Drug Information

Fenofibric Acid

What is FENOFIBRIC ACID?

(FENOFIBRIC ACID) Fenofibric acid is used along with a proper diet to help lower "bad" cholesterol and fats (such as LDL, triglycerides) and raise "good" cholesterol (HDL) in the blood. It works by increasing the natural substance (enzyme) that breaks down fats in the blood. Fenofibric acid belongs to a group of drugs known as "fibrates." Lowering triglycerides in people with very high triglyceride blood levels may decrease the risk of pancreas disease (pancreatitis). However, fenofibric acid might not lower your risk of a heart attack or stroke. Talk to your doctor about the risks and benefits of fenofibric acid. In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.

How should I use FENOFIBRIC ACID?

Take this medication by mouth with or without food as directed by your doctor, usually once daily. The manufacturer directs not to crush or chew the tablet before taking it. However, many similar drugs (immediate-release tablets) can be crushed or chewed. Follow your doctor's directions on how to take this medication. The dosage is based on your medical condition and response to treatment. If you are also taking certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take fenofibric acid at least 1 hour before or at least 4 to 6 hours after taking these medications. These medications can bind to fenofibric acid, preventing your body from fully absorbing the drug. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your cholesterol/triglycerides level will not lower faster, and your risk of side effects will increase. Keep taking this medication even if you feel well. Most people with high cholesterol/triglycerides do not feel sick. It is very important to continue to follow your doctor's advice about diet and exercise. It may take up to 2 months before you get the full benefit of this medication.

What should I tell my health care provider before I take FENOFIBRIC ACID?

Before taking fenofibric acid, tell your doctor or pharmacist if you are allergic to it; or to other "fibrates" (such as fenofibrate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease (such as biliary cholangitis, hepatitis), gallbladder disease, alcohol use. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 5 days after the last dose. Consult your doctor before breastfeeding.

What may interact with FENOFIBRIC ACID?

See also How to Use section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: "blood thinners" (such as warfarin). Fenofibric acid is very similar to fenofibrate. Do not use medications containing fenofibrate while using fenofibric acid.

What if I miss a dose of FENOFIBRIC ACID?

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

What side effects may I notice from receiving FENOFIBRIC ACID?

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This medication may rarely cause gallstones and liver problems. If you notice any of the following unlikely but serious side effects, tell your doctor right away: nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine. This drug may rarely cause muscle problems (which can rarely lead to a very serious condition called rhabdomyolysis). Tell your doctor right away if you develop any of these symptoms: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), signs of kidney problems (such as change in the amount of urine). Rarely, this medication has caused severe lowering of HDL ("good" cholesterol) levels. This is the opposite of what should happen to your HDL levels (paradoxical reaction). Your HDL cholesterol levels should be checked regularly. Keep all of your lab appointments. Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, unusual tiredness. Get medical help right away if you have any very serious side effects, including: chest pain, sudden pain/redness/swelling usually in the leg, signs of infection (such as sore throat that doesn't go away, fever, swollen lymph nodes, chills, cough). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Where should I keep FENOFIBRIC ACID?

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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