ANADIN ANALGESIC

Main information

  • Trade name:
  • ANADIN ANALGESIC
  • Dosage:
  • 325/ 15/ 1 Milligram
  • Pharmaceutical form:
  • Film Coated Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ANADIN ANALGESIC
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0172/004/005
  • Authorization date:
  • 10-01-1983
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AnadinAnalgesicFilm-coatedTablets

Aspirin325mg

Caffeine15mg

QuinineSulphate1mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains;

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Whitecapsuleshaped,filmcoatedtablets(tablets)debossedonbothfaceswith‘ANADIN’.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthereliefofpainofheadache,neuralgia,rheumaticpain,periodpain,dentalpain,toothache,andthereliefof

symptomsofthecommoncold.

4.2Posologyandmethodofadministration

Oral

AdultsandAdolescentsover16years:Take2tabletsevery4hoursifnecessary.Donotexceed12tabletsinany24

hourperiod.

Donotgivetochildrenandadolescentsagedunder16years,exceptonmedicaladvice,wherethebenefitoutweighs

therisk.

Elderly:Non-steroidalanti-inflammatorydrugsshouldbeusedwithparticularcautioninelderlypatientswhoaremore

pronetoadverseevents.Thelowestdosecompatiblewithadequatesafeclinicalcontrolshouldbeemployed.Seealso

Section4.4.

4.3Contraindications

Patientswithahistoryofhypersensitivityreactions(e.g.bronchospasm,rhinitis,urticaria)inresponsetoAnadin

AnalgesicFilm-coatedTablets,aspirinorothernon-steroidalanti-inflammatorydrugsoranyoftheotherconstituents.

Childrenandadolescentsunder16years.

Breast-feeding.

Last-trimesterofpregnancy.

Concurrentanti-coagulanttherapy.

Acetylsalicylicacid(aspirin) 325.0mg

Caffeine 15.0mg

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Intakeofmorethan15mgmethotrexateperweek.

Historyofgastrointestinalbleedingorperforation,relatedtopreviousNSAIDstherapy.Activeorhistoryofrecurrent

pepticulcer/haemorrhage(twoormoredistinctepisodesofprovenulcerationorbleeding).

Useinpatientswithsevereheartfailure.

Useinpatientswithbleedingdisorders.

4.4Specialwarningsandprecautionsforuse

TheuseofAnadinTabletswithconcomitantNSAIDsincludingcyclooxygenase-2selectiveinhibitorsshouldbe

avoided.

Undesirableeffectsmaybeminimizedbyusingtheminimumeffectivedosefortheshortestdurationnecessaryto

controlsymptoms.

Elderly:TheelderlyhaveanincreasedfrequencyofadversereactionstoNSAIDsespeciallygastrointestinal

bleedingandperforationwhichmaybefatal(seesection4.2)

Gastrointestinalbleeding,ulcerationandperforation:GIbleeding,ulcerationorperforation,whichcanbefatal,has

beenreportedwithallNSAIDsatanytimeduringtreatment,withorwithoutwarningsymptomsoraprevious

historyofseriousGUevents.

TheriskifGIbleeding,ulcerationorperforationishigherwithincreasingNSAIDdoses,inpatientswithahistory

ofulcer,particularlyifcomplicatedwithhaemorrhageorperforation(seesection4.3),andintheelderly.These

patientsshouldcommencetreatmentonthelowestdoseavailable.Combinationtherapywithprotectiveagents(e.g.

misoprostolorprotonpumpinhibitors)shouldbeconsideredforthesepatientsandalsoforpatientsrequiring

concomitantlowdoseaspirinorotherdrugslikelytoincreasegastrointestinalrisk(seebelowand4.5)

PatientswithahistoryofGItoxicity,particularlywhenelderly,shouldreportanyunusualabdominalsymptoms

(especiallyGIbleeding)particularlyintheinitialstagesoftreatment.

Cautionshouldbeadvisedinpatientsreceivingconcomitantmedicationswhichcouldincreasetheriskof

ulcerationorbleedingsuchasoralcorticosteroids,anticoagulantssuchaswarfarin,selectiveserotonin-reuptake

inhibitorsoranti-plateletagentssuchasaspirin(seesection4.5).

WhenGIbleedingorulcerationoccursinpatientsreceivingAnadinTablets,thetreatmentshouldbewithdrawn.

NSAIDsshouldbegivenwithcaretopatientswithahistoryofgastrointestinaldisease(ulcerativecolitis,Crohn’s

disease)astheirconditionmaybeexacerbated(seesections4.8–undesirableeffects).

Patientswithahistoryof,inflammatoryboweldisease,coagulationdisorders,orasthmashouldconsultadoctorbefore

usingthisproduct.

Aspirinmayinduceasthmaticattacksinhypersensitivepatients.

ThereisapossibleassociationbetweenaspirinandReye’ssyndromewhengiventochildren.Reye’ssyndromeisa

veryraredisease,whichaffectsthebrainandliverandcanbefatal.Forthisreason,aspirinshouldnotbegivento

childrenandadolescentsagedunder16yearsunlessspecificallyindicated.

Prolongeduse,exceptundermedicalsupervision,canbeharmful.Ifsymptomspersist,thephysicianshouldbe

consulted.

Ifyouaretakinganyothermedicationsorareunderthecareofadoctoryoushouldconsultthephysicianbeforeusing.

Inpatientswithrenal,cardiac,orhepaticimpairment,cautionisrequiredsincetheuseofNSAIDsmayresultin

deteriorationofrenalfunction.Assessmentofrenalfunctionshouldoccurpriortotheinitiationoftherapyandregularly

thereafter.AsNSAIDscaninterferewithplateletfunction,theyshouldbeusedwithcautioninpatientswith

intercranialhaemorrhageandbleedingdiathesis.

Thereissomeevidencethatdrugswhichinhibitcyclo-oxygenase/prostaglandinsynthesismaycauseimpairmentof

femalefertilitybyaneffectonovulation.Thisisreversibleonwithdrawaloftreatment.

Cautionisrequiredinpatientswithahistoryofhypertensionand/orheartfailureasfluidretentionandoedema

havebeenreportedinassociationwithNSAIDtherapy.

AsNSAIDscaninterferewithplateletfunction,theyshouldbeusedwithcautioninpatientswithintracranial

haemorrhageandbleedingdiathesis.

Seriousskinreactions,someofthemfatal,includingexfoliativedermatitis,Stevens-Johnsonsyndromeandtoxic

epidermalnecrolysis,havebeenreportedveryrarelyinassociationwiththeuseofNSAIDs(see4.8).Patientsappearto

beathighestriskofthesereactionsearlyinthecourseoftherapy,theonsetofthereactionoccurringinthemajorityof

caseswithinthefirstmonthoftreatment.AnadinAnalgesicTabletsshouldbediscontinuedatthefirstappearanceof

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Careshouldbetakeninpatientstreatedwithanyofthefollowingdrugsasinteractionshavebeenreported

Experimentaldatasuggestthatibuprofenmayinhibittheeffectoflowdoseaspirinonplateletaggregationwhenthey

aredosedconcomitantly.However,thelimitationsofthesedataandtheuncertaintiesregardingextrapolationofex

vivodatatotheclinicalsituationimplythatnofirmconclusionscanbemadeforregularibuprofenuse,andno

clinicallyrelevanteffectisconsideredtobelikelyforoccasionalibuprofenuse(seesection5.1).

Anti-coagulants:ItisconsideredunsafetotakeNSAIDsincombinationwithwarfarinorheparinunless

underdirectmedicalsupervisionasNSAIDsmayenhancetheeffectsofanti-coagulants.

Anti-plateletagentsandselectiveserotoninreuptakeinhibitors(SSRIs):increasedriskofgastrointestinalbleeding(see

section4.4).

Anti-hypertensives:reducedanti-hypertensiveeffect

Diuretics,ACEinhibitorsandAngiotensinIIAntagonists:NSAIDsmayreducethe

effectofdiureticsandotherantihypertensivedrugs.Insomepatientswithcompromisedrenalfunction(e.g.dehydrated

patientsorelderlypatientswith

compromisedrenalfunction)theco-administrationofanACEinhibitororAngiotensinIIantagonistandagentsthat

inhibitcyclo-oxygenasemayresultinfurtherdeteriorationofrenalfunction,includingpossibleacuterenalfailure,

whichisusuallyreversible.TheseinteractionsshouldbeconsideredinpatientstakingAnadinAnalgesicFilm-coated

TabletsconcomitantlywithACEinhibitorsorangiotensinIIantagonists.Therefore,thecombinationshouldbe

administeredwithcaution,especiallyintheelderly.Patientsshouldbeadequatelyhydratedandconsiderationshouldbe

giventomonitoringofrenalfunctionafterinitiationofconcomitanttherapy,andperiodicallythereafter.

Cardiacglycosides:NSAIDsmayexacerbatecardiacfailure,reduceGFRandincreaseplasmacardiacglycosidelevels

Lithium:decreasedeliminationoflithium

Methotrexate:decreasedeliminationofmethotrexate

Cyclosporin:increasedriskofnephrotoxicitywithNSAIDs

OtherNSAIDs:avoidconcomitantuseoftwoormoreNSAIDs

Corticosteroids:increasedriskofgastrointestinalbleedingandulceration

Aminoglycosides:reductioninrenalfunctioninsusceptibleindividuals,decreasedeliminationofaminoglycosideand

increasedplasmaconcentrations

Probenecid:reductioninmetabolismandeliminationofNSAIDandmetabolites

Oralhypoglycemicagents:inhibitionofmetabolismofsulfonylureadrugs,prolongedhalf-lifeandincreasedriskof

hypoglycaemia

Metoclopramide:Metoclopramideincreasestherateofabsorptionofaspirin.However,concurrentuseneednotbe

avoided.

Phenytoin:Theeffectofphenytoinmaybeenhancedbyaspirin.However,nospecialprecautionsareneeded.

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4.6Fertility,pregnancyandlactation

Acetylsalicylicacidshouldnotbeusedduringthefirstandsecondtrimesterofpregnancyunlessclearlynecessary.If

acetylsalicylicacidisusedbyawomanattemptingtoconceive,orduringthefirstandsecondtrimesters,thedose

shouldbekeptaslowaspossibleandthedurationofuseasshortaspossible.Ithasbeensuggestedinepidemiological

studiesthatprostaglandinsynthesisinhibitioninearlypregnancyisassociatedwithanincreasedriskofmiscarriage,

cardiacmalformationandgastroschisis.Animalstudieshaveshownanincreasedriskofpreandpost-implantationloss

andvariousmalformationsincludingcardiovascular.

Thereisclinicalandepidemiologicalevidenceofsafetyofaspirininpregnancy,butitmayprolonglabourand

contributetomaternalandneonatalbleeding,andsoshouldnotbeusedinthethirdtrimester.Thereisalsotheriskof

cardiopulmonarytoxicity(prematureclosureoftheductusarteriosusandpulmonaryhypertension)andrenal

dysfunction.

Aspirinappearsinbreastmilkandregularhighdosesmayaffectneonatalclotting.Notrecommendedwhilebreast

feedingduetopossibleriskofReye’sSyndromeaswellasneonatalbleedingduetohypoprothrombinaemia.

Caffeineappearsinbreastmilk.Irritabilityandpoorsleepingpatternintheinfanthavebeenreported.

Quininecrossestheplacentaandisexcretedinthebreastmilk.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Bloodandlymphaticsystem

disorders Bleeding

Immunesystemdisorders Hypersensitivityreactions.

Acetylsalicyclicacidmayprecipitate

goutinsusceptibleindividuals.

Earandlabyrinthdisorders Tinnitus

Cardiacdisorders Cardiacfailureandoedemahavebeen

reportedinassociationwithNSAID

treatment.Highdosesofcaffeinecan

causepalpitations.

Vasculardisorders Hypertension

Respiratory,thoracicand

mediastinaldisorders Asthma.Acetylsalicyclicacidmay

precipitatebronchospasmandinduce

asthmaattacksorotherhypersensitivity

reactionsinsusceptibleindividuals.

Gastrointestinaldisorders Pepticulcers,perforationorGI

bleeding,sometimesfatalintheelderly,

mayoccur(seesection4.4).Nausea,

vomiting,diarrhoea,flatulence,

constipation,dyspepsia,abdominalpain,

melaena,haematemesis,ulcerative

stomatitis,exacerbationofcolitisand

Crohn’sdisease(seesection4.4–

Specialwarningsandprecautionsfor

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4.9Overdose

Salicylatepoisoningisusuallyassociatedwithplasmaconcentrations>350mg/l(2.5mmol/l).Mostadultdeathsoccur

inpatientswhoseconcentrationsexceed700mg/l(5.1mmol/L).Singledoselessthan100mg/kgareunlikelytocause

serious

poisoning.

Aspirin

Commonfeaturesincludevomiting,dehydration,tinnitus,vertigo,deafness,sweating,warmextremitieswithbounding

pulses,increasedrespiratoryrateandhyperventilation.Somedegreeofacid-basedisturbanceispresentinmostcases.

AmixedrespiratoryalkalosisandmetabolicacidosiswithnormalorhigharterialpH(normalorreducedhydrogenion

concentration)isusualinadultsandchildrenovertheageoffouryearsold.Inchildrenagedfouryearsorless,a

dominantmetabolicacidosiswithlowarterialpH(raisedhydrogenionconcentration)iscommon.Acidosismay

increasesalicylatetransferacrossthebloodbrainbarrier.Uncommonfeaturesincludehaematemesis,hyperpyrexia,

hypoglycaemia,hypokalaemia,thrombocytopaenia,increasedINR/PTR,intravascularcoagulation,renalfailureand

non-cardiacpulmonaryoedema.

Centralnervoussystemfeaturesincludingconfusion,disorientation,comaandconvulsionsaremorecommonin

childrenthanadults.

Caffeine

CommonfeaturesincludeCNSstimulation;anxiety,nervousness,restlessness,insomnia,excitement,muscletwitching,

confusion,convulsions.CardiacSymptomsinclude tachycardia,cardiacarrhythmia.Gastricsymptomsinclude

abdominalorstomachpains.

Othersymptomsofoverdosage,associatedwiththecaffeinecomponent,includediuresisandfacialflushing.

Management

Aspirin

Giveactivatedcharcoalifanadultpresentswithinonehourofingestionofmorethan250mg/kg.Theplasmasalicylate

concentrationshouldbemeasured,althoughtheseverityofpoisoningcannotbedeterminedfromthisaloneandthe

clinicalandbiochemicalfeaturesmustbetakenintoaccount.Eliminationisincreasedbyurinaryalkalinisation,which

isachievedbytheadministrationof1.26%sodiumbicarbonate.

TheurinepHshouldbemonitored.Correctmetabolicacidosiswithintraveneous8.4%sodiumbicarbonate(firstcheck

serumpotassium).Forceddiuresisshouldnotbeusedsinceitdoesnotenhancesalicylateexcretionandmaycause

pulmonaryoedema.

Haemodialysisisthetreatmentofchoiceforseverepoisoningandshouldbeconsideredinpatientswithplasma

salicylateconcentrations>700mg/l(5.1mmol/l),orlowerconcentrationsassociatedwithsevereclinicalormetabolic

features.Patientsunder10yearsorover70yearshaveincreasedriskofsalicylatetoxicityandmayrequiredialysisat

administration.

Lessfrequently,gastritishasbeen

observed.

Hepatobiliarydisorders ThereisapossibleriskofReye’s

Syndromeinchildrenunder16years.

Skinandsubcutaneoustissue

disorders Veryrare BullousreactionsincludingStevens-

Johnsonsyndromeandtoxicepidermal

necrolysis(veryrare).

Musculoskeletaland

connectivetissuedisorders Highdosesofcaffeinecancausetremor

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Caffeine

Treatmentofcaffeineoverdoseisprimarilysymptomaticandsupportive.Diuresisshouldbetreatedbymaintaining

fluidandelectrolytebalanceandCNSsymptomscanbecontrolledbyintravenousadministrationofdiazepam.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCcode:N02BE51

Pharmacotherapeuticgroup:Otheranalgesicsandantipyretics

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

Quininehasmildanalgesicandantipyreticproperties.

Caffeineincreasesthepain-relievingeffectoftheproduct.

Aspirin

Mechanismsofaction/effect

Salicylatesinhibittheactivityoftheenzymecyclo-oxygenasetodecreasetheformationofprecursorsofprostaglandins

andthromboxanesfromarachidonicacid.Althoughmanyofthetherapeuticeffectsmayresultfrominhibitionof

prostaglandinsynthesis(andconsequentreductionofprostaglandinactivity)invarioustissues,otheractionsmayalso

contributesignificantlytothetherapeuticeffects.

Analgesic

Producesanalgesiathroughaperipheralactionbyblockingpainimpulsegenerationandviaacentralaction,possiblyin

thehypothalamus.

Anti-inflammatory(Nonsteriodal)

Exactmechanismshavenotbeendetermined.Salicylatesmayactperipherallyininflamedtissueprobablyby

inhibitingthesynthesisofprostaglandinsandpossiblybyinhibitingthesynthesisand/oractionsofothermediatorsof

theinflammatoryresponse.

Antipyretic

Mayproduceantipyresisbyactingcentrallyonthehypothalamicheat-regulatingcentretoproduceperipheral

vasodilationresultinginincreasedcutaneousbloodflow,sweatingandheatloss.

Experimentaldatasuggestthatibuprofenmayinhibittheeffectoflowdoseaspirinonplateletaggregationwhenthey

aredosedconcomitantly.Inonestudy,whenasingledoseofibuprofen400mgwastakenwithin8hbeforeorwithin

30minafterimmediatereleaseaspirindosing(81mg),adecreasedeffectofASAontheformationofthromboxaneor

plateletaggregationoccurred.However,thelimitationsofthesedataandtheuncertaintiesregardingextrapolationof

exvivodatatotheclinicalsituationimplythatnofirmconclusionscanbemadeforregularibuprofenuse,andno

clinicallyrelevanteffectisconsideredtobelikelyforoccasionalibuprofenuse.

Caffeine

Mechanismsofaction/effect

Centralnervoussystemstimulant-caffeinestimulatesalllevelsoftheCNS,althoughitscorticaleffectsaremilderand

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Analgesiaadjunct

Caffeineconstrictscerebralvasculaturewithanaccompanyingdecreaseinthecerebralbloodflowandintheoxygen

tensionofthebrain.Itisbelievedthatcaffeinehelpstorelieveheadachebyprovidingmorerapidonsetofaction

and/orenhancingpainreliefwithlowerdosesofanalgesic.Recentstudieswithergotamineindicatethatthe

enhancementofeffectbytheadditionofcaffeinemayalsobeduetoimprovedgastrointestinalabsorptionof

ergotaminewhenadministeredwithcaffeine.

5.2Pharmacokineticproperties

Absorption

Absorptionofnon-ionisedaspirinoccursinthestomach.AspirinislargelyhydrolysedintheGItract,liverandblood

tosalicylate,whichisfurthermetabolisedprimarilyintheliver.

Caffeineiscompletelyandrapidlyabsorbedafteroraladministrationwithpeakconcentrationsoccurringbetween5and

90minutesafterthedoseinfastedsubjects.Thereisnoevidenceofpresystemicmetabolism.Eliminationisalmost

entirelybyhepaticmetabolisminadults.

Quinineisrapidlyandalmostcompletelyabsorbedfromthegastro-intestinaltract.

Metabolism

Themainmetabolicproductsforsalicylatesaretheglycineconjugatesalicyluricacid,thephenolicglucuronide,the

esterglucuronideandtheoxidationproductgentisicacid.

Caffeineismetabolisedalmostcompletelyviaoxidation,demethylationandacetylation.

Quinineisextensivelymetabolisedintheliverandexcretedintheurine.

Excretion

Aspirinisexcretedassalicylicacidasglucuronideconjugatesandassalicyluricandgentisicacid.

Caffeineisexcretedintheurine.Themajormetabolitesare1-methylxanthine,7-methylxanthineand1,7-

dimethylxanthine(paraxanthine).Minormetabolitesinclude1-methyluricacid,and5-acetylamino-6formylamino3-

methyluracil(AMFU).

Inadults,markedindividualvariabilityintherateofeliminationoccurs.Themeanplasmaeliminationhalflifeis4.9

hourswitharangeof1.9-12.2hours.Caffeinedistributesintoallbodyfluids.Themeanplasmaproteinbindingof

caffeineis35%.

Quinineisextensivelymetabolisedintheliverandexcretedintheurine.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

TabletCore:

MicrocrystallineCellulose

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CalciumStearate

FilmCoating:

Macrogol

Hypromellose(MethocelE5)

Hypromellose(MethocelE15)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

36months.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Packsof6,8,12and24comeinblisterpackcomposedofwhite,opaque,unplasticisedpolyvinylchlorideandprinted

aluminiumfoil,coatedonthebrightsidewithheatseallacquerforsealingtoPVC.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

PfizerConsumerHealthcareLtd

RamsgateRoad

Sandwich

Kent

CT139NJ

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA172/4/5

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:10 th

January1983

Dateoflastrenewal:10 th

January2008

10DATEOFREVISIONOFTHETEXT

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