03-A199 Trilipix CB Stand(2).qxp:032-244610 5/11/09 12:23 PM Page 1

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CONSUMER BRIEF SUMMARY

CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION

Trilipix™

(try-lip-iks)

(fenofibric acid) delayed release capsules

Patient Information

Read the Medication Guide before you start taking Trilipix 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 Trilipix?

Trilipix can be used with other cholesterol-lowering medicines called statins. Statins include:

• atorvastatin (Lipitor, Caduet) • fluvastatin (Lescol, Lescol XL) • lovastatin (Altoprev, Mevacor, Advicor) • pravastatin (Pravachol) • rosuvastatin (Crestor) • simvastatin (Zocor, Simcor, Vytorin)

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 Trilipix 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.

• Heart medicine • Stomach medicine • Antibiotic • Anti-fungal • Cholesterol-lowering medicine • Hormones • HIV/AIDS medicine • Antidepressant • Immunosuppressant • Anti-seizure medicine

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 is Trilipix?

Trilipix is a prescription medicine used to treat cholesterol in the blood by lowering the total amount of triglycerides and LDL (bad) cholesterol, and increasing

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the HDL (good) cholesterol. You should be on a low fat and low cholesterol diet while you take Trilipix.

The safety and effectiveness of Trilipix in children is not known.

Who should not take Trilipix? Do not take Trilipix if you:

• are allergic to fenofibric acid, or any of the ingredients in Trilipix. See the end of this brief summary for a list of all the ingredients in Trilipix.

• have severe kidney disease. • have liver disease. • have gallbladder disease. • are a nursing mother.

Talk to your healthcare provider before you take Trilipix if you have any of these conditions.

What should I tell my healthcare provider before taking Trilipix?

Before taking Trilipix, tell your healthcare provider about all your medical conditions, including if you:

• are allergic to any medicines. • have ever had kidney problems. • have ever had liver problems. • have ever had gallbladder problems.

• are pregnant or if you plan to become pregnant. It is not known if Trilipix will harm your unborn baby.

• are breastfeeding or plan to breastfeed. It is not known if Trilipix passes into your breast milk. You and your healthcare provider should decide if you will take Trilipix or breastfeed. You should not do both.

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

Using Trilipix with certain other medicines can affect the way these medicines work and other medicines may affect how Trilipix works. In some cases, using Trilipix 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 Trilipix?" or any of the medicines listed below:

• anticoagulants, also known as blood thinners (warfarin, Coumadin)

• bile acid resins • cyclosporine

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

How should I take Trilipix?

• You should be on a low fat and low cholesterol diet while you take Trilipix. Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60