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Trilipix delayed-release capsules

Generic Name: fenofibric acid (FEN-oh-FYE-bric AS-id)
Brand Name: Trilipix

Trilipix delayed-release capsules are used for:

Lowering high cholesterol and triglyceride levels in the blood. It also increases high-density lipoprotein (HDL) ("good") cholesterol levels. It is used along with an appropriate diet. It may also be used in combination with other cholesterol-lowering medicines.

Trilipix delayed-release capsules are a lipid-lowering agent. It works by increasing a certain substance that helps to remove triglycerides from the blood. This also helps the body to decrease the amount of other bad cholesterol in the blood.

Do NOT use Trilipix delayed-release capsules if:

  • you are allergic to any ingredient in Trilipix delayed-release capsules or to fenofibrate
  • you have gallbladder problems, liver problems (eg, cirrhosis, hepatitis), or persistent abnormal liver function tests
  • you have severe kidney problems or are receiving dialysis
  • you are breast-feeding

Contact your doctor or health care provider right away if any of these apply to you.

Before using Trilipix delayed-release capsules:

Some medical conditions may interact with Trilipix delayed-release capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines or other substances
  • if you have a history of diabetes, an underactive thyroid, heart problems (eg, heart blood vessel problems), gallbladder problems (eg, gallstones), pancreatitis, kidney or liver problems, or muscle problems
  • if you have a history of blood clots in your veins or lungs (deep vein thrombosis or pulmonary embolism)
  • if you are very overweight, have an inactive lifestyle, have a poor diet, or you drink alcohol or have a history of alcohol abuse
  • if you have trouble swallowing
  • if you are taking a beta-blocker (eg, propranolol), estrogen, or thiazide diuretic (eg, hydrochlorothiazide)

Some MEDICINES MAY INTERACT with Trilipix delayed-release capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Colchicine or HMG-CoA reductase inhibitors (statins) (eg, simvastatin) because the risk of serious muscle problems may be increased
  • Immunosuppressants (eg, cyclosporine) or other medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) because they may increase the risk of Trilipix delayed-release capsules's side effects. Ask your doctor if you are unsure if any of your medicines might harm the kidney
  • Anticoagulants (eg, warfarin) because the risk of their side effects may be increased by Trilipix delayed-release capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Trilipix delayed-release capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Trilipix delayed-release capsules:

Use Trilipix delayed-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Trilipix delayed-release capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Trilipix delayed-release capsules refilled.
  • Take Trilipix delayed-release capsules by mouth with or without food.
  • Swallow Trilipix delayed-release capsules whole. Do not open, crush, chew, or dissolve before swallowing. If you cannot swallow Trilipix delayed-release capsules whole, tell your doctor. You may need a different medicine.
  • If you also take a bile acid-binding resin (eg, cholestyramine), do not take it within 4 to 6 hours before or 1 hour after taking Trilipix delayed-release capsules. Check with your doctor if you have any questions.
  • Take Trilipix delayed-release capsules on a regular schedule to get the most benefit from it.
  • Taking Trilipix delayed-release capsules at the same time each day will help you remember to take it.
  • Continue to take Trilipix delayed-release capsules even if you feel well. Do not miss any doses.
  • If you miss a dose of Trilipix delayed-release capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Do not take more than 1 dose of Trilipix delayed-release capsules in the same day unless your doctor tells you otherwise.

Ask your health care provider any questions you may have about how to use Trilipix delayed-release capsules.

Important safety information:

  • Tell your doctor or dentist that you take Trilipix delayed-release capsules before you receive any medical or dental care, emergency care, or surgery.
  • Follow the diet, exercise, and weight loss program given to you by your health care provider.
  • Do NOT take more than the recommended dose, change your dose, or stop taking Trilipix delayed-release capsules without checking with your doctor.
  • Muscle problems (myopathy) may occur with Trilipix delayed-release capsules. The risk of muscle problems may be greater in elderly patients and in people who have kidney problems or low thyroid function. It may also be greater in those who take Trilipix delayed-release capsules with certain other medicines (eg, colchicine; HMG-CoA reductase inhibitors [statins], such as simvastatin). Tell your doctor right away if you notice any unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or general body discomfort.
  • Severe skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis) have happened. They can cause serious health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • Lab tests may be performed while you use Trilipix delayed-release capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Trilipix delayed-release capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially muscle problems.
  • PREGNANCY and BREAST-FEEDING: It is not known if Trilipix delayed-release capsules can cause harm to the fetus. If you become pregnant or plan to become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Trilipix delayed-release capsules while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking Trilipix delayed-release capsules.

Possible side effects of Trilipix delayed-release capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; diarrhea; dizziness; headache; heartburn or indigestion; nausea; nose and throat irritation; runny or stuffy nose.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); calf or leg pain, swelling, redness, or tenderness; chest pain; coughing up blood; decreased urination; fever, chills, or persistent sore throat; muscle pain, tenderness, or weakness (especially along with fever or unusual tiredness); severe or persistent joint pain or swelling; shortness of breath; symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, right-sided stomach pain, yellowing of the skin or eyes); symptoms of pancreatitis (eg, severe stomach or back pain, with or without nausea or vomiting); unusual bruising or bleeding; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Trilipix delayed-release capsules:

Store Trilipix delayed-release capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Trilipix delayed-release capsules out of the reach of children and away from pets.

General information:

  • If you have any questions about Trilipix delayed-release capsules, please talk with your doctor, pharmacist, or other health care provider.
  • Trilipix delayed-release capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Trilipix delayed-release capsules or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Trilipix delayed-release capsules. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Trilipix delayed-release capsules. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Trilipix delayed-release capsules.

Issue Date: June 3, 2015

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.