Land: Sverige
Språk: svenska
Källa: Läkemedelsverket (Medical Products Agency)
febuxostathemihydrat
G.L. Pharma GmbH
M04AA03
febuxostathemihydrat
80 mg
Filmdragerad tablett
mannitol Hjälpämne; natriumlaurilsulfat Hjälpämne; febuxostathemihydrat 82,28 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 Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Feburo 80 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80 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 17.6 x 6.0 mm, plain on both sides and engraved with “F80” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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 in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 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). _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 in patients with mild or moderate renal impairment. _Hepatic impairment_ The efficacy and safety of febuxostat has not been studied in patients with severe hepatic impairment (Child Pugh Class C). The recommended dose in patients with mild hepatic impairment is 80 mg. Limited information is available in patients with moderate hepatic impairment. _Paediatric population_ The safety and the efficacy of febuxostat in children aged below the age of 18 years have not been established. No data are available. Method of administration Oral use Feburo should be taken by mouth and can Läs hela dokumentet