or stiffness


• Muscle spasms


• Nausea


• Nervousness


• Pain in the arms or legs


• Pounding in the ears


• Shivering


• Shortness of breath


• Slow or fast heartbeat


• Sweating


• Swollen joints


• Tightness in the chest


• Trouble sleeping


• Vomiting


• Wheezing

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:

Less common

• Acid or sour stomach


• Belching


• Difficulty having a bowel movement (stool)


• Heartburn


• Indigestion


• Pain or tenderness around the eyes and cheekbones


• Sleeplessness


• Stomach discomfort, upset, or pain


• Unable to sleep

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.