DULCOLAX

Main information

  • Trade name:
  • DULCOLAX Suppositories 10 Milligram
  • Dosage:
  • 10 Milligram
  • Pharmaceutical form:
  • Suppositories
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DULCOLAX Suppositories 10 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1151/045/002
  • Authorization date:
  • 22-06-2007
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PPA1151/045/002

CaseNo:2076834

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

ImbatLimited

UnitL2,NorthRingBusinessPark,Santry,Dublin9

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Dulcolax10mgSuppositories

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom20/05/2010until21/06/2012.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 20/05/2010 CRN 2076834 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Dulcolax10mgSuppositories

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachsuppositorycontains10mgofbisacodyl.

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Suppository

ProductimportedfromGreece

Smooth,whitetorpedo-shapedsuppositories

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forevacuationofthecoloninconstipationandinpreparationforradiologicalinvestigations.

4.2Posologyandmethodofadministration

1.InConstipation:

AdultsandChildrenover10years:One10mgsuppositorytobeadministeredinthemorning.

Childrenunder10years:One5mgsuppositorytobeadministeredundermedicalsupervisiononly.

Suppositoriesareusuallyeffectiveinabout30minutes.

Asuppositoryshouldbeunwrappedandinsertedintotherectumpointedendfirst.

2.Forpreparationfordiagnosticproceduresandpreoperatively:

WhenusingDulcolaxtopreparethepatientforradiographicexaminationoftheabdomenoremployingit

preoperatively,DulcolaxTablets5mgshouldbecombinedwithsuppositoriesinordertoachievecompleteevacuation

oftheintestine.

Adultsandchildrenover10years:Twotofourtabletsthenightbeforeandinsertone10mgsuppositorythefollowing

morning.

Childrenaged4-10years:Onetabletthenightbeforeandinsertone5mgsuppositorythefollowingmorning.

Nospecificinformationontheuseofthisproductintheelderlyisavailable.Clinicaltrialshaveincludedpatientsover

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4.3Contraindications

Dulcolaxiscontraindicatedinpatientswithileus,intestinalobstruction,acutesurgicalabdominalconditionsincluding

appendicitis,acuteinflammatoryboweldiseasesandsevereabdominalpainassociatedwithnauseaandvomitingwhich

maybeindicativeoftheaforementionedsevereconditions.

Dulcolaxisalsocontraindicatedinseveredehydrationandinpatientswithaknownhypersensitivitytobisacodylor

anyothercomponentoftheproduct.

DulcolaxSuppositoriesshouldnotbeusedwhenanalfissuresorulcerativeproctitiswithmucosaldamagearepresent.

4.4Specialwarningsandprecautionsforuse

Aswithalllaxatives,Dulcolaxshouldnotbetakenonacontinuousdailybasisformorethanfivedayswithout

investigatingthecauseofconstipation.

DulcolaxSuppositoriesshouldnotbeusedwhenanalfissuresorulcerativeproctitiswithmucosaldamagearepresent.

Prolongedexcessiveusemayleadtofluidandelectrolyteimbalanceandhypokalaemia.

Dizzinessand/orsyncopehavebeenreportedinpatientsduringdefecation,consistentwithdefecationsyncope(or

syncopeattributabletostrainingatstool),orwithavasovagalresponsetoabdominalpainwhichmayberelatedtothe

constipationthatpromptedthesepatientstoresorttotheuseoflaxatives.

Theuseofsuppositoriesmayleadtopainfulsensationsandlocalirritation,especiallyinanalfissuresorulcerative

proctitis.

Dulcolaxshouldnotbetakenbychildrenunder10yearswithoutmedicaladvice.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Theconcomitantuseofdiureticsoradreno-corticosteroidsmayincreasetheriskofelectrolyteimbalanceifexcessive

dosesofDulcolaxaretaken.

Electrolyteimbalancemayleadtoincreasesensitivitytocardiacglycosides.

4.6Pregnancyandlactation

Therearenoadequateandwell-controlledstudiesinpregnantwomen.Longexperiencehasshownnoevidenceof

undesirableordamagingeffectsduringpregnancy.

Thereisnoevidenceastowhetherbisacodylisexcretedintobreastmilk.

Nevertheless,aswithallmedicines,Dulcolaxshouldnotbetakeninpregnancy,especiallythefirsttrimester,and

duringbreastfeedingunlesstheexpectedbenefitisthoughttooutweighanypossibleriskandonlyonmedicaladvice.

4.7Effectsonabilitytodriveandusemachines

Notstated.

4.8Undesirableeffects

Adverseeventshavebeenrankedunderheadingsoffrequencyusingthefollowingconvention:Verycommon( ≥

1/10);

common( ≥1/100,<1/10);uncommon(≥1/1000,<1/100);rare(≥1/10000,<1/1000);veryrare(<1/10000)

Notknown–incidencecannotbeestimatedfromtheavailabledata.

Immunesystemdisorders

Notknow:anaphylacticreactions,angioneuroticoedemaandotherhypersensitivity.

Gastrointestinaldisorders

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Common:Abdominaldiscomfort,abdominalpain,abdominalcramps,nauseaanddiarrhoea.

Notknown:colitis.

Localirritationhasbeenreportedwhenthesuppositoryformulationhasbeenadministered.

4.9Overdose

Symptoms:

Ifhighdosesaretakendiarrhoea,abdominalcrampsandaclinicallysignificantlossofpotassiumandotherelectrolytes

canoccur.

Laxativeswhentakeninchronicoverdosemaycausechronicdiarrhoea,abdominalpain,hypokalaemia,secondary

hyperaldosteronismandrenalcalculi.

Renaltubulardamage,metabolicalkalosisandmuscleweaknesssecondarytohypokalaemiahavealsobeendescribed

inassociationwithchroniclaxativeabuse.

Therapy:

WithinashorttimeafteringestionoforalformsofDulcolaxabsorptioncanbeminimisedorpreventedbyinducing

vomiting.Otherwise,gastriclavageshouldbeperformed.Replacementoffluidsandcorrectionofelectrolyte

imbalance(particularlyhypokalaemia)mayberequired.Thisisespeciallyimportantintheelderlyandtheyoung.

Administrationofantispasmodicsmaybeofsomevalue.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Bisacodylisalocallyactinglaxativefromthetriarylmethanegroup,whichafterbacterialcleavageinthecolon,hasthe

dual-actionofstimulatingthemucosaofboththelargeintestinecausingperistalsisandoftherectumcausingincreased

motilityandafeelingofrectalfullness.

Therectaleffectmayhelptorestorethe“calltostool”althoughitsclinicalrelevanceremainstobeestablished.

5.2Pharmacokineticproperties

Hydrolysisofbisacodylbyenzymesoftheentericmucosaformsdesacetylbisacodylwhichisabsorbedandexcreted

partlyviaurineandbileasglucuronide.Bybacterialcleavagetheactiveform,thefreediphenol,isformedinthecolon.

Formulationsofbisacodylwhichareresistanttogastricandsmallintestinaljuice,likeDulcolaxsugar-coatedtablets,

reachthecolonwithoutanyappreciableabsorptionandthereforeavoidenterohepaticcirculation.Consequently,these

oralformshaveanonsetofactionbetween6-12hoursafteradministration.

Suppositoryformulationsofbisacodylhaveanonsetofactionwithin15-30minutes,althoughinsomecasesitmaybe

prolongedto15-60minutes.Theonsetofactionisdeterminedbythereleaseoftheactivesubstancefromthe

preparation.

Afteradministration,onlysmallamountsofthedrugaresystemicallyavailable.Urinaryexcretionreflectslowsystemic

burdenafteroralandrectaladministration.

Thereisnorelationshipbetweenthelaxativeeffectandplasmalevelsoftheactivediphenol.

5.3Preclinicalsafetydata

Therearenopre-clinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

Irish Medicines Board

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Hardfat(Adepssolidus).

6.2Incompatibilities

Notapplicable

6.3ShelfLife

Theshelflifeexpirydateofthisproductshallbethedateshownonthecontainerandouterpackageoftheproducton

themarketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25ºC.

Keeptheblisterintheoutercarton.

6.5Natureandcontentsofcontainer

Over-labelledoutercontainingblisterstrips.

Packsizesof6

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements

7PARALLELPRODUCTAUTHORISATIONHOLDER

ImbatLimited

UnitL2

NorthRingBusinessPark

Santry

Dublin9

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1151/45/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisation:22ndJune2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 20/05/2010 CRN 2076834 page number: 5