Fenofibric acid (By mouth)

Brand Name(s)

Trilipix, Fibricor

When This Medicine Should Not Be Used

How to Use This Medicine

Delayed Release Capsule, Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• You may take this medicine with or without food.
• Swallow the delayed-release capsule whole. Do not crush, break, or chew it.
• Carefully follow your doctor's instructions about any special diet. Your doctor may want you to exercise and to control your weight as part of your treatment.
• If you also use a medicine called a statin, you may use 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 or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

Introduction

Fenofibric Acid (fen-oh-FYE-brik AS-id)

Treats high cholesterol and triglycerides (fats).

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you use cyclosporine (Gengraf®, Neoral®, Sandimmune®) or a blood thinner (such as warfarin, Coumadin®).
• Tell your doctor if you also use cholestyramine (Questran®), colestipol (Colestid®), or colesevelam (Welchol®). You must take this medicine at least 1 hour before or 4 to 6 hours after you take any of these other medicines.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Do not drink more than 1 quart of grapefruit juice a day while you use this medicine.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant. Also make sure your doctor knows if you have kidney disease, heart disease, blood clotting problems, diabetes, thyroid problems, or a history of muscle pain or weakness.
• Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also feel tired or have a fever. These could be symptoms of serious muscle damage. The risk is higher in older people and in people who have diabetes, low thyroid, or kidney problems.
• Call your doctor right away if you have stomach pain with nausea and vomiting. This medicine may increase your risk of gallstones.
• Tell your doctor right away if you have stomach pain, nausea, vomiting, fever, or lightheadedness. These may be symptoms of pancreatitis.
• 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 rash; sores or ulcers on the skin; or fever or chills.
• This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Change in how much or how often you urinate
• Chest pain, dizziness, slow or fast heartbeat
• Dark-colored urine or pale stools
• Fever, chills, cough, sore throat, and body aches
• Muscle pain, tenderness, or weakness
• Stomach pain, nausea, vomiting, and lightheadedness
• Unusual bleeding, bruising, tiredness, or weakness
• Yellowing of your skin or the whites of your eyes

If you notice these less serious side effects, talk with your doctor:

• Back pain
• Diarrhea
• Headache
• Stuffy or runny nose

If you notice other side effects that you think are caused by this medicine, tell your doctor

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