PATIENT INFORMATION
ULORIC® (U– -'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:
s;TAKE;!ZATHIOPRINE;;!ZASAN®, Imuran®)
s;TAKE;-ERCAPTOPURINE;;0URINETHOL®)
s;; TAKE;4HEOPHYLLINE;;4HEO;;;®, Elixophyllin®, Theochron®,
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:
s;HAVE;LIVER;OR;KIDNEY;PROBLEMS
s;HAVE;A;HISTORY;OF;HEART;DISEASE;OR;STROKE
s;; ARE;PREGNANT;OR;PLAN;TO;BECOME;PREGNANT;;)T;IS;NOT;KNOWN;IF;
ULORIC will harm your unborn baby. Talk with your healthcare
provider if you are pregnant or plan to become pregnant.
s;; ARE;BREAST;FEEDING;OR;PLAN;TO;BREAST;FEED;;)T;IS;NOT;KNOWN;IF; 5,/2)#;
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?
s;; 4AKE; 5,/2)#;EXACTLY;AS;YOUR;HEALTHCARE;PROVIDER;TELLS;YOU;TO;
take it.
s; 5,/2)#;CAN;BE;TAKEN;WITH;OR;WITHOUT;FOOD;
s; 5,/2)#;CAN;BE;TAKEN;WITH;ANTACIDS;
s;; 9OUR;GOUT;MAY;mARE;UP;WHEN;YOU;START;TAKING; 5,/2)#;;DO;NOT;
STOP;TAKING;YOUR; 5,/2)#;EVEN;IF;YOU;HAVE;A;mARE;;9OUR;HEALTH
care provider may give you other medicines to help prevent
YOUR;GOUT;mARES;
s;; 9OUR;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 events.
The most common side effects of ULORIC include:
s;LIVER;PROBLEMS
s;NAUSEA
s;GOUT;mARES
s;JOINT;PAIN
s;RASH
Tell your healthcare provider if you have any side effect that
bothers you or that does not go away. These are not all of the
possible side effects of ULORIC. For more information, ask your
healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may
report side effects to the FDA at 1-800-FDA-1088.
HOW SHOULD I STORE ULORIC?
Store ULORIC between 59°F - 86°F ( 15°C - 30°C).
Keep ULORIC out of the light.
Keep ULORIC and all medicines out of the reach of children.
GENERAL INFORMATION ABOUT THE SAFE AND
EFFECTIVE USE OF ULORIC.
-EDICINES;ARE;SOMETIMES;PRESCRIBED;FOR;PURPOSES;OTHER;THAN;
THOSE;LISTED;IN;A;PATIENT;INFORMATION;LEAmET;;$O;NOT;USE; 5,/2)#;
for a condition for which it was not prescribed. Do not give
ULORIC to other people, even if they have the same symptoms
that you have. It may harm them.
4HIS;PATIENT;INFORMATION;LEAmET;SUMMARIZES;THE;MOST;IMPORTANT;
information about ULORIC. If you would like more information
about ULORIC talk with your healthcare provider. You can ask your
healthcare provider or pharmacist for information about
ULORIC that is written for health professionals. For more
information go to www.uloric.com, or call 1-877-825-3327.
WHAT ARE THE INGREDIENTS IN ULORIC?
Active Ingredient: febuxostat
Inactive ingredients include: lactose monohydrate, micro-
crystalline cellulose, hydroxypropyl cellulose, sodium
croscarmellose, silicon dioxide, magnesium stearate, and
Opadry II, green
Distributed by Takeda Pharmaceuticals America, Inc.
NEED HELP PAYING FOR PRESCRIPTIONS?
Takeda Help At Hand provides patients with options
for receiving free or low-cost medications. For more
information, visit www.takedahelpathand.com.
