CODALAX

Main information

  • Trade name:
  • CODALAX Oral Suspension 200mg/25mg
  • Dosage:
  • 200mg/25mg
  • Pharmaceutical form:
  • Oral Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CODALAX Oral Suspension 200mg/25mg
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1688/003/003
  • Authorization date:
  • 07-01-2011
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CODALAX200mg/25mgper5mlsuspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

5mlofsuspensioncontains200mgPoloxamer188and25mgDantron

Excipients:Each5mlalsocontains:1000mgSorbitolliquid(non-crystallising),0.2ml96%ethanoland10mgNiasept

sodiumcontainingsodiumethyl,methylandpropylparahydroxybenzoates(E215,E219andE217).

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Oralsuspension

Orange-yellowcolouredoralsuspension,withanodourofpeachandasweettaste.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Useonlyinthetreatmentofanalgesicinducedconstipationintheterminallyillpatient.

4.2Posologyandmethodofadministration

Oral.

Adults

Oneortwo5mlspoonfulsdaily.

Children

Halftoone5mlspoonfulsdaily.

4.3Contraindications

Incommonwithothergastro-intestinalevacuants,CODALAXandCODALAXFortesuspensionsshouldnot

begivenwhenacuteorpainfulconditionsoftheabdomenarepresentorwhenthecauseofconstipationis

suspectedtobeintestinalobstruction.

Pregnancy.

Hypersensitivitytoanyoftheconstituentsoftheproduct.

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Oraladministrationofdantronhasbeenreportedtocauseintestinaltumoursinratsandmice.Ithasalsobeen

reportedtobehepatocarcinogenicinratsaswellasinmice.Thereisnosoundevidencetoconcludeanoeffect

doseandthereforetheremaybeariskofsucheffectsinhumans.

Inbabies,childrenandpatientswearingnappies,theremaybestainingofthebuttocks.Thismayleadto

superficialsloughingoftheskin.Therefore,CODALAXandCODALAXFortesuspensionsshouldnotbe

giventoinfantsinnappies,andusedwithcautioninallincontinentpatients.

Patientswithrarehereditaryproblemsoffructoseintoleranceshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Fertility,pregnancyandlactation

CODALAXandCODALAXFortesuspensionsshouldnotbeadministeredduringpregnancyandlactation.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Dantronmaycausetemporaryharmlesspinkorredcolouringoftheurineandperi-analskin.Inprolongedhighdosage,

themucosaofthelargeintestinemaybecomecoloured.

4.9Overdose

Incaseofoverdosagepatientsshouldbegivenplentyoffluids.Ananticholinergicagentsuchasatropinesulphatemay

begiventooffsetexcessiveintestinalmotility.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Dantron,combinations

ATCCode:AO6AB53

CODALAXsuspensionowesitslaxativeactiontothemildpurgativedantron.Thisisananthraquinone,derivative

chemicallyrelatedtoemodin,theactiveprincipleofcascaraandothernaturallyoccurringproductssuchassenna,aloes

andrhubarb.Itactsonthenerveendingsofthemyentericplexusandstimulatesthemusclesofthelargeintestine.

Poloxamer188isawettingagentwhichincreasesthepenetrationofwaterintofaecalmaterial.Thesurfaceactivityof

thepoloxamerhasalubricanteffectonthegutcontents.

5.2Pharmacokineticproperties

Likeotheranthraquinonecompounds,dantronispartiallyabsorbedfromthesmallintestine,whereithasnoaction,and

iscarriedviathecirculationtothelargeintestinewhereitactsonthenerveendingsofthemyentericplexusto

stimulatethemusclesofthelargeintestine.Becauseitdoesnotaffectthesmallintestine,gripingandcrampingdonot

occur.Dantronbeginstoactbetween6and12hoursafteradministration.

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5.3Preclinicalsafetydata

Therearenopre-clinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Butylhydroxytoluene(E321)

Sorbitolliquid(noncrystallising)

Ethanol96%

PropyleneGlycol

Magnesiumaluminiumsilicate

PeachFlavour

Hydroxyethylcellulose

Glycerylmono/di-oleate

Disodiumphosphatedodecahydrate

Niaseptsodiumcontaining:

Sodiummethylparahydroxybenzoate(E219)

Sodiumethylparahydroxybenzoate(E215)

Sodiumpropylparahydroxybenzoate(E217)

CitricAcidmonohydrate

Potassiumsorbate

Saccharinsodium

PotableWater.

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Threeyears.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

C.Storeintheoriginalcontainer.

6.5Natureandcontentsofcontainer

Amberglassbottleswithsteranwaddedmetalclosuresorchild-resistant,tamper-evidentclosurescontaining30ml,

50ml,100ml,250ml,300ml,500mlsuspension.

Amberglassbottleswithblackplasticscrewcapsorchild-resistant,tamper-evidentclosurescontaining1litre

suspension.

AmberPETbottleswithchild-resistant,tamper-evidentclosurescontaining30ml,50ml,100ml,250ml,300mlor1

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Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

MundipharmaPharmaceuticalsLimited

MillbankHouse

ArkleRoad

Sandyford

Dublin18

8MARKETINGAUTHORISATIONNUMBER

PA1688/3/3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:26March1993

Dateoflastrenewal:26March2008

10DATEOFREVISIONOFTHETEXT

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