País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Febuxostat
Clonmel Healthcare Ltd
M04AA; M04AA03
Febuxostat
120 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Preparations inhibiting uric acid production; febuxostat
Marketed
2018-04-27
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER Febuxostat Clonmel 80mg Film-coated Tablets Febuxostat Clonmel 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 Clonmel is and what it is used for 2. What you need to know before you take Febuxostat Clonmel 3. How to take Febuxostat Clonmel 4. Possible side effects 5. How to store Febuxostat Clonmel 6. Contents of the pack and other information 1. WHAT FEBUXOSTAT CLONMEL IS AND WHAT IT IS USED FOR Febuxostat Clonmel 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 Clonmel works by reducing uric acid levels. Keeping uric acid levels low by taking Febuxostat Clonmel 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 Clonmel 120 mg tablets is also used to treat and prevent high blood levels of uric acid that may occur when you start to rec Leia o documento completo
Health⋅Products⋅Regulatory⋅Authority 04⋅July⋅2022 CRN00CTRY Page⋅1⋅of⋅14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Febuxostat⋅Clonmel⋅120⋅mg⋅Film-coated⋅tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each⋅film-coated⋅tablet⋅contains⋅120 mg⋅of⋅febuxostat⋅(as⋅hemihydrate). For⋅the⋅full⋅list⋅of⋅excipients,⋅see⋅section⋅6.1. 3 PHARMACEUTICAL FORM Film-coated⋅tablet. Yellow,⋅oblong,⋅biconvex,⋅18⋅mm⋅x⋅8⋅mm⋅film-coated⋅tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Febuxostat⋅Clonmel⋅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⋅Clonmel⋅is⋅indicated⋅for⋅the⋅prevention⋅and⋅treatment⋅of⋅hyperuricaemia⋅in⋅adult⋅patients⋅undergoing⋅ chemotherapy⋅for⋅haematologic⋅malignancies⋅at⋅intermediate⋅to⋅high⋅risk⋅of⋅Tumour⋅Lysis⋅Syndrome⋅(TLS). Febuxostat⋅Clonmel⋅is⋅indicated⋅in⋅adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Gout_ The⋅recommended⋅oral⋅dose⋅of⋅Febuxostat⋅Clonmel is⋅80 mg⋅once⋅daily⋅without⋅regard⋅to⋅food.⋅If⋅serum⋅uric⋅acid⋅is⋅> 6 mg/dl⋅ (357 micromol/l)⋅after⋅2-4 weeks,⋅Febuxostat⋅Clonmel⋅120 mg⋅once⋅daily⋅may⋅be⋅considered. Febuxostat⋅Clonmel 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 micromol/l). Gout⋅flare⋅prophylaxis⋅of⋅at⋅least⋅6 months⋅is⋅recommended⋅(see⋅section⋅4.4). _Tumour Lysis Syndrome_ The⋅recommended⋅oral⋅dose⋅of⋅Febuxostat⋅Clonmel⋅is⋅120 mg⋅once⋅daily⋅without⋅regard⋅to⋅food. Febuxostat⋅Clonmel⋅should⋅be⋅started Leia o documento completo