DISPROL PARACETAMOL ORAL SUSPENSION

Main information

  • Trade name:
  • DISPROL PARACETAMOL ORAL SUSPENSION
  • Dosage:
  • 120mg/5ml MG/5ml
  • Pharmaceutical form:
  • Oral Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DISPROL PARACETAMOL ORAL SUSPENSION
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0979/008/001
  • Authorization date:
  • 19-11-1996
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0979/008/001

CaseNo:2043497

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

ReckittBenckiserIrelandLtd

7Riverwalk,CitywestBusinessCampus,Dublin24,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

DisprolParacetamolOralSuspension120mg/5ml

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom29/11/2007.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 01/12/2007 CRN 2043497 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DisprolParacetamolOralSuspension120mg/5ml

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Paracetamol120mg/5ml.

Excipients:alsoincludeshydrogenatedglucosesyrup3.25gper5ml;methylhydroxybenzoate(E218)8.75mgper5ml

andpropylhydroxybenzoate(E216)3.75mgper5ml.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Oralsuspension.

Translucent,paleyellow,viscoussuspensionwithbanana-likeodour.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Analgesic/antipyretic.Inthemanagementofsymptomsofheadache,toothache,commoncold,influenzaandmusculo-

skeletalpain.

4.2Posologyandmethodofadministration

Routeofadministration:oral.

Forbabieswhodevelopfeverfollowingvaccinationattwomonths,a2.5mldoseissuitable.Inallothercases,notto

begiventochildrenunder3monthswithoutdoctor'sadvice.

Dosesmayberepeatedevery4hoursuptoamaximumoffourdosesin24hours.

Whenprescribedforababyweighinglessthan4.4kg,doseat0.5ml/kg(12mg/kg)usinganoralmeasuringsyringe.

Wheredilutionisprescribed,theproductmaybedilutedwithanequalvolumeofboiled,thencooledwater,togivea

suspensionof12mg/ml(60mg/5ml)withafourteendayshelf-life.

4.3Contraindications

Children: 6yearsto12years: Twotofour5mlspoonfuls.

1yearto6years: Onetotwo5mlspoonfuls.

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4.4Specialwarningsandprecautionsforuse

Usewithcautioninpatientswithhepaticorrenaldysfunction.Each5mlofsuspensioncanprovideupto12Kcaland

thisshouldbetakenintoaccountwhentreatingdiabeticchildren.

Patientswithrarehereditaryproblemsoffructoseintoleranceshouldnottakethismedicine.

Speciallabellingrequirement:

Dosageshouldnotbecontinuedformorethanthreedayswithoutconsultingadoctor.

Donotexceedthestateddose.

Ifsymptomspersist,consultyourdoctor.

Nottobegiventochildrenunder3monthsexceptonmedicaladvice.

Donotgivewithothermedicinescontainingparacetamol.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Drugswhichinducehepaticmicrosomalenzymes,suchasalcohol,barbituratesandtricyclicantidepressants,may

increasethehepatotoxicityofparacetamol,particularlyafteroverdosage.

4.6Pregnancyandlactation

Notapplicable.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Therehavebeenisolatedreportsofagranulocytosis,methaemoglobinaemiaandthrombocytopenicpurpura;after

overdosageorprolongedadministrationisolatedcasesofchronichepaticnecrosis,acutepancreatitisand

nephrotoxicity.

Maycauseallergicreactions(possiblydelayed).

4.9Overdose

Overdosageshouldbetreatedpromptlybygastriclavage,followedbyintravenousn-acetylcysteineororalmethionine

sinceliverdamagefollowingoverdosagedoesnotbecomeapparentforonetosixdaysafteringestion.Initialmild

symptomsconsistofnausea,vomitingandpallor.Measurementofthebloodparacetamollevelandthetimeelapsed

sinceingestionisimportantinordertodeterminewhetherfurthertherapywithn-acetylcysteineisnecessary.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Paracetamolhasbothanalgesicandantipyreticactivitywhichisbelievedtobemediatedprincipallythroughits

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5.2Pharmacokineticproperties

Paracetamolisabsorbedrapidlyandcompletelymainlyfromthesmallintestineproducingpeakplasmalevelsafter15-

20minutesfollowingoraldosing.Thesystemicavailabilityissubjecttofirst-passmetabolismandvarieswithdose

between70%and90%.Thedrugisrapidlyandwidelydistributedthroughoutthebody,andiseliminatedfromplasma

withaT½ofapproximately2hours.Themajormetabolitesareglucuronideandsulphateconjugates(>80%)whichare

excretedinurine.

5.3Preclinicalsafetydata

Nopreclinicalfindingsofrelevancehavebeenreported.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Hydrogenatedglucosesyrup

Glycerol

Carbomer

Sodiumhydroxide

Methylparahydroxybenzoate(E218)

Propylparahydroxybenzoate(E216)

AnhydrousCitricacid

Saccharinsodium

Bananaflavour

Riboflavinsodiumphosphate

Water,purified

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Twoyears.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

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6.5Natureandcontentsofcontainer

(a)Amberglassbottlewithchildresistantpolythene/polypropyleneclosurewithexpandedpolythenewadorPVdC

facedpulpboardwadandtamper-evidentband.

Packsizes:50ml,60ml,100mland140ml.

(b)Amberpolyethyleneterephthalate(PET)bottleswithtamperevident/CRCcapwithexpandedpolythenewador

PVdCfacedpulpboardwad.

Packsizes:50ml,60ml,100mland140ml.

(c)Four-ply5mllaminatesachetcomposedofpaper,polythene,aluminiumfoilandSurlynionomer.

Cartonpacksof2,6,10or12sachets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Taketherequireddoseintheenclosedspoon.Shakebottlebeforeuse.

7MARKETINGAUTHORISATIONHOLDER

ReckittBenckiserIrelandLimited

7RiverWalk

CitywestBusinessCampus

Dublin24

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA979/8/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:19November1986

Dateoflastrenewal:19November2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 01/12/2007 CRN 2043497 page number: 5