Fenofibric Acid Oral capsule, gastro-resistant pellets

What is this medicine?

FENOFIBRIC ACID (fen o FI brik AS id) can help lower blood fats and cholesterol in the blood. Diet and lifestyle changes are often used with this drug. This medicine is only for patients whose blood fats are not controlled by diet.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• gallbladder disease

• heart disease

• kidney disease

• liver disease

• an unusual or allergic reaction to fenofibric acid, fenofibrate, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take this medicine with or without food. If it upsets your stomach, take it with food. You should be on a low fat and low cholesterol diet while you take this medicine. Do not cut, crush or chew this medicine. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

This medicine may interact with the following medications:

• certain medicines for cholesterol

• cholestyramine or colestipol

• cyclosporine

• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Your blood fats and other tests will be measured from time to time.

This medicine is only part of a total cholesterol-lowering program. Your health care professional or dietician can suggest a low-cholesterol and low-fat diet that will reduce your risk of getting heart and blood vessel disease. Avoid alcohol and smoking, and keep a proper exercise schedule.

If you are diabetic, close regulation and monitoring of your blood sugars can help your blood fat levels. This medicine may change the way your diabetic medication works, and sometimes will require that your dosages be adjusted. Check with your doctor or health care professional.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• dark urine

• fever

• lower back or side pain

• muscle pain, tenderness, or weakness

• skin-bruising

• stomach pain

• trouble passing urine or change in the amount of urine

• unusually weak or tired

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation

• headache

• nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

Fenofibric Acid Oral tablet

What is this medicine?

FENOFIBRIC ACID (fen o FI brik AS id) can help lower blood fats and cholesterol in the blood. Diet and lifestyle changes are often used with this drug. This medicine is only for patients whose blood fats are not controlled by diet.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• gallbladder disease

• heart disease

• kidney disease

• liver disease

• an unusual or allergic reaction to fenofibric acid, fenofibrate, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take this medicine with or without food. If it upsets your stomach, take it with food. You should be on a low fat and low cholesterol diet while you take this medicine. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

This medicine may interact with the following medications:

• certain medicines for cholesterol

• cholestyramine or colestipol

• cyclosporine

• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Your blood fats and other tests will be measured from time to time.

This medicine is only part of a total cholesterol-lowering program. Your health care professional or dietician can suggest a low-cholesterol and low-fat diet that will reduce your risk of getting heart and blood vessel disease. Avoid alcohol and smoking, and keep a proper exercise schedule.

If you are diabetic, close regulation and monitoring of your blood sugars can help your blood fat levels. This medicine may change the way your diabetic medication works, and sometimes will require that your dosages be adjusted. Check with your doctor or health care professional.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• dark urine

• fever

• lower back or side pain

• muscle pain, tenderness, or weakness

• skin-bruising

• stomach pain

• trouble passing urine or change in the amount of urine

• unusually weak or tired

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• constipation

• headache

• nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.