CODALAX FORTE 1000MG/75MG PER 5ML SUSPENSION

Main information

  • Trade name:
  • CODALAX FORTE 1000MG/75MG PER 5ML SUSPENSION
  • Dosage:
  • 1000mg/75mg
  • Pharmaceutical form:
  • Oral Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CODALAX FORTE 1000MG/75MG PER 5ML SUSPENSION
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1688/003/004
  • Authorization date:
  • 07-01-2011
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CodalaxForte1000mg/75mgper5mlsuspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

5mlofsuspensioncontains1000mgPoloxmer188and75mgDantron.

Excipients:Each5mlalsocontain:1000mgSorbitolliquid(non-crystallising),0.2ml96%ethanoland10mgNiasept

sodiumcontainingsodiumethyl,methylandpropylparahydroxybenzoate(E215,E219andE217)

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Oralsuspension.

Orange-yellowcolouredoralsuspension,withanodourofpeachandasweettaste.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Useonlyinthetreatmentofanalgesicinducedconstipationintheterminallyillpatient.

4.2Posologyandmethodofadministration

Oral

AdultsandElderly

One5mlspoonfulsatbedtime.

Children

Notrecommendedforchildrenundertwelveyearsofage.

4.3Contraindications

○Incommonwithothergastro-intestinalevacuants,CODALAXandCODALAXFortesuspensionsshouldnotbe

givenwhenacuteorpainfulconditionsoftheabdomenarepresentorwhenthecauseofconstipationissuspectedto

beintestinalobstruction.

○Pregnancy.

○Hypersensitivitytoanyoftheconstituentsoftheproducts.

4.4Specialwarningsandprecautionsforuse

○Oraladministrationofdantronhasbeenreportedtocauseintestinaltumoursinratsandmice.Ithasalsobeen

reportedtobehepatocarcinogenicinratsaswellasinmice.Thereisnosoundevidencetoconcludeanoeffect

doseandthereforetheremaybeariskofsucheffectsinhumans.

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sloughingoftheskin.Therefore,CODALAXandCODALAXFortesuspensionsshouldnotbegiventoinfantsin

nappies,andusedwithcautioninallincontinentpatients.

○Patientswithrarehereditaryproblemsoffructoseintoleranceshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Fertility,pregnancyandlactation

CODALAXandCODALAXFortesuspensionsshouldnotbeadministeredduringpregnancyandlactation.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Dantronmaycausetemporaryharmlesspinkorredcolouringoftheurineandperi-analskin.Inprolongedhigh

dosage,themucosaofthelargeintestinemaybecomecoloured.

4.9Overdose

Incaseofoverdosagepatientsshouldbegivenplentyoffluids.Ananticholinergicagentsuchasatropinesulphatemay

begiventooffsetexcessiveintestinalmotility.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Dantron,combinations

ATCcode:A06AB53

CODALAXFortesuspensionowesitslaxativeactiontothemildpurgativedantron.Thisisananthraquinone,

derivativechemicallyrelatedtoemodin,theactiveprincipleofcascaraandothernaturallyoccurringproductssuchas

senna,aloesandrhubarb.Itactsonthenerveendingsofthemyentericplexusandstimulatesthemusclesofthelarge

intestine.

Poloxamer188isawettingagentwhichincreasesthepenetrationofwaterintofaecalmaterial.Thesurfaceactivityof

thepoloxamerhasalubricanteffectonthegutcontents.

5.2Pharmacokineticproperties

Likeotheranthraquinonecompounds,dantronispartiallyabsorbedfromthesmallintestine,whereithasnoaction,and

iscarriedviathecirculationtothelargeintestinewhereitactsonthenerveendingsofthemyentericplexusto

stimulatethemusclesofthelargeintestine.Becauseitdoesnotaffectthesmallintestine,gripingandcrampingdonot

occur.Dantronbeginstoactbetween6and12hoursafteradministration.

Poloxamer188,anon-ionicsurfactantisnotabsorbedandisfullyrecoveredinthefaeces.

5.3Preclinicalsafetydata

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sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Butylhydroxytoluene(E321)

Sorbitolliquid(noncrystallising)

Ethanol96%

PropyleneGlycol

Magnesiumaluminiumsilicate

PeachFlavour

Capsicumoleoresin

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

Amblerglassbottleswithsteranwaddedmetalclosuresorchild-resistant,tamper-evidentclosurescontaining30ml,50

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

Amberglassbottleswithblackplasticscrewcapsorchild-resistant,tamper-evidentclosurescontaining1litre

suspension.

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

litresuspension.

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6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

MundipharmaPharmaceuticalsLimited

MillbankHouse

ArkleRoad

Sandyford

Dublin18

8MARKETINGAUTHORISATIONNUMBER

PA1688/3/4

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:26March1993

Dateoflastrenewal:26March2008

10DATEOFREVISIONOFTHETEXT

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