ARCOXIA 60 Milligram Film Coated Tablet

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
ETORICOXIB
Available from:
B & S Healthcare
ATC code:
M01AH05
INN (International Name):
ETORICOXIB
Dosage:
60 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Coxibs
Authorization status:
Authorised
Authorization number:
PPA1328/159/003
Authorization date:
2012-05-04

Packageleaflet:Informationfortheuser

ARCOXIA ® 30mgfilm-coated tablets

ARCOXIA ® 60mgfilm-coated tablets

ARCOXIA ® 90mgfilm-coated tablets

ARCOXIA ® 120mgfilm-coated tablets

(etoricoxib)

Readall ofthisleafletcarefullybeforeyoustarttaking

thismedicinebecauseitcontainsimportantinformation

foryou.

Keepthisleaflet.Youmayneedtoreaditagain.

Ifyouhaveanyfurtherquestions,askyourdoctoror

pharmacist.

Thismedicinehasbeenprescribedforyouonly.Donotpass

itontoothers.Itmayharmthem,eveniftheirsignsof

illnessarethesameasyours.

Ifyougetanysideeffects,talktoyourdoctoror

pharmacist.Thisincludesanypossiblesideeffectsnotlisted

inthisleaflet.Seesection4.

ThenameofyourmedicineisARCOXIA30mgfilm-coated

tabletsorARCOXIA60mgfilm-coatedtabletsorARCOXIA

90mgfilm-coatedtabletsorARCOXIA120mgfilm-coated

tabletsbut,willbereferredtoasARCOXIAthroughoutthis

leaflet.

Whatisinthisleaflet

1.WhatARCOXIAisandwhatitisusedfor

2.WhatyouneedtoknowbeforeyoutakeARCOXIA

3.HowtotakeARCOXIA

4.Possiblesideeffects

5.HowtostoreARCOXIA

6.Contentsofthepackandotherinformation

1.WhatARCOXIA isandwhatitisusedfor

WhatisARCOXIA?

ARCOXIAcontainstheactivesubstanceetoricoxib ARCOXIA

isoneofagroupofmedicinescalledselectiveCOX-2

inhibitors.Thesebelongtoafamilyofmedicinescallednon-

steroidalanti-inflammatorydrugs(NSAIDs).

WhatisARCOXIA usedfor?

ARCOXIAhelpstoreducethepainandswelling

(inflammation)inthejointsandmusclesofpeople16years

ofageandolderwithosteoarthritis,rheumatoidarthritis,

ankylosingspondylitisandgout.

ARCOXIAisalsousedfortheshorttermtreatmentof

moderatepainafterdentalsurgeryinpeople16yearsof

ageandolder.

Whatisosteoarthritis?

Osteoarthritisisadiseaseofthejoints.Itresultsfromthe

gradualbreakdownofthecartilagethatcushionstheendsof

thebones.Thiscausesswelling(inflammation),pain,

tenderness,stiffnessanddisability.

Whatisrheumatoidarthritis?

Rheumatoidarthritisisalongterminflammatorydiseaseofthe

joints.Itcausespain,stiffness,swelling,andincreasinglossof

movementinthejointsitaffects.Itmayalsocause

inflammationinotherareasofthebody.

Whatisgout?

Goutisadiseaseofsudden,recurringattacksofverypainful

inflammationandrednessinthejoints.Itiscausedbydeposits

ofmineralcrystalsinthejoint.

Whatisankylosingspondylitis?

Ankylosingspondylitisisaninflammatorydiseaseofthespine

andlargejoints.

2.Whatyouneedto knowbeforeyoutakeARCOXIA

DonottakeARCOXIA:

ifyouareallergic(hypersensitive)toetoricoxiboranyof

theotheringredientsofthismedicine(listedinsection6)

ifyouareallergictonon-steroidalanti-inflammatorydrugs

(NSAIDs),includingaspirinandCOX-2inhibitors

(seePossibleSideEffects,section4)

ifyouhaveacurrentstomachulcerorbleedinginyour

stomachorintestines

ifyouhaveseriousliverdisease

ifyouhaveseriouskidneydisease

ifyouareorcouldbepregnantorarebreast-feeding(see

‘Pregnancy,breastfeedingandfertility’)

ifyouareunder16yearsofage

ifyouhaveinflammatoryboweldisease,suchasCrohn’s

Disease,UlcerativeColitis,orColitis

ifyouhavehighbloodpressurethathasnotbeencontrolled

bytreatment(checkwithyourdoctorornurseifyouare

notsurewhetheryourbloodpressureisadequately

controlled)

ifyourdoctorhasdiagnosedheartproblemsincludingheart

failure(moderateorseveretypes),angina(chestpain)

ifyouhavehadaheartattack,bypasssurgery,peripheral

arterialdisease(poorcirculationinlegsorfeetdueto

narroworblockedarteries)

ifyouhavehadanykindofstroke(includingmini-stroke,

transientischaemicattackorTIA).Etoricoxibmayslightly

increaseyourriskofheartattackandstrokeandthisiswhy

itshouldnotbeusedinthosewhohavealreadyhadheart

problemsorstroke.

Ifyouthinkanyofthesearerelevanttoyou,donottakethe

tabletsuntilyouhaveconsultedyourdoctor.

Warningsandprecautions

TalktoyourdoctororpharmacistbeforetakingARCOXIAif:

Youhaveahistoryofstomachbleedingorulcers.

Youaredehydrated,forexamplebyaprolongedboutof

vomitingordiarrhoea.

Youhaveswellingduetofluidretention.

Youhaveahistoryofheartfailure,oranyotherformof

heartdisease.

Youhaveahistoryofhighbloodpressure.ARCOXIAcan

doses,andyourdoctorwillwanttocheckyourblood

pressurefromtimetotime.

Youhaveanyhistoryofliverorkidneydisease.

Youarebeingtreatedforaninfection.ARCOXIAcanmask

orhideafever,whichisasignofinfection.

Youhavediabetes,highcholesterol,orareasmoker.These

canincreaseyourriskofheartdisease.

Youareawomantryingtobecomepregnant

Youareover65yearsofage.

Ifyouarenotsureifanyoftheaboveapplytoyou,talkto

yourdoctorbeforetakingARCOXIAtoseeifthismedicine

issuitableforyou.

ARCOXIAworksequallywellinolderandyoungeradult

patients.Ifyouareover65yearsofage,yourdoctorwillwant

toappropriatelykeepacheckonyou.Nodosageadjustmentis

necessaryforpatientsover65yearsofage.

Childrenandadolescents

Donotgivethismedicinetochildrenandadolescentsunder16

yearsofage.

OthermedicinesandARCOXIA

Tellyourdoctororpharmacistifyouaretaking,haverecently

takenormighttakeanyothermedicines,includingmedicines

obtainedwithoutaprescription.

Inparticularifyouaretakinganyofthefollowingmedicines,

yourdoctormaywanttomonitoryoutocheckthatyour

medicinesareworkingproperly,onceyoustarttaking

ARCOXIA:

medicinesthatthinyourblood(anticoagulants),suchas

warfarin

rifampicin(anantibiotic)

methotrexate(adrugusedforsuppressingtheimmune

system,andoftenusedinrheumatoidarthritis)

ciclosporinortacrolimus(drugsusedforsuppressingthe

immunesystem)

medicinesusedtohelpcontrolhighbloodpressureand

heartfailurecalledACEinhibitorsandangiotensinreceptor

blockers,examplesincludeenalaprilandramipril,and

losartanandvalsartan

lithium(amedicineusedtotreatsometypesofdepression)

diuretics(watertablets)

digoxin(amedicineforheartfailureandirregularheart

rhythm)

minoxidil(adrugusedtotreathighbloodpressure)

salbutamoltabletsororalsolution(amedicineforasthma)

birthcontrolpills(thecombinationmayincreaseyourrisk

ofsideeffects)

hormonereplacementtherapy(thecombinationmay

increaseyourriskofsideeffects)

aspirin,theriskofstomachulcersisgreaterifyoutake

ARCOXIAwithaspirin.

-aspirinforpreventionofheartattacksorstroke:

ARCOXIAcanbetakenwithlow-doseaspirin.Ifyouare

currentlytakinglow-doseaspirintopreventheartattacksor

stroke,youshouldnotstoptakingaspirinuntilyoutalkto

yourdoctor

-aspirinandothernon-steroidalanti-inflammatorydrugs

(NSAIDs):

donottakehighdoseaspirinorotheranti-inflammatory

medicineswhiletakingARCOXIA.

ARCOXIAwithfoodanddrink

TheonsetoftheeffectofARCOXIAmaybefasterwhentaken

withoutfood.

Pregnancy, breast-feedingandfertility

Pregnancy

ARCOXIAtabletsmustnotbetakenduringpregnancy.Ifyou

arepregnantorthinkyoucouldbepregnant,orifyouare

planningtobecomepregnant,donottakethetablets.Ifyou

becomepregnant,stoptakingthetabletsandconsultyour

doctor.Consultyourdoctorifyouareunsureorneedmore

advice.

Breast-feeding

ItisnotknownifARCOXIAisexcretedinhumanmilk.Ifyou

arebreast-feeding,orplanningtobreast-feed,consultyour

doctorbeforetakingARCOXIA.IfyouareusingARCOXIA,you

mustnotbreast-feed.

Fertility

ARCOXIAisnotrecommendedinwomenattemptingtobecome

pregnant.

Drivingandusingmachines

Dizzinessandsleepinesshavebeenreportedinsomepatients

takingARCOXIA.

Donotdriveifyouexperiencedizzinessorsleepiness.

Donotuseanytoolsormachinesifyouexperiencedizzinessor

sleepiness.

ARCOXIAcontainslactose

Ifyouhavebeentoldbyyourdoctorthatyouareunableto

toleratesomesugars,contactyourdoctorbeforetakingthis

medicinalproduct.

3. Howtotake ARCOXIA

Alwaystakethismedicineexactlyasyourdoctorhastoldyou.

Youshouldcheckwithyourdoctororpharmacistifyouarenot

sure.

Donottakemorethantherecommendeddoseforyour

condition.Yourdoctorwillwanttodiscussyourtreatmentfrom

timetotime.Itisimportantthatyouusethelowestdosethat

controlsyourpainandyoushouldnottakeARCOXIAforlonger

thannecessary.Thisisbecausetheriskofheartattacksand

strokesmightincreaseafterprolongedtreatment,especially

withhighdoses.

Therearedifferentstrengthsavailableforthismedicinal

productanddependingonyourdiseaseyourdoctorwill

prescribethetabletstrengththatisappropriateforyou.

Therecommendeddoseis:

Osteoarthritis

Therecommendeddoseis30mgonceaday,increasetoa

maximumof60mgonceadayifneeded.

Rheumatoidarthritis

Therecommendeddoseis90mgonceaday.

Ankylosingspondylitis

Therecommendeddoseis90mgonceaday.

Acutepainconditions

Etoricoxibshouldbeusedonlyfortheacutepainfulperiod.

Gout

Therecommendeddoseis120mgonceadaywhich

shouldonlybeusedfortheacutepainfulperiod,limitedto

amaximumof8daystreatment.

Postoperativedentalsurgerypain

Therecommendeddoseis90mgoncedaily,limitedtoa

maximumof3daystreatment.

Peoplewithliverproblems

Ifyouhavemildliverdisease,youshouldnottakemore

than60mgaday.

Ifyouhavemoderateliverdisease,youshouldnottake

morethan30mgaday.

Useinchildrenandadolescents

ARCOXIAtabletsshouldnotbetakenbychildrenor

adolescentsunder16yearsofage.

Elderly

Nodoseadjustmentisnecessaryforelderlypatients.Aswith

othermedicines,cautionshouldbeexercisedinelderly

patients.

Methodofadministration

ARCOXIAisfororaluse.Takethetabletsonceaday.ARCOXIA

canbetakenwithorwithoutfood.

IfyoutakemoreARCOXIAthanyoushould

Youshouldnevertakemoretabletsthanthedoctor

recommends.IfyoudotaketoomanyARCOXIAtablets,you

shouldseekmedicalattentionimmediately.

IfyouforgettotakeARCOXIA

ItisimportanttotakeARCOXIAasyourdoctorhasprescribed.

Ifyoumissadose,justresumeyourusualschedulethe

followingday.Donottakeadoubledosetomakeupforthe

forgottentablet.

Ifyouhaveanyfurtherquestionsontheuseofthismedicine,

askyourdoctororpharmacist.

4.Possiblesideeffects

Likeallmedicines,thismedicinecancausesideeffects,

althoughnoteverybodygetsthem.

Ifyoudevelopanyofthesesignsyoushouldstop

ARCOXIAandtalkto yourdoctorimmediately(see‘What

youneedto knowbeforeyoutakeARCOXIA’section2):

shortnessofbreath,chestpains,orankleswellingappear

oriftheygetworse

yellowingoftheskinandeyes(jaundice)–thesearesigns

ofliverproblems

severeorcontinualstomachpainoryourstoolsbecome

black

anallergicreaction–whichcanincludeskinproblemssuch

asulcersorblistering,orswellingoftheface,lips,tongue,

orthroatwhichmaycausedifficultyinbreathing

Thefrequencyofpossiblesideeffectslistedbelowisdefined

usingthefollowingconvention:

Verycommon(affectsmorethan1userin10)

Common(affects1to10usersin100)

Uncommon(affects1to10usersin1,000)

Rare(affects1to10usersin10,000)

Veryrare(affectslessthan1userin10,000)

Thefollowingsideeffectscanoccurduringtreatmentwith

ARCOXIA:

Verycommon

stomachpain

Common

drysocket(inflammationandpainafteratoothextraction)

swellingofthelegsand/orfeetduetofluidretention

(oedema)

dizziness,headache

palpitations(fastorirregularheartbeat),irregularheart

rhythm(arrhythmia),

increasedbloodpressure

wheezingorshortnessofbreath(bronchospasms)

constipation,wind(excessivegas),gastritis(inflammation

oftheliningofthestomach),heartburn,diarrhoea,

indigestion(dyspepsia)/stomachdiscomfort,nausea,being

sick(vomiting),inflammationoftheoesophagus,mouth

ulcers

changesinbloodtestsrelatedtoyourliver

bruising

weaknessandfatigue,flu-likeillness

Uncommon

gastroenteritis(inflammationofthegastrointestinaltract

thatinvolvesboththestomachandsmallintestine/stomach

flu),upperrespiratoryinfection,urinarytractinfection

changesinlaboratoryvalues(decreasednumberofred

bloodcells,decreasednumberofwhitebloodcells,platelets

decreased)

hypersensitivity(anallergicreactionincludinghiveswhich

maybeseriousenoughtorequireimmediatemedical

attention)

appetiteincreasesordecreases,weightgain

anxiety,depression,decreasesinmentalsharpness;seeing,

feelingorhearingthingsthatarenotthere(hallucinations)

tastealteration,inabilitytosleep,numbnessortingling,

blurredvision,eyeirritationandredness

ringingintheears,vertigo(sensationofspinningwhile

remainingstill)

abnormalheartrhythm(atrialfibrillation),fastheartrate,

heartfailure,feelingoftightness,pressureorheavinessin

thechest(anginapectoris),heartattack

flushing,stroke,mini-stroke(transientischaemicattack),

severeincreaseinbloodpressure,inflammationofthe

bloodvessels

cough,breathlessness,nosebleed

stomachorbowelbloating,changesinyourbowelhabits,

drymouth,stomachulcer,inflammationofthestomach

liningthatcanbecomeseriousandmayleadtobleeding,

irritablebowelsyndrome,inflammationofthepancreas

swellingoftheface,skinrashoritchyskin,rednessofthe

skin

musclecramp/spasm,musclepain/stiffness

highlevelsofpotassiuminyourblood,changesinbloodor

urinetestsrelatingtoyourkidney,seriouskidneyproblems

chestpain

Rare

angioedema(anallergicreactionwithswellingoftheface,

lips,tongueand/orthroatwhichmaycausedifficultyin

breathingorswallowing,whichmaybeseriousenoughto

requireimmediatemedicalattention)/anaphylactic/

anaphylactoidreactionsincludingshock(aseriousallergic

reactionthatrequiresimmediatemedicalattention)

confusion,restlessness

liverproblems(hepatitis)

lowbloodlevelsofsodium

liverfailure,yellowingoftheskinand/oreyes(jaundice)

severeskinreactions

Reportingofsideeffects

Ifyougetanysideeffects,talktoyourdoctororpharmacist.

Thisincludesanypossiblesideeffectsnotlistedinthisleaflet.

Youcanalsoreportsideeffectsdirectly(seedetailsbelow).By

reportingsideeffects,youcanhelpprovidemoreinformation

onthesafetyofthismedicine.

Ireland:HPRAPharmacovigilance,EarlsfortTerrace,IRL-

Dublin2,Tel:+35316764971,Fax:+35316762517,

Website:www.hpra.ie,e-mail:medsafety@hpra.ie

UnitedKingdom:YellowCardSchemeat:

www.mhra.gov.uk/yellowcard

5.HowtostoreARCOXIA

Keepoutofthesightandreachofchildren.

DonotuseARCOXIAaftertheexpirydatewhichisstatedon

thepackafter‘Exp’.Theexpirydatereferstothelastdayof

themonth.

Storeintheoriginalpackinordertoprotectfrommoisture.

Medicinesshouldnotbedisposedviawastewaterorhousehold

waste.Askyourpharmacisthowtodisposeofmedicinesno

longerrequired.Thesemeasureswillhelpprotectthe

environment.

6.Contentsofthepackandotherinformation

WhatARCOXIAcontains

Theactivesubstanceisetoricoxib.Eachfilm-coatedtablet

contains30mgor60mgor90mgor120mgetoricoxib.

Theotheringredientsare-

Core:calciumhydrogenphosphate(anhydrous),

croscarmellosesodium,magnesiumstearate,microcrystalline

cellulose.

Tabletcoating:carnaubawax,lactosemonohydrate,

hypromellose,titaniumdioxide(E171),triacetin.

Each30mg,60mgand120mgfilm-coatedtabletsalsocontains

yellowironoxide(E172,colouringagent)andindigocarmine

lake(E132,colouringagent).

WhatARCOXIAlookslikeandcontentsofthepack

ARCOXIA30mgtabletsareblue-green,apple-shaped,

biconvex,film-coatedtabletsmarked‘ACX30’ononesideand

‘101’ontheother.

ARCOXIA60mgtabletsaredarkgreen,apple-shaped,biconvex

filmcoatedtabletsmarked‘ARCOXIA60’ononesideand‘200’

ontheother.

ARCOXIA90mgtabletsarewhite,apple-shaped,biconvexfilm

coatedtabletsmarked‘ARCOXIA90’ononesideand‘202’on

theother.

ARCOXIA120mgtabletsarepale-green,apple-shaped,

biconvexfilmcoatedtabletsmarked‘ARCOXIA120’ononeside

and‘204’ontheother.

ARCOXIA30mg,60mgand90mgtabletsareavailableinpacks

of28tablets.

ARCOXIA120mgtabletsareavailableinpacksof14tablets.

Manufactured by:

ARCOXIA30mgtabletsaremanufacturedby:

MerckSharp&DohmeB.V.,Waarderweg39,2031BN

Haarlem,Netherlands.

ARCOXIA60mg,90mgtabletsaremanufacturedby:

MerckSharp&DohmeB.V.,Waarderweg39,POBox581,

2003PCHaarlem,Netherlands.

ARCOXIA120mgtabletsaremanufacturedby:

MerckSharp&DohmeBV.,Waarderweg39,2031B.N

Haarlem,TheNetherlands.

ProcuredfromwithintheEUandrepackagedbyPPA

holder:B&SHealthcare,Unit4,BradfieldRoad,Ruislip,

Middlesex,HA40NU,UK.

ARCOXIA ® 30mgfilm-coatedtablets-PPA1328/159/1

ARCOXIA ® 60mgfilm-coatedtablets-PPA1328/159/3

ARCOXIA ® 90mgfilm-coatedtablets-PPA1328/159/4

ARCOXIA ® 120mgfilm-coatedtablets-PPA1328/159/2

Leafletdate:24.09.2015

ARCOXIAisaregisteredtrademarkofMerckSharp&Dohme

Limited. POM POM

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Arcoxia60mgFilm-coatedTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachfilm-coatedtabletcontains60mgofetoricoxib.

Excipient:lactosemonohydrate

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Filmcoatedtablet

ProductimportedfromPortugal:

Darkgreen,apple-shaped,biconvextabletsdebossed‘200’ononesideand‘ARCOXIA60'ontheotherside.

4CLINICALPARTICULARS

AsperPA1286/007/002

5PHARMACOLOGICALPROPERTIES

AsperPA1286/007/002

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Core:

Calciumhydrogenphosphate(anhydrous)

Croscarmellosesodium

Magnesiumstearate

Microcrystallinecellulose

Tabletcoating:

Carnaubawax

Lactosemonohydrate

Hypromellose

Titaniumdioxide(E171)

Triacetin

Indigocarminelake(E132)andYellowferricoxide(E172)

6.2Incompatibilities

Health Products Regulatory Authority

______________________________________________________________________________________________________________________

Date Printed 27/11/2015 CRN 2168560 page number: 1

6.3Shelflife

Theshelf-lifeexpirydateofthisproductshallbethedateshownontheblisterandouterpackageoftheproductonthe

marketinthecountryoforigin.

6.4Specialprecautionsforstorage

Storeintheoriginalpackageinordertoprotectfrommoisture.

6.5Natureandcontentsofcontainer

Aluminum/aluminiumblistersinpackscontaining28tablets.

6.6Specialprecautionsfordisposalandotherhandling

Nospecialrequirements.

7PARALLELPRODUCTAUTHORISATIONHOLDER

B&SHealthcare

Unit4,BradfieldRoad

Ruislip

MiddlesexHA40NU

UnitedKingdom

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1328/159/003

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:4 th

May2012

10DATEOFREVISIONOFTHETEXT

Health Products Regulatory Authority

______________________________________________________________________________________________________________________

Date Printed 27/11/2015 CRN 2168560 page number: 2

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