Χώρα: Σουηδία
Γλώσσα: Σουηδικά
Πηγή: Läkemedelsverket (Medical Products Agency)
febuxostathemihydrat
G.L. Pharma GmbH
M04AA03
febuxostathemihydrat
120 mg
Filmdragerad tablett
mannitol Hjälpämne; natriumlaurilsulfat Hjälpämne; febuxostathemihydrat 123,42 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 14 tabletter (Al); Blister, 14 tabletter (plast/Al); Blister, 28 tabletter (Al); Blister, 28 tabletter (plast/Al); Blister, 42 tabletter (Al); Blister, 42 tabletter (plast/Al); Blister, 56 tabletter (Al); Blister, 56 tabletter (plast/Al); Blister, 84 tabletter (Al); Blister, 84 tabletter (plast/Al); Blister, 98 tabletter (Al); Blister, 98 tabletter (plast/Al); Blister, 10 tabletter (Al); Blister, 30 tabletter (Al); Blister, 10 tabletter (plast/Al); Blister, 30 tabletter (plast/Al)
Godkänd
2017-10-02
1 PACKAGE LEAFLET: INFORMATION FOR THE USER FEBURO 80 MG FILM-COATED TABLETS FEBURO 120 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 Feburo is and what it is used for 2. What you need to know before you take Feburo 3. How to take Feburo 4. Possible side effects 5 How to store Feburo 6. Contents of the pack and other information 1. WHAT FEBURO IS AND WHAT IT IS USED FOR Feburo 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. Feburo works by reducing uric acid levels. Keeping uric acid levels low by taking Feburo 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. Feburo 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 acco Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Feburo 120 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 120 mg of febuxostat. 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 of 19.0 x 7.6 mm, plain on both sides and engraved with “F120” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Feburo 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). Feburo is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS). Feburo is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Gout:_ The recommended oral dose of febuxostat 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 120 mg once daily may be considered. Febuxostat 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). _Tumor Lysis Syndrome:_ The recommended oral dose of febuxostat is 120 mg once daily without regard to food. Febuxostat should be started two days before the beginning of cytotoxic therapy and continued for a minimum of 7 days; however treatment may be prolonged up to 9 days according to chemotherapy duration as per clinical judgment. _Elderly people_ 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 i Διαβάστε το πλήρες έγγραφο