देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Febuxostat
Accord Healthcare Ireland Ltd.
M04AA03
Febuxostat
80 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
febuxostat
Marketed
2019-02-08
1 PACKAGE LEAFLET: INFORMATION FOR THE USER FEBUXOSTAT TABLETS 80 MG FILM-COATED TABLETS febuxostat READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Febuxostat Tablets is and what it is used for 2. What you need to know before you take Febuxostat Tablets 3. How to take Febuxostat Tablets 4. Possible side effects 5. How to store Febuxostat Tablets 6. Contents of the pack and other information 1. WHAT FEBUXOSTAT TABLETS IS AND WHAT IT IS USED FOR Febuxostat Tablets 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. Febuxostat Tablets works by reducing uric acid levels. Keeping uric acid levels low by taking Febuxostat Tablets 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 Tablets is for adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FEBUXOSTAT TABLETS DO NOT TAKE FEBUXOSTAT TABLETS: - if you are allergic to febuxostat or any of the other ingredi पूरा दस्तावेज़ पढ़ें
Health Products Regulatory Authority 26 January 2023 CRN00CZRX Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Febuxostat Accord 80mg Film Coated Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80 mg of febuxostat (as magnesium salts). _Excipient with known effect:_ Each tablet contains 76.50 mg lactose monohydrate. Each tablet contains 0.17 mmol (3.9 mg) sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet) Pale yellow to yellow, film-coated, capsule shaped tablets, engraved with “80” on one side, 17.2 ± 0.2 mm in length, 6.2 ± 0.2 mm in width, 5.6 ± 0.2 mm in thickness. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Febuxostat Accord is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat Accord is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Gout: The recommended oral dose of Febuxostat Accord is 80 mg once daily without regard to food. If serum uric acid is > 6 mg/dL (357 μmol/L) after 2-4 weeks, Febuxostat Accord 120 mg once daily may be considered. Febuxostat Accord works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks. The therapeutic target is to decrease and maintain serum uric acid below 6 mg/dL (357 μmol/L). Gout flare prophylaxis of at least 6 months is recommended (see section 4.4). _ _ _Elderly_ No dose adjustment is required in the elderly (see section 5.2). _Renal impairment_ The efficacy and safety have not been fully evaluated in patients with severe renal impairment (creatinine clearance < 30 mL/min, see section 5.2). No dose adjustment is necessary in patients with mild or moderate renal impairment. _ _ _Hepatic impairment_ The efficacy and safety of febuxostat have not been studied in patients with severe hepatic impairment (Child-Pugh Class C). Gout: The recommended dose in patie पूरा दस्तावेज़ पढ़ें