CALPOL SUGAR/COLOUR FREE INFANT

Main information

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

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0823/010/006
  • Authorization date:
  • 16-02-1996
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CalpolSugar/ColourFreeInfantSuspension.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

CalpolSugar/ColourFreeInfantSuspensioncontains–

ParacetamolPh.Eur.120mgper5ml.

3PHARMACEUTICALFORM

OralSuspension.

Anoff-whitesuspensionwithanodourofstrawberry.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Inthemanagementofpainandfeverassociatedwithsuchconditionsascommoncold,influenza,headaches,teething.

4.2Posologyandmethodofadministration

Agedover6years: Theusualdosageisupto20ml(480mg)fourtimesdaily

Aged1to6years: Theusualdosageis5to10ml(120-240mg)fourtimesdaily

Aged3monthsto12months:Theusualdosageis2.5to5ml(60-120mg)fourtimesdaily

Under3months:A2.5mldoseissuitableforbabieswhodevelopafeverfollowingvaccinationat2months.In

othercases,useonlyundermedicalsupervision.

4.3Contraindications

Useinpatientswithaknownhypersensitivitytoparacetamol.

4.4Specialwarningsandprecautionsforuse

Calpolshouldbeusedwithcautioninpatientswithseverehepaticorrenaldysfunction.

SpecialLabellingRequirements

Prolongeduseexceptundermedicalsupervisioncouldbeharmful.

Consultthedoctorifthereisnoimprovementwithin24hours.

Donotexceedthestateddose.

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Donottakewithotherproductscontainingparacetamol.

Storebelow25 o

Protectfromlight.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Patientswhohavetakenbarbiturates,tricyclicantidepressantsandalcoholmayshowdiminishedabilitytometabolise

largedosesofparacetamol,theplasmahalf-lifeofwhichcanbeprolonged.

Alcoholcanincreasethehepatotoxicityofparacetamoloverdosageandmayhavecontributedtotheacutepancreatitis

reportedinonepatientwhohadtakenanoverdoseofparacetamol.

Chronicingestionofanticonvulsantsororalsteroidcontraceptivesinduceliverenzymesandmaypreventattainmentof

therapeuticparacetamollevelsbyincreasingfirstpassmetabolismorclearance.

Thespeedofabsorptionofparacetamolmaybeincreasedbymetoclopramideordomperidoneandabsorptionreduced

bycholestyramine.

Theanticoagulanteffectofwarfarinandothercoumarinsmaybeenhancedbyprolongedregularuseofparacetamol

withincreasedriskofbleeding;occasionaldoseshavenosignificanteffect.

4.6Pregnancyandlactation

DataarenotavailableontheuseofCalpolduringpregnancy.Thereisepidemiologicalevidenceofsafetyof

paracetamolinhumanpregnancy.

Apharmacokineticstudyin12nursingmothersrevealedthatlessthan1%ofthedoseingestedbyanursingmother

appearsinhumanmilk.Thereforematernalingestionoftherapeuticdosesdoesnotpresentarisktotheinfant.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Paracetamolhasbeenwidelyusedandwhentakenattheusualrecommendeddosagesideeffectsaremildand

infrequentandreportsofadversereactionsarerare.Skinrashesandotherallergicreactionsoccurrarely.

Mostreportsofadversereactionstoparacetamolrelatetooverdosagewiththedrug.

Isolatedcasesofthrombocytopenicpurpura,haemolyticanaemiaandagranulocytosishavebeenrecorded.

Chronichepaticnecrosishasbeenreportedinapatientwhotookdailytherapeuticdosesofparacetamolforabouta

yearandliverdamagehasbeenreportedafterdailyingestionofexcessiveamountsforshorterperiods.Areviewofa

groupofpatientswithchronicactivehepatitisfailedtorevealdifferencesintheabnormalitiesofliverfunctioninthose

whowerelong-termusersofparacetamolnorwasthecontroloftheirdiseaseimprovedafterparacetamolwithdrawal.

Nephrotoxicityfollowingtherapeuticdosesofparacetamolisuncommon,butpapillarynecrosishasbeenreportedafter

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4.9Overdose

Pallor,anorexia,nauseaandvomitingarefrequentearlysymptomsofparacetamoloverdosage.Hepaticnecrosisisa

dose-relatedcomplicationofparacetamolover-dosage.Hepaticenzymesmaybecomeelevatedandprothrombintime

prolongedwithin12-48hoursbutclinicalsymptomsmaynotbeapparentuntil1to6daysafteringestion.Toxicityis

likelyinadultswhohavetakenmorethan10g.

Treatment

Toprotectthepatientagainstdelayedhepatotoxicity,paracetamoloverdosageshouldbetreatedpromptlybygastric

lavagefollowedbyintravenousN-acetylcysteineororalmethionine.Additionaltherapy(Furthermethionineor

intravenouscysteamineorintravenousN-acetylcysteine)isnormallyconsideredinthelightofbloodparacetamol

contentandtimeelapsedsinceingestion.Fulminanthepaticfailure,whichmayfollowparacetamoloverdosage,

requiresspecialisedmanagement.

Inparacetamoloverdosagewithlivercelldamage,paracetamolhalf-lifeisoftenprolongedfromaround2hoursin

normaladultsto4hoursorlonger.However,livercelldamagehasbeenfoundinpatientswithaparacetamolhalf-life

lessthan4hours.Diminutionin 14

excretionafteroral 14

C-aminopyrinehasbeenreportedtocorrelatebetterwith

livercelldamageinparacetamoloverdosagethandoeitherplasmaparacetamolconcentrationorhalf-lifeor

conventionalliverfunctiontestmeasurements.Concomitatntrenalfailureduetoacutetubularnecrosismay

accompanyparacetamol-inducedfulminatehepaticfailure.Theincidenceofthisishowever,nomorefrequentinthese

patientsthaninotherswithfulminanthepaticfailuresfromothercauses.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Paracetamolhasanalgesicandantipyreticeffectssimilartothoseofaspirinandisusefulinthetreatmentofmildto

moderatepain.Ithasonlyweakanti-inflammatoryeffects.

5.2Pharmacokineticproperties

Paracetamolisrapidlyandalmostcompletelyabsorbedfromthegastro-intestinaltractPeakplasmaconcentrationsare

reached30-90minutespostdoseandtheplasmahalf-lifeisintherangeof1to3hoursaftertherapeuticdoses.Drugis

widelydistributedthroughoutmostbodyfluidsfollowingtherapeuticdoses90-100%ofthedrugisrecoveredinthe

urinewithin24hours,almostentirelyfollowinghepaticconjugationwithglucuronicacid(about60%),sulphuricacid

(about35%)orcysteine(about3%).Smallamountsofhydroxylatedanddeacetylatedmetaboliteshavealsobeen

detected.Childrenhavelesscapacityforglucuronidationofthedrugthandoadults.Inoverdosagethereisincreased

N-hydroxylationfollowedbyglutathioneconjugation.Whenthelatterisexhaustedreactionwithhepaticproteinsis

increasedleadingtonecrosis.

5.3Preclinicalsafetydata

Mutagenicity

TherearenostudiesrelatingtothemutagenicpotentialofCalpolSugar/ColourFreeSuspension.

Invivomutagenicitytestsofparacetamolinmammalsarelimitedandshowconflictingresults.Therefore,thereis

insufficientinformationtodeterminewhetherparacetamolposesamutagenicrisktoman.

Paracetamolhasbeenfoundtobenon-mutagenicinbacterialmutagenicityassays,althoughaclearclastogeniceffect

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Carcinogenicity

TherearenostudiesrelatingtothecarcinogenicpotentialofCalpolSugar/ColourFreeInfantSuspension.

Thereisinadequateevidencetodeterminethecarcinogenicpotentialofparacetamolinhumans.Apositiveassociation

betweentheuseofparacetamolandcanceroftheureter(butnotofothersitesintheurinarytract)wasobservedina

case-controlstudyinwhichapproximatelifetimeconsumptionofparacetamol(whetheracuteorchronic)was

estimated.However,othersimilarstudieshavefailedtodemonstrateastatisticallysignificantassociationbetween

paracetamolandcanceroftheurinarytract,orparacetamolandrenalcellcarcinoma.

Thereislimitedevidenceforthecarcinogenicityofparacetamolinexperimentalanimals.Livercelltumourscanbe

detectedinratsfollowingchronicfeedingof500mg/kg/dayparacetamol.

Teratogenicity

ThereisnoinformationrelatingtotheteratogenicpotentialofCalpolSugar/ColourFreeInfantSuspension.In

humans,paracetamolcrossestheplacentaandattainsconcentrationinthefoetalcirculationsimilartothoseinthe

maternalcirculation.Intermittentmaternalingestionoftherapeuticdosesofparacetamolarenotassociatedwith

teratogeniceffectsinhumans.

Paracetamolhasbeenfoundtobefoetotoxictoculturedratembryo.

Fertility

ThereisnoinformationrelatingtotheeffectsofCalpolSugar/ColourFreeInfantSuspensiononfertility.Asignificant

decreaseintesticularweightwasobservedwhenmaleSprague-Dawleyratsweregivendailyhighdosesofparacetamol

(500mg/kg/bodyweight/day)orallyfor70days.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Hydrogenatedglucosesyrup

Sorbitolsolution(70%)(non-crystallising)

Glycerol

Dispersiblecellulose

Xanthangum

Flavour,strawberry

Methylhydroxybenzoate

Purifiedwater

Propylhydroxybenzoate

6.2Incompatibilities

Noneknown.

6.3ShelfLife

36monthsunopened.

6.4Specialprecautionsforstorage

Storebelow25°C.

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6.5Natureandcontentsofcontainer

Amberglassbottleswithanominalcapacityof70,100,140and200mlclosedwithatwo-pieceplasticchildresistant,

tamperevidentclosurefittedwithapolyethylene/polyvinylidenechloride(PVDC).polyethylenelaminatefacedwad.

or

Amberglassbottleswithanominalcapacityof70,100,140and200mlclosedwithathree-pieceplasticchild

resistant,tamperevidentclosurefittedwithapolyethylene/polyvinylidenechloride(PVDC)/Polyethylenelaminate

facedwad.

and

Amberglassbottleswithanominalcapacityof500and1000mlwithplasticscrewcapswithpolyvinylidenechloride

(PVDC)wads.

and

5mlPaper/aluminiumfoil/polyethylenelaminatesachets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Noneacceptable.

7MARKETINGAUTHORISATIONHOLDER

McNeilHealthcare(Ireland)Ltd.,

AirtonRoad,

Tallaght

Dublin24

8MARKETINGAUTHORISATIONNUMBER

PA0823/010/006

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:16February1996

Dateoflastrenewal:16February2001

10DATEOFREVISIONOFTHETEXT

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