Febuxostat Oral tablet

What is this medicine?

FEBUXOSTAT is used to treat gout. People with gout have too much uric acid in their body. This medicine works to lower how much uric acid the body makes.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart disease
• history of stroke
• kidney disease
• liver disease
• taking theophylline, azathioprine, or mercaptopurine
• an unusual or allergic reaction to febuxostat, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• azathioprine
• mercaptopurine
• theophylline

This medicine may also interact with the following medications:

• allopurinol
• medicines used to treat cancer
• rasburicase

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. You will need regular blood tests while you are taking this medicine. Your gout may flare up while you are taking this medicine. If you have gout pain, do not stop taking this medicine. You may need to take another medicine with this medicine for gout pain.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• changes in vision
• chest pain
• confusion, trouble speaking or understanding
• dizziness
• fast, irregular heartbeat
• feeling faint or lightheaded, falls
• gout pain
• muscle aches or pains
• severe headaches
• sudden numbness or weakness of the face, arm or leg
• trouble walking, dizziness, loss of balance or coordination
• unusually weak or tired
• yellowing of the eyes or skin

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• changes in appetite
• constipation or diarrhea
• nausea
• red, hot flush to face or skin
• stomach upset or pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light and moisture. Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.