Šalis: Malta
kalba: anglų
Šaltinis: Medicines Authority
FEBUXOSTAT
PharOS – Pharmaceutical Oriented Services Limited Lesvou str. (end), Thesi Loggos, Industrial Zone, 144 52 Metamorfossi Attikis,, Greece
M04AA03
FEBUXOSTAT 120 mg
FILM-COATED TABLET
FEBUXOSTAT 120 mg
POM
ANTIGOUT PREPARATIONS
Withdrawn
2017-09-19
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ FEBUXOSTAT PHAROS 80 MG FILM-COATED TABLETS FEBUXOSTAT PHAROS 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 Febuxostat PharOS is and what it is used for 2. What you need to know before you take Febuxostat PharOS 3. How to take Febuxostat PharOS 4. Possible side effects 5. How to store Febuxostat PharOS 6. Contents of the pack and other information 1. WHAT FEBUXOSTAT PHAROS IS AND WHAT IT IS USED FOR Febuxostat PharOS 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 PharOS works by reducing uric acid levels. Keeping uric acid levels low by taking Febuxostat PharOS 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 PharOS 120 mg: _ Febuxostat PharOS 120 mg tablets is also used to treat and prevent high blood levels of uric acid that may Perskaitykite visą dokumentą
Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Febuxostat PharOS 80 mg film-coated tablets Febuxostat PharOS 120 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Febuxostat PharOS 80 mg: Each tablet contains 80 mg of febuxostat equivalent to 82.28 mg febuxostat hemihydrate. Febuxostat PharOS 120 mg: Each tablet contains 120 mg of febuxostat equivalent to 123.42 mg febuxostat hemihydrate. Excipient(s) with known effect: Febuxostat PharOS 80 mg: Each tablet contains 72.68 mg of lactose (as monohydrate). Febuxostat PharOS 120 mg: Each tablet contains 109.02 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Febuxostat PharOS 80 mg: Pale yellow to yellow, film-coated, capsule shaped tablets, engraved with “80” on one side and plain on the other, with dimensions 16.5 mm x 7.0 mm ± 5%. Febuxostat PharOS 120 mg: Pale yellow to yellow, film-coated, capsule shaped tablets, engraved with “120” on one side and plain on the other, with dimensions 18.5 mm x 9.0 mm ± 5%. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Febuxostat PharOS 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 PharOS 120 mg: _ Febuxostat PharOS 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 PharOS is indicated in adults. Page 2 of 18 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Gout:_ The recommended oral dose of Febuxostat PharOS 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 PharOS 120 mg once daily may be considered. Febuxostat PharOS works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks. The therapeutic t Perskaitykite visą dokumentą