ASPIRIN

Main information

  • Trade name:
  • ASPIRIN Dispersable Tablet 75 Milligram
  • Dosage:
  • 75 Milligram
  • Pharmaceutical form:
  • Dispersable Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ASPIRIN Dispersable Tablet 75 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0176/015/003
  • Authorization date:
  • 27-08-1985
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Aspirin75mgDispersibleTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachdispersibletabletcontains75mgacetylsalicylicacid(aspirin)

Excipients:alsocontainslactose34.25mgpertablet

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

DispersibleTablet

White,circular,flatbevelled-edgeuncoatedtabletsimpressedwiththeword“C”andidentifyingletters“AY”onone

face.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Aspirinhasanalgesic,antipyreticandanti-inflammatoryactionsandanantithromboticeffectthroughinhibitionof

plateletactivation.Thispreparationisindicatedfortheprophylacticmanagementofcardiovasculardiseaseor

myocardialinfarction.

4.2Posologyandmethodofadministration

Thetabletsshouldbedispersedinwaterbeforeadministration,andtakenimmediately.

Adults:Theusualdoseis75mgdaily.

Elderly:NSAIDsshouldbeusedwithparticularcautioninelderlypatientswhoaremorepronetoadverseevents.The

lowestdosecompatiblewithadequatesafeclinicalcontrolshouldbeemployed.Seealsosection4.4.Treatmentshould

bereviewedatregularintervalsanddiscontinuedifnobenefitisseenorintoleranceoccurs.

Donotgivetochildrenandadolescentsagedunder16years,exceptonmedicaladvice,wherethebenefitoutweighs

therisk.

Undesirableeffectsmaybeminimisedbyusingtheshortestdurationnecessarytocontrolsymptoms(seesection4.4).

4.3Contraindications

Aspirinshouldnotbetakenbypatientswiththefollowingconditions:

Knownhypersensitivitytoaspirin,otheringredientsintheproduct,othersalicylatesornon-steroidalanti-

inflammatorydrugs(apatientmayhavedevelopedanaphylaxis,angioedema,asthma,rhinitisorurticariainducedby

aspirinorotherNSAIDs).

Historyofgastrointestinalbleedingorperforation,relatedtopreviousNSAIDstherapy.Activeorhistoryof

recurrentpepticulcer/haemorrhage(twoormoredistinctepisodesofprovenulcerationorbleeding).

Severeheartfailure.

4.4Specialwarningsandprecautionsforuse

Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactasedeficiencyorglucose-galactose

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 21/07/2011 CRN 2097111 page number: 1

Beforecommencinglong-termaspirintherapyforthemanagementofcardiovascularorcerebrovasculardisease,

patientsshouldconsulttheirdoctorwhocanadviseontherelativebenefitsversustherisksfortheindividualpatient.

ThereisapossibleassociationbetweenaspirinandReye’ssyndromewhengiventochildren.Reye’ssyndromeisa

veryraredisease,whichaffectsthebrainandliver,andcanbefatal.Forthisreason,aspirinshouldnotbegivento

childrenandadolescentsagedunder16yearsunlessspecificallyindicated.

Undesirableeffectsmaybeminimisedbyusingtheminimumeffectivedosefortheshortestpossibledurationnecessary

tocontrolsymptoms(seesection4.2,GIandcardiovascularbelow).PatientstreatedwithNSAIDslong-termshould

undergoregularmedicalsupervisiontomonitorforadverseevents.

TheelderlyhaveanincreasedfrequencyofadversereactionstoNSAIDsespeciallygastrointestinalbleedingand

perforationwhichmaybefatal(seesection4.2).

Inpatientswithrenal,cardiacorhepaticimpairment,cautionisrequiredsincetheuseofNSAIDsmayresultin

deteriorationofrenalfunction.Assessmentofrenalfunctionshouldoccurpriortotheinitiationoftherapyandregularly

thereafter.

AsNSAIDscaninterferewithplateletfunction,theyshouldbeusedwithcautioninpatientswithintercranial

haemorrhageandbleedingdiathesis.

TheuseofaspirinwithconcomitantNSAIDsincludingcyclooxygenase-2selectiveinhibitorsshouldbeavoided.

Gastrointestinalbleeding,ulcerationandperforation:GIbleeding,ulcerationorperforation,whichcanbefatal,has

beenreportedwithallNSAIDsatanytimeduringtreatment,withorwithoutwarningsymptomsoraprevioushistoryof

seriousGIevents.

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.

Cautionshouldbeadvisedinpatientsreceivingconcomitantmedicationswhichcouldincreasetheriskofulcerationor

bleeding,suchasoralcorticosteroids,anticoagulantssuchaswarfarin,selectiveserotonin-reuptakeinhibitorsor

antiplateletagentssuchasaspirin(seesection4.5).

WhenGIbleedingorulcerationoccursinpatientsreceivingaspirin,thetreatmentshouldbewithdrawn.

NSAIDsshouldbegivenwithcaretopatientswithahistoryofgastrointestinaldisease(ulcerativecolitis,Crohn’s

disease)astheirconditionmaybeexacerbated(seesection4.8).

Cautionisrequiredinpatientswithahistoryofhypertensionand/orheartfailureasfluidretentionandoedemahave

beenreportedinassociationwithNSAIDtherapy.

Seriousskinreactions,someofthemfatal,includingexfoliativedermatitis,Stevens-Johnsonsyndrome,andtoxic

epidermalnecrolysis,havebeenreportedveryrarelyinassociationwiththeuseofNSAIDs(see4.8).Patientsappearto

beathighestriskofthesereactionsearlyinthecourseoftherapy,theonsetofthereactionoccurringinthemajorityof

caseswithinthefirstmonthoftreatment.Aspirinshouldbediscontinuedatthefirstappearanceofskinrash,mucosal

lesions,oranyothersignofhypersensitivity.

Cardiovascularandcerebrovasculareffects

Appropriatemonitoringandadvicearerequiredforpatientswithahistoryofhypertensionand/ormildtomoderate

congestiveheartfailureasfluidretentionandoedemahavebeenreportedinassociationwithNSAIDtherapy.

ClinicaltrialandepidemiologicaldatasuggestthatuseofsomeNSAIDs(particularlyathighdosesandinlongterm

treatment)maybeassociatedwithasmallincreasedriskofarterialthromboticevents(forexamplemyocardial

infarctionorstroke).Thereareinsufficientdatatoexcludesuchariskforaspirin.

Patientswithuncontrolledhypertension,congestiveheartfailure,establishedischaemicheartdisease,peripheral

arterialdisease,and/orcerebrovasculardiseaseshouldonlybetreatedwithaspirinaftercarefulconsideration.Similar

considerationshouldbemadebeforeinitiatinglonger-termtreatmentofpatientswithriskfactorsforcardiovascular

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

Aspirinshouldbeusedwithcautioninpatientswith:

allergicdisease

anaemia(maybeexacerbatedbyGIbloodloss)

asthma(increasedriskofbronchospasticsensitivityreactions)

cardiacfailure(conditionswhichpredisposetofluidretentionasNSAIDsmayexacerbatethis)

dehydration

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 21/07/2011 CRN 2097111 page number: 2

glucose-6-phosphatedehydrogenasedeficiency(aspirinrarelycauseshaemolyticanaemia)

gout(serumuratemaybeincreased)

haemophiliaorotherhaemorrhagicdisorder(includingthrombocytopenia)asthereisanincreasedriskofbleeding

nasalpolypsassociatedwithasthma(highriskofseveresensitivityreactions)

surgery.Aspirinshouldbediscontinuedseveraldaysbeforescheduledsurgery(includingdentalextractions)

systemiclupuserythematosusandotherconnectivetissuedisorders(hepaticandrenalfunctionmaybeimpairedin

theseconditions)

Inpatientswithstrokes,aspirinshouldnotbegivenuntilthepossibilityofcerebralhaemorrhagehasbeenexcluded.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Thefollowingdruginteractionsshouldbeconsideredwhenprescribingaspirin:

ItisconsideredunsafetotakeNSAIDsincombinationwithwarfarinorheparinunlessunderdirectmedical

supervision.

Alcohol-mayenhancegastro-intestinalsideeffectofaspirin.

Analgesics-avoidconcomitantadministrationofothersalicylatesorotherNSAIDs(includingtopicalformulations

egibuprofen)asincreasedriskofsideeffects.

Alkalizersofurine(egcarbonicanhydraseinhibitorssuchasacetazolamide,antacids,citratesegsodiumcitrate)-

increasedexcretionofaspirin.

Anticoagulants-NSAIDsmayenhancetheeffectsofanti-coagulants,suchaswarfarin(seesection4.4).

Antiepilepticdrugs(egphenytoin,sodiumvalproate)-increasedeffect.

Antihypertensives-reducedanti-hypertensiveeffect.

Anti-plateletagentsandselectiveserotoninreuptakeinhibitors(SSRIs):increasedriskofgastrointestinalbleeding

(seesection4.4).

Corticosteroidseghydrocortisone,prednisone-increasedriskofgastro-intestinalbleedingorulceration(seesection

4.4).

Diuretics:furosemideandacetazolamide(riskoftoxiceffects),spironolactone(antagonizeddiureticaction).All

diureticscancausenephrotoxicity.

Cardiacglycosides:NSAIDsmayexacerbatecardiacfailure,reduceGFRandincreaseplasmacardiacglycoside

levels.

Lithium:decreasedeliminationoflithium

Oralhypoglycaemicsegglibenclamide,gliclazide-enhancedactivity.Inhibitionofmetabolismofsulfonylurea

drugs,prolongedhalf-lifeandincreasedriskofhypoglycaemia

Methotrexate:decreasedeliminationofmethotrexate,increasedtoxicity.

Ciclosporin:increasedriskofnephrotoxicitywithNSAIDs.

OtherNSAIDs:avoidconcomitantuseoftwoormoreNSAIDs.

Aminoglycosides:reductioninrenalfunctioninsusceptibleindividuals,decreasedeliminationofaminoglycoside

andincreasedplasmaconcentrations.

Probenecid:reductioninmetabolismandeliminationofNSAIDandmetabolites.

Mifepristone-avoidaspirinuntil8-12daysaftermifepristone.

Metoclopramideanddomperidone-increasedrateofabsorptionofaspirin.

Ototoxicmedicine(egvancomycin)-potentialforototoxicityincreased.Hearinglossmayoccurandmayprogress

todeafnessevenafterdiscontinuationofthemedication.Effectsmaybereversiblebutareusuallypermanent.

Uricosurics(egsulfinpyrazone)-effectsofuricosuricsreduced.

Laboratoryinvestigations-aspirinmayinterferewithsomelaboratorytestssuchasurine5-hydroxyundoleacetic

aciddeterminationsandcoppersulphateurinesugartests.

Experimentaldatasuggestthatibuprofenmayinhibittheeffectoflowdoseaspirinonplateletaggregationwhenthey

aredosedconcomitantly.However,thelimitationsofthesedataandtheuncertaintiesregardingextrapolationofexvivo

datatotheclinicalsituationimplythatnofirmconclusionscanbemadeforregularibuprofenuse,andnoclinically

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 21/07/2011 CRN 2097111 page number: 3

4.6Fertility,pregnancyandlactation

Salicylatesreadilycrosstheplacentaandhavebeenshowntobeteratogenicinanimals.Althoughsomestudiesand

anecdotalreportshaveimplicatedaspirinintheformationofcongenitalabnormalities,mostlargestudieshavefailedto

findanysignificantriskorevidenceofteratogenicity.Ingestionofaspirinduringthelasttwoweeksofpregnancymay

increasetheriskoffoetalorneonatalhaemorrhage.

Regularorhighdoseuseofsalicylateslateinpregnancymayresultinconstrictionorprematureclosingofthefoetal

ductusarteriosus,increasedriskofstillbirthorneonataldeath,decreasedbirthweight,prolongedlabour,complicated

deliveriesandincreasedriskofmaternalorfoetalhaemorrhageandpossiblypersistentpulmonaryhypertensionof

newbornorkernicterusinjaundicedneonates.Pregnantwomenshouldbeadvisednottotakeaspirininthelastthree

monthsofpregnancyunlessundermedicalsupervision.

Aspirinisdistributedinbreastmilk.Aspirinshouldbeavoidedwhilebreastfeeding.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Adverseeffectsofaspirintreatmentwhichhavebeenreportedinclude:

Allergicreactions-rhinitis,urticaria,angioneuroticoedemaandworseningofasthma.Aspirinmayprecipitate

bronchospasmandinduceasthmaattacksorotherhypersensitivityreactionsinsusceptibleindividuals.

EffectsonGIsystem-themostcommonlyobservedadverseeventsaregastrointestinalinnature.Pepticulcers,

perforationorGIbleeding,sometimesfatal,particularlyintheelderly,mayoccur(sesection4.4).Nausea,vomiting,

diarrhoea,flatulenceconstipation,dyspepsia,abdominalpain,melaena,haematemesis,ulcerativestomatitis,

exacerbationofcolitisandCrohn’sdisease(seesection4.4)havebeenreportedfollowingadministration.Less

frequently,gastritishasbeenobserved.

Effectsonblood-anaemia,haemolyticanaemia,hypoprothrombinaemia,thrombocytopenia,aplasticanaemia,

pancytopenia.

Effectsonsensorysystem-tinnitus.

Effectsonheart–oedema,hypertensionandcardiacfailurehavebeenreportedinassociationwithNSAID

treatment.

Effectsontheskin–bullousreactionsincludingStevens-Johnsonsyndromeandtoxicepidermalnecrolysis(very

rare).

Salicylism-mildchronicsalicylateintoxicationmayoccurafterrepeatedadministrationoflargedoses.Symptoms

includedizziness,tinnitus,deafness,sweating,nausea,vomiting,headacheandmentalconfusion,andmaybe

controlledbyreducingthedose.

ClinicaltrialandepidemiologicaldatasuggestthatuseofsomeNSAIDs(particularlyathighdosesandinlongterm

treatment)maybeassociatedwithasmallincreasedriskofarterialthromboticevents(forexamplemyocardial

infarctionorstroke)(seesection4.4).

4.9Overdose

Salicylatepoisoningisusuallyassociatedwithplasmaconcentrations>350mg/L(2.5mmol/L).Mostadultdeathsoccur

inpatientswhoseconcentrationsexceed700mg/L(95.1mmol/L).Singledoseslessthan100mg/kgareunlikelyto

causeseriouspoisoning.

Symptoms

Commonfeaturesincludevomiting,dehydration,tinnitus,vertigo,deafness,sweating,warmextremitieswithbounding

pulses,increasedrespiratoryrateandhyperventilation.Somedegreeofacid-basedisturbanceispresentinmostcases.

AmixedrespiratoryalkalosisandmetabolicacidosiswithnormalorhigharterialpH(normalorreducedhydrogenion

concentration)isusualinadultsandchildrenovertheageof4years.Inchildrenaged4yearsorless,adominant

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 21/07/2011 CRN 2097111 page number: 4

salicylatetransferacrossthebloodbrainbarrier.

Uncommonfeaturesincludehaematemesis,hyperpyrexia,hypoglycaemia,hypokalaemia,thrombocytopenia,increased

INR/PTR,intravascularcoagulation,renalfailureandnon-cardiacpulmonaryoedema.

Centralnervoussystemfeaturesincludingconfusion,disorientation,comaandconvulsionsarelesscommoninadults

thaninchildren.

Management

Giveactivatedcharcoalifanadultpresentswithinonehourofingestionofmorethan250mg/kg.Theplasmasalicylate

concentrationshouldbemeasured,althoughtheseverityofpoisoningcannotbedeterminedfromthisaloneandclinical

andbiochemicalfeaturesmustbetakenintoaccount.Eliminationisincreasedbyurinaryalkalinisation,whichis

achievedbytheadministrationof1.26%sodiumbicarbonate.TheurinepHshouldbemonitored.Correctmetabolic

withintravenous8.4%sodiumbicarbonate(firstcheckserumpotassium).Forceddiuresisshouldnotbeusedsinceit

doesnotenhancesalicylateexcretionandmaycausepulmonaryoedema.

Haemodialysisisthetreatmentofchoiceforseverepoisoningandshouldbeconsideredinpatientswithplasma

salicylateconcentrations>700mg/L(5.1mmol/L),orlowerconcentrationsassociatedwithsevereclinicalormetabolic

features.Patientsunder10yearsorover70haveincreasedriskofsalicylatetoxicityandmayrequiredialysisatan

earlierstage.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCode:N02BA01Salicylicacidandderivatives.

Aspirinisananti-inflammatoryanalgesicandantipyretic.Itinhibitsprostaglandinsynthetaseandplateletaggregation.

Experimentaldatasuggestthatibuprofenmayinhibittheeffectoflowdoseaspirinonplateletaggregationwhenthey

aredosedconcomitantly.Inonestudy,whenasingledoseofibuprofen400mgwastakenwithin8hbeforeorwithin

30minafterimmediatereleaseaspirindosing(81mg),adecreasedeffectofASAontheformationofthromboxaneor

plateletaggregationoccurred.However,thelimitationsofthesedataandtheuncertaintiesregardingextrapolationofex

vivodatatotheclinicalsituationimplythatnofirmconclusioncanbemadeforregularibuprofenuse,andnoclinically

relevanteffectisconsideredtobelikelyforoccasionalibuprofenuse.

5.2Pharmacokineticproperties

Absorption

Absorptionofnon-ionisedaspirinoccursinthestomachandintestine.

Distribution

Salicylatesappearinbreastmilkandcrosstheplacenta.

Metabolism

Someaspirinishydrolysedtosalicylateinthegutwall.Afterabsorptionaspirinisrapidlyconvertedtosalicylatebut

duringthefirst20minutesaspirinisthepredominantformofthedrugintheplasma.Aspirinisboundtoplasma

proteinsandiswidelydistributed.Plasma-aspirinconcentrationsdeclinerapidly(half-life15-20minutes)asplasma

salicylateconcentrationsincrease.Bothaspirinandsalicylatehavepharmacologicalactivity;onlyaspirinhasananti-

plateleteffect.Salicylateismainlyeliminatedbyhepaticmetabolism;themetabolitesincludesalicyluricacid,salicyl

phenolicglucuronide,gentisicacid,andgentisuricacid.

Elimination

Salicylateisalsoexcretedunchangedintheurine;theamountexcretedbythisrouteincreaseswithincreasingdoseand

alsodependsonurinarypH,about30%ofadosebeingexcretedinalkalineurinecomparedwith2%ofadoseinacidic

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 21/07/2011 CRN 2097111 page number: 5

5.3Preclinicalsafetydata

Therearenopre-clinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

AnhydrousCitricacid

Lactose

Maizestarch

Saccharinsodium

Calciumcarbonate(E170)

6.2Incompatibilities

Notapplicable.

6.3Shelflife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

Keepthecontainertightlyclosedinordertoprotectfrommoisture.

6.5Natureandcontentsofcontainer

PPtabletcontainerwithaPEclosure.A2gsilicagelcontainerisincludedineachpack.

Packsize:1000tablets

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Disperseinwaterimmediatelybeforeuse.

7MARKETINGAUTHORISATIONHOLDER

ActavisUKLtd

TradingasActavis

WhiddonValley

BARNSTAPLE

NorthDevonEX328NS

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 21/07/2011 CRN 2097111 page number: 6

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorization:27August1985

Dateoflastrenewal:27August2010

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 21/07/2011 CRN 2097111 page number: 7