Read the Patient Information Leaflet provided by your pharmacist before you start febuxostat and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
Dosage is based on your medical condition and response to treatment. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.
You may have more gout attacks for several months after starting this medicine while the body removes extra uric acid. Febuxostat is not a pain reliever. Your doctor may prescribe medication (such as colchicine, NSAIDs such as ibuprofen, naproxen, or indomethacin) to prevent/treat a gout attack during the first several months you are taking febuxostat. Continue to take your prescribed medicines for gout attacks as directed by your doctor.
Tell your doctor if your condition persists or worsens.
Nausea may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Febuxostat may rarely cause serious (possibly fatal) liver disease. It may also cause an increase in liver enzymes. Your doctor will order blood tests to measure these enzymes. Keep all medical/lab appointments. Tell your doctor immediately if you develop symptoms of liver disease, including persistent nausea, stomach/abdominal pain, dark urine, yellowing eyes/skin.
Tell your doctor immediately if any of these rare but very serious side effects occur: chest pain/pressure, sudden tiredness, weakness, jaw/left arm pain, weakness on one side of the body, slurred speech, sudden vision changes, confusion, pink/bloody urine, painful urination.
Febuxostat may cause a rash that could be a sign of a severe reaction. Therefore, tell your doctor immediately if you develop any rash.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking febuxostat, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: azathioprine, mercaptopurine.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Do not share this medication with others.
Laboratory and/or medical tests (such as uric acid blood levels, liver function tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature at 77 degrees F (25 degrees C). Brief storage between 59-86 degrees F (15-30 degrees C) is permitted.
Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.
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