ASPRO

Main information

  • Trade name:
  • ASPRO Tablets 320 Milligram
  • Dosage:
  • 320 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ASPRO Tablets 320 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0021/058/001
  • Authorization date:
  • 01-07-2005
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AsproTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Acetylsalicylicacid(Aspirin)320mg/tablet.

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

Tablet

Whitetocreamywhitebiconvexcirculartablets.Onesideisimpressedwiththeword‘Aspro’,thelettersbeingradially

arrangedaroundtheperiphery.Theotherfaceisbisectedwithabreakline.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Inthemanagementofsymptomsassociatedwithheadache,rheumatic,muscularorneuralgicpain,toothache,common

cold,influenza,fever.

4.2Posologyandmethodofadministration

Posology:Oral.

Adults:Adultsandchildrenover12years:onetotwotabletseveryfourhoursasrequired.Donotexceedtwelve

tabletsin24hoursunlessdirectedbyadoctor.

Elderly:Aspirinshouldbeusedwithparticularcautioninelderlypatientswhoaremorepronetoadverseevents.The

lowestdosecompatiblewithadequatesafeclinicalcontrolshouldbeemployed.SeealsoSection4.4.

Children:Donotgivetochildrenunder12unlessyourdoctortellsyouto.

4.3Contraindications

Activepepticulceration.

Asaspirincaninterferewithplateletfunction,aspirinshouldnotbeusedinpatientswithbleedingdiathesessuchas

haemophilia.

Historyofhypersensitivityreactions(bronchospasm,rhinirisandurticaria)toaspirin,othernon-steroidalanti-

inflammatorydrugsoranyoftheingredients.

4.4Specialwarningsandprecautionsforuse

Prolongeduseexceptundermedicalsupervisioncanbeharmful.Ifsymptomspersist,thephysicianshouldbe

consulted.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 24/10/2006 CRN 2029093 page number: 1

Ifsymptomspersistconsultyourdoctor.

Inpatientswithrenal,cardiacorhepaticimpairment,cautionisrequiredsincetheuseofnonsteroidalanti-inflamatory

drugs(NSAIDs)mayresultindeteriorationofrenalfunction.Assessmentofrenalfunctionshouldoccurpriortothe

initiationoftherapyandregularlythereafter.

ElderlypatientsareparticularlysusceptibletotheadverseeffectsofNSAIDs.ProlongeduseofNSAIDsintheelderly

isnotrecommended.Whereprolongedtherapyisrequired,patientsshouldbereviewedregularly.

Asproshouldbeusedwithcautioninpatientswithahistoryofpepticulceration.

Usewithcautioninpatientswithgout.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ITISCONSIDEREDUNSAFETOTAKENSAIDsINCOMBINATIONWITHWARFARINORHEPARIN

UNLESSUNDERDIRECTMEDICALSUPERVISION.

Careshouldbetakeninpatientstreatedwithanyofthefollowingdrugsasinteractionshavebeenreported:

ACE(angiotensinconvertingenzyme)inhibitorsandbeta-blockers:reducedanti-hypertensiveeffect.

Diuretics:reduceddiureticeffect.DiureticscanincreasetheriskofnephrotoxicityofNSAIDs.

Methotrexate:decreasedeliminationofmethotrexate.

OtherNSAIDs:avoidconcomitantuseoftwoormoreNSAIDs.

Corticosteroids:increasedriskofgastrointestinalbleeding.

Probenecid:reductioninmetabolismandeliminationofNSAIDandmetabolites.

Oralhypoglycemicagents:inhibitionofmetabolismofsulfonylureadrugs,prolongedhalf-lifeandincreasedriskof

hypoglycaemia.

4.6Pregnancyandlactation

Thereisclinicalandepidemiologicalevidenceofsafetyofaspirininpregnancy,butitmayprolonglabourand

contributetomaternalandneo-natalbleedingsoitisbestavoidedatterm.Breastfeedingiscontraindicatedathigh

dosesduetothetheoreticalriskofaffectingclottingmechanisms.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Aspirinmayprecipitatebronchospasmandinduceasthmaticattacksinsusceptiblesubjects.Itmayinducegastro-

intestinalhaemorrhage,occasionallymajor.

4.9Overdose

Gastriclavage,forcedalkalinediuresisandsupportivetherapymaybeemployed.Restorationofacid-basebalancemay

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 24/10/2006 CRN 2029093 page number: 2

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Aspirin-Analgesic,Anti-Pyretic,Anti-Inflammatory.

5.2Pharmacokineticproperties

Thebiologicalhalf-lifeofAspirinisreportedat2-3hoursafterasingledose,butappearstobenearer10hoursafter

multiple1gdoses.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Potatostarch

Sodiumlaurylsulphate

Colloidalanhydroussilica

6.2Incompatibilities

None.

6.3ShelfLife

5years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

AluminiumFoil/PVCFilmBlisterPacks.

Packsizes:10or20tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Notapplicable.

7MARKETINGAUTHORISATIONHOLDER

Bayerplc

BayerHouse

StrawberryHill

Newbury

BerkshireRG141JA

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 24/10/2006 CRN 2029093 page number: 3

8MARKETINGAUTHORISATIONNUMBER

PA21/58/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1978

Dateoflastrenewal:01April2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 24/10/2006 CRN 2029093 page number: 4