• Febuxostat is 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 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.
• Febuxostat is also used to treat and prevent high blood levels of uric acid that may occur when you start to receive chemotherapy for blood cancers. When chemotherapy is given, cancer cells are destroyed, and uric acid levels increase in the blood accordingly, unless the formation of uric acid is prevented.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is one tablet daily.

Gout: Febuxostat is available as either a 40 mg tablet or a 80 mg tablet. Your doctor will have prescribed the strength most suitable for you. 

Continue to take Febuxostat every day even when you are not experiencing gout flare or attack.

Methods:

The tablets should be taken by mouth and can be taken with or without food.

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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) 

Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking this medicine and contact your doctor immediately or go to an emergency department nearby if the following rare (may affect up to 1 in 1,000 people) side effects occur, because a serious allergic reaction might follow: 

• anaphylactic reactions, drug hypersensitivity 
• potentially life-threatening skin rashes characterized by formation of blisters and shedding of the skin and inner surfaces of body cavities, e.g. mouth and genitals, painful ulcers in the mouth and/or genital areas, accompanied by fever, sore throat and fatigue (StevensJohnson Syndrome/ Toxic Epidermal Necrolysis), or by enlarged lymph nodes, liver enlargement, hepatitis (up to liver failure), raising of the white-cells count in the blood (drug reaction with eosinophilia and systemic symptoms-DRESS)
• generalized skin rashes 

Common side effects: 

• abnormal liver test results 
• diarrhea 
• headache 
• rash (including various types of rash, please see below under “uncommon” and “rare” sections) 
• nausea 
• increase in gout symptoms 
• localized swelling due to retention of fluids in tissues (oedema) 

Uncommon side effects: 

• decreased appetite, change in blood sugar levels (diabetes) of which a symptom may be excessive thirst, increased blood fat levels, weight increase 
• loss of sex drive, difficulty in sleeping, sleepiness 
• dizziness, numbness, tingling, reduced or altered sensation (hypoesthesia, hemiparesis or paraesthesia), altered sense of taste, diminished sense of smell (hyposmia) 
• abnormal ECG heart tracing, irregular or rapid heartbeats, feeling your heartbeat (palpitation) 
• hot flushes or flushing (e.g. redness of the face or neck), increased blood pressure, bleeding (hemorrhage, seen only in patients taking chemotherapy for blood disorders) 
• 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, skin discoloration, small red or purple spots on the skin, small, flat red spots on the skin, flat, red area on the skin that is covered with small confluent bumps, rash, areas of redness and spots on the skin, 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, chest pain, chest discomfort, stones in the gallbladder or in bile ducts (cholelithiasis), increase in blood thyroid stimulating hormone (TSH) level, changes in blood chemistry or amount of blood cells or platelets (abnormal blood test results), kidney stones, erectile difficulties 

Rare side effects: 

• muscle damage, a condition which on rare occasions can be serious. It may cause muscle problems and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown. Contact your doctor immediately if you experience muscle pain, tenderness or weakness 
• severe swelling of the deeper layers of the skin, especially around the lips, eyes, genitals, hands, feet or tongue, with possible sudden difficulty breathing 
• high fever in combination with measles-like skin rash, enlarged lymph nodes, liver enlargement, hepatitis (up to liver failure), raising of the white-cells count in the blood (leukocytosis, with or without eosinophilia) 
• reddening of the skin (erythema), rash in various types (e.g. itchy, with white spots, with blisters, with blisters containing pus, with shedding of the skin, measles-like rash), widespread erythema, necrosis, and bullous detachment of the epidermis and mucous membranes, resulting in exfoliation and possible sepsis (Stevens-Johnson Syndrome/Toxic epidermal necrolysis) 
• nervousness, feeling thirsty, ringing in the ears, blurred vision, change in vision, hair loss, mouth ulceration, inflammation of the pancreas: common symptoms are abdominal pain, nausea and vomiting 
• increased sweating, weight decrease, increased appetite, uncontrolled loss of appetite (anorexia), muscle and/or joint stiffness 

Do not take Febuxostat Tablets: if you are allergic (hypersensitive) to febuxostat. 

Warnings and precautions 

Talk to your doctor before taking Febuxostat : 

• If you have or have had heart failure or heart problems 
• If you have or have had renal disease and/or serious allergic reaction to Allopurinol (a medication used for the treatment of Gout) 
• If you have or have had liver disease or liver function test abnormalities 
• If you are being treated for high uric acid levels as a result of Lesch-Nyhan syndrome (a rare inherited condition in which there is too much uric acid in the blood) 
• If you have thyroid problems. 

Should you experience allergic reactions to Febuxostat , stop taking this medicine. 

Possible symptoms of allergic reactions might be: rash including severe forms (e.g. blisters, nodules, itchy, exfoliative rash), itchiness, swelling of limbs or face, difficulties in breathing, fever with enlarged lymph nodes, but also serious life threatening allergic conditions with cardiac and circulatory arrest. 

Your doctor might decide to permanently stop treatment with Febuxostat.

There have been rare reports of potentially life-threatening skin rashes (Stevens-Johnson Syndrome) with the use of Febuxostat, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. It may also include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). The rash may progress to widespread blistering or peeling of the skin.

If you have developed Stevens-Johnson-Syndrome with the use of febuxostat, you must not be restarted on Febuxostat at any time. If you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell them that you are taking this medicine. 

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). 

In patients with very high urate levels (e.g. those undergoing cancer chemotherapy), treatment with uric acid-lowering medicines could lead to the build-up of xanthine in the urinary tract, with possible stones, even though this has not been observed in patients being treated with Febuxostat for Tumor Lysis Syndrome. 

Children and adolescents: Do not give this medicine to children under the age of 18 because the safety and efficacy have not been established.t 

Pregnancy, breast-feeding and fertility It is not known if Febuxostat may harm your unborn child. Febuxostat should not be used during pregnancy. 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. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines: Be aware that you may experience dizziness, sleepiness, blurred vision and numbness or tingling sensation during treatment and should not drive or operate machines if affected.