Fenofibric Acid capsules

What is this medication?

FENOFIBRIC ACID (fen o FI brik AS id) lowers triglyceride levels in the blood. It also increases good cholesterol levels. It is used with lifestyle changes, like diet and exercise. It may be used alone or with other medicines.

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

COMMON BRAND NAME(S): Trilipix

What should I tell my care team before I take this medication?

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

• diabetes (high blood sugar)
• gallbladder disease
• heart disease
• history of pancreatitis
• kidney disease
• liver disease
• low thyroid levels
• an unusual or allergic reaction to fenofibrate, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth. Take it as directed on the prescription label at the same time every day. Do not cut, crush or chew this medicine. Swallow the capsules whole. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your health care provider tells you to stop.

Take bile acid sequestrants at a different time of day than this medicine. Take this medicine 1 hour BEFORE or 4 to 6 hours AFTER bile acid sequestrants.

Talk to your health care provider about 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 medication?

This medicine may interact with the following medications:

• bile acid sequestrants like cholestyramine, colesevelam, and colestipol
• certain medicines for cholesterol like atorvastatin, lovastatin, and simvastatin
• certain medicines for diabetes, like glipizide or glyburide
• certain medicines that suppress the body's immune response like cyclosporine and tacrolimus
• colchicine
• ezetimibe
• supplements like red yeast rice
• 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 medication?

Visit your health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your health care provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

Taking this medicine is only part of a total heart healthy program. Your health care provider may give you a special diet to follow. Avoid alcohol. Avoid smoking. Ask your health care provider how much you should exercise.

Your health care provider may tell you to stop taking this medicine if you develop muscle problems. If your muscle problems do not go away after stopping this medicine, contact your health care provider.

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 sunscreen. Do not use sun lamps or tanning beds/booths.

This medicine may cause a decrease in vitamin B12. You should make sure that you get enough B12 while you are taking this medicine. Discuss the foods you eat and the vitamins you take with your health care provider.

What side effects may I notice from receiving this medication?

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

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• blood clot (chest pain; shortness of breath; pain, swelling, or warmth in the leg)
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite, right upper belly pain; unusually weak or tired, yellowing of the eyes or skin)
• low red blood cell counts (trouble breathing, feeling faint; lightheaded, falls; unusually weak or tired)
• muscle injury (dark urine; trouble passing urine or change in the amount of urine; unusually weak or tired; muscle pain; back pain)
• pancreatitis (stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting, fast heartbeat)
• redness, blistering, peeling, or loosening of the skin, including inside the mouth
• unusual bruising or bleeding

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

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 medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from moisture. Keep the container tightly closed. Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, empty the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.