FENOFIBRIC ACID- fenofibric acid capsule, delayed release 
Zydus Pharmaceuticals USA Inc

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MEDICATION GUIDE

FENOFIBRIC ACID DELAYED RELEASE CAPSULES

Read this Medication Guide before you start taking fenofibric acid delayed release capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about fenofibric acid delayed release capsules?

Fenofibric acid delayed release capsules can be used with other cholesterol-lowering medicines called statins. Statins include:

Statins can cause muscle pain, tenderness or weakness, which may be symptoms of a rare but serious muscle condition called rhabdomyolysis. In some cases rhabdomyolysis can cause kidney damage and death. The risk of rhabdomyolysis may be higher when fenofibric acid delayed release capsules is given with statins. If you take a statin, tell your healthcare provider.

Other medicines or large amounts of grapefruit juice (more than a quart) may raise the levels of statins in your body, and could then raise the risk of muscle problems. Tell your healthcare provider if you are taking any medicines listed below.

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

Tell your healthcare provider if you drink grapefruit juice.

What are fenofibric acid delayed release capsules?

Fenofibric acid delayed release capsules are a prescription medicine used to treat cholesterol in the blood by lowering the total amount of triglycerides and LDL (bad) cholesterol, and increasing the HDL (good) cholesterol. Fenofibric acid delayed release capsules have not been shown to lower your risk of having heart problems or a stroke. You should be on a low fat and low cholesterol diet while you take fenofibric acid delayed release capsules.

The safety and effectiveness of fenofibric acid delayed release capsules in children are not known.

Who should not take fenofibric acid delayed release capsules?

Do not take fenofibric acid delayed release capsules if you:

Talk to your healthcare provider before you take fenofibric acid delayed release capsules if you have any of these conditions.

What should I tell my healthcare provider before taking fenofibric acid delayed release capsules?

Before taking fenofibric acid delayed release capsules, tell your healthcare provider about all your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

Using fenofibric acid delayed release capsules with certain other medicines can affect the way these medicines work and other medicines may affect how fenofibric acid delayed release capsules work. In some cases, using fenofibric acid delayed release capsules with other medicines can cause serious side effects.

Know all the medicines you take. Keep a list of them and show it to your healthcare provider when you get a new medicine.

It is especially important to tell your healthcare provider if you take any of the medicines mentioned in, "What is the most important information I should know about fenofibric acid delayed release capsules?" or any of the medicines listed below:

Ask your healthcare provider if you are not sure if your medicine is one of these.

How should I take fenofibric acid delayed release capsules?

What are the possible side effects with fenofibric acid delayed release capsules?

Fenofibric acid delayed release capsules may cause serious side effects, including:

Call your healthcare provider right away if you have any of these serious side effects.

The most common side effects with fenofibric acid delayed release capsules include:

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of fenofibric acid delayed release capsules. For more information, ask your healthcare provider or pharmacist.

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

How do I store fenofibric acid delayed release capsules?

Keep fenofibric acid delayed release capsules and all medicines out of the reach of children.

General information about the safe and effective use of fenofibric acid delayed release capsules

Medicines are sometimes prescribed for conditions that are not mentioned in the Medication Guide. Do not use fenofibric acid delayed release capsules for a condition for which it was not prescribed. Do not give fenofibric acid delayed release capsules to other people, even if they have the same condition you have. It may harm them.

This Medication Guide summarizes the most important information about fenofibric acid delayed release capsules. If you would like more information, talk to your healthcare provider. You can also ask your pharmacist or healthcare provider for information that is written for health professionals.

What are the ingredients in fenofibric acid delayed release capsules?

Active Ingredient: Fenofibric acid

Inactive Ingredients: Hypromellose, povidone, water, hydroxylpropyl cellulose, colloidal silicon dioxide, sodium stearyl fumarate, methacrylic acid copolymer, talc, triethyl citrate, gelatin, titanium dioxide, and yellow iron oxide. Additionally, the 45 mg capsule shell contains black iron oxide and red iron oxide, and the 135 mg capsule shell contains FD&C Blue #2.



Manufactured by:
Fournier Laboratories Ireland Limited, Anngrove, Carrigtwohill Co. Cork, Ireland

Distributed by:
Zydus Pharmaceuticals USA Inc.
Pennington, NJ 08534

03–A889 November, 2013


This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: 03/2014
 
Zydus Pharmaceuticals USA Inc