非布司他片（febuxostat)的产品信息(EMA).pdf

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1

1.NAMEOFTHEMEDICINALPRODUCT

FebuxostatKrka80mgfilm-coatedtablets

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachfilm-coatedtabletcontains80mgfebuxostat.

Excipient(s)withknowneffect

-lactose(asmonohydrate:73mg

Forthefulllistofexcipients,seesection6.1.

3.PHARMACEUTICALFORM

Film-coatedtablet(tablet

Offpink,oval,biconvex,film-coatedtabletsscoredononeside.Tabletdimension:approximatelly

16mm×8mm.Thescorelineisonlytofacilitatebreakingforeaseofswallowingandnottodivide

intoequaldoses.

4.CLINICALPARTICULARS

4.1Therapeuticindications

FebuxostatKrkaisindicatedforthetreatmentofchronichyperuricaemiainconditionswhereurate

depositionhasalreadyoccurred(includingahistory,orpresenceof,tophusand/orgoutyarthritis).

FebuxostatKrkaisindicatedinadults.

4.2Posologyandmethodofadministration

Posology

TherecommendedoraldoseofFebuxostatKrkais80mgoncedailywithoutregardtofood.Ifserum

uricacidis6mg/dL(357μmol/L)after2-4weeks,FebuxostatKrka120mgoncedailymaybe

considered.

FebuxostatKrkaworkssufficientlyquicklytoallowretestingoftheserumuricacidafter2weeks.The

therapeutictargetistodecreaseandmaintainserumuricacidbelow6mg/dL(357μmol/L).

Goutflareprophylaxisofatleast6monthsisrecommended(seesection4.4).

Elderly

Nodoseadjustmentisrequiredintheelderly(seesection5.2).

Renalimpairment

Theefficacyandsafetyhavenotbeenfullyevaluatedinpatientswithsevererenalimpairment

(creatinineclearance30mL/min,seesection5.2).

Nodoseadjustmentisnecessaryinpatientswithmildormoderaterenalimpairment.

Hepaticimpairment

Theefficacyandsafetyoffebuxostathasnotbeenstudiedinpatientswithseverehepaticimpairment