CALPOL SUGAR FREE INFANT

Main information

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

Documents

Localization

  • Available in:
  • CALPOL SUGAR FREE INFANT
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1447/075/001
  • Authorization date:
  • 19-11-2010
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Calpol120mg/5mlSugarFreeInfantOralSuspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

CalpolSugarFreeInfantOralSuspensioncontains120mgparacetamolineach5ml.

Excipients:alsoincludesthefollowingsubstancesineach5ml:

Maltitolliquid

Sorbitolsolution(E420)

Ethylparahydroxybenzoate(E214)

Methylparahydroxybenzoate(E218)

Propylparahydroxybenzoate(E216)

Carmoisine(E122)

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

OralSuspension

ProductimportedfromtheUK:

Apinksuspensionwithastrawberryodour.

4CLINICALPARTICULARS

4.1TherapeuticIndications

CALPOLSugarFreeInfantSuspensionisindicatedforthetreatmentofpain(includingteethingpain),andasan

antipyretic.

CalpolSugarFreeInfantSuspensionisindicatedforthereliefofheadache,migraine,neuralgia,toothacheandteething

pains,sorethroat,rheumaticachesandpains,influenza,feverishnessandfeverishcolds.

4.2Posologyandmethodofadministration

4.2.1 Posology

Childrenaged6yearsto12years:

Oral.10to20ml(240mgto480mgparacetamol).Repeatevery4hours,ifnecessary,uptoamaximumof4dosesper

24hours.

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,uptoamaximumof4dosesper24hours.Donot

useformorethan2dayswithoutmedicalsupervision.

Under2months:

ConsultyourDoctor.

TheElderly:

Intheelderlytherateandextentofparacetamolabsorptionisnormalbutplasmahalf-lifeislongerandparacetamol

clearanceislowerthaninyoungadults.

Hepatic/renaldysfunction:

Cautionshouldbeexercisedwhenadministeringtheproducttopatientswithseverehepaticorrenalimpairment.

4.3Contraindications

CALPOLSugarFreeInfantSuspensioniscontra-indicatedinpatientswithknownhypersensitivitytoparacetamol,orany

oftheothercomponents.

4.4Specialwarningsandprecautionsforuse

CALPOLSugarFreeInfantSuspensionshouldbeusedwithcautioninmoderatetosevererenalimpairmentorsevere

hepaticimpairment.

Thelabelcontainsthefollowingstatements:

Storebelow25 °

C.Protectfromlight.

Containsparacetamol.Donotexceedthestateddose.

Keepoutofreachandsightofchildren.

Donottakemorethan4dosesin24hours.

Dose4timesaday.

Donotrepeatdosesmorefrequentlythan4hourly.

Donotgiveformorethan3dayswithoutconsultingadoctor.

Inthecaseofinfantslessthan3months,donotgiveformorethan2dayswithoutconsultingadoctor.

Ifsymptomspersistconsultyourdoctor.

Ifyourchildistakinganyothermedicine,consultyourdoctororpharmacistbeforetakingthisproduct.

Immediatemedicaladviceshouldbesoughtintheeventofanoverdose,evenifyoufeelwell(label).

Immediatemedicaladviceshouldbesoughtintheeventofanoverdose,evenifyoufeelwell,becauseoftheriskof

irreversibleliverdamage(leaflet).

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Containsmaltitolandsorbitol:patientswithrarehereditaryproblemsoffructoseintoleranceshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Chronicalcoholintakecanincreasethehepatotoxicityofparacetamoloverdoseandmayhavecontributedtotheacute

pancreatitisreportedinonepatientwhohavetakenanoverdoseofparacetamol.Acutealcoholintakemaydiminishan

individual’sabilitytometaboliselargedosesofparacetamol,theplasmahalflifeofwhichcanbeprolonged.

Theuseofdrugsthatinducehepaticmicrosomalenzymes,suchasanticonvulsantsandoralcontraceptives,may

increasetheextentofmetabolismofparacetamol,resultinginreducedplasmaconcentrationsofthereducedplasma

concentrationsofthedrugandafastereliminationrate.

Thespeedofabsorptionofparacetamolmaybeincreasedbymetoclopramideordomperidoneandabsorptionreduced

bycholestyramine.

Theanticoagulanteffectofwarfarinandothercoumarinsmaybeenhancedbyprolongedregularuseofparacetamol

withincreasedriskofbleeding;occasionaldoseshavenosignificanteffect.

4.6Fertility,pregnancyandlactation

ThesafeuseofCALPOLSugarFreeInfantSuspensionduringpregnancyhasnotbeenestablished.Thereis

epidemiologicalevidenceofthesafetyofparacetamolinhumanpregnancy.

Apharmacokineticstudyin12nursingmothersrevealedthatlessthan1%ofthedoseingestedbyanursingmother

appearsinhumanbreastmilk,thereforematernalingestionoftherapeuticdosesdoesnotpresentarisktotheinfant.

4.7Effectsonabilitytodriveandusemachines

Nospecialcomment-unlikelytoproduceaneffect.

4.8Undesirableeffects

Paracetamolhasbeenwidelyusedand,whentakenattheusualrecommendeddosage,sideeffectsaremildandinfrequent

andreportsofadversereactionsarerare.Skinrashandotherallergicreactionsoccurrarely.

Mostreportsofadversereactionstoparacetamolrelatetooverdosagewiththedrug.

Isolatedcasesofthrombocyticpurpura,haemolyticanaemiaandagranulocytosishavebeenreported.

Chronichepaticnecrosishasbeenreportedinapatientwhotookdailytherapeuticdosesofparacetamolforaboutayear

andliverdamagehasbeenreportedafterdailyingestionofexcessiveamountsforshorterperiods.

Areviewofagroupofpatientswithchronicactivehepatitisfailedtorevealdifferencesintheabnormalitiesofliver

functioninthosewhowerelong-termusersofparacetamolnorwasthecontrolofthediseaseimprovedafterparacetamol

withdrawal.

Nephrotoxiceffectsfollowingtherapeuticdosesofparacetamolareuncommon.Papillarynecrosishasbeenreportedafter

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4.9Overdose

Symptomsandsigns

Pallor,anorexia,nauseaandvomitingarefrequentearlysymptomsofparacetamoloverdosage,althoughinmanycases

therearenosymptomsformanyhours.

Hepaticnecrosisisadose-relatedcomplicationofparacetamoloverdose.Hepaticenzymesmaybecomeelevatedand

prothrombintimeprolongedwithin12to48hoursbutclinicalsymptomsmaynotbeapparentfor1to6daysafter

ingestion.Toxicityislikelyinsubjectswhohavetakensingledosesof10g.

Treatment

Toprotectthepatientagainstdelayedhepatotoxicity,paracetamoloverdosageshouldbetreatedpromptlybygastric

lavagefollowedbyintravenousN-acetylcysteineororalmethionine.Additionaltherapy(furthermethionineor

intravenouscysteamineorintravenousN-acetylcysteine)isnormallyconsideredinthelightofbloodparacetamol

contentandthetimeelapsedsinceingestion.Fulminanthepaticfailurewhichmayfollowparacetamoloverdosage

requiresspecialisedmanagement.

Inparacetamoloverdosagewithlivercelldamage,paracetamolhalf-lifeisoftenprolongedfromaround2hoursinnormal

adultsto4hoursorlonger.

Howeverlivercelldamagehasbeenfoundinpatientswithaparacetamolhalflifelessthan4hours.Diminutionof 14

excretionafter 14

C-aminopyrinehasbeenreportedtocorrelatebetterwithlivercelldamageinparacetamoloverdosage

thandoeitherplasmaparacetamolconcentrationorhalf-life,orconventionalliverfunctiontestmeasurements.Renal

failureduetoacutetubularnecrosismayfollowparacetamol-inducedfulminanthepaticfailure.Theincidenceofthisis,

however,nomorefrequentinthesepatientsthaninotherswithfulminanthepaticfailurefromothercauses.

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.InoverdosagethereisincreasedN-

hydroxylationfollowedbyglutathioneconjugation.Whenthelatterisexhausted,reactionwithhepaticproteinsis

increasedleadingtonecrosis.

5.3Preclinicalsafetydata

Mutagenicity

TherearenostudiesrelatingtothemutagenicpotentialofCALPOLSugarFreeInfantSuspension.

Invivomutagenicitytestsofparacetamolinmammalsarelimitedandshowconflictingresults.Therefore,thereis

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Paracetamolhasbeenfoundtobenon-mutagenicinbacterialmutagenicityassays,althoughaclearclastogeniceffecthas

beenobservedinmammaliancellsinvitrofollowingexposuretoparacetamol(3and10mMfor2hr).

Carcinogenicity

TherearenostudiesrelatingtothecarcinogenicpotentialofCALPOLSugarFreeInfantSuspension.

Thereisinadequateevidencetodeterminethecarcinogenicpotentialofparacetamolinhumans.Apositiveassociation

betweentheuseofparacetamolandcanceroftheureter(butnotofothersitesintheurinarytract)wasobservedinacase-

controlstudyinwhichapproximatelifetimeconsumptionofparacetamol(whetheracuteorchronic)wasestimated.

However,othersimilarstudieshavefailedtodemonstrateastatisticallysignificantassociationbetweenparacetamoland

canceroftheurinarytract,orparacetamolandrenalcellcarcinoma.

Thereislimitedevidenceforthecarcinogenicityofparacetamolinexperimentalanimals.Livercelltumourscanbe

detectedinmiceandliverandbladdercarcinomascanbedetectedinratsfollowingchronicfeedingof500mg/kg/day

paracetamol.

Teratogenicity

ThereisnoinformationrelatingtotheteratogenicpotentialofCALPOLSugarFreeInfantSuspension.Inhumans,

paracetamolcrossestheplacentaandattainsconcentrationsinthefoetalcirculationsimilartothoseinthematernal

circulation.Intermittentmaternalingestionoftherapeuticdosesofparacetamolarenotassociatedwithteratogeniceffects

inhumans.

Paracetamolhasbeenfoundtobefetotoxictoculturedratembryo.

Fertility

ThereisnoinformationrelatingtotheeffectsofCALPOLSugarFreeInfantSuspension.Asignificantdecreasein

testicularweightwasobservedwhenmaleSprague-Dawleyratsweregivendailyhighdosesofparacetamol(500mg/kg

bodyweight/day)orallyfor70days.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Maltitolliquid

Sorbitolsolution(E420)

Glycerol

Dispersiblecellulose

Xanthangum

Ethylparahydroxybenzoate(E214)

Methylparahydroxybenzoate(E218)

Propylparahydroxybenzoate(E216)

Polysorbate80

Strawberryflavour

Carmoisine(E122)

Purifiedwater

6.2Incompatibilities

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6.3Shelflife

Theshelf-lifeexpirydateofthisproductisthedateshownonthebottleandoutercartonoftheproductonthemarket

inthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

Keepintheoutercontainer.

6.5Natureandcontentsofcontainer

Aspoonwitha5mland2.5mlmeasureissuppliedwiththispack.

100mlamberglassbottlewithaplasticchild-resistantclosurepackedinanoverlabelledoutercarton.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7PARALLELPRODUCTAUTHORISATIONHOLDER

G&ALicensingLtd.

Ballymurray

Co.Roscommon

Ireland

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1447/75/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:19 th

November2010

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