국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
Febuxostat
Pinewood Laboratories Ltd
M04AA03
Febuxostat
120 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
febuxostat
Marketed
2018-11-30
1 PACKAGE LEAFLET: INFORMATION FOR THE USER FEBUXOSTAT PINEWOOD 80 MG FILM-COATED TABLETS FEBUXOSTAT PINEWOOD 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 Pinewood is and what it is used for 2. What you need to know before you take Febuxostat Pinewood 3. How to take Febuxostat Pinewood 4. Possible side effects 5. How to store Febuxostat Pinewood 6. Contents of the pack and other information 1. WHAT FEBUXOSTAT PINEWOOD IS AND WHAT IT IS USED FOR Febuxostat Pinewood 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 Pinewood works by reducing uric acid levels. Keeping uric acid levels low by taking Febuxostat Pinewood 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 Pinewood 120 mg tablets are also used to treat and prevent high blood levels of uric acid that may occur when you start to 전체 문서 읽기
HealthProductsRegulatoryAuthority 22March2023 CRN00CWWX Page1of15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT FebuxostatPinewood120mgfilm-coatedtablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Eachtabletcontains120mgoffebuxostat(asmagnesiumsalts). _Excipient(s) with known effect:_ Eachtabletcontains114.70mglactosemonohydrate. Eachtabletcontains0.25mmol(5.86mg)sodium. Forthefulllistofexcipients,seesection6.1. 3 PHARMACEUTICAL FORM Film-coatedtablet(tablet) Paleyellowtoyellow,film-coated,capsuleshapedtablets,engravedwith"120"ononeside,19.2±0.2mminlength,8.2±0.2 mminwidth,6.1±0.2mminthickness. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS FebuxostatPinewood120mgfilm-coatedtabletsisindicatedforthetreatmentofchronichyperuricaemiainconditionswhere uratedepositionhasalreadyoccurred(includingahistory,orpresenceof,tophusand/orgoutyarthritis). FebuxostatPinewood120mgfilm-coatedtabletsisindicatedforthepreventionandtreatmentofhyperuricaemiainadult patientsundergoingchemotherapyforhaematologicmalignanciesatintermediatetohighriskofTumorLysisSyndrome(TLS). FebuxostatPinewoodisindicatedinadults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Gout:TherecommendedoraldoseofFebuxostatPinewoodis80mgoncedailywithoutregardtofood.Ifserumuricacidis> 6mg/dL(357micromol/L)after2-4weeks,FebuxostatPinewood120mgoncedailymaybeconsidered. FebuxostatPinewoodworkssufficientlyquicklytoallowretestingoftheserumuricacidafter2 weeks. 전체 문서 읽기