CODALAX FORTE

Main information

  • Trade name:
  • CODALAX FORTE
  • Dosage:
  • 500mg/37.5 Milligram
  • Pharmaceutical form:
  • Capsules Hard
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CODALAX FORTE
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1688/003/002
  • Authorization date:
  • 20-05-2011
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CODALAXFORTE500mg/37.5mgcapsules

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachcapsulecontains500mgPoloxamer188and37.5mgDantron.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Capsule,hard(capsule)

Opaquegreen/lightbrown,size0,hardgelatincapsulemarked‘CXF’andNAPPinwhite.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Useonlyinthetreatmentofanalgesicinducedconstipationintheterminallyillpatient.

4.2Posologyandmethodofadministration

Recommendeddosage:

Adults

Oneortwocapsulesatbedtime.

Childrenunder12years

Notrecommended.

Elderly

Asrecommendedbythephysician.

4.3Contraindications

Incommonwithothergastro-intestinalevacuants,CODALAXFORTEcapsulesshouldnotbegivenwhen

acuteorpainfulconditionsoftheabdomenarepresentorwhenthecauseoftheconstipationisthoughttobe

intestinalobstruction.

Pregnancyandlactation.

Irish Medicines Board

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Date Printed 23/05/2011 CRN 2099871 page number: 1

4.4Specialwarningsandprecautionsforuse

Oraladministrationofdantronhasbeenreportedtocauseliverorintestinaltumoursinratsandmice.Thereis

nosoundevidencetoconcludeanoeffectdoseandthereforetheremaybeariskofsucheffectsinhumans.

CODALAXFORTEuseshouldthereforeberestrictedtothelicensedindications.

Inbabies,childrenandpatientswearingnappiestheremaybestainingofthebuttocks.Thismayleadto

superficialsloughingoftheskin.Therefore,CODALAXFORTEshouldnotbegiventoinfantsinnappies

andshouldbeusedwithcautioninallincontinentpatients.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nonestated.

4.6Fertility,pregnancyandlactation

CODALAXFORTEcapsulesarecontraindicatedinpregnantwomenandnursingmothers.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Dantronmaycausetemporaryharmlesspinkorredcolouringoftheurineandperi-analskin.Withprolongedhigh

dosagethemucosaofthelargeintestinemaybecomecoloured.

4.9Overdose

Incasesofoverdosage,patientsshouldbegivenplentyoffluids.Ananti-cholinergicpreparationsuchasatropine

sulphatemaybegiventooffsettheexcessiveintestinalmotility.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Dantron,combinations

ATCcode:A06AB53

Dantronisananthraquinonederivative,whichactsonthenerveendingsofthemyentericplexusandstimulatesthe

musclesofthelargeintestine.

Poloxamer188isawettingagent,whichincreasesthepenetrationofwaterintofaecalmaterial.Thesurfaceactivityof

thepoloxamerhasalubricanteffectonthegutcontents.

5.2Pharmacokineticproperties

Likeother,anthraquinonecompounds,dantronispartiallyabsorbedfromthesmallintestine.Becauseitdoesnotaffect

thesmallintestine,gripingandcrampingdonotoccur.Dantronbeginstoactbetween6-12hoursafteradministration.

Irish Medicines Board

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Date Printed 23/05/2011 CRN 2099871 page number: 2

5.3Preclinicalsafetydata

Therearenopre-clinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Butylhydroxytoluene(E321)

Capsuleshell

Contains:

Gelatin

Erythrosine(E127)

Ironoxide(E172)

Indigocarmine(E132)

Titaniumdioxide(E171)

Sodiumlaurilsuphfate

Printingink

OpacodeS-1-7085

Contains:

Shellac

Simeticone

Propyleneglycol(E1520)

Titaniumdioxide(E171)

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Threeyears.

6.4Specialprecautionsforstorage

Donotstoreabove30 o

6.5Natureandcontentsofcontainer

Polypropylenecontainerswithpolyethylenelids

PVdCcoatedPVCblisterpackswithaluminiumbackingfoil.

Packsizesof30and60capsulesandmedicalsamplepacksof4and10capsules.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Irish Medicines Board

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Date Printed 23/05/2011 CRN 2099871 page number: 3

7MARKETINGAUTHORISATIONHOLDER

MundipharmaPharmaceuticalsLimited

MillbankHouse

ArkleRoad

Sandyford

Dublin18

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA1688/003/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:26June1995

Dateoflastrenewal:26March2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 23/05/2011 CRN 2099871 page number: 4