DISPROL SOLUBLE PARACETAMOL

Main information

  • Trade name:
  • DISPROL SOLUBLE PARACETAMOL
  • Dosage:
  • 120 Milligram
  • Pharmaceutical form:
  • Tablets Effervescent
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DISPROL SOLUBLE PARACETAMOL
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0979/008/002
  • 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)

PA0979/008/002

CaseNo:2033335

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

ReckittBenckiserIrelandLtd

7Riverwalk,CitywestBusinessCampus,Dublin24,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

DisprolSolubleParacetamolEffervescentTablets120mg

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom19/09/2007.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 21/09/2007 CRN 2033335 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DisprolSolubleParacetamolEffervescentTablets120mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Paracetamol120mg.

Excipients:Alsoincludes5.3mmolsodium(121.6mg)pertypicaldose,andsulphurdioxide(E220),traceamounts.

Forafulllistofexcipients,seeSection6.1.

3PHARMACEUTICALFORM

Effervescenttablet

Circular,bevelededge,white,effervescenttablet.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Analgesic/antipyretic.Inthemanagementofsymptomsofheadache,toothache,commoncold,influenzaand

musculo-skeletalpain.

4.2Posologyandmethodofadministration

Children

Threemonthstounderoneyear:Halftoonetablet.Maximumnumberoftabletsin24hours-four.

Oneyeartoundersixyears:Onetotwotablets.Maximumnumberoftabletsin24hours-eight.

Sixtotwelveyears:Twotofourtablets.Maximumnumberoftabletsin24hours-sixteen.

(Underthreemonths-ondoctor'sadviceonly).

Dosesmayberepeatedafter4hours,uptomaximumdailydose.

Tabletsshouldbedissolvedinwaterorinafavouritefruitdrink,priortoingestion.

4.3Contraindications

Irish Medicines Board

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4.4Specialwarningsandprecautionsforuse

Usewithcautioninpatientswithhepaticorrenaldysfunction.

Speciallabellingrequirement

Dosageshouldnotbecontinuedformorethanthreedayswithoutconsultingadoctor.

Donotexceedthestateddose.

Ifsymptomspersist,consultyourdoctor.

Nottobegiventochildrenunderthreemonthsexceptonmedicaladvice.

Donotgivewithothermedicinescontainingparacetamol.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Drugswhichinducehepaticmicrosomalenzymes,suchasalcohol,barbituratesandtricyclicantidepressants,may

increasethehepatotoxicityofparacetamol,particularlyafteroverdosage.

4.6Pregnancyandlactation

Notapplicable.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Therehavebeenisolatedreportsofagranulocytosis,methaemoglobinaemiaandthrombocytopenicpurpuraandafter

overdosageorprolongedadministrationisolatedcasesofchronichepaticnecrosis,acutepancreatitisand

nephrotoxicity.

4.9Overdose

Overdosageshouldbetreatedpromptlybygastriclavagefollowedbyintravenousn-acetylcysteineororalmethionine

sinceliverdamagefollowingoverdosagedoesnotbecomeapparentforonetosixdaysafteringestion.Initialmild

symptomsconsistofnausea,vomitingandpallor.Measurementofthebloodparacetamollevelandthetimeelapsed

sinceingestionisimportantinordertodeterminewhetherfurthertherapywithn-acetylcysteineisnecessary.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Paracetamolhasbothanalgesicandantipyreticactivitywhichisbelievedtobemediatedprincipallythroughits

Irish Medicines Board

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5.2Pharmacokineticproperties

Paracetamolisabsorbedrapidlyandcompletelymainlyfromthesmallintestineproducingpeakplasmalevelsafter

15-20minutesfollowingoraldosing.Thesystemicavailabilityissubjecttofirst-passmetabolismandvarieswithdose

between70%and90%.Thedrugisrapidlyandwidelydistributedthroughoutthebodyandiseliminatedfromplasma

withaT½ofapproximately2hours.Themajormetabolitesareglucuronideandsulphateconjugates(>80%)whichare

excretedinurine.

5.3Preclinicalsafetydata

Nopreclinicalfindingsofrelevancehavebeenreported.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumhydrogencarbonate

AnhydrousSodiumcarbonate

Saccharinsodium

AnhydrousCitricacid

Maltodextrin

Fantasylimeflavour(containssulphurdioxide(E220))

Magnesiumstearate

Povidone

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Threeyears.

6.4Specialprecautionsforstorage

Donotstoreabove30 °

6.5Natureandcontentsofcontainer

Tabletscontainedinstripsofsofttemperaluminiumfoilwithinternalheat-seallacquer.Foilstripspackedina

cardboardoutercarton.Eachpackwillcontain24tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

Irish Medicines Board

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7MARKETINGAUTHORISATIONHOLDER

ReckittBenckiserIrelandLimited

7Riverwalk

CitywestBusinessCampus

Dublin24

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA979/8/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:19November1986

Dateoflastrenewal:19November2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 21/09/2007 CRN 2033335 page number: 5