ANADIN EXTRA

Main information

  • Trade name:
  • ANADIN EXTRA
  • Dosage:
  • 300/200/45 Milligram
  • Pharmaceutical form:
  • Film Coated Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1447/076/001
  • Authorization date:
  • 01-10-2010
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AnadinExtraFilm-coatedTablets

Aspirin300mg

Paracetamol200mg

Caffeine45mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

ActiveIngredients: mg/tablet

AcetylsalicylicAcid 300.0mg

Paracetamol 200.0mg

Caffeine 45.0mg

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Filmcoatedtablet(tablet).

ProductimportedfromUK

ACapsuleshapedwhitetabletwithabreakbarononesideandwith‘A‘and‘E’debossedontheotherside.

Thescorelineistoallowbreakingforeaseofswallowing.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthereliefofpainof:

Headache.

Neuralgia.

Myalgia.

Rheumatism.

Toothache.

Dysmenorrhoea.

Symptomsofthecommoncoldorinfluenza.

4.2Posologyandmethodofadministration

AdultsandAdolescentsover16years:

1-2tabletsevery4hourswithamaximumof6inany24hourperiod.

Donotgivetochildrenandadolescentsagedunder16years,exceptonmedicaladvice,wherethebenefitoutweighs

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TheElderly:

Dosageisasabove.

Non-steroidalAnti-inflammatoryDrugsshouldbeusedwithparticularcautioninelderlypatientswhoaremoreprone

toadverseevents.Thelowestdosecompatiblewithadequatesafeclinicalcontrolshouldbeemployed.

Seealsosection4.4.

Treatmentshouldbereviewedatregularintervalsanddiscontinuedifnobenefitisseenorintoleranceoccurs.

4.3Contraindications

Hypersensitivitytotheactiveingredientsoranyotherconstituents.Patientswithahistoryofhypersensitivity

reactions(e.g.bronchospasm,rhinitis,urticaria)inresponsetoAnadinExtra,aspirinorothernon-steroidalanti-

inflammatorydrugsoranyoftheotherconstituents.

Bleedingdisorders,concurrentanti-coagulanttherapy.

Children,adolescentsunder16yearsandwhenbreastfeedingbecauseofpossibleriskofReye’sSyndrome(see

section4.6).

Historyofgastrointestinalbleedingorperforation,relatedtopreviousNSAIDstherapy.

Activeorhistoryofrecurrentpepticulcer/haemorrhage(twoormoredistinctepisodesofprovenulcerationor

bleeding).

Patientswithsevereheartfailure.

4.4Specialwarningsandprecautionsforuse

TheuseofAnadinExtraTabletswithconcomitantNSAIDsincludingcyclooxygenase-2selectiveinhibitorsshouldbe

avoided.

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.

Cautionshouldbeadvisedinpatientsreceivingconcomitantmedicationwhichcouldincreasetheriskofulcerationor

bleedingsuchasoralcorticosteroids,anticoagulantssuchaswarfarin,selectiveserotonin-reuptakeinhibitorsoranti-

plateletagentssuchasaspirin(seesection4.5).

WhenGIbleedingorulcerationoccursinpatientsreceivingAnadinExtraTablets,thetreatmentshouldbewithdrawn.

NSAIDsshouldbegivenwithcaretopatientswithahistoryofgastrointestinaldisease(ulcerativecolitis,Crohn’s

disease)astheirconditionmaybeexacerbated(seesection4.8–undesirableeffects).

Patientswithahistoryofinflammatoryboweldisease,coagulationdisorders,asthmaorallergicdiseaseshould

consultadoctorbeforeusingthisproduct.

Aspirinmayinduceasthmaticattacksinhypersensitivepatients.

ThereisapossibleassociationbetweenaspirinandReye’ssyndromewhengiventochildren.Reyes’ssyndromeis

averyraredisease,whichaffectsthebrainandliverandcanbefatal.Forthisreason,aspirinshouldnotbegiven

tochildrenandadolescentsagedunder16yearsunlessspecificallyindicated.

Prolongeduse,exceptundermedicalsupervision,canbeharmful.Ifsymptomspersist,thephysicianshouldbe

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Ifthepatientistakinganyothermedicationsorisunderthecareofadoctoryoushouldconsultthephysician

beforeusing.

Inpatientswithrenal,cardiacorhepaticimpairment,cautionisrequiredsincetheuseofNSAIDsmayresultin

deteriorationofrenalfunction.Assessmentofrenalfunctionshouldoccurpriortotheinitiationoftherapyand

regularlythereafter.

AsNSAIDscaninterferewithplateletfunction,theyshouldbeusedwithcautioninpatientswithintracranial

haemorrhageandbleedingdiathesis.

Thereissomeevidencethatdrugswhichinhibitcyclo-oxygenase/prostaglandinsynthesismaycauseimpairment

offemalefertilitybyaneffectonovulation.Thisisreversibleonwithdrawaloftreatment.

Cautionisrequiredinpatientswithahistoryofhypertensionand/orheartfailureasfluidretentionandoedema

havebeenreportedinassociationwithNSAIDtherapy.

Seriousskinreaction,someofthemfatal,includingexfoliativedermatitis,Stevens-Johnsonsyndromeandtoxic

epidermalnecrolysis,havebeenreportedveryrarelyinassociationwiththeuseofNSAIDs(see4.8).Patients

appeartobeathighestriskofthesereactionsearlyinthecourseoftherapy,theonsetofthereactionoccurringin

themajorityofcaseswithinthefirstmonthoftreatment.AnadinExtraTabletsshouldbediscontinuedatthefirst

appearanceofskinrash,mucosallesions,oranyothersignofhypersensitivity.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Aspirin

Careshouldbetakeninpatientstreatedwithanyofthefollowingdrugsasinteractionshavebeenreported:

Anti-coagulants: ItisconsideredunsafetotakeNSAIDsincombinationwithwarfarinorheparinunlessunder

directmedicalsupervisionasNSAIDsmayenhancetheeffectsofanti-coagulants.

Experimentaldatasuggestthatibuprofenmayinhibittheeffectoflowdoseaspirinonplateletaggregationwhentheyare

dosedconcomitantly.However,thelimitationsofthesedataandtheuncertaintiesregardingextrapolationofexvivodata

totheclinicalsituationimplythatnofirmconclusionscanbemadeforregularibuprofenuse,andnoclinicallyrelevant

effectisconsideredtobelikelyforoccasionalibuprofenuse(seesection5.1).

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.

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Oralhypoglycemic

agents: Inhibitionofmetabolismofsulfonylureadrugs,prolongedhalf-lifeandincreasedriskof

hypoglycaemia.

Metoclopramide: Metoclopramideincreasestherateofabsorptionofaspirin.

However,concurrentuseneednotbeavoided.

Phenytoin: Theeffectofphenytoinmaybeenhancedbyaspirin.However,nospecialprecautionsare

needed.

Valproate: Theeffectofvalproatemaybeenhancedbyaspirin.

Paracetamol

Cholestyramine: Theabsorptionofparacetamolisreducedbycholestyramine.Thereforecholestyramine

shouldnotbetakenwithinonehourifmaximalanalgesiaisrequired.

Metoclopramide

andDomperidone: Theabsorptionofparacetamolisincreasedbymetoclopramideanddomperidone.

However,concurrentuseneednotbeavoided.

Warfarin: Potentiationofwarfarinwithcontinualhighdosageofparacetamol.

Chloramphenicol: Increasedplasmaconcentrationofchloramphenicol.

4.6Fertility,pregnancyandlactation

Aswithallotherdrugs,aspirinandparacetamolshouldbeusedduringpregnancyonlyafterstrictriskbenefit

evaluation.Thereisclinicalandepidemiologicalevidenceofsafetyofaspirininpregnancy,butitmayprolonglabour

andcontributetomaternalandneonatalbleeding,maycauseprematureclosureoftheductusarteriosusandsoshould

notbeusedinthelasttrimesterofpregnancy.

Aspirinappearsinbreastmilkandregularhighdosesmayaffectneonatalclotting.Notrecommendedwhilebreast

feedingduetopossibleriskofReye’sSyndromeaswellasneonatalbleedingduetohypoprothrombinaemia.

Thereisepidemiologicalevidenceofsafetyofparacetamolinhumanpregnancy.

Caffeineappearsinbreastmilk.Irritabilityandpoorsleepingpatternintheinfanthavebeenreported.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Themostcommonobservedadverseeventsaregastrointestinalinnature.Pepticulcers,perforationofGIbleeding,

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

dyspepsia,abdominalpain,melaena,haematemesis,ulcerativestomatitis,excerbationofcolitisandCrohn'sdisease

(seesection4.4-Specialwarningsandprecautionsforuse)havebeenreportedfollowingadministration.Less

frequently,gastritishasbeenobserved.Bronchospasm,rhinitisandskinreactionsinhypersensitivepatients.Aspirin

mayinducegastro-intestinalhaemorrhage,occasionallymajorwithsignssuchashaematemesisandmelena.Itmay

precipitategoutinsusceptibleindividuals.PossibleriskofReye’sSyndromeinchildrenunder16years.Isolated

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Inisolatedcases,followingprolongedadministrationoroverdose,chronichepaticnecrosis,acutepancreatitisand

nephrotoxicityhavebeenassociatedwithNSAIDuse.Suchsideeffectsarenotexpectedwhentheproductisusedas

intended.

BullousreactionsincludingStevens-Johnsonsyndromandtoxicepidermalnecrolysis(veryrare).

Oedema,hypertensionandcardiacfailurehavebeenreportedinassociationwithNSAIDtreatment.

Highdosesofcaffeinecancausetremorandpalpitations.

4.9Overdose

Aspirin:

Severeintoxicationfromheavyoverdosageisshownbyhyperventilation,fever,restlessness,ketosis,respiratory

alkalosis,metabolicacidosisandconvulsions.Gastrointestinalhaemorrhageisfrequentinoverdose.

Paracetamol:

Immediatemedicaladviceshouldbesoughtintheeventofoverdosagebecauseoftheriskofirreversibleliverdamage.

Symptomsofparacetamoloverdosageinthefirst24hoursarepallor,nausea,vomiting,anorexiaandabdominalpain.

Liverdamagemaybecomeapparent12to48hoursafteringestionandthismaybemanifestedinincreasing

prothrombintime,whichisareliableindicatorofdeterioratingliverfunction.Abnormalitiesofglucosemetabolismand

metabolicacidosismayoccur.Inseverepoisoning,hepaticfailuremayprogresstoencephalopathy,comaanddeath.

Acuterenalfailurewithacutetubularnecrosismaydevelopevenintheabsenceofsevereliverdamage.Cardiac

arrhythmiasandpancreatitishavebeenreported.

Liverdamageislikelyinadultswhohavetaken10gormoreofparacetamolbuthasalsooccurredatdoseslowerthan

this.Itisconsideredthatexcessquantitiesoftoxicmetabolite(usuallyadequatelydetoxifiedbyglutathionewhen

normaldosesofparacetamolareingested),becomeirreversiblyboundtolivertissue.

Treatment

Aspirin:

Aworthwhilerecoveryofsalicylatescanbeachievedupto24hoursafteringestion.Treatmentmustbeinhospital

whereplasmasalicylatepHandelectrolytescanbemeasured.Fluidlossesarereplacedandforcedalkalinediuresisis

consideredwhentheplasmasalicylateconcentrationisgreaterthan500mg/litre(3.6mmol/litre)inadultsor

300mg/litre(2.2mmol/litre)inchildren.

Paracetamol:

Immediatetreatmentisessentialinthemanagementofparacetamoloverdose.Despitealackofsignificantearly

symptoms,patientsshouldbereferredtohospitalurgentlyforimmediatemedicalattention.Anypatientwhohas

ingestedaround7.5gormoreofparacetamolinthepreceding4hoursshouldundergogastriclavage.IntravenousN-

Acetylcysteineororalmethionineprotectstheliverifadministeredwithin8to12hoursofingestingtheoverdose.N-

Acetylcysteineiseffectiveuptoandpossiblybeyond24hours,butexpertadviceisessential.Generalsupportive

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCcode:N02BA51

Pharmacotherapeuticgroup:Otheranalgesicsandantipyretics.

ASPIRIN

Mechanismsofaction/effect

Salicylatesinhibittheactivityoftheenzymecyclo-oxygenasetodecreasetheformationofprecursorsofprostaglandins

andthromboxanesfromarachidonicacid.Althoughmanyofthetherapeuticeffectsmayresultfrominhibitionof

prostaglandinsynthesis(andconsequentreductionofprostaglandinactivity)invarioustissues,otheractionsmayalso

contributesignificantlytothetherapeuticeffects.

Analgesic

Producesanalgesiathroughaperipheralactionbyblockingpainimpulsegenerationandviaacentralaction,possiblyin

thehypothalamus.

Anti-inflammatory(Non-steroidal)

Exactmechanismshavenotbeendetermined.Salicylatesmayactperipherallyininflamedtissueprobablybyinhibiting

thesynthesisofprostaglandinsandpossiblybyinhibitingthesynthesisand/oractionsofothermediatorsofthe

inflammatoryresponse.

Antipyretic

Mayproduceantipyresisbyactingcentrallyonthehypothalamicheatregulatingcentretoproduceperipheral

vasodilationresultinginincreasedcutaneousbloodflow,sweatingandheatloss.

PARACETAMOL

Mechanismofaction/effect

Analgesic

Themechanismofanalgesicactionhasnotbeenfullydetermined.Paracetamolmayactpredominatelybyinhibiting

prostaglandinsynthesisinthecentralnervoussystem(CNS)and,toalesserextent,throughaperipheralactionby

blockingpainimpulsegeneration.

Theperipheralactionmayalsobeduetoinhibitionofprostaglandinsynthesisorinhibitionofthesynthesisoractions

ofothersubstancesthatsensitisepainreceptorstomechanicalorchemicalstimulations.

Antipyretic

Paracetamolprobablyproducesantipyresisbyactingcentrallyonthehypothalamicheat-regulationcentretoproduce

peripheralvasodilationresultinginincreasedbloodflowthroughtheskin,sweatingandheatloss.Thecentralaction

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CAFFEINE

Mechanismsofaction/effect

Centralnervoussystemstimulant

CaffeinestimulatesalllevelsoftheCNS,althoughitscorticaleffectsaremilderandofshorterdurationthatthoseof

amphetamines.

Analgesiaadjunct

Caffeineconstrictscerebralvasculaturewithanaccompanyingdecreaseinthecerebralbloodflowandintheoxygen

tensionofthebrain.Itisbelievedthatcaffeinehelpstorelieveheadachebyprovidingmorerapidonsetofactionand/or

enhancedpainreliefwithlowerdosesofanalgesic.Recentstudieswithergotamineindicatethattheenhancementof

effectbytheadditionofcaffeinemayalsobeduetoimprovedgastrointestinalabsorptionofergotaminewhen

administeredwithcaffeine.

Experimentaldatasuggestthatibuprofenmayinhibittheeffectoflowdoseaspirinonplateletaggregationwhenthey

aredosedconcomitantly.Inonestudy,whenasingledoseofibuprofen400mgwastakenwithin8hbeforeorwithin

30minafterimmediatereleaseaspirindosing(81mg),adecreasedeffectofASAontheformationofthromboxaneor

plateletaggregationoccurred.However,thelimitationsofthesedataandtheuncertaintiesregardingextrapolationof

exvivodatatotheclinicalsituationimplythatnofirmconclusionscanbemadeforregularibuprofenuse,andno

clinicallyrelevanteffectisconsideredtobelikelyforoccasionalibuprofenuse.

5.2Pharmacokineticproperties

ASPIRIN

AbsorptionandFate

Absorptionisgenerallyrapidandcompletefollowingadministration.Itislargelyhydrolysedinthegastrointestinal

tract,liverandbloodtosalicylatewhichisfurthermetabolisedprimarilyintheliver.

PARACETAMOL

AbsorptionandFate

Paracetamolisreadilyabsorbedfromthegastro-intestinaltractwithpeakplasmaconcentrationsoccurringabout30

minutesto2hoursafteringestion.Itismetabolisedintheliverandexcretedintheurinemainlyastheglucuronideand

sulphateconjugates.Lessthen5%isexcretedasunchangedparacetamol.Theeliminationhalf-lifevariesfromabout1

to4hours.Plasma-proteinbindingisnegligibleatusualtherapeuticconcentrationsbutincreaseswithincreasing

concentrations.

Aminorhydroxylatedmetabolitewhichisusuallyproducedinverysmallamountsbymixed-functionoxidasesinthe

liverandwhichisusuallydetoxifiedbyconjugationwithliverglutathionemayaccumulatefollowingparacetamol

overdosageandcauseliverdamage.

CAFFEINE

AbsorptionandFate

Caffeineiscompletelyandrapidlyabsorbedafteroraladministrationwithpeakconcentrationsoccurringbetween5and

90minutesafterdoseinfastedsubjects.Thereisnoevidenceofpre-systemicmetabolism.Eliminationisalmost

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Inadults,markedindividualvariabilityintherateofeliminationoccurs.Themeanplasmaeliminationhalflifeis4.9

hourswitharangeof1.9-12.2hours.Caffeinedistributesintoallbodyfluids.Themeanplasmaproteinbindingof

caffeineis35%.

Caffeineismetabolisedalmostcompletelyviaoxidation,demethylation,andacetylationandisexcretedintheurine.

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

metabolitesinclude1-methyluricacidand5-acetylamino-6formylamion,3-methyluracil(AMFU).

5.3Preclinicalsafetydata

TheactiveingredientsinAnadinExtraTabletshaveawellestablishedsafetyrecord.Thiscombinationofingredients

hasbeenmarketedforanumberofyears.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

MaizeStarch

MicrocrystallineCellulose(E460)

HydrogenatedVegetableOil

HydroxypropylMethylcellulose(E464)

Polyethyleneglycol

PregelatinisedStarch

Povidone

6.2Incompatibilities

Notapplicable

6.3Shelflife

Theshelflifeexpirydateofthisproductisthedateshownontheblisterstripsandoutercartonoftheproductas

marketedinthecountryoforigin

6.4Specialprecautionsforstorage

Donotstoreabove25°C

Storeintheoriginalpackage(toprotectfrommoisture).

6.5Natureandcontentsofcontainer

Blisterpackscontaining16tabletsinanoverlabelledcarton

6.6Specialprecautionsfordisposalandotherhandling

Nospecialrequirements

7PARALLELPRODUCTAUTHORISATIONHOLDER

G&ALicensingLtd

Ballymurray

Co.Roscommon

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8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1447/76/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:1 st

October2010

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