ASPIRIN

Main information

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

Documents

Localization

  • Available in:
  • ASPIRIN Tablets 300 mg Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0688/002/001
  • Authorization date:
  • 16-09-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Aspirin (Acetylsalicylicacid)Tablets300 mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each tabletcontains300mg ofAspirin (also known asacetylsalicylicacid)

Forexcipients, see6.1

3PHARMACEUTICALFORM

Tablet

White, circular, biconvex plain tablet.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthereliefofmild to moderatepainin headaches, toothacheand neuralgia.

Forreduction oftemperature.

Forreduction ofinflammation in lumbago.

4.2Posologyandmethodofadminstration

Adultsonly:300mg to 600mg threeto fourtimesdaily.

Do notgiveto children oradolescentsaged under16 years,excepton medicaladvice, wherethebenefitoutweighsthe

risk.

Elderly:Non steroidalanti-inflammatory drugsshould beused with particularcaution in elderly patientswho aremore

proneto adverseevents.Thelowestdosecompatiblewith adequateclinicalcontrolshould beemployed.Seealso

section 4.4.

Routeofadministration

Oral.

4.3Contraindications

Hypersensitivity to any oftheingredientsorto othernon-steroidalanti-flammatory drugs.

Irish Medicines Board

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Date Issued 02/09/2005 CRN 2014464 page number: 1

4.4Special warningsandspecialprecautionsforuse

Aspirin may precipitatebronchospasmand induceattacksofasthmaorhypersensitivity in susceptiblesubjects.

Iftheperson istaking any othermedicineorisunderdoctor’scare, heshould consultthephysician

beforeusing aspirin.

iii) Prolonged useexceptundermedicaldirection may beharmful.

Interferencewith laboratory tests:Salicylatesmay producefalsely increased resultsforblood creatinine,

urate(lowdoseaspirin)and urea.Falsely decreased resultsmay beobtained forblood thyroxineand

urate(>4g/day aspirin)and forurinary 5-HIAA(with nitrosonaphyholmethod).UrinaryVMA(HMMA)

levelsmay befalsely increased ordecreased depending on themethod ofanalysis.

Thereispossibleassociation between aspirin and Reye’ssyndromewhen given to children. Reye’ssyndrome

isavery raredisease, which affectsthebrain and liver, and can befatal. Forthisreason aspirin should notbe

given to children and adolescentsaged under16yearsunlessspecifically indicated.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Itisconsidered unsafeto takeNSAIDsin combinationwith warfarin orheparin unlessunderdirectmedical

supervision.

Careshould betaken in patientstreated with anyofthefollowing drugsasinteractionshavebeen reported.

Anti-hypertensives:reduced anti-hypertensiveeffect.

Diuretics:reduced diureticeffect. Diureticscanincreasetherisk ofnephrotoxicity ofNSAIDs.

Cardiacglycosides:NSAIDsmay exacerbatecardiacfailure, reduceGFRand increaseplasmacardiacglycoside

levels.

Lithium:decreased elimination oflithium.

Methotrexate:decreased elimination ofmethotrexate.

Cyclosporin:increased risk ofnephrotoxicity with NSAIDs.

OtherNSAIDs:avoid concomitantuseoftwo ormoreNSAIDs.

Corticosteroids:increased risk ofgastrointestinalbleeding.

Aminoglycosides:reduction in renalfunction in susceptibleindividuals, decreasedelimination ofaminoglycosideand

increased plasmaconcentrations.

Probenecid:reduction in metabolismand elimination ofNSAIDand metabolites.

Oralhypoglycaemicagents:inhibition ofmetabolismofsulfonylureadrugs, prolonged half-lifeand increased risk of

hypoglycaemia.

4.6Pregnancyandlactation

Although clinicaland epidemiologicalevidencewould suggestthesafety ofaspirin foruseduring pregnancy,caution

should beexercised when prescribing forpregnantpatients. Aspirin may prolong labourand contributeto maternaland

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Usagein nursing mothers:Asaspirin isexcreted into breastmilk, aspirin should notbetaken by patientswho arebreast

feeding.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Aspirin isharmfulto thegastricmucosa, increasestheincidenceofmucosallesions(erosions, ulcersorboth)and

promotesgastricbleeding. Long-termuseincreasestherisk ofsudden massivehaemorrhaging. Aspirin may also

inducehypersensitivity, asthma, uratekidney stones, tinnitus, nauseaand vomiting.

4.9Overdose

Overdosageproducesdizziness, tinnitus, sweating, nauseaand vomiting, confusion and hyperventilation. Gross

overdosagemay lead to CNSdepression with coma, cardiovascularcollapseand respiratory depression. Ifoverdosage

issuspected, thepatientshould bekeptunderobservation foratleast24 hours, assymptomsand salicylateblood levels

may notbecomeapparentforseveralhours. Treatmentofoverdosageconsistsofgastriclavageand forced alkaline

diuresis. Haemodialysismay benecessary in severecases.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Asan antipyreticaspirin, likemany related drugs, actson theheat-regulating centresofthebrain to bring abouta

dissipation ofbody heatthrough cutaneousvasodilatation. Theusualdoseofaspirin asan analgesicand antipyreticis

0.3 to 1g which may berepeated according to clinicalneeds, up to amaximumof4g daily.

Aspirin isused inthetreatmentofacuteand chronicrheumaticstates. Maximumsuppression ofrheumaticsymptoms

occurswith plasmaconcentrationsofabout300µg perml. Theseconcentrationsarefrequently associated with mild

toxiceffectssuch asnauseaand tinnitus;adequatecontrolofrheumaticsymptomsmay often beachieved with lower

concentrations. In chronicrheumaticdisease, 300 to 900 mg isadministrated every 4 hoursoverlong periods. In acute

rheumatism, 4-8 g daily in divideddosesissometimesrecommended. Dosesof150 mg perkg bodyweightdaily have

been given initially.

5.2Pharmacokineticproperties

Aspirin isreadily absorbed fromthegutand rapidly distributed to allbody tissues, into breastmilk and crossesthe

placenta. Protein binding isextensive. Therateofexcretion varieswith urinary pH, increasingasthisrises.

5.3Preclinical safetydata

No information submitted.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Starch Maize

6.2Incompatibilities

Irish Medicines Board

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Date Issued 02/09/2005 CRN 2014464 page number: 3

6.3ShelfLife

3 years.

6.4Special precautionsforstorage

Blister:

Do notstoreabove25°C.

Storein theoriginalpackage.

6.5Natureandcontentsofcontainer

Blisterpacksconsisting ofclearPVCand 20µmhard temperaluminiumfoilcontained in acarton.

Pack sizes:10, 20, 30 and 50 tablets.

6.6Instructionsforuseandhandling

No specialrequirements.

7MARKETINGAUTHORISATIONHOLDER

ChanelleMedicalLimited

Loughrea

Co. Galway

8MARKETINGAUTHORISATIONNUMBER

PA688/2/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 16 th

September1988

Dateoflastrenewal: 16 th

September2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Issued 02/09/2005 CRN 2014464 page number: 4