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RESILIA tablets contain the active substance Febuxostat and 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 may form in and around joints. These tophi may cause joint and bone damage. RESILIA works by reducing uric acid levels. Keeping uric acid levels low by taking RESILIA 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. How to use Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is one tablet daily. The tablets should be taken by mouth and can be taken with or without food. Gout RESILIA is available as either a 40 mg tablet or an 80 mg tablet. Your doctor will have prescribed the strength most suitable for you. Continue to take RESILIA every day even when you are not experiencing gout flare or attack. Prevention and treatment of high uric acid levels in patients undergoing cancer chemotherapy RESILIA is available as a 40 tablet, and 80 mg tablet. Start taking RESILIA two days before chemotherapy and continue its use according to your doctor’s advice. Usually treatment is short-term. Warnings and precautions Do not take RESILIA If you are allergic to Febuxostat or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before taking RESILIA: If you have or have had heart failure, heart problems or stroke 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 RESILIA, stop taking this medicine (see also section4). 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. Side Effects 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 (see also section 2 “Warnings and precautions”) Potentially life-threatening skin rashes characterised 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 (Stevens- Johnson 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) (see section 2) Generalised skin rashes The common side effects (may affect up to 1 in 10 people) are: abnormal liver test results diarrhoea headache rash nausea increase in gout symptoms localised swelling due to retention of fluids in tissues (oedema) Storage Information The medicine is stored in its original package to protect from moisture. Store below 30 ° C Drug Interactions 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 RESILIA 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) Ingredients The active substance is Febuxostat.
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