ASPIRIN MIGRAINE

Main information

  • Trade name:
  • ASPIRIN MIGRAINE
  • Dosage:
  • 500 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ASPIRIN MIGRAINE
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0021/051/001
  • Authorization date:
  • 13-07-2001
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AspirinMigraineEffervescentTablets500mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eacheffervescenttabletcontainsacetylsalicylicacid500mg.

Forexcipientssee6.1.

3PHARMACEUTICALFORM

Effervescenttablets

White,round,flateffervescenttabletswithBayercrossembossedononeside.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthesymptomaticreliefofheadacheassociatedwithmigraine.

4.2Posologyandmethodofadministration

Adults:

1,000mgassingledose(correspondingtotwoeffervescenttablets).

Iftheattackpersiststhedosemayberepeatedatintervalsof4-8hours.

Amaximumdailydoseof3g(sixtablets)mustnotbeexceeded.

AspirinMigrainetabletsmustnotbetakenformorethan3dayswithoutconsultingaphysician.Ifmigraineattacks

occurfrequently,iffrequencyofattacksincreaseorifsymptomspersist,aphysicianshouldbeconsultedandan

alternativetreatmentshouldbeconsidered.

CHILDREN:

TheuseofAspirinMigrainetabletsisnotrecommendedinchildrenasnostudieshaveincludedthispopulation.

AspirinMigrainetabletsmustbedissolvedinaglassofwaterbeforetaking.

4.3Contraindications

Activepepticulcers;

Haemorrhagicdiathesis;

Hypersensitivitytoacetylsalicylicacid,toothersalicylates,ortoanyothercomponentsoftheproduct;

Ahistoryofasthmainducedbytheadministrationofsalicylatesorsubstanceswithasimilaraction,notably

non-steroidalanti-inflammatorydrugs;

Severehepaticfailure;

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Severeuncontrolledcardiacfailure;

CombinationwithMethotrexateatdosesof15mg/weekormore(seeinteractionswithothermedicinalproducts

andotherformsofinteraction);

Lasttrimesterofpregnancy.

4.4Specialwarningsandprecautionsforuse

Concomitanttreatmentwithanticoagulants;

Historyofgastro-intestinalulcersincludingchronicorrecurrentulcerdiseaseorhistoryofgastro-intestinal

bleedings;

Impairedrenalfunction;

Impairedhepaticfunction;

Hypersensitivitytoanti-inflammatoryorantirheumaticdrugsorotherallergens.

Medicinalproductscontainingacetylsalicylicacidshouldbeusedinchildrenandadolescentswithfebrilediseasesonly

aftercarefulrisk-benefitevaluationbecauseofthepossibilityofReye’ssyndrome,ararebutseriousillness.

Acetylsalicylicacidmayprecipitatebronchospasmandinduceasthmaattacksorotherhypersensitivityreactions.Risk

factorsarepresentbronchialasthma,hayfever,nasalpolyps,orchronicrespiratorydisease.

Thisappliesalsoforpatientsshowingallergicreactions(e.g.cutaneousreactions,itching,urticaria)toother

substances.

Duetoitsinhibitoryeffectonplateletaggregationacetylsalicylicacidmayleadtoanincreasedbleedingtendency

duringandaftersurgicaloperations(includingminorsurgeries,e.g.dentalextractions).

Atlowdoses,acetylsalicylicacidreducestheexcretionofuricacid.Thiscantriggergoutinpatientswhoalreadytend

tohavealowuricacidexcretion.

Chronicintakeofanalgesicsmaycauseheadachewhichcanleadtoreneweddosingandthustoacontinuationof

headache.

Habitualuseofanalgesics(particularlycombinationsofdifferentanalgesicdrugs)maypermanentlydamagethe

kidneys(analgesicnephropathy).

Theproductcontains1086mgsodiumperdose.Tobetakenintoconsiderationbypatientsonacontrolledsodiumdiet.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Contra-indicatedInteractions:

Methotrexateusedatdosesof15mg/weekormore:

Increasedhaematologicaltoxicityofmethotrexate(decreasedrenalclearanceofmethotrexatebyanti-inflammatory

agentsingeneralanddisplacementofmethotrexatefromitsplasmaproteinbindingbysalicylates)(seeSection4.3

Contraindications).

Combinationsrequiringprecautionsforuse:

Methotrexate,usedatdosesoflessthan15mg/week:

Increasedhaematologicaltoxicityofmethotrexate(decreasedrenalclearanceofmethotrexatebyanti-inflammatory

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Anticoagulants,e.g.coumarin,heparin:

Increasedriskofbleedingviainhibitionofplateletfunction,damagetogastroduodenalmucosaanddisplacementof

oralanticoagulantsfromtheirplasmaproteinbindingsites.

Othernon-steroidalanti-inflammatorydrugswithsalicylatesathighdoses(3g/day):

Increasedriskofulcersandgastrointestinalbleedingduetosynergisticeffect.

Uricosuricssuchasbenzbromarone,probenecid:

Decreaseduricosuricseffect(competitionofrenaltubularuricacidelimination).

Antidiabetics,e.g.insulin,sulphonylureas:

Increasedhypoglycaemiceffectbyhighdosesofacetylsalicylicacidviahypoglycaemicactionofacetylsalicylicacid

anddisplacementofsulphonylureafromitsplasmaproteinbinding.

Thrombolytics/Otherantiplateletagents,e.g.ticlopidine:

Increasedriskofbleeding.

Diureticsincombinationwithacetylsalicylicacidatdosesof3g/dayormore:

Decreasedglomerularfiltrationviadecreasedrenalprostaglandinsynthesis.

Systemicglucocorticoids,excepthydrocortisoneusedasreplacementtherapyinAddison'sdisease:

Decreasedbloodsalicylatelevelsduringcorticosteroidtreatmentandriskofsalicylateoverdoseafterthistreatmentis

stoppedviaincreasedeliminationofsalicylatesbycorticosteroids.

Angiotensinconvertingenzymeinhibitors(ACE):

Atdosesof3g/dayandmore,decreasedglomerularfiltrationviainhibitionofvasodilatorprostaglandins.Furthermore,

decreasedantihypertensiveeffect.

Valproicacid:

Increasedtoxicityofvalproicacidduetodisplacementfromproteinbindingsites.

Alcohol:

Increaseddamagetogastro-intestinalmucosaandprolongedbleedingtimeduetoadditiveeffectsofacetylsalicylic

acidandalcohol.

4.6Pregnancyandlactation

Pregnancy

Animalstudieshaverevealedevidenceofateratogeniceffectofacetylsalicylicacid.

Firstandsecondtrimesters:

Acetylsalicylicacidasoccasionaltreatment:

Epidemiologicalstudyresultsappeartoruleoutanyparticularmalformativeeffectofacetylsalicylicacid;

Acetylsalicylicacidaschronictreatment:

Currentdataarenumericallyinsufficienttoevaluateanypossiblemalformativeeffectofacetylsalicylicacidtakenas

chronictreatmentatmorethan150mg/day.

Consequently,

Acetylsalicylicacidcanbeprescribedifnecessaryasoccasionaltreatment,

Asaprecautionarymeasure,itispreferablenottouseacetylsalicylicacidaschronictreatmentatmorethan

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Thirdtrimester:

Acetylsalicylicacidat 500mgperdoseandperday,asotherprostaglandinsynthesisinhibitors,mayexposethe

foetusto:

Cardiopulmonarytoxicity(withprematureclosureoftheductusarteriosusandpulmonaryhypertension);

Renaldysfunction,potentiallytothepointofrenalfailurewitholigo-hydramnios;

Motherandbaby,attheendofpregnancy,topossiblelengtheningofbleedingtime.Thisanti-aggreganteffect

mayoccurevenatverylowdoses.

Consequently,apartfromextremelylimitedcardiologicandobstetricuseswhichjustifyamedicaladviceanda

specialistmonitoring,allmedicinescontainingacetylsalicylicacidarecontraindicatedduringthelasttrimesterof

pregnancy.

Lactation

Salicylatesanditsmetabolitespassintobreastmilkinsmallquantities.Sincenoadverseeffectsontheinfanthavebeen

observedsofarafteroccasionaluse,interruptionofbreast-feedingisusuallyunnecessary.However,onregularuseor

onintakeofhighdoses,breastfeedingshouldbediscontinuedearly.

4.7Effectsonabilitytodriveandusemachines

Noeffectsonabilitytodriveandusemachineshavebeenobserved.

4.8Undesirableeffects

Gastrointestinaleffects:

Abdominalpain,heartburn,nausea,vomiting.

Evident(hematemesis,melena)oroccultgastro-intestinalbleedingwhichmaycauseirondeficiencyanaemia.Such

bleedingiscommonerwhenthedosageishigher.

Gastro-duodenalulcerandperforation.

Effectsonthecentralnervoussystem:

Headache,vertigo,feelingsofimpairedhearing,tinnitus,whichareusuallyindicativeofoverdose.

Haematologicaleffects:

Bleedingsyndromes(epistaxis,gingivalbleeding,purpura,etc.)withprolongedbleedingtime.Thisactionmaypersist

for4to8daysafteracetylsalicylicacidisstopped.Itmayresultintheriskofbleedingduringsurgery.

Hypersensitivityreactions:.

Urticaria,skinreactions,anaphylacticreactions,asthma,Quinckeoedema.

4.9Overdose

Poisoningmustbefearedintheelderlyandaboveallinyoungchildren(therapeuticoverdoseorfrequentaccidental

poisoning)inwhomitmaybefatal.

Symptomatology:

Moderatepoisoning:

tinnitus,feelingofimpairedhearing,headache,vertigoandmentalconfusionareobservedincaseofoverdoseandcan

becontrolledbyadosagereduction.

Severepoisoning:

fever,hyperventilation,ketosis,respiratoryalkalosis,metabolicacidosis,coma,cardiovascularshock,respiratory

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Emergencymanagement:

Immediatetransfertohospitalspecialistunit,gastriclavage,administrationofactivatedcharcoal,checkofacid-base

balance,alkalinediuresissoastoobtainaurinepHbetween7.5and8,forcedalkalinediuresisshouldbeconsidered

whentheplasmasalicylateconcentrationisgreaterthan:500mg/litre(3.6mmol/litre)inadultsor300mg/litre(2.2

mmol/litre)inchildren,possibilityofhemodialysisinseverepoisoning,fluidlossesshouldbereplaced,symptomatic

treatment.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Nervoussystem,otheranalgesicsandantipyretics.

ATC-Code:N02BA01.

Acetylsalicylicacidbelongstothegroupofacidicnonsteroidalanti-inflammatorydrugswithanalgesic,antipyreticand

anti-inflammatoryproperties.Itsmechanismofactionisbasedonirreversibleinhibitionofcyclo-oxygenaseenzymes

involvedinprostaglandinsynthesis.

Acetylsalicylicacidinoraldosesofingeneral0.5to1.0gisusedforthereliefofmildtomoderatepainandinminor

febrileconditions,suchascoldsorinfluenza,forthereductionoftemperatureandreliefofthejointandmusclepains.

Itisalsousedinacuteandchronicinflammatorydisorderssuchasrheumatoidarthritis,osteoarthritis,andankylosing

spondylitis.Generallyhighdosesof4to8gdailyindivideddosesareusedforthesedisorders.

AcetylsalicylicacidalsoinhibitsplateletaggregationbyblockingthromboxaneA

synthesisinplatelets.Thus,itis

usedforvariouscardiovascularindicationsatdosesofingeneral75to100mgdaily.TheuseofAspirinMigraineis

notrecommendedforplateletaggregationinhibition.

5.2Pharmacokineticproperties

Followingoraladministration,acetylsalicylicacidisabsorbedrapidlyandcompletelyfromthegastro-intestinaltract.

Duringandafterabsorptionacetylsalicylicacidisconvertedintoitsmainactivemetabolitesalicylicacid.Maximal

plasmalevelsarereachedafter10-20minutesforacetylsalicylicacidandafter0.3-2hoursforsalicylicacid,resp.

Bothacetylsalicylicacidandsalicylicacidareextensivelyboundtoplasmaproteinsandrapidlydistributedtoallbody

parts.Salicylicacidappearsinbreastmilkandcrossestheplacenta.

Salicylicacidismainlyeliminatedbyhepaticmetabolism;metabolitesincludesalicyluricacid,salicylphenolic

glucuronide,salicylacylglucuronide,gentisicacid,andgentisuricacid.

Theeliminationkineticsofsalicylicacidisdose-dependent,asthemetabolismislimitedbythecapacityofliver

enzymes.Thus,theeliminationhalf-lifevariesbetween2to3hoursafterlowdosestoabout15hoursathighdoses.

Salicylicacidanditsmetabolitesareexcretedmainlyviathekidneys.

5.3Preclinicalsafetydata

Thepreclinicalsafetyprofileofacetylsalicylicacidiswelldocumented.Inanimaltestssalicylatescausedkidney

damagebutnootherorganiclesions.

Acetylsalicylicacidhasbeenadequatelytestedformutagenicityandcarcinogenicity;norelevantevidenceofa

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

MonosodiumCitrate

SodiumHydrogenCarbonate

CitricAcid,anhydrous

SodiumCarbonate,anhydrous

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

Strips(Paper/Polyethylene/Aluminium/Copolymer),eachcontaining2effervescenttablets.

Stripsarepackedintocardboardoutersinpacksof6x2/12x2effervescenttablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Bayerplc

TradingasBayerplc,ConsumerCareDivision

BayerHouse

StrawberryHill

Newbury

BerkshireRG141JA

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA21/51/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:13July2001

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10DATEOFREVISIONOFTHETEXT

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