FEBUXOSTAT tablets are used to treat gout, which is associated with an excess of a chemical called uric acid (urate) in the body. In some people, the amount of uric acid builds up in the blood and may become too high to remain soluble. When this happens, urate crystals may form in and around the joints and kidneys. These crystals can cause sudden, severe pain, redness, warmth and swelling in a joint (known as a gout attack). Left untreated, larger deposits called tophi (TOE-FI) may form in and around joints. These tophi may cause joint and bone damage. FEBUXOSTAT works by reducing uric acid levels. Keeping uric acid levels low by taking FEBUXOSTAT once every day stops crystals building up, and over time it reduces symptoms. Keeping uric acid levels sufficiently low for a long enough period can also shrink tophi.
||•If you are allergic (hypersensitive) to febuxostat, the active ingredient of FEBUXOSTAT, or any of the other ingredients in these tablets.
|Drug Special Care
||Tell your doctor before you start to take this medicine:
•If you have or have had heart failure or heart problems
•If you are being treated for high uric acid levels as a result of cancer disease or Lesch-Nyhan syndrome (a rare inherited condition in which there is too much uric acid in the blood)
•If you have thyroid problems
If you are having a gout attack at the moment (a sudden onset of severe pain, tenderness, redness, warmth and swelling in a joint), wait for the gout attack to subside before first starting treatment with FEBUXOSTAT. For some people, gout attacks may flare up when starting certain medicines that control uric acid levels. Not everyone gets flares, but you could get a flare-up even if you are taking FEBUXOSTAT, and especially during the first weeks or months of treatment. It is important to keep taking FEBUXOSTAT even if you have a flare, as FEBUXOSTAT is still working to lower uric acid. Over time, gout flares will occur less often and be less painful if you keep taking FEBUXOSTAT every day.
Your doctor will often prescribe other medicines, if they are needed, to help prevent or treat the symptoms of flares (such as pain and swelling in a joint). Your doctor may ask you to have blood tests to check that your liver is working normally.
|Drug Drug Interactions
||Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
It is especially important to tell your doctor or pharmacist if you are taking medicines containing any of the following substances as they may interact with FEBUXOSTAT and your doctor may wish to consider necessary measures:
•Mercaptopurine (used to treat cancer)
•Azathioprine (used to reduce immune response)
•Theophylline (used to treat asthma)
|Drug Pregnancy Interaction
||It is not known if FEBUXOSTAT may harm your unborn child. Tell your doctor if you think you are pregnant or if you are planning to become pregnant as FEBUXOSTAT should not be used during pregnancy.
|Drug Breast feeding Interaction
||It is not known if FEBUXOSTAT may pass into human breast milk. You should not use FEBUXOSTAT if you are breast feeding, or if you are planning to breastfeed.
|Drug Machinery Interaction
||No studies on the effects of FEBUXOSTAT on the ability to drive and use machines have been performed. However, you should be aware that you may experience dizziness, sleepiness and numbness or tingling sensation during treatment and should not drive or operate machines if affected.
|Drug More Information
||The tablets should be taken by mouth and can be taken with or without food.
|How to take the
||Always take FEBUXOSTAT exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. FEBUXOSTAT is available as either an 80 mg tablet or a 120 mg tablet. Your doctor will have prescribed the strength most suitable for you.
||•The usual dose is one tablet daily. The back of the blister pack is marked with the days of the week to help you check that you have taken a dose each day.
•The tablets should be taken by mouth and can be taken with or without food.
It is important that you do not stop taking FEBUXOSTAT unless your doctor tells you to.
Continue to take FEBUXOSTAT every day even when you are not experiencing gout flare or attack.
|Excess Drug Consumption
||In the event of an accidental overdose ask your doctor what to do, or contact your nearest accident and emergency department.
|Forgot Drug Consumption
||If you miss a dose of FEBUXOSTAT take it as soon as you remember unless it is almost time for your next dose, in which case miss out the forgotten dose and take your next dose at the normal time. Do not take a double dose to make up for a forgotten dose.
|Stop Drug Consumption
||Do not stop taking FEBUXOSTAT without the advice of your doctor even if you feel better. If you stop taking FEBUXOSTAT your uric acid levels may begin to rise and your symptoms may worsen due to the formation of new crystals of urate in and around your joints and kidneys.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
|Common Drug Side Effects
||• abnormal liver test results
• increase in gout symptoms
|Rare Drug Side Effects
||• allergic reactions (e.g. skin rash, itching, swelling)
• generalised skin rashes
Stop taking Febuxostat and contact your doctor immediately if these side effects occur, because a serious allergic reaction might follow
• feeling thirsty
• erectile difficulties
• ringing in the ears
• hair loss
• mouth ulceration
• inflammation of the pancreas: common symptoms are abdominal pain, nausea and vomiting
• increased sweating
• weight change (increase/decrease), increased appetite, uncontrolled loss of appetite (anorexia)
• muscle and/or joint stiffness
• abnormally low blood cell counts (white or red blood cells)
• urgent need to urinate
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
|Very Rare Drug Side Effects
||• decreased appetite, change in blood sugar levels (diabetes) of which a symptom may be excessive thirst, increased blood fat levels
• loss of sex drive
• difficulty in sleeping, sleepiness
• dizziness, numbness, tingling, reduced or altered sensation (hypoaesthesia or paraesthesia), altered or reduced sense of taste
• abnormal ECG heart tracing, irregular heartbeats, feeling your heart beat
• hot flushes or blushing (e.g. redness of the face or neck), increased blood pressure
•cough, shortness of breath, chest discomfort or pain, inflammation of nasal passage and/or throat (upper respiratory tract infection), bronchitis
•dry mouth, abdominal pain/discomfort or wind, heartburn/indigestion, constipation, more frequent passing of stools, vomiting, stomach discomfort
•itching, hives, skin inflammation or discolouration, other type of skin conditions
•muscle cramp, muscle weakness, pain/ache in muscles/joints, bursitis or arthritis (inflammation of joints usually accompanied by pain, swelling and/or stiffness), pain in extremity, back pain, muscle spasm
•blood in the urine, abnormal frequent urination, abnormal urine tests (increased level of proteins in the urine), a reduction in the ability of the kidneys to function properly
• fatigue, localised swelling due to the retention of fluids in the tissues (oedema), chest pain, chest discomfort
• stones in the gallbladder or in bile ducts (cholelithiasis)
• changes in blood chemistry or amount of blood cells or platelets (abnormal blood test results)
• kidney stones
|Drug Side Effects Symptoms
|How to Store the
|How to Store the Medicine
||• Keep out of the reach and sight of children.
•Do not use after the expiry date which is stated on the carton and the tablet blister foil after ‘EXP.’ The expiry date refers to the last day of that month.
•This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.