ANADIN MAXIMUM STRENGTH

Main information

  • Trade name:
  • ANADIN MAXIMUM STRENGTH
  • Dosage:
  • 500/32 Milligram
  • Pharmaceutical form:
  • Capsules Hard
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ANADIN MAXIMUM STRENGTH
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0172/004/006
  • Authorization date:
  • 27-01-1984
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AnadinMaximumStrengthHardCapsules

Aspirin500mg,caffeine32mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachcapsulecontains:

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Capsules,hard.

Size0hardgelatincapsuleswithgreencapsandyellowbodies,containingawhitepowder/granulemixture.‘Anadin

500’isprintedlongitudinallyinblackoneachhalf.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetreatmentofheadaches,neuralgia,rheumatic,periodanddentalpain,andthesymptomsofcoldsandflu.

4.2Posologyandmethodofadministration

Oral.

AdultsandChildrenover16years:

1capsuleeverythreetofourhours.

Donotexceed8capsulesin24hours.

Donotgivetochildrenandadolescentsagedunder16years,exceptonmedicaladvice,wherethebenefitoutweighs

therisk.

Elderly:

Non-steroidalanti-inflammatorydrugsshouldbeusedwithparticularcautioninelderlypatientswhoaremoreproneto

adverseevents.Thelowestdosecompatiblewithadequatesafeclinicalcontrolshouldbeemployed.

SeealsoSection4.4.

Treatmentshouldbereviewedatregularintervalsanddiscontinuedifnobenefitisseenorintoleranceoccurs.

4.3Contraindications

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

otherconstituents.

Historyofgastrointestinalbleedingorperforation,relatedtopreviousNSAIDstherapy.Activeorhistoryof

recurrentpepticulcer/haemorrhage(twoormoredistinctepisodesofprovenulcerationorbleeding).

Useinpatientswithbleedingdisorders.

Aspirin(AcetylsalicylicAcid) 500.0mg

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4.4Specialwarningsandprecautionsforuse

TheuseofAnadinMaximumStrengthcapsuleswithconcomitantNSAIDsincludingcyclooxygenase-2selective

inhibitorsshouldbeavoided.

Undesirableeffectsmaybeminimizedbyusingtheminimumeffectivedosefortheshortestdurationnecessaryto

controlsymptoms.

Elderly:TheelderlyhaveanincreasedfrequencyofadversereactionstoNSAIDsespeciallygastrointestinalbleeding

andperforationwhichmaybefatal(seesection4.2).

Gastrointestinalbleeding,ulcerationandperforation:GIbleeding,ulcerationorperforation,whichcanbefatal,has

beenreportedwithallNSAIDsatanytimeduringtreatment,withorwithoutwarningsymptomsoraprevioushistory

ofseriousGIevents.

TheriskofGIbleeding,ulcerationorperforationishigherwithincreasingNSAIDdoses,inpatientswithahistoryof

ulcer,particularlyifcomplicatedwithhaemorrhageorperforation(seesection4.3),andintheelderly.Thesepatients

shouldcommencetreatmentonthelowestdoseavailable.Combinationtherapywithprotectiveagents(e.g.

misoprostolorprotonpumpinhibitors)shouldbeconsideredforthesepatientsandalsoforpatientsrequiring

concomitantlowdoseaspirinorotherdrugslikelytoincreasegastrointestinalrisk(seebelowand4.5).

PatientswithahistoryofGItoxicity,particularlywhenelderly,shouldreportanyunusualabdominalsymptoms

(especiallyGIbleeding)particularlyintheinitialstagesoftreatment.

Cautionshouldbeadvisedinpatientsreceivingconcomitantmedicationwhichcouldincreasetheriskofulceration

orbleedingsuchasoralcorticosteroids,anticoagulantssuchaswarfarin,selectiveserotonin-reuptakeinhibitorsor

anti-plateletagentssuchasaspirin(seesection4.5).

WhenGIbleedingorulcerationoccursinpatientsreceivingAnadinMaximumStrengthCapsules,thetreatment

shouldbewithdrawn.

NSAIDsshouldbegivenwithcaretopatientswithahistoryofgastrointestinaldisease(ulcerativecolitis,Crohn’s

disease)astheirconditionmaybeexacerbated(seesection4.8–undesirableeffects).

Patientswithahistoryofinflammatoryboweldisease,coagulationdisorders,orasthmashouldconsultadoctor

beforeusingthisproduct.

Aspirinmayinduceasthmaticattacksinhypersensitivepatients.

ThereisapossibleassociationbetweenaspirinandReye’ssyndromewhengiventochildren.Reyes’ssyndromeisa

veryraredisease,whichaffectsthebrainandliverandcanbefatal.Forthisreason,aspirinshouldnotbegivento

childrenandadolescentsagedunder16yearsunlessspecificallyindicated.

Prolongeduse,exceptundermedicalsupervision,canbeharmful.Ifsymptomspersist,thephysicianshouldbe

consulted.

Ifyouaretakinganyothermedicationsorareunderthecareofadoctoryoushouldconsultthephysicianbefore

using.

Inpatientswithrenal,cardiacorhepaticimpairment,cautionisrequiredsincetheuseofNSAIDsmayresultin

deteriorationofrenalfunction.Assessmentofrenalfunctionshouldoccurpriortotheinitiationoftherapyand

regularlythereafter.

AsNSAIDscaninterferewithplateletfunction,theyshouldbeusedwithcautioninpatientswithintracranial

haemorrhageandbleedingdiathesis.

Thereissomeevidencethatdrugswhichinhibitcyclo-oxygenase/prostaglandinsynthesismaycauseimpairmentof

femalefertilitybyaneffectonovulation.Thisisreversibleonwithdrawaloftreatment.

Cautionisrequiredinpatientswithahistoryofhypertensionand/orheartfailureasfluidretentionandoedemahave

beenreportedinassociationwithNSAIDtherapy

Seriousskinreaction,someofthemfatal,includingexfoliativedermatitis,Stevens-Johnsonsyndromeandtoxic

epidermalnecrolysis,havebeenreportedveryrarelyinassociationwiththeuseofNSAIDs(see4.8).Patientsappear

tobeathighestriskofthesereactionsearlyinthecourseoftherapy,theonsetofthereactionoccurringinthe

majorityofcaseswithinthefirstmonthoftreatment.AnadinMaximumStrengthHardCapsulesshouldbe

discontinuedatthefirstappearanceofskinrash,mucosallesions,oranyothersignofhypersensitivity.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Experimentaldatasuggestthatibuprofenmayinhibittheeffectoflowdoseaspirinonplateletaggregationwhenthey

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vivodatatotheclinicalsituationimplythatnofirmconclusionscanbemadeforregularibuprofenuse,andno

clinicallyrelevanteffectisconsideredtobelikelyforoccasionalibuprofenuse(seesection5.1).

Careshouldbetakeninpatientstreatedwithanyofthefollowingdrugsasinteractionshavebeenreported:

Anti-coagulants:ItisconsideredunsafetotakeNSAIDsincombinationwithwarfarinorheparinunlessunder

directmedicalsupervisionasNSAIDsmayenhancetheeffectsofanti-coagulants.

Anti-plateletagentsandselectiveserotoninreuptakeinhibitors(SSRIs):increasedriskofgastrointestinalbleeding(see

section4.4).

Anti-hypertensives: Reducedanti-hypertensiveeffect.

Diuretics: Reduceddiureticeffect.DiureticscanincreasetheriskofnephrotoxicityofNSAIDs.

Cardiacglycosides: NSAIDsmayexacerbatecardiacfailure,reduceGFRandincreaseplasmacardiacglycoside

levels.

Lithium: Decreasedeliminationoflithium.

Methotrexate: Decreasedeliminationofmethotrexate.

Cyclosporin: IncreasedriskofnephrotoxicitywithNSAIDs.

OtherNSAIDs: AvoidconcomitantuseoftwoormoreNSAIDs.

Corticosteroids: Increasedriskofgastrointestinalbleedingandulceration.

Aminoglycosides: Reductioninrenalfunctioninsusceptibleindividuals,decreasedeliminationof

aminoglycosideandincreasedplasmaconcentrations.

Probenecid: ReductioninmetabolismandeliminationofNSAIDandmetabolites.

Oralhypoglycemic

agents: Inhibitionofmetabolismofsulfonylureadrugs,prolongedhalf-lifeandincreased

riskofhypoglycaemia.

4.6Fertility,pregnancyandlactation

Thereisclinicalandepidemiologicalevidenceofsafetyofaspirininpregnancy,butitmayprolonglabourand

contributetomaternalandneonatalbleeding,andsoshouldnotbeusedinlatepregnancy.

Aspirinappearsinbreastmilkandregularhighdosesmayaffectneonatalclotting.Notrecommendedwhilebreast

feedingduetopossibleriskofReye’sSyndromeaswellasneonatalbleedingduetohypoprothrombinaemia.

Caffeineappearsinbreastmilk.Irritabilityandpoorsleepingpatternintheinfanthavebeenreported.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Aspirinmayprecipitatebronchospasmandinduceasthmaattacksorotherhypersensitivityreactionsinsusceptible

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Themostcommonobservedadverseeventsaregastrointestinalinnature.Pepticulcers,perforationofGIbleeding,

sometimesfatalintheelderly,mayoccur(seesection4.4).Nausea,vomiting,diarrhoea,flatulence,constipation,

dyspesia,abdominalpain,malaena,haematemesis,ulcerativestomatitis,exacerbationofcolitisandCrohn'sdisease

(seesection4.4-Specialwarningsandprecautionsforuse)havebeenreportedfollowingadministration.Less

frequently,gastritishavebeenobserved.

Othersideeffectsincludeasthma,renaluratecalculiformation,bleedingandtinnitus.Aspirinmayprecipitategoutin

susceptibleindividuals.

BullousreactionsincludingStevens-Johnsonsyndromeandtoxicepidermalnecrolysis(veryrare).

Oedema,hypertensionandcardiacfailurehavebeenreportedinassociationwithNSAIDtreatment.

Highdosesofcaffeinecancausetremorandpalpitations.

4.9Overdose

Severeintoxicationfromheavyoverdoseisshownbyhyperventilation,fever,restlessness,ketosis,respiratory

alkalosis,metabolicacidosisandconvulsions.

Aworthwhilerecoveryofsalicylatescanbeachievedupto24hoursafteringestion.Treatmentmustbeinhospital

whereplasmasalicylatepHandelectrolytescanbemeasured.Fluidlossesarereplacedandforcedalkalinediuresisis

consideredwhentheplasmasalicylateconcentrationisgreaterthan500mg/litreinadultsor300mg/litre(2.2mmol/litre)

inchildren.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCode:NO2BE51

Pharmaceuticalgroup:otheranalgesicsandantipyretics.

Aspirinisanon-steroidalanti-inflammatoryagent.Ithasanalgesic,antipyreticandanti-inflammatoryproperties.

Caffeineincreasesthepain-relievingeffectoftheproduct.

Experimentaldatasuggestthatibuprofenmayinhibittheeffectoflowdoseaspirinonplateletaggregationwhenthey

aredosedconcomitantly.Inonestudy,whenasingledoseofibuprofen400mgwastakenwithin8hbeforeorwithin

30minafterimmediatereleaseaspirindosing(81mg),adecreasedeffectofASAontheformationofthromboxaneor

plateletaggregationoccurred.However,thelimitationsofthesedataandtheuncertaintiesregardingextrapolationof

exvivodatatotheclinicalsituationimplythatnofirmconclusionscanbemadeforregularibuprofenuse,andno

clinicallyrelevanteffectisconsideredtobelikelyforoccasionalibuprofenuse.

5.2Pharmacokineticproperties

ASPIRIN

Absorptionandfate

Absorptionisgenerallyrapidandcompletefollowingoraladministration.Itislargelyhydrolysedinthegastrointestinal

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CAFFEINE

Absorptionandfate

Caffeineiscompletelyandrapidlyabsorbedafteroraladministrationwithpeakconcentrationsoccurringbetween5and

90minutesafterdoseinfastedsubjects.Thereisnoevidenceofpresystemicmetabolism.Eliminationisalmostentirely

byhepaticmetabolisminadults.

Inadults,markedindividualvariabilityintherateofeliminationoccurs.Themeanplasmaeliminationhalflifeis4.9

hourswitharangeof1.9-12.2hours.Caffeinedistributesintoallbodyfluids.Themeanplasmaproteinbindingof

caffeineis35%.

Caffeineismetabolisedalmostcompletelyviaoxidation,demethylation,andacetylation,andisexcretedintheurine.

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

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

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

MaizeStarch

Dimethicone

Quinolineyellow(E104)

TitaniumDioxide(E171)

Gelatin

Redironoxide(E172)

Yellowironoxide(E172)

PatentblueV(E131)

PrintingInk

Shellac

Ironoxide,black(E172)

Propyleneglycol

6.2Incompatibilities

Notapplicable.

6.3Shelflife

36months.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Storeinoriginalpackage.

6.5Natureandcontentsofcontainer

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Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

PfizerConsumerHealthcareLtd

RamsgateRoad

Sandwich

Kent

CT139NJ

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA172/4/6

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:27January1984

Dateoflastrenewal:27January2009

10DATEOFREVISIONOFTHETEXT

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