Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Febuxostat
Laboratorios Tillomed Spain, S.L.U.
M04AA03
Febuxostat
120 milligram(s)
Film-coated tablet
febuxostat
Not marketed
2020-06-26
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Febuxostat Tillomed 80mg film-coated tablets Febuxostat Tillomed 120mg 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 Tillomed is and what it is used for 2. What you need to know before you take Febuxostat Tillomed 3. How to take Febuxostat Tillomed 4. Possible side effects 5. How to store Febuxostat Tillomed 6. Contents of the pack and other information 1. WHAT FEBUXOSTAT TILLOMED IS AND WHAT IT IS USED FOR Febuxostat Tillomed film-coated 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 Tillomed works by reducing uric acid levels. Keeping uric acid levels low by taking febuxostat 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 Tillomed 120 mg tablets are also used to treat and prevent high blood levels of uric acid that may occur Διαβάστε το πλήρες έγγραφο
Health Products Regulatory Authority 14 November 2022 CRN00D5M5 Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Febuxostat Tillomed 120 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 120 mg of febuxostat (as febuxostat hemihydrate). Excipient(s) with known effects: Each tablet contains 430.80 mg of lactose (as monohydrate) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablets). Pale yellow to yellow, capsule shaped, film coated tablet debossed with "EM 48" on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Febuxostat Tillomed 120 mg film-coated tablets 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 Tillomed 120 mg film-coated tablets 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). Febuxostat Tillomed 120 mg film-coated tablets is indicated in adults. Febuxostat Tillomed 120 mg film-coated tablets is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Gout: The recommended oral dose of Febuxostat Tillomed 80 mg film-coated tablets 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 Tillomed 120 mg film-coated tablets 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 (357μmol/L). Gout flare prophylaxis of at least 6 months is recommended (see section 4.4). Tumor Lysis Syndrome: The recommended oral dose of Febuxostat Tillomed 120 mg film-coated tablets is 120 mg once daily without regard to food. Febuxostat Tillomed 120 mg film-coate Διαβάστε το πλήρες έγγραφο