ANIALL 500 / 50 MG TABLETS

Main information

  • Trade name:
  • ANIALL 500 / 50 MG TABLETS
  • Dosage:
  • 500mg, 50m Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ANIALL 500 / 50 MG TABLETS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0172/004/007
  • Authorization date:
  • 07-09-2007
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995,asamended

MedicinalProducts(ControlofPlacingontheMarket)Regulations,2007,asamended

PA0172/004/007

CaseNo:2086521

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

PfizerConsumerHealthcareLtd

RamsgateRoad,Sandwich,Kent,CT139NJ,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Aniall500/50mgTablets

theparticularsofwhicharesetoutintheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsasmaybespecifiedin

thesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom28/07/2010until06/09/2012.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 28/07/2010 CRN 2086521 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Aniall500/50mgTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

EachTabletcontains:

Aspirin(Acetylsalicylicacid) 500mg

Caffeine 50mg

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Tablet.

White,round,biconvextablets,withdiametricallyoppositenotches,engravedonbothsideswith“AMX”.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetreatmentofheadaches,neuralgia,rheumaticpain,periodpain,dentalpain,andthesymptomsofcoldsandflu.

4.2Posologyandmethodofadministration

Oral.

Adultsandchildrenover12years:

1tableteverythreetofourhours.

Donotexceed8tabletsin24hours.

Elderly:

Non-steroidalanti-inflammatorydrugsshouldbeusedwithparticularcautioninelderlypatientswhoareproneto

adverseevents.Thelowestdosecompatiblewithadequatesafeclinicalcontrolshouldbeemployed.SeealsoSection

4.4.

4.3Contraindications

Useinpatientshypersensitive(e.g.bronchospasm,rhinitis,urticaria)totheactiveingredientsoranyofthe

otherconstituents.

Useinthepresenceofactivepepticulcerationandthosewithahistoryofpepticulceration.

Useinpatientswithhaemophilia.

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4.4Specialwarningsandprecautionsforuse

Undesirableeffectsmaybereducedbyusingtheminimumeffectivedosefortheshortestpossibleduration.

PatientstreatedwithNSAIDslongtermshouldundergoregularmedicalsupervisiontomonitorforadverse

events.

ElderlypatientsareparticularlysusceptibletotheadverseeffectsofNSAIDs.

Patientswithahistoryof,orexistent,pepticulcerationorinflammatoryboweldisease,coagulationdisorders,or

asthmashouldconsultadoctorbeforeusingthisproduct.

Aspirinmayinduceasthmaticattacksinhypersensitivepatients.

ThereisapossibleassociationbetweenAspirinandReye’ssyndromewhengiventochildren.Reye’ssyndrome

isaveryraredisease,whichaffectsthebrainandliverandcanbefatal.Forthisreason,Aspirinshouldnotbe

giventochildrenandadolescentsagedunder16yearsunlessspecificallyindicated.

Cautionshouldbeexercisedinpatientswithallergicdiseaseordehydration.

Inpatientswithrenal,cardiacorhepaticimpairment,cautionisrequiredsincetheuseofNSAIDsmayresultin

deteriorationofrenalfunction.

Ifsymptomspersistformorethat3days,orsymptomsunrelatedtotheoriginalconditionareexperiencedthe

patientshouldcontacttheirdoctor.

Ifthepatientistakinganyothermedicationsorareunderthecareofadoctorhe/sheshouldconsultthedoctor

beforeusing.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ItisconsideredunsafetotakeNSAID'sincombinationwithwarfarinorheparinunlessunderdirectmedical

supervision.

Experimentaldatasuggestthatibuprofenmayinhibittheeffectoflowdoseaspirinonplateletaggregationwhenthey

aredosedconcomitantly.However,thelimitationsofthesedataandtheuncertaintiesregardingextrapolationofex

vivodatatotheclinicalsituationimplythatnofirmconclusionscanbemadeforregularibuprofenuse,andno

clinicallyrelevanteffectisconsideredtobelikelyforoccasionalibuprofenuse(seesection5.1).

Careshouldbetakeninpatientstreatedwithanyofthefollowingdrugsasinteractionshavebeenreported.

Anti-hypertensives: reducedanti-hypertensiveeffect.

Diuretics: reduceddiureticeffect.Diureticscanincreasetherisk

ofnephrotoxicityofNSAIDs.

Cardiacglycosides: NSAIDsmayexacerbatecardiacfailure,reduceGFR

andincreaseplasmacardiacglycosidelevels.

Methotrexate: decreasedeliminationofmethotrexate.

Cyclosporin: increasedriskofnephrotoxicitywithNSAIDs

OtherNSAID’s avoidconcomitantuseoftwoormoreNSAIDs

Corticosteroids: increasedriskofgastrointestinalbleeding

Aminoglycosides: reductioninrenalfunctioninsusceptibleindividuals

decreasedeliminationofaminoglycosideand

increasedplasmaconcentrations.

Probenecid: reductioninmetabolismandeliminationofNSAID

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4.6Pregnancyandlactation

Thereisclinicalandepidemiologicalevidenceofsafetyofaspirininpregnancy,butitmayprolonglabourand

contributetomaternalandneonatalbleeding.Thisproductshouldonlybetakenduringpregnancyontheadviceofa

doctorandshouldnotbeusedinthethirdtrimesterofpregnancy.

Aspirinappearsinbreastmilkandregularhighdosesmayaffectneonatalclotting.Takingaspirinisnotrecommended

whilebreastfeedingduetopossibleriskofReye'sSyndromeaswellasneonatalbleedingdueto

hypoprothrombinaemia.

Caffeineappearsinbreastmilk.Irritabilityandpoorsleepingpatternintheinfanthavebeenreported.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Undesirableeffectsaremildandinfrequent,butthefollowinghavebeenreported:

Gastrointestinal:Gastro-intestinalirritationwithslightasymptomaticbloodloss.Gastrointestinaldisordershavebeen

reportedforaspirin-containingproductse.g.nausea,diarrhoea,vomitingandgastro-intestinalbleedingwhichmaylead

toanaemiainsomecases.Gastrointestinalulcerationleadingtohaemorrhageandperforationmayoccur.

Blood:Increasedbleedingtime.

HypersensitivityReactions:Aspirinmayprecipitatebronchospasmandinduceasthmaattacksorotherhypersensitivity

reactionsinsusceptibleindividuals.

Other:Aspirinmayprecipitategoutinsusceptibleindividuals.ThereisapossibleriskofReye'sSyndromeinchildren

under12years.

Highdosesofcaffeinecancausetremorandpalpitations.

4.9Overdose

Severeintoxicationfromheavyoverdoseisshownbyhyperventilation,fever,restlessness,ketosis,respiratory

alkalosis,metabolicacidosisandconvulsions.

Aworthwhilerecoveryofsalicylatecanbeachievedupto24hoursafteringestion.Treatmentmustbeinhospital

whereplasmasalicylatepHandelectrolytescanbemeasured.Fluidlossesarereplacedandforcedalkalinediuresisis

consideredwhentheplasmasalicylateconcentrationisgreaterthan500mg/litreinadultsor300mg/litre

Oralhypoglycaemicagents: inhibitionofmetabolismofsulfonylureadrugs,

prolongedhalf-lifeandincreasedriskof

hypoglycaemia.

Phenytoin: Theeffectofphenytoinmaybeenhancedbyaspirin.

However,nospecialprecautionsareneeded.

Irish Medicines Board

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Aspirinisanon-steroidalanti-inflammatoryagent.Ithasanalgesicantipyreticandanti-inflammatoryproperties.

Caffeineincreasesthepainrelievingeffectoftheproduct.

Experimentaldatasuggestthatibuprofenmayinhibittheeffectoflowdoseaspirinonplateletaggregationwhenthey

aredosedconcomitantly.Inonestudy,whenasingledoseofibuprofen400mgwastakenwithin8hbeforeorwithin

30minafterimmediatereleaseaspirindosing(81mg),adecreasedeffectofASAontheformationofthromboxaneor

plateletaggregationoccurred.However,thelimitationsofthesedataandtheuncertaintiesregardingextrapolationof

exvivodatatotheclinicalsituationimplythatnofirmconclusionscanbemadeforregularibuprofenuse,andno

clinicallyrelevanteffectisconsideredtobelikelyforoccasionalibuprofenuse.

5.2Pharmacokineticproperties

ASPIRIN

Absorptionandfate

Absorptionisgenerallyrapidandcompletefollowingoraladministration. Itislargelyhydrolysedinthe

gastrointestinaltract.,liverandbloodtosalicylatewhichisfurthermetabolisedprimarilyintheliver.

CAFFEINE

AbsorptionandFate

Caffeineiscompletelyandrapidlyabsorbedafteroraladministrationwithpeakconcentrationsoccurringbetween5and

90minutesafterdoseinfastedsubjects.Thereisnoevidenceofpresystemicmetabolism.Eliminationisalmost

entirelybyhepaticmetabolisminadults.

Inadults,markedindividualvariabilityintherateofeliminationoccurs.Themeanplasmaeliminationhalf-lifeis4.9

hourswitharangeof1.9–12.2hours.Caffeinedistributesintoallbodyfluids.Themeanplasmaproteinbindingof

caffeineis35%.

Caffeineismetabolisedalmostcompletelyviaoxidation,demethylationandacetylationandisexcretedintheurine.

Themajormetabolitesare1-methylxanthine,7-methylxanthine,1,7-dimethylxanthine(paraxanthine).Minor

metabolitesinclude1-methyluricacidand5-acetylamino-6formylamino-3-methyluracil(AMFU).

5.3Preclinicalsafetydata

Notapplicable

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

MaizeStarch

MicrocrystallineCellulose

6.2Incompatibilities

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6.3ShelfLife

2Years

6.4Specialprecautionsforstorage

Donotstoreabove25 °

Storeintheoriginalpackagetoprotectfrommoisture.

6.5Natureandcontentsofcontainer

Cartonscontainingblisterstripsof12and16tablets.Theblisteriscomposedof:

Blister:WhiteopaqueuPVC,withPVdCcoating,heat-sealedtothefoil.

Foil: Glassine/Aluminiumfoil/Heatseallacquer.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements

7MARKETINGAUTHORISATIONHOLDER

PfizerConsumerHealthcareLtd

RamsgateRoad

Sandwich

Kent

CT139NJ

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA172/4/7

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisation:7thSeptember2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 28/07/2010 CRN 2086521 page number: 6