CALPOL 120MG/5ML SUGAR FREE INFANT ORAL SUSPENSION

Main information

  • Trade name:
  • CALPOL 120MG/5ML SUGAR FREE INFANT ORAL SUSPENSION
  • Dosage:
  • 120 MG/5ml
  • Pharmaceutical form:
  • Oral Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CALPOL 120MG/5ML SUGAR FREE INFANT ORAL SUSPENSION
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA0465/172/001
  • Authorization date:
  • 28-04-2006
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Calpol120mg/5mlSugarFreeInfantOralSuspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each5mlcontains120mgofparacetamol.

Excipients:

Maltitol

Sorbitol

Carmoisine

Ethylhydroxybenzoate

Propylhydroxybenzoate

Methylhydroxybenzoate

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Oralsuspension

ProductimportedfromtheUK:

Apinksuspensionwithastrawberrycolour

4CLINICALPARTICULARS

4.1TherapeuticIndications

CALPOLSugarFreeInfantSuspensionisindicatedforthetreatmentofpain(includingteethingpain),andasan

antipyretic.

CalpolSugarFreeInfantSuspensionisindicatedforthereliefofheadache,migraine,neuralgia,toothacheandteething

pains,sorethroat,rheumaticachesandpains,influenza,feverishnessandfeverishcolds.

4.2Posologyandmethodofadministration

Childrenaged6yearsto12years:

Oral.10to20ml(240mgto480mgparacetamol).Repeatevery4hours,ifnecessary,uptoamaximumof4doses

per24hours.

Childrenaged1tounder6years:

Oral.5to10ml(120mgto240mgparacetamol).Repeatevery4hours,ifnecessary,uptoamaximumof4dosesper

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Infants3monthstounder1year:

Oral.2.5to5ml(60mgto120mgparacetamol).Repeatevery4hours,ifnecessary,uptoamaximumof4dosesper

24hours.

Infants2-3months(>3kgbodyweight)

Oral2.5ml(60mgparacetamol)Repeatevery4hours,ifnecessary,uptoamaximumof4

dosesper24hours.Donotuseformorethan2dayswithoutmedicalsupervision.

Under2months

Consultyourdoctor.

TheElderly:

Intheelderlytherateandextentofparacetamolabsorptionisnormalbutplasmahalf-lifeislongerandparacetamol

clearanceislowerthaninyoungadults.

Hepatic/renaldysfunction

Cautionshouldbeexercisedwhenadministeringtheproducttopatientswithseverehepaticorrenalimpairment.

4.3Contraindications

CALPOLSugarFreeInfantSuspensioniscontra-indicatedinpatientswithknownhypersensitivitytoparacetamol,or

anyoftheothercomponents.

4.4Specialwarningsandprecautionsforuse

CALPOLSugarFreeInfantSuspensionshouldbeusedwithcautioninmoderatetosevererenalimpairmentorsevere

hepaticimpairment.

Thelabelcontainsthefollowingstatements:

Storebelow25 °

C.Protectfromlight.

Containsparacetamol.

Donotexceedthestateddose.

Keepoutofreachofchildren.

Donottakemorethan4dosesin24hours.

Dose4timesaday.

Donotrepeatdosesmorefrequentlythan4hourly.

Donotgiveformorethan3dayswithoutconsultingadoctor.

Inthecaseofinfantslessthan3months,donotgiveformorethan2dayswithoutconsultingadoctor.

Ifsymptomspersistconsultyourdoctor.

Ifyouchildistakinganyothermedicine,consultyourdoctororpharmacistbeforetakingthisproduct.

Immediatemedicaladviceshouldbesoughtintheeventofanoverdose,evenifyoufeelwell.(label)

Immediatemedicaladviceshouldbesoughtintheeventofanoverdose,evenifyoufeelwell,becauseoftheriskof

irreversibleliverdamage.(leaflet)

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Chronicalcoholintakecanincreasethehepatotoxicityofparacetamoloverdoseandmayhavecontributedtotheacute

pancreatitisreportedinonepatientwhohadtakenanoverdoseofparacetamol.Acutealcoholintakemaydiminishan

individual’sabilitytometaboliselargedosesofparacetamol,theplasmahalflifeofwhichcanbeprolonged.

Theuseofdrugsthatinducehepaticmicrosomalenzymes,suchasanticonvulsantsandoralcontraceptives,may

increasetheextentofparacetamol,resultinginreducedplasmaconcentrationsofthereducedplasmaconcentrationsof

thedrugandafastereliminationrate.

Thespeedofabsorptionofparacetamolmaybeincreasedbymetoclopramideordomperidoneandabsorptionreduced

bycholestyramine.

Theanticoagulanteffectofwarfarinandothercoumarinsmaybeenhancedbyprolongedregularuseofparacetamol

withincreasedriskofbleeding;occasionaldoseshavenosignificanteffect.

4.6Pregnancyandlactation

ThesafeuseofCALPOLSugarFreeInfantSuspensionduringpregnancyhasnotbeenestablished.Thereis

epidemiologicalevidenceofthesafetyofparacetamolinhumanpregnancy.

Apharmacokineticstudyin12nursingmothersrevealedthatlessthan1%ofthedoseingestedbyanursingmother

appearsinhumanbreastmilk,thereforematernalingestionoftherapeuticdosesdoesnotpresentarisktotheinfant.

4.7Effectsonabilitytodriveandusemachines

Nospecialcomment–unlikelytoproduceaneffect.

4.8Undesirableeffects

Paracetamolhasbeenwidelyusedand,whentakenattheusualrecommendeddosage,sideeffectsaremildand

infrequentandreportsofadversereactionsarerare.Skinrashandotherallergicreactionsoccurrarely.

Mostreportsofadversereactionstoparacetamolrelatetooverdosagewiththedrug.

Isolatedcasesofthrombocyticpurpura,haemolyticanaemiaandagranulocytosishavebeenreported.

Chronichepaticnecrosishasbeenreportedinapatientwhotookdailytherapeuticdosesofparacetamolforabouta

yearandliverdamagehasbeenreportedafterdailyingestionofexcessiveamountsforshorterperiods.

Areviewofagroupofpatientswithchronicactivehepatitisfailedtorevealdifferencesintheabnormalitiesofliver

functioninthosewhowerelong-termusersofparacetamolnorwasthecontrolofthediseaseimprovedafter

paracetamolwithdrawal.

Nephrotoxiceffectsfollowingtherapeuticdosesofparacetamolareuncommon.Papillarynecrosishasbeenreported

afterprolongedadministration.

4.9Overdose

Symptomsandsigns

Pallor,anorexia,nauseaandvomitingarefrequentearlysymptomsofparacetamoloverdosage,althoughinmanycases

therearenosymptomsformanyhours.

Hepaticnecrosisisadose-relatedcomplicationofparacetamoloverdose.Hepaticenzymesmaybecomeelevatedand

prothrombintimeprolongedwithin12to48hoursbutclinicalsymptomsmaynotbeapparentfor1to6daysafter

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Treatment

Toprotectthepatientagainstdelayedhepatotoxicity,paracetamoloverdosageshouldbetreatedpromptlybygastric

lavagefollowedbyintravenousN-acetylcysteineororalmethionine.Additionaltherapy(furthermethionineor

intravenouscysteamineorintravenousN-acetylcysteine)isnormallyconsideredinthelightofbloodparacetamol

contentandthetimeelapsedsinceingestion.Fulminanthepaticfailurewhichmayfollowparacetamoloverdosage

requiresspecialisedmanagement

Inparacetamoloverdosagewithlivercelldamage,paracetamolhalf-lifeisoftenprolongedfromaround2hoursin

normaladultsto4hoursorlonger.

Howeverlivercelldamagehasbeenfoundinpatientswithaparacetamolhalflifelessthan4hours.Diminutionof

excretionafter 14

C-aminopyrinehasbeenreportedtocorrelatebetterwithlivercelldamageinparacetamol

overdosagethandoeitherplasmaparacetamolconcentrationorhalf-life,orconventionalliverfunctiontest

measurements.Renalfailureduetoacutetubularnecrosismayfollowparacetamol-inducedfulminanthepaticfailure.

Theincidenceofthisis,however,nomorefrequentinthesepatientsthaninotherswithfulminanthepaticfailurefrom

othercauses.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Paracetamolhasanalgesicandantipyreticeffectssimilartothoseofaspirinandisusefulinthetreatmentofmildto

moderatepain.Ithasweakanti-inflammatoryeffects.

5.2Pharmacokineticproperties

Paracetamolisrapidlyandalmostcompletelyabsorbedfromthegastrointestinaltract.Peakplasmaconcentrationsare

reached30-90minutespostdoseandtheplasmahalf-lifeisintherangeof1to3hoursaftertherapeuticdoses.Drugis

widelydistributedthroughoutmostbodyfluids.Followingtherapeuticdoses90-100%ofthedrugisrecoveredinthe

urinewithin24hoursalmostentirelyfollowinghepaticconjugationwithglucuronicacid(about60%),sulphuricacid

(about35%)orcysteine(about3%).Smallamountsofhydroxylatedanddeacetylatedmetaboliteshavealsobeen

detected.Childrenhavelesscapacityforglucuronidationofthedrugthandoadults.Inoverdosagethereisincreased

N-hydroxylationfollowedbyglutathioneconjugation.Whenthelatterisexhausted,reactionwithhepaticproteinsis

increasedleadingtonecrosis.

5.3Preclinicalsafetydata

Mutagenicity

TherearenostudiesrelatingtothemutagenicpotentialofCALPOLSugarFreeInfantSuspension.

Invivomutagenicitytestsofparacetamolinmammalsarelimitedandshowconflictingresults.Therefore,thereis

insufficientinformationtodeterminewhetherparacetamolposesamutagenicrisktoman.

Paracetamolhasbeenfoundtobenon-mutagenicinbacterialmutagenicityassays,althoughaclearclastogeniceffect

hasbeenobservedinmammaliancellsinvitrofollowingexposuretoparacetamol(3and10mMfor2hr).

Carcinogenicity

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Thereisinadequateevidencetodeterminethecarcinogenicpotentialofparacetamolinhumans.Apositiveassociation

betweentheuseofparacetamolandcanceroftheureter(butnotofothersitesintheurinarytract)wasobservedina

case-controlstudyinwhichapproximatelifetimeconsumptionofparacetamol(whetheracuteorchronic)was

estimated.However,othersimilarstudieshavefailedtodemonstrateastatisticallysignificantassociationbetween

paracetamolandcanceroftheurinarytract,orparacetamolandrenalcellcarcinoma.

Thereislimitedevidenceforthecarcinogenicityofparacetamolinexperimentalanimals.Livercelltumourscanbe

detectedinmiceandliverandbladdercarcinomascanbedetectedinratsfollowingchronicfeedingof500mg/kg/day

paracetamol.

Teratogenicity

ThereisnoinformationrelatingtotheteratogenicpotentialofCALPOLSugarFreeInfantSuspension.Inhumans,

paracetamolcrossestheplacentaandattainsconcentrationsinthefoetalcirculationsimilartothoseinthematernal

circulation.Intermittentmaternalingestionoftherapeuticdosesofparacetamolarenotassociatedwithteratogenic

effectsinhumans.

Paracetamolhasbeenfoundtobefetotoxictoculturedratembryo.

Fertility

ThereisnoinformationrelatingtotheeffectsofCALPOLSugarFreeInfantSuspension.Asignificantdecreasein

testicularweightwasobservedwhenmaleSprague-Dawleyratsweregivendailyhighdosesofparacetamol(500

mg/kgbodyweight/day)orallyfor70days.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Maltitolliquid

Sorbitol(E420)

Glycerol

DispersibleCellulose

Xanthangum

Ethylhydroxybenzoate(E214)

Propylhydroxybenzoate(E218)

Methylhydroxybenzoate(E216)

Polysorbate80

Strawberryflavour

Carmoisine(E122)

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Theshelf-lifeexpirydateforthisproductshallbethedateonthecontainerandouterpackageoftheproductinthe

countryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25°C

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6.5Natureandcontentsofcontainer

Amberglassbottle,withchildresistantclosure,containing100ml.

Thebottleispackedinanoutercardboardcarton.

Aspoonwitha5mland2.5mlmeasureissuppliedwithallpacks.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7ParallelProductAuthorisationHolder

PCOManufacturingLimited

Unit10,AshbourneBusinessPark

Rath

Ashbourne

Co.Meath

8ParallelProductAuthorisationNumber

PA0465/172/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisation:28April2006

10DATEOFREVISIONOFTHETEXT

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