CODIS DISPERSIBLE TABLETS, 500MG ASPIRIN, 8MG CODE

Main information

  • Trade name:
  • CODIS DISPERSIBLE TABLETS, 500MG ASPIRIN, 8MG CODE
  • Dosage:
  • 500/8 Milligram
  • Pharmaceutical form:
  • Dispersable Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CODIS DISPERSIBLE TABLETS, 500MG ASPIRIN, 8MG CODE
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0979/003/001
  • Authorization date:
  • 01-04-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0979/003/001

CaseNo:2057368

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

ReckittBenckiserIrelandLtd

7Riverwalk,CitywestBusinessCampus,Dublin24,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

CodisDispersibleTablets,500mgAspirin,8mgCodeinephosphate

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom28/04/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/04/2009 CRN 2057368 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CodisDispersibleTablets

500mgAspirin

8mgCodeinephosphate

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Dispersibletablet.

White,flat,bevel-edgeddispersibletabletwith‘ConSword’motifengravedononefaceand‘Plain’ontheother.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthereliefofmoderatepainsuchasisassociatedwithheadache,toothache,neuralgia,periodpains,muscularaches

andpains.

Symptomaticreliefinupperrespiratorytractinfections(suchasfeverishness,coldsandflu,sorethroat).

Reductionofinflammationsuchasinlumbago.

4.2Posologyandmethodofadministration

Fororaladministration,afterdissolutioninwater.

Adultsonly:Onetabletevery3hoursifrequireduptoamaximumofeightdosesper24hoursorasdirectedbythe

physician.

Elderly:Non-steroidalanti-inflammatorydrugsshouldbeusedwithparticularcautioninelderlypatientswhoare

morepronetoadverseevents.Thelowestdosecompatiblewithadequatesafeclinicalcontrolshouldbeemployed.

Donotgivetochildrenandadolescentsagedunder16years,exceptonmedicaladvice,wherethebenefitoutweighs

ActiveSubstances mg/tablet

Aspirin 500.0

Codeinephosphate* 8.0

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/04/2009 CRN 2057368 page number: 2

4.3Contraindications

Severeheartfailure.

HistoryofgastrointestinalbleedingorperforationrelatedtopreviousNSAIDstherapy.Active,orhistoryofrecurrent

pepticulcer/haemorrhage(twoormoredistinctepisodesofprovenulcerationorbleeding

Nottobegiventopatientshypersensitive(e.g.bronchospasm,rhinitis,urticaria)toaspirinortoothernon-steroidal

anti-inflammatorydrugs.Donotuseinpatientssufferingfrompepticulcerationorcoagulationdisorders.

Useofcodeineproductsiscontraindicatedinmotherswhoarebreastfeedingunlessprescribedbyadoctor.

4.4Specialwarningsandprecautionsforuse

TheusewithconcomitantNSAIDsincludingcyclooxygenase-2selectiveinhibitorsshouldbeavoided.

Caution(discussionwithdoctororpharmacist)isrequiredpriortostartingtreatmentinpatientswithahistoryof

hypertensionand/orheartfailureasfluidretentionandoedemahavebeenreportedinassociationwithNSAIDtherapy.

Undesirableeffectsmaybeminimisedbyusingtheminimumeffectivedosefortheshortestdurationnecessaryto

controlsymptoms(Seesection4.2,andGIandcardiovascularrisksbelow).

Gastrointestinalbleeding,ulcerationandperforation:GIbleeding,ulcerationorperforation,whichcanbefatal,has

beenreportedwithallNSAIDsatanytimeduringtreatment,withorwithoutanywarningsymptomsoraprevious

historyofseriousGIevents.

TheriskofGIbleeding,ulcerationorperforationishigherwithincreasingNSAIDdoses,inpatientswithahistoryof

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

shouldcommencetreatmentonthelowestdoseavailable.Combinationtherapywithprotectiveagents(e.g.

misoprostolorprotonpumpinhibitors)shouldbeconsideredforthesepatients,andalsoforpatientsrequiring

concomitantlowdoseaspirin,orotherdrugslikelytoincreasegastrointestinalrisk(seebelowand4.5).

PatientswithahistoryofGItoxicity,particularlywhenelderly,shouldreportanyunusualabdominalsymptoms

(especiallyGIbleeding)particularlyintheinitialstagesoftreatment.

Cautionshouldbeadvisedinpatientsreceivingconcomitantmedicationswhichcouldincreasetheriskofulcerationor

bleeding,suchasoralcorticosteroids,anticoagulantssuchaswarfarin,selectiveserotoninreuptakeinhibitorsoranti-

plateletagentssuchasaspirin(seesection4.5).

WhenGIbleedingorulcerationoccursinpatientsreceivingCodisTablets,thetreatmentshouldbewithdrawn.

NSAIDsshouldbegivenwithcaretopatientswithahistoryofgastrointestinaldisease(ulcerativecolitis,Crohn’s

Disease)astheirconditionmaybeexacerbated(seesection4.8–undesirableeffects).

Cardiovascularandcerebrovasculareffects:Clinicaltrialandepidemiologicaldatasuggestthatuseofsome

NSAIDs(particularlyathighdosesandinlongtermtreatment)maybeassociatedwithasmallincreasedriskofarterial

thromboticevents(forexamplemyocardialinfarctionorstroke).Thereareinsufficientdatatoexcludesuchariskfor

aspirinwhengivenatadailydoseof ≤

4000mg .

Seriousskinreactions,someofthemfatal,includingexfoliativedermatitis,Stevens-Johnsonsyndrome,andtoxic

epidermalnecrolysis,havebeenreportedveryrarelyinassociationwiththeuseofNSAIDs(see4.8).Patientsappear

tobeathighestriskofthesereactionsearlyinthecourseoftherapy,theonsetofthereactionoccurringinthemajority

ofcaseswithinthefirstmonthoftreatment.CodisTabletsshouldbediscontinuedatthefirstappearanceofskinrash,

mucosallesions,oranyothersignofhypersensitivity.

Thereissomeevidencethatdrugswhichinhibitcyclo-oxygenase/prostaglandinsynthesismaycauseimpairmentof

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/04/2009 CRN 2057368 page number: 3

Elderly:TheelderlyhaveanincreasedfrequencyofadversereactionstoNSAIDsespeciallygastrointestinalbleeding

andperforationwhichmaybefatal(seesection4.2)

Elderlypatientsareparticularlysusceptibletotheadverseeffectsofnon-steroidalanti-inflammatorydrugs.

Unsupervisedprolongeduseofnon-steroidalanti-inflammatorydrugsintheelderlyisnotrecommended.

Theproductshouldbetakenonlywhennecessary.

Prolongeduseexceptonmedicaladvicecanbeharmful.

Undesirableeffectsmaybereducedbyusingtheminimumeffectivedosefortheshortestpossibleduration.

Thedoctorshouldbeconsultedifthereisnoimprovementon24hours.

Ifthepatientisonanymedicationconsultthedoctororpharmacistbeforeusing.

Ifthepatientsuffersfromasthma,hasrenalorhepaticimpairment,orahistoryofpepticulcerationorinflammatory

boweldisease,thenadoctorshouldbeconsultedbeforetakingtheproduct.

Donottakeifyouhaveorhaveeverhadastomachulcerorothergastrointestinaldiseaseorifyouhaveworseningof

asthma,urticariaorrhinitisassociatedwithaspirinorothernon-steroidalanti-inflammatorydrugsorareallergictoany

oftheingredients.

Donottakewithotheraspirinornon-steroidalanti-inflammatorydrugs.

ThereispossibleassociationbetweenaspirinandReye'ssyndromewhengiventochildren.Reye'ssyndromeisavery

raredisease,whichaffectsthebrainandliver,andcanbefatal.Forthisreasonaspirinshouldnotbegiventochildren

andadolescentsagedunder16yearsunlessspecificallyindicated.

Prolongedregularuse,exceptundermedicalsupervision,mayleadtophysicalandpsychologicaldependence

(addiction)andresultinwithdrawalsymptoms,suchasrestlessnessandirritability,oncethedrugisstopped.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Anti-coagulants:NSAIDsmayenhancetheeffectsofanticoagulants,suchaswarfarin(seesection4.4).

ItisconsideredunsafetotakeNSAIDsincombinationwithwarfarinorheparinunlessunderdirectmedical

supervision.

Anti-plateletagentsandselectiveserotoninreuptakeinhibitors(SSRIs):increasedriskofgastrointestinalbleeding(see

section4.4).

Aspirinmayenhancetheeffectsofanticoagulants,inhibittheeffectsofuricosuricsandreducetheexcretionof

methotrexate(increasingitstoxicity).

Diuretics:Reduceddiureticeffect.DiureticscanincreasetheriskofnephrotoxicityofNSAIDs.

Othernon-steroidals:Avoidconcomitantuseoftwoormorenon-steroidalanti-inflammatorydrugs.

Corticosteroids:increasedriskofgastrointestinalulcerationorbleeding(seesection4.4).

Antihypertensives:Reducedantihypertensiveeffect.

Cardiacglycosides:NSAIDsmayexacerbatecardiacfailure,reduceGFRandincreaseplasmacardiacglycoside

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/04/2009 CRN 2057368 page number: 4

Lithium:Decreasedeliminationoflithium.

Cyclosporin:IncreasedriskofnephrotoxicitywithNSAIDs.

Aminoglycosides:Reductioninrenalfunctioninsusceptibleindividuals,decreasedeliminationofaminoglycosideand

increasedplasmaconcentrations.

Methotrexate:Decreasedeliminationofmethotrexate.

Probenecid:ReductioninmetabolismandeliminationofNSAIDandmetabolites.

Experimentaldatasuggestthatibuprofenmayinhibittheeffectoflowdoseaspirinonplateletaggregationwhenthey

aredosedconcomitantly.However,thelimitationsofthesedataandtheuncertaintiesregardingextrapolationofexvivo

datatotheclinicalsituationimplythatnofirmconclusionscanbemadeforregularibuprofenuse,andnoclinically

relevanteffectisconsideredtobelikelyforoccasionalibuprofenuse(seesection5.1).

4.6Pregnancyandlactation

Aswithallotherdrugs,aspirinshouldbetakenduringpregnancyonlyafterstrictrisk-benefitevaluation.

Inthelastthreemonthsofpregnancy,theprolongedadministrationofaspirin(>300mg/day)canleadtodelayedonset

andincreaseddurationoflabour,prematureclosureoftheductusarteriosusandinhibitionofuterinecontractions.An

increasedhaemorrhagictendencyhasbeenobservedinboththemotherandchild.Administrationofaspirininhigh

dosesshortlybeforebirthcanleadtointracranialhaemorrhages,particularlyinprematurebabies.

Salicylatespassintobreastmilkinsmallquantities.Asnoadverseeffectsontheinfanthavebeenobservedafter

occasionaluse,interruptionofbreastfeedingisusuallyunnecessary.However,ifhighdoses(>300mg/day)areused

regularly,breastfeedingshouldbediscontinued,astoxicitytothenew-borncannotberuledout.

Innursingmothers,whoareultra-rapidmetabolisersofcodeine,higherthanexpectedserumandbreastmilkmorphine

levelscanoccur.Morphinetoxicityinbabiescancauseexcessivesomnolence,hypotonia,miosisanddifficulty

breastfeedingorbreathing.Inseverecasesrespiratorydepressionanddeathcanoccur.Inseverecases,naloxonemay

beappropriatetoreversetheeffects.Thelowesteffectivedoseshouldbeused,fortheshortestpossibletime.

Nursingmothersshouldbeinformedaboutcarefullymonitoringtheinfantduringtreatmentforanysignsand/or

symptomsofmorphinetoxicitysuchasincreaseddrowsinessorsedation,difficultybreastfeeding,breathing

difficulties,miosisanddecreasedtone,andseekingimmediatemedicalcareifsuchsymptomsorsignsarenoticed.The

nursingmothershouldbeinformedaboutmonitoringforsignsandsymptomsofmaternalopioidtoxicityaswell.

Shouldsuchsigns/symptomsbenotedinmotherorbaby,themothershouldimmediatelystoptakingallcodeine-

containingmedicinesandseekmedicaladvice.

Codeine-containingproductsmustnotbeusedwhilebreastfeedingunlessprescribedbyadoctor.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Adverseeffectsoccurringwithaspirinincludegastro-intestinaldisturbance,pepticulcerationandgastro-intestinal

bleeding.Otherlessfrequentadverseeffectstoaspirinincludeheadache,skinrash,oedema,blurredvision,

hypersensitivity,thrombocytopenia,abnormalliverfunctionandimpairedrenalfunction.

Gastrointestinal:Themostcommonlyobservedadverseeventsaregastrointestinalinnature.Pepticulcers,perforation

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/04/2009 CRN 2057368 page number: 5

flatulence,constipation,dyspepsia,abdominalpain,melaena,haematemesis,ulcerativestomatitis,exacerbationof

colitisandCrohn’sdisease(seesection4.4–Specialwarningsandprecautionsforuse)havebeenreportedfollowing

administration.Lessfrequently,gastritishasbeenobserved.Gastrointestinalbloodlossesleadingtoanaemiahave

beenreportedwithnon-steroidalanti-inflammatorydrugssuchasaspirin.

Cardiovascular:Oedema,hypertensionandcardiacfailurehavebeenreportedinassociationwithNSAIDtreatment.

Cardiovascularandcerebrovasculareffects:ClinicaltrialandepidemiologicaldatasuggestthatuseofsomeNSAIDs,

(particularlyathighdosesandinlongtermtreatment)maybeassociatedwithasmallincreasedriskofarterial

thromboticevents(forexamplemyocardialinfarctionorstroke)(seesection4.4).

Skinreactions:BullousreactionsincludingStevens-Johnsonsyndromeandtoxicepidermalnecrolysis(veryrare).

Non-steroidalanti-inflammatorydrugsincludingaspirinmayprecipitatebronchospasm,rhinitisorurticaria,orinduce

attacksofasthmainsusceptiblesubjects.

Isolatedcasesofliver(increasedtransaminases)andkidneydysfunctionandsevereskinreactionshavebeendescribed.

4.9Overdose

Acutesalicylatepoisoningisusuallymanifestedwithhypokalaemiawithmetabolicacidosisandrespiratory

alkalosis.Nausea,vomiting,tinnitus,hyperpnoea,hyperpyrexiaconfusion,disorientated,dizziness,comaand/or

convulsionsarecommon.Gastrointestinalhaemorrhageisfrequent.However,alkalaemiaoracidaemia,alkaluriaor

aciduria,hyperglycaemiaorhypoglycaemia,andwaterandelectrolyteimbalances,canoccur.

Chronicsalicylateintoxicationiscommonlyassociatedwithdailyheadaches,nausea,tinnitus,dizziness,lethargyand

confusion;comamayoccur.Thesymptomscanmimicthoseresultingfromillnessforwhichthedrugwasgiven.

Irritability,lethargy,delayedunresponsivenessandencephalopathymaybeseenonetothreedaysfollowing

withdrawalofaspirin.Atthesametime,theconcentrationofsalicylateintheCNSmaybehigh,withnon-toxicvalues

intheserum.

Serumsalicylatelevelsabove3.6mmol/linadults(2.2mmol/linchildren)arelikelytobetoxicandlevelsof54.4

mmol/lcanbefatal.

Treatment:Fluidandelectrolytemanagementisthemainstayoftherapy;theimmediateaimistocorrectacidosis,

hyperpyrexia,hypokalaemiaanddehydration.Drugabsorptioncanbearrestedbyinductionofemesisorgastriclavage

withinanhourofingestion.Drugexcretionisenhancedbyforcedalkalinediuresisandbytheearlyuseofactivated

charcoal.Rarely,haemodialysisisnecessary.Delayedencephalopathymayrespondtotheadministrationofmannitol.

Forrespiratorydepressioncausedbythecodeine,nalorphineornaloxoneshouldbegivenbyinjection.Itisadvisable

forthepatienttobesenttohospitalforappropriatebiochemicalassessmentandtreatment.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Aspirin

Aspirininhibitsthecyclo-oxygenaseenzymeinvolvedinconversionofphospholipidstoprostaglandinsanditseffect

onthebodyisbelievedtoresultprimarilyfrompreventionofprostaglandinproduction.Theseeffectsinclude

peripheralanalgesia,feverreduction,reductionininflammationandinhibitionofplateletaggregation.

Experimentaldatasuggeststhatibuprofenmayinhibittheeffectoflowdoseaspirinonplateletaggregationwhenthey

aredosedconcomitantly.Inonestudy,whenasingledoseofibuprofen400mgwastakenwithin8hbeforeorwithin

30minafterimmediatereleaseaspirindosing81mg,adecreasedeffectofASAontheformationofthromboxaneor

plateletaggregationoccurred.However,thelimitationsofthesedataandtheuncertaintiesregardingextrapolationofex

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/04/2009 CRN 2057368 page number: 6

clinicallyrelevanteffectisconsideredtobelikelyforoccasionalibuprofenuse.

Codeine

Codeineisanopioidanalgesicstructurallyrelatedtomorphinewhichactsuponthecentralnervoussystemandthe

bowelthroughspecificbindingsites.Itsactionsincludeanalgesia,inhibitionofthecoughreflexandreductionin

gastrointestinalmotility.

5.2Pharmacokineticproperties

Aspirin

Aspirinisrapidlyabsorbedfromthestomachanduppergastrointestinaltractwithpeaklevelsafteraround20-30

minutesfollowingdissolution.Itissubjecttofirst-passmetabolismwithanoverallbioavailabilityofaround70%.

Metabolismisbyconversiontosalicylicacidandthenfurthertoothermetabolites.Theseareexcretedbothfreeand

conjugatedmainlybythekidneys.Theplasmahalf-lifeofaspirinisaround15-20minutesandofsalicylicacidis2-3

hours.

Codeine

Codeineiswellabsorbedfromthegastrointestinaltractwithpeakconcentrationsoccurringafteraround1hour.

Absorptionisrapidandvirtuallycompletewithabioavailabilityofaround60%.Itismetabolisedintheliverand

excretedmainlyintheurineasfreeandconjugatedmetabolites.Thehalf-lifeofcodeineinplasmais2.5-4hours.

5.3Preclinicalsafetydata

Nopreclinicalfindingsofrelevancehavebeenreported.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Calciumcarbonate

Maizestarch

CitricacidAnhydrous

Talc

Sodiumlaurilsulphate

Saccharin

6.2Incompatibilities

NotApplicable

6.3ShelfLife

Threeyears.

6.4Specialprecautionsforstorage

Donotstoreabove30°C.Keepinoriginalpackageinordertoprotectfromlight.

6.5Natureandcontentsofcontainer

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/04/2009 CRN 2057368 page number: 7

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithlocalrequirements.

7MARKETINGAUTHORISATIONHOLDER

ReckittBenckiserIrelandLimited

7Riverwalk

CitywestBusinessCampus

Dublin24

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA979/3/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1978

Dateoflastrenewal:01April2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/04/2009 CRN 2057368 page number: 8