17 PATIENT COUNSELING INFORMATION
[see FDA-Approved Patient Labeling (17.2)]

17.1 General Information
Patients should be advised of the potential benefits and risks of ULORIC. Patients should be informed about the potential for gout flares, elevated liver enzymes and adverse cardiovascular events after initiation of ULORIC therapy.

Concomitant prophylaxis with an NSAID or colchicine for gout flares should be considered.

Patients should be instructed to inform their healthcare professional if they develop a rash, chest pain, shortness of breath or neurologic symptoms suggesting a stroke. Patients should be instructed to inform their healthcare professional of any other medications they are currently taking with ULORIC, including over-the-counter medications.

17.2 FDA-Approved Patient Labeling
Patient Information
ULORIC® (Ū – 'lor – ik)
(febuxostat) tablets

Read the Patient Information that comes with ULORIC before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is ULORIC?

ULORIC is a prescription medicine called a xanthine oxidase (XO) inhibitor, used to lower blood uric acid levels in adults with gout.

It is not known if ULORIC is safe and effective in children under 18 years of age.

Who should not take ULORIC?

Do not take ULORIC if you:

take Azathioprine (Azasan®, Imuran®)
take Mercaptopurine (Purinethol®)
take Theophylline (Theo-24®, Elixophyllin®, Theochron®, Theolair®, Uniphyl®)
It is not known if ULORIC is safe and effective in children under 18 years of age.

What should I tell my healthcare provider before taking ULORIC?

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

have liver or kidney problems
have a history of heart disease or stroke
are pregnant or plan to become pregnant. It is not known if ULORIC will harm your unborn baby. Talk with your healthcare provider if you are pregnant or plan to become pregnant.
are breast-feeding or plan to breast-feed. It is not known if ULORIC passes into your breast milk. You and your healthcare provider should decide if you should take ULORIC while breast-feeding.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. ULORIC may affect the way other medicines work, and other medicines may affect how ULORIC works.

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

How should I take ULORIC?

Take ULORIC exactly as your healthcare provider tells you to take it.
ULORIC can be taken with or without food.
ULORIC can be taken with antacids.
Your gout may flare up when you start taking ULORIC, do not stop taking your ULORIC even if you have a flare. Your healthcare provider may give you other medicines to help prevent your gout flares.
Your healthcare provider may do certain tests while you take ULORIC.
What are the possible side effects of ULORIC?

Heart problems. A small number of heart attacks, strokes and heart-related deaths were seen in clinical studies. It is not certain that ULORIC caused these event