BAYER ASPIRIN

Main information

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

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0021/006/001
  • Authorization date:
  • 01-04-1978
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BayerAspirin 300 mg Tablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Onetabletcontains300 mg ofAcetylsalicylicacid.

Forexcipients, see6.1.

3PHARMACEUTICALFORM

Tablet

Whitetabletwith theword 'Aspirin' and '0.3' on onesurfaceand theBayercrosson theother.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthesymptomaticreliefofheadache,neuralgia,musculoskeletalaches,rheumatism,commoncold,influenzaand

menstrualpain.

4.2Posologyandmethodofadminstration

Theusualdosein adultsand childrenaged 12 and overis600 to 900mg. Thedosemay berepeated atfourhourly

intervalsifnecessary.Thedaily maximumdoseis12 tablets(3.6g).

Do notgiveto children and adolescentsaged under16 years, excepton medicaladvice, wherethebenefitoutweighs

therisk.

Elderly

Aspirin should beused with particularcaution inelderly patientswho aremoreproneto adverseevents.Thelowest

dosecompatiblewith adequatesafeclinicalcontrolshould beemployed.Seealso section 4.4.

4.3Contraindications

Aspirin should notbeadministered to patients:

Withahistoryofhypersensitivityreactions(e.g.bronchospasm,rhintis,urticaria)inresponsetoasprin,other

salicylatesorsubstanceswith similaractionse.g. non-steroidalanti-inflammatory drugs.

With known hypersensitivity to any oftheotheringredients, referto section 6.1.

With activepepticulceration orahistory ofpepticulceration.

With haemorrhagicdiseasessuch ashaemophilia.

You arepregnantofbreast-feeding.

Irish Medicines Board

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Date Issued 22/08/2005 CRN 2012521 page number: 1

4.4Special warningsandspecialprecautionsforuse

Aspirin may precipitatebronchospasmand induceasthmaattacksorotherhypersensitivity reactionsin susceptible

individuals.

Undesirableeffectsmay bereduced by using theminimumeffectivedosefortheshortestpossibleduration.Patients

treated with NSAIDslong-termshould undergo regularmedicalsupervision to monitorforadverseevents.

In patientswith renal, cardiacorhepaticimpairment, caution isrequired sincetheuseofNSAIDsmay resultin

deteriorationofrenalfunction. Assessmentoftherenalfunction should occurpriorto theinitiation oftherapy and

regularlythereafter.

Elderly patientsareparticularly susceptibleto theadverseeffectsofNSAIDs.Prolonged useofNSAIDsin theelderly

isnotrecommended.Whereprolonged therapy isrequired, patientsshouldbereviewed regularly.

Caution should beexercised in patients:

With ahistory ofgastrointestinaldisorders

Taking anti-coagulants(e.g. coumarin derivativesorheparin)

Who arehypersensitiveto anti-inflammatory oranti-rheumaticdrugs

With inflammatory boweldisease

Aspirin can causegoutin patientswith lowuricacid excretion.

Thereisapossibleassociation between aspirin and Reye’ssyndromegiven to children.Reyes’ssyndromeisavery

rarediseasewhich affectsthebrain and liver, and can befatal.Forthisreason aspirin should notbegiven tochildren

and adolescentsunder16 yearsunlessspecifically indicated.

Prolonged use, exceptundermedicalsupervision can beharmful.Adoctorshould beconsulted if:

Symptomspersist

Dosageisnecessary formorethan threedays

Thepatientison othermedication orunderthecareofadoctor.

Dueto itsinhibitory effecton plateletaggregation, aspirinmay causeincreased bleeding during and aftersurgery.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ItisconsideredunsafetotakeNSAIDsincombinationwithwarfarinorheparinunlessunderdirectmedical

supervision.

BayerAspirin Tabletsmay:

Enhancetheactivity ofanticoagulants, insulin and sulphonylureahypoglycaemicagents.

Enhancetheactivity ofmethrotrexateand increaseitstoxicity.

Diminish theeffectsofuricosuricagents.

Diminish theeffectsofdiuretics.

Irish Medicines Board

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Date Issued 22/08/2005 CRN 2012521 page number: 2

Potentiatetheeffectsand sideeffectsofothernon-steroidalanti-inflammatory drugs.

Enhancetheplasmaconcentrationsofdigoxin.

Enhancetheeffectsofsomeanti-epileptics, such assodiumvalproateand phenytoin.

Increasetherisk ofbleeding with thrombolyticsand otheranti-plateletagentse.g. ticlopidine.

NumerousNSAIDsmay interactwith antihypertensivemedicinesalthough ofallNSAIDs, aspirin and sulindacare

thoughtto havetheleasteffect.

Decreased blood salicylatelevelsmay occurwhen aspirin istaken concomitantly withglucocorticoids.Thereisarisk

ofsalicylateoverdosewhen glucocorticoidstreatmentisstopped.

Atdosesofaspirin 3g/day ormore, aspirin may:

Increasetherisk ofulcersand gastro-intestinalbleeding when taken with otherNSAIDs.

Decreaseglomerularfiltration when taken with diuretics.

Decreaseglomerularfiltration and anti-hypersensitiveeffectwhentaken with angiotensin converting enzyme

(ACE)inhibitors.

When taken with alcohol, theeffectsofaspirin on thegastro-intestinaltractmay increase.

4.6Pregnancyandlactation

Althoughclinicalandepidemiologicalevidencesuggeststhatthesafetyofacetylsalicylicacidforuseinpregnancy,

caution should beexercised when administered to pregnantpatients.

Acetylsalicylicacidhastheabilitytoalterplateletfunctionand,therefore,theremaybeariskofhaemorrhagein

infantswhosemothershaveconsumedacetylsalicylicacidduringpregnancy.Theonsetoflabourmaybedelayedand

theduration increased, with an increasein maternalblood loss.Therefore, analgesicdosesshould beavoided atterm.

Highdosesofacetylsalicylicacidmayresultinclosureoffoetalductusarteriosusinuteroandpossiblypersistent

pulmonary hypertension in thenewborn.Kernicterusmay beaconsequenceofjaundicein neonates.

Administrationofacetylsalicylicacidatdosesgreaterthan300mg/dayshortlybeforebirthcanleadtointra-cranial

haemorrhages, particularly in prematurebabies.

Theintakeofacetylsalicylicacidbybreast-feedingpatientsshouldbeavoided,asthereisariskofReye’ssyndrome.

Regularuseofhighdosescouldimpairplateletfunctionandproducehypoprothrombinaemiaintheinfantifneonatal

vitamin Kstoresarelow.

4.7Effectsonabilitytodriveandusemachines

None

4.8Undesirableeffects

Gastrointestinaldisordershavebeen reported foraspirin containing products, e.g. nausea, diarrhoea, vomiting and

gastro-intestinalbleeding which can lead to anaemiain somecases.Gastrointestinalulcersmay develop, which may

lead to haemorrhaging and perforation.

Irish Medicines Board

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Date Issued 22/08/2005 CRN 2012521 page number: 3

Isolated casesofliver(increased transaminases)and kidney dysfunction, hypoglycaemiaand severeskin reactionshave

been described.

Dueto theeffecton plateletaggregation acetylsalicylicacid may beassociated withan increased risk ofbleeding.

Dizzinessand tinnitushavealso been reported butthesesideeffectsaremorecommonly indicativeofan overdose.

4.9Overdose

Themainfeaturesofanoverdoseofacetylsalicylicacidarehyperventilation,tinnitus,deafness,vasodilatationand

sweating.Comaisuncommonbutindicatesveryseverepoisoning.Treatmentconsistsofgastriclavage,forced

alkalinediuresiswhereneeded, normalising acid baseandelectrolytebalance.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Aspirin, aswithothersalicylates,generallyactsthroughitssalicylicacidcontent,althoughsomeeffectsofaspirinarea

resultofitscapacity to acetylateproteins.

Theantipyreticeffectofaspirinappearstobethroughtheactionofsalicylatesonthecentralnervoussystem(a

hypothalamicsiteofaction hasbeen implicated).

5.2Pharmacokineticproperties

Aspirinabsorptionisaffectedbythephysicalcharacteristicsoftheformulationaswellasphysiologicalfactorsthat

influenceaspirinsolubilitye.g.pH.Absorptionisbypassivediffusionwithahalf-lifedependantupongastro-intestinal

pHand gastricemptying times, thusexplaining thelargesubjectvariation observed.

Onceabsorbed,aspirinisdistributedextensivelythroughthebodyfluids.Theserumhalf-lifeforaspirinis,however,

intheregionof20minutesandisassociatedwithanincreaseinsalicylicacidconcentrationduetotheactionofnon-

specifichepaticand gastricesterases, which hydrolyseaspirin to givetheacetyland salicylatemoieties.

TheacetylcomponentofaspirinisprimarilymetabolisedviatheKreb’scycleandexcretedascarbondioxide.The

amountoffreesalicylicacidexcretedintheurineissmall(about10%)andisdependantuponurinepHandurinary

flowrate.Theremainingsalicylicacidismetabolisedthroughglucuronideformation,oxidationtogentisicacidand

conjugationwithglycine.Thedose-dependantserumhalf-lifeofsalicylicacid(increasinghalf-lifewithhigherdoses)

isduetothefactthattheaforementionedpathwaysbecomesaturated.Themetabolisedformsofsalicylicacidare

excreted renally.

5.3Preclinical safetydata

Nonerelevant

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Cellulose, powdered

Maizestarch

6.2Incompatibilities

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 22/08/2005 CRN 2012521 page number: 4

6.3ShelfLife

30 months.

6.4Special precautionsforstorage

No specialprecautionsforstorage.

6.5Natureandcontentsofcontainer

300µmtransparentPPblisterpack sealed with20µmaluminiumhard foilwith 3.5 g/m 2

heat-sealPPcoating.The

blisterpacksareenclosed in acardboard outercarton containing 20 or50 tablets.

6.6Instructionsforuseandhandling

No specialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Bayerplc

ConsumerCareDivision

BayerHouse

Strawberry Hill

Newbury, Berkshire

RG141JA

United Kingdom

8MARKETINGAUTHORISATIONNUMBER

PA21/6/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:1 st

April1978

Dateoflastrenewal:1 st

April2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Issued 22/08/2005 CRN 2012521 page number: 5