AIRTAL 100MG FILM-COATED TABLETS.

Main information

  • Trade name:
  • AIRTAL 100MG FILM-COATED TABLETS.
  • Dosage:
  • 100 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AIRTAL 100MG FILM-COATED TABLETS.
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0968/003/001
  • Authorization date:
  • 08-01-1996
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0968/003/001

CaseNo:2043804

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

LaboratoriosAlmirallS.A.

GeneralMitre,151,08022,Barcelona,Spain

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Airtal100mgFilm-coatedTablets

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom12/08/2008until.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

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PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Airtal100mgFilm-coatedTablets.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Aceclofenac100mg

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

Film-coatedTablet

White,round,film-coatedtablet,8mmindiameter,withan‘A’embossedononeside.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Airtal ®

isindicatedforthereliefofpainandinflammationinosteoarthritis,rheumatoidarthritisandankylosing

spondylitis.

4.2Posologyandmethodofadministration

Airtal ®

tabletsaresuppliedfororaladministrationandshouldbeswallowedwholewithasufficientquantityofliquid.

WhenAirtal ®

wasadministeredtofastingandfedhealthyvolunteers,onlytherateandnottheextentofaceclofenac

absorptionwasaffectedandassuchAirtal ®

canbetakenwithfood.

Routeofadministration

Oral

Recommendeddosage

Adults

Therecommendeddoseis200mgdaily,takenastwoseparate100mgdoses,onetabletinthemorningandonein

theevening.

Children

TherearenoclinicaldataontheuseofAirtal ®

inchildren.

Elderly

ThepharmacokineticsofAirtal ®

arenotalteredinelderlypatients,thereforeitisnotconsiderednecessaryto

modifythedoseordosefrequency.

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elderlypatients,whoaregenerallymorepronetoadversereactions,andwhoaremorelikelytobesufferingfrom

impairedrenal,cardiovascularorhepaticfunctionandreceivingconcomitantmedication.

Renalinsufficiency

ThereisnoevidencethatthedosageofAirtal ®

needstobemodifiedinpatientswithmildrenalimpairment,butas

withotherNSAIDscautionshouldbeexercised.

Hepaticinsufficiency

ThereissomeevidencethatthedoseofAirtal ®

shouldbereducedinpatientswithhepaticimpairmentanditis

suggestedthataninitialdoseof100mgbeused.

Undesirableeffectsmaybeminimisedbyusingthelowesteffectivedosefortheshortestdurationnecessarytocontrol

symptoms(seesection4.4).

4.3Contraindications

Airtal ®

shouldnotbeadministeredtopatientswithahistoryofgastrointestinalbleedingorperforation,relatedto

previousNSAIDtherapy.Airtal ®

isalsocontraindicatedinpatientswithanactiveorhistoryofrecurrentpeptic

ulcer/haemorrhage(twoormoredistinctepisodesofprovenulcerationorbleeding).

Airtal ®

shouldnotbegiventopatientswithmoderatetosevererenalimpairment.

Airtal ®

shouldnotbegiventopatientswithsevereheartfailure.

Airtal ®

shoudlnotbeprescribedduringpregnancy,unlesstherearecompellingreasonsfordoingso.Thelowest

effectivedosageshouldbeused.

Airtal ®

shouldnotbeadministeredtopatientspreviouslysensitivetoaceclofenacorinwhomaspirinorNSAIDs

precipitateattacksofasthma,acuterhinitisorurticariaorwhoarehypersensitivetothesedrugs.

4.4Specialwarningsandprecautionsforuse

Warnings

TheuseofAirtal®withconcomitantNSAIDsincludingcyclooxygenase-2selectiveinhibitorsshouldbeavoided.

Undesirableeffectsmaybeminimisedbyusingtheminimumeffectivedosefortheshortestdurationnecessaryto

controlsymptoms(seesection4.2,andGIandcardiovascularrisksbelow).

Gastrointestinalbleeding,ulcerationandperforation

GIbleeding,ulcerationorperforation,whichcanbefatal,hasbeenreportedwithallNSAIDsatanytimeduring

treatment,withorwithoutwarningsymptomsoraprevioushistoryofseriousGIevents.Intherareinstanceswhere

gastro-intestinalbleedingorulcerationoccursinpatientsreceivingAirtal ®

,thedrugshouldbewithdrawn.

TheriskofGIbleeding,ulcerationorperforationishigherwithincreasingNSAIDdoses,inpatientswithahistoryof

ulcer,particularlyifcomplicatedwithhaemorrhageorperforation(seesection4.3),andintheelderly.Thesepatients

shouldcommencetreatmentonthelowestdoseavailable.Combinationtherapywithprotectiveagents(e.g.misoprostol

orprotonpumpinhibitors)shouldbeconsideredforthesepatients,andalsoforpatientsrequiringconcomitantlowdose

aspirin,orotherdrugslikelytoincreasegastrointestinalrisk(seebelowand4.5).

PatientswithahistoryofGItoxicity,particularlywhenelderly,shouldreportanyunusualabdominalsymptoms

(especiallyGIbleeding)particularlyintheinitialstagesoftreatment.

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bleeding,suchasoralcorticosteroids,anticoagulantssuchaswarfarin,selectiveserotonin-reuptakeinhibitorsoranti-

plateletagentssuchasaspirin(seesection4.5).

WhenGIbleedingorulcerationoccursinpatientsreceivingAirtal,thetreatmentshouldbewithdrawn.

NSAIDsshouldbegivenwithcaretopatientswithahistoryofgastrointestinaldisease(ulcerativecolitis,Crohn’s

disease)astheirconditionmaybeexacerbated(seesection4.8Undesirableeffects).

Cardiovascularandcerebrovasculareffects

Appropriatemonitoringandadvicearerequiredforpatientswithahistoryofhypertensionand/ormildtomoderate

congestiveheartfailureasfluidretentionandoedemahavebeenreportedinassociationwithNSAIDtherapy.

ClinicaltrialandepidemiologicaldatasuggestthatuseofsomeNSAIDs(particularlyathighdosesandinlongterm

treatment)maybeassociatedwithasmallincreasedriskofarterialthromboticevents(forexamplemyocardial

infarctionorstroke).Thereareinsufficientdatatoexcludesuchariskforaceclofenac.

Patientswithuncontrolledhypertension,congestiveheartfailure,establishedischaemicheartdisease,peripheral

arterialdiseaseand/orcerebrovasculardiseaseshouldonlybetreatedwithaceclofenacaftercarefulconsideration.

Similarconsiderationshouldbemadebeforeinitiatinglonger-termtreatmentofpatientswithriskfactorsfor

cardiovasculardisease(e.g.hypertension,hyperlipidaemia,diabetesmellitus,smoking).

Skinreactions

Seriousskinreactions,someofthemfatal,includingexfoliativedermatitis,Stevens-Johnsonsyndromeandtoxic

epidermalnecrolysis,havebeenreportedveryrarelyinassociationwiththeuseofNSAIDSs(seesection4.8).Patients

appeartobeathighestriskofthesereactionsearlyinthecourseoftherapy,theonsetofthereactionoccurringinthe

majorityofcaseswithinthefirstmonthoftreatment.Airtal®shouldbediscontinuedatthefirstappearanceofskin

rash,mucosallesions,oranyothersignofhypersensitivity.

Elderly

TheelderlyhaveanincreasedfrequencyofadversereactionstoNSAIDsespeciallygastrointestinalbleedingand

perforationwhichmaybefatal(seesection4.2).

Hepatic

Closemedicalsurveillanceisalsoimperativeinpatientssufferingfromsevereimpairmentofhepaticfunction.

Hypersensitivityreactions

AswithotherNSAIDs,allergicreactions,includinganaphylactic/anaphylactoidreactions,canalsooccurwithout

earlierexposuretothedrug.

Drug-inducedpancreatitisisuncommon.NeverthelesspancreatitishasbeenreportedinrelationwithNSAIDs.

Precautions:

Renal

Patientswithmildrenalorcardiacimpairmentandtheelderlyshouldbekeptundersurveillance,sincetheuseof

NSAID'smayresultindeteriorationofrenalfunction.Thelowesteffectivedoseshouldbeusedandrenalfunction

monitoredregularly.

Theimportanceofprostaglandinsinmaintainingrenalbloodflowshouldbetakenintoaccountinpatientswith

impairedcardiacorrenalfunction,thosebeingtreatedwithdiureticsorrecoveringfrommajorsurgery.Effectsonrenal

functionareusuallyreversibleonwithdrawalofAirtal®.

Hepatic

Ifabnormalliverfunctiontestspersistorworsen,clinicalsignsorsymptomsconsistentwithliverdiseasedeveloporif

othermanifestationsoccur(eosinophilia,rash),Airtal®shouldbediscontinued.Hepatitismayoccurwithoutprodromal

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UseofAirtal®inpatientswithhepaticporphyriamaytriggeranattack.

Haematological

Airtal®mayreversiblyinhibitplateletaggregation(seeanticoagulantsunder'Interactions').

Femalefertility

TheuseofAirtal®,aswthanydrugknowntoinhibitcyclo-oxyfenase/prostaglandinsynthesis,mayimpairfemale

fertilityandisnotrecommendedinwomenattemptingtoconceive.Inwomenwhohavedifficultiesconceivingorwho

areundergoinginvestigationofinfertility,withdrawalofaceclofenacshouldbeconsidered.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Lithiumanddigoxin:Airtal ®

,likemanyNSAIDs,mayincreaseplasmaconcentrationsoflithiumanddigoxin.

Diuretics:Airtal ®

,likeotherNSAIDs,mayinhibittheactivityofdiuretics.Althoughitwasnotshowntoaffect

bloodpressurecontrolwhenco-administeredwithbendrofluazide,interactionswithotherdiureticscannotberuled

out.Whenconcomitantadministrationwithpotassium-sparingdiureticsisemployed,serumpotassiumshouldbe

monitored.

Corticosteroids:increasedriskofgastrointestinalulcerationorbleeding(seesection4.4).

Anti-coagulants:NSAIDsmayenhancetheeffectsofanti-coagulants,suchaswarfarin(seesection4.4).Close

monitoringofpatientsoncombinedanticoagulantandAirtal ®

therapyshouldbeundertaken.

Anti-plateletagentsandselectiveserotoninreuptakeinhibitors(SSRIs):increasedriskofgastrointestinalbleeding(see

section4.4).

Antidiabeticagents:Clinicalstudieshaveshownthatdiclofenaccanbegiventogetherwithoralantidiabetic

agentswithoutinfluencingtheirclinicaleffect.However,therehavebeenisolatedreportsofhypoglycaemicand

hyperglycaemiceffects.ThuswithAirtal ®

,considerationshouldbegiventoadjustmentofthedosageof

hypoglycaemicagents.

Methotrexate:CautionshouldbeexercisedifNSAIDsandmethotrexateareadministeredwithin24hoursofeach

other,sinceNSAIDsmayincreasemethotrexateplasmalevels,resultinginincreasedtoxicity.

OtherNSAIDsandsteroids:Concomitanttherapywithaspirin,otherNSAIDsandsteroidsmayincreasethe

frequencyofsideeffects.

Cyclosporin:CyclosporinnephrotoxicitymaybeincreasedbytheeffectofNSAIDsonrenalprostaglandins.

Quinoloneantimicrobials:ConvulsionsmayoccurduetoaninteractionbetweenquinolonesandNSAIDs.This

mayoccurinpatientswithorwithoutaprevioushistoryofepilepsyorconvulsions.Therefore,cautionshouldbe

exercisedwhenconsideringtheuseofaquinoloneinpatientswhoarealreadyreceivingaNSAID.

4.6Pregnancyandlactation

Pregnancy:ThereisnoinformationontheuseofAirtal ®

duringpregnancy.TheregularuseofNSAIDsduring

thelasttrimesterofpregnancymaydecreaseuterinetoneandcontraction.NSAIDusemayalsoresultin

prematureclosureofthefetalductusarteriosusinuteroandpossiblypersistentpulmonaryhypertensionofthenew

born,delayonsetandincreasedurationoflabour.

Animalstudiesindicatethattherewasnoevidenceofteratogenesisinratsalthoughthesystemicexposurewaslow

andinrabbits,treatmentwithaceclofenac(10mg/kg/day)resultedinaseriesofmorphologicalchangesinsome

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Lactation:ThereisnoinformationonthesecretionofAirtal ®

tobreastmilk:therewashowevernonotable

transferofradio-labelled(C)aceclofenactothemilkoflactatingrats.

TheuseofAirtal ®

shouldthereforebeavoidedinpregnancyandlactationunlessthepotentialbenefitstothe

motheroutweighthepossibleriskstothefetus.

4.7Effectsonabilitytodriveandusemachines

Patientssufferingfromdizziness,vertigo,orothercentralnervoussystemdisorderswhilsttakingNSAIDsshould

refrainfromdrivingorhandlingdangerousmachinery.

4.8Undesirableeffects

Gastrointestinal:Themostcommonlyobservedadverseeventsaregastrointestinalinnature.Pepticulcers,perforation

orGIbleeding,sometimesfatal,particularlyintheelderly,mayoccur(seesection4.4).Nausea,vomiting,diarrhoea,

flatulence,constipation,dyspepsia,abdominalpain,melaena,haematemesis,ulcerativestomatitis,exacerbationof

colitisandCrohn'sdisease(seesection4.4Specialwarningsandprecautionsforuse)havebeenreportedfollowing

administration.Lessfrequently,gastritishasbeenobserved.

Themajorityofsideeffectsobservedhavebeenreversibleandofaminornatureandinclude,gastro-intestinal

disorders(dyspepsia,abdominalpain,nauseaanddiarrhoea)andoccasionaloccurrenceofdizziness.

Dermatologicalcomplaintsincludingpruritusandrashandabnormalhepaticenzymelevelsandraisedserum

creatininehaveoccasionallybeenreported.

Oedema,hypertensionandcardiacfailurehavebeenreportedinassociationwithNSAIDtreatment.

BullousreactionsincludingStevens-Johnsonsyndromeandtoxicepidermalnecrolysis(veryrare).

ClinicaltrialandepidemiologicaldatasuggestthatuseofsomeNSAIDs(particularlyathighdosesandinlongterm

treatment)maybeassociatedwithasmallincreasedriskofarterialthromboticevents(forexamplemyocardial

infarctionorstroke)(seesection4.4).

Ifseriousside-effectsoccur,Airtal ®

shouldbewithdrawn.

Thefollowingisatableofadversereactionsreportedfromclinicaltrialsandpost-authorisationuse,groupedby

system-OrganClassesandestimatedfrequencies.

MeDRaSOC Common

<10%->1% Uncommon

<1%->0.1% Rare

<0.1%->0.01% Veryrare/isolated

reports<0.01%

Bloodand

lymphaticsystem

disorders Anaemia Granulocytopenia

Thrombocytopenia

Immunesystem

disorders Anaphylactic

reaction(including

Shock)

Hypersensitivity

Metabolismand

nutrition Hyperkalemia

Psychiatric

disorders Depression

Abnormaldreams

Insomnia

Nervoussystem

disorder Dizziness Paraesthesia

Somnolence

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4.9Overdose

Managementofacutepoisoningwithnon-steroidalanti-inflammatorydrugsessentiallyconsistsofsupportiveand

symptomaticmeasures.

TherearenohumandataavailableontheconsequencesofAirtal ®

overdosage.Thetherapeuticmeasurestobe

takenare:absorptionshouldbepreventedassoonaspossibleafteroverdosagebymeansofgastriclavageand

treatmentwithactivatedcharcoal;supportiveandsymptomatictreatmentshouldbegivenforcomplicationssuch

ashypotension,renalfailure,convulsions,gastrointestinalirritation,andrespiratorydepression;specifictherapies

suchasforceddiuresis,dialysisorhaemoperfusionareprobablyofnohelpineliminatingnon-steroidalanti-

inflammatorydrugsduetotheirhighrateofproteinbindingandextensivemetabolism.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Dysgeusia

(Abnormaltaste)

Tremor

Eyedisorders Visualdisturbance

Earandlabyrinth

disorders Vertigo

Cardiacdisorders Cardiacfailure Palpitations

Vascular

disorders Hypertension <?xml:namespace

prefix=st1ns=

"urn:schemas-

microsoft-

com:office:smarttags"/><st1:place

w:st="on"> Flushing </st1:place>

Hotflush

Respiratory

thoracicand

mediastinal

disorders Dyspnoea

Gastrointestinal

disorders Dyspepsia

Abdominal

pain

Nausea

Diarrhoea Flatulence

Gastritis

Constipation

Vomiting

Mouthulceration Melaena

Gastrointestinal

perforation Stomatitis

Haematemesis

Pepticulcer

Gastrointestinal

haemorrhage

Hyperkalaemia

Skinand

subcutaneous

Tissuedisorders Pruritus

Rash

Dermatitis

Urticaria Faceoedema Purpura

Seriousmucocutaneous

skinreactions

Renalandurinary

disorders NephriticSyndrome

Generaldisorders

administration

siteconditions OedemaFatigue

Investigations Hepatic

enzyme

increased Bloodurea

increasedBlood

creatinine

increased Bloodalkaline

phosphataseincreased

Weightincrease

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Themodeofactionofaceclofenacislargelybasedontheinhibitionofprostaglandinsynthesis.Aceclofenacisapotent

inhibitoroftheenzymecyclo-oxygenase,whichisinvolvedintheproductionofprostaglandins.

5.2Pharmacokineticproperties

Afteroraladministration,aceclofenacisrapidlyandcompletelyabsorbedasunchangeddrug.Peakplasma

concentrationsarereachedapproximately1.25to3.00hoursfollowingingestion.Aceclofenacpenetratesintothe

synovialfluid,wheretheconcentrationsreachapproximately57%ofthoseinplasma.Thevolumeofdistribution

isapproximately25L.

Themeanplasmaeliminationhalf-lifeisaround4hours.Aceclofenacishighlyprotein-bound(>99%).

Aceclofenaccirculatesmainlyasunchangeddrug.4'-Hydroxyaceclofenacisthemainmetabolitedetectedin

plasma.Approximatelytwo-thirdsoftheadministereddoseisexcretedviatheurine,mainlyas

hydroxymetabolites.

Nochangesinthepharmacokineticsofaceclofenachavebeendetectedintheelderly.

5.3Preclinicalsafetydata

TheresultsfrompreclinicalstudiesconductedwithaceclofenacareconsistentwiththoseexpectedforNSAIDs.

Theprincipaltargetorganwasthegastro-intestinaltract.Nounexpectedfindingswererecorded.

Aceclofenacwasnotconsideredtohaveanymutagenicactivityinthreeinvitrostudiesandaninvivostudyinthe

mouse.

Aceclofenacwasnotfoundtobecarcinogenicineitherthemouseorrat.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Tabletcore

Microcrystallinecellulose

CroscarmelloseSodium

Glycerylpalmitostearate

Povidone

Filmcoating

Sepifilm752White

Consistingof:

Hypromellose

Microcrystallinecellulose

Macrogol40stearate

Titaniumdioxide(E171)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

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6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

TheimmediatecontainerforAirtal100mgFilm-coatedTabletsisalaminatedaluminium/aluminiumfoilpack.Each

foilstripcontains10tablets.Oneorsixfoilstrips(10or60tablets)willbeprovidedwithapatientinformationleaflet

insideacarton.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

LaboratoriosAlmirallS.A.

GeneralMitre,15108022

Barcelona

Spain

8MARKETINGAUTHORISATIONNUMBER

PA968/3/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:8 th

January1996

Dateoflastrenewal: 8 th

January2006

10DATEOFREVISIONOFTHETEXT

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