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AGOUT tablets 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 (TOE-FI) may form in and around joints. These tophi may cause joint and bone damage. AGOUT works by reducing uric acid levels. Keeping uric acid levels low by taking AGOUT 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. AGOUT 120 mg tablets 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. AGOUT is for adults. How to use This medicine is intended for adults over 18 years of age. Take this medicine as directed by your doctor. The usual recommended dose is 40 mg once daily. Your doctor may increase the dose to 80 mg once daily if necessary. The dose may be increased to 120 mg once daily if your doctor deems it appropriate. Warnings and precautions Tell your doctor about all of your health conditions, including if you have: If you have liver or kidney problems. If you have heart problems or a history of heart disease or stroke. If you are undergoing treatment for cancer or have a health problem known as Lesch-Nyhan syndrome. You may have more gout attacks after you start taking this medicine. Do not stop taking it. People with heart disease who take this drug are at higher risk of death from heart problems than patients who take allopurinol. You may experience liver problems after using this drug. Side Effects Like all medicines, Agout 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 (see also section 2 “Warnings and precautions”) • potentially life-threatening skin rashes characterized by formation of blisters and shedding of the skin and inner surfaces of body cavities, eg. 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) (see section 2). • generalised skin rashes Common side effects (reported in more than 1 in 100 patients but less than 1 in 10 patients) are: Abnormal liver test results. Diarrhea. Headache. Rashes. Nausea. Increase in gout symptoms. Localized swelling due to retention of fluids in tissues (oedema). Storage Information Store below 30oC 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 Agout 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 Tablet core: lactose fast flow, microcrystalline cellulose, magnesium stearate, hydroxypropylcellulose low-S, croscarmellose sodium, colloidal Silicon Dioxide. Film-coating: Opadry OY-37202 Dark Tan, Purified Water. Specifications Agout 80mg film-coated tablets are light brown to brown color, Oblong, biconvex, with "23" debossed on one side and plain surface on the other.
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