CITRAFLEET

Main information

  • Trade name:
  • CITRAFLEET Powder for Oral Solution
  • Pharmaceutical form:
  • Powder for Oral Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CITRAFLEET Powder for Oral Solution
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1420/003/001
  • Authorization date:
  • 21-08-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CitraFleet,Powderfororalsolutioninsachet

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachsachet(15.08g)containsthefollowingactiveingredients:

Eachsachetalsocontains5mmol(or195mg)potassium(seesection4.4).

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Powderfororalsolution,insachet

Whitecrystallinepowderwithalemonflavour .

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forbowelcleansingpriortoanydiagnosticproceduresrequiringacleanbowele.g.colonoscopyorx-rayexamination.

4.2Posologyandmethodofadministration

Routeofadministration:Oral

Alowresiduedietisrecommendedonthedaypriortothehospitalprocedure.Toavoiddehydrationduringtreatment

withCitraFleet,itisrecommendedtodrinkapproximately250mlperhour,ofwaterorotherclearfluidwhilethe

washouteffectpersists.

Directionsforreconstitution:

Refertosection6.6.

Adults(includingtheelderly)aged18yearsandover:

Onesachetreconstitutedinwaterasdirected,takenbefore8amonthedaybeforetheprocedure.Secondsachet6to8

hourslater.

4.3Contraindications

Hypersensitivitytoanyoftheingredientsoftheproduct,congestivecardiacfailure,severedehydration,

hypermagnesaemia,gastricretention,gastro-intestinalulceration,toxiccolitis,toxicmegacolon,ileus,nauseaand

vomiting,ascites , acutesurgicalabdominalconditionssuchasacuteappendicitisandknownorsuspectedgastro-

Sodiumpicosulfate 10.0mg

Lightmagnesiumoxide 3.5g

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Donotuseinpatientswithrhabdomyolysisaslaxativesmayinducerhabdomyolysisandmaythereforeexacerbatethe

condition.

Donotuseinpatientswithactiveinflammatoryboweldiseasee.g.Crohn’sdisease,ulcerativecolitis.

Inpatientswithseverelyreducedrenalfunction,accumulationofmagnesiuminplasmamayoccur.Another

preparationshouldbeusedinsuchcases.

4.4Specialwarningsandprecautionsforuse

CitraFleetshouldnotbeusedasaroutinelaxative.

CitraFleetcouldrarelyleadtosevereandpotentiallyfatalcasesofelectrolytedisordersinfragileordebilitatedelderly

patients.Therefore,thebenefit/riskratioofCitraFleetneedstobecarefullyconsideredbeforeinitiatingtreatmentin

thisat-riskpopulation.

SpecialattentionshouldbetakenwhenprescribingCitraFleettoanypatientwithregardtoknowncontra-indications

andspecialattentionmadetotheimportanceofadequatehydrationand,inat-riskpopulations(asdefinedbelow),tothe

importanceofalsoobtainingbaselineandpost-treatmentelectrolytelevels.

Elderlyanddebilitatedpatients,andpatientsatriskofhypokalaemiaorhyponatraemia,mayneedparticularattention.

CitraFleetshouldbeusedwithcautioninpatientswithknowndisordersofwaterand/orelectrolytebalanceorondrugs

thatmightaffectwaterand/orelectrolytebalancee.g.diuretics,corticosteroids,lithium(see4.5).

Careshouldalsobetakeninpatientswhohaverecentlyundergonegastrointestinalsurgeryorwhohaverenal

impairment,mildtomoderatedehydration,hypotensionorheartdisease.

Theperiodofbowelcleansingshouldnotexceed24hoursbecauselongerpreparationmayincreasetheriskofwater

andelectrolyteimbalance.

CitraFleetmaymodifytheabsorptionofregularlyprescribedoralmedicationandshouldbeusedwithcautione.g.there

havebeenisolatedreportsofseizuresinpatientsonantiepileptics,withpreviouslycontrolledepilepsy(see4.5and4.8).

Thismedicinecontains5mmol(or195mg)potassiumpersachet.Thisshouldbetakenintoconsiderationbypatients

withreducedkidneyfunctionorpatientsonacontrolledpotassiumdiet.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Asapurgative,CitraFleetincreasesthegastrointestinaltransitrate.Absorptionofotherorallyadministeredmedicines

(e.g.anti-epileptics,contraceptives,anti-diabetics,antibiotics)maythereforebemodifiedduringthetreatmentperiod

(see4.4).Tetracyclineandfluoroquinoloneantibiotics,andpencillamine,shouldbetakenatleast2hoursbeforeand

notlessthan6hoursaftertheadministrationofCitraFleettoavoidchelationwithmagnesium.

TheefficacyofCitraFleetisloweredbybulk-forminglaxatives.

Careshouldbetakenwithpatientsalreadyreceivingdrugswhichmaybeassociatedwithhypokalaemia(suchas

diureticsorcorticosteroids,ordrugswherehypokalaemiaisaparticularriski.e.cardiacglycosides).Cautionisalso

advisedwhenCitraFleetisusedinpatientsonNSAIDsordrugsknowntoinduceSIADHe.g.tricyclicantidepressants,

selectiveserotoninre-uptakeinhibitors,antipsychoticdrugsandcarbamazepineasthesedrugsmayincreasetheriskof

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4.6Fertility,pregnancyandlactation

ForCitraFleetneitherclinicaldataonexposedpregnancynorreproductivetoxicityareavailable.Aspicosulfateisa

stimulantlaxative,forsafetymeasure,itispreferabletoavoidtheuseofCitraFleetduringpregnancy.

ThereisnoexperiencewiththeuseofCitraFleetinnursingmothers.However,duetothepharmacokineticproperties

oftheactiveingredients,treatmentwithCitraFleetmaybeconsideredforfemaleswhoarebreastfeeding.

4.7Effectsonabilitytodriveandusemachines

CitraFleetmaycausefatigueordizziness,probablyasaresultofdehydration,andthismayhaveamildormoderate

effectontheabilitytodriveorusemachinery.

4.8Undesirableeffects

Themostcommonadverseeventsreportedinclinicaltrialsusingthecombinationofsodiumpicosulfateand

magnesiumcitratewererelatedtodirecteffectsonthebowel(abdominalpainandnausea)andtheconsequencesof

diarrhoeaanddehydration(sleepdisturbance,drymouth,thirst,headacheandfatigue).

UndesirableeffectsarepresentedbelowbyMedDRASystemOrganClassandPreferredTerm,usingthefollowing

frequencyconvention:verycommon( 1/10);common( 1/100,<1/10);uncommon( 1/1,000,<1/100).The

frequencycalculationsarebasedondataderivedfromananalysisofclinicalstudies.Undesirableeffectsthatwerenot

reportedintheseclinicaltrialsaredescribedas‘Frequencynotknown’.

Immunesystemdisorders

Frequencynotknown:Anaphylactoidreaction,hypersensitivity

Metabolismandnutritiondisorders

Frequencynotknown:Hyponatraemia

Psychiatricdisorders

Common:Sleepdisorder

Nervoussystemdisorders

Common:Headache

Uncommon:Dizziness

Frequencynotknown:Epilepsy,grandmalconvulsion,convulsion,confusionalstate

Vasculardisorders

Uncommon:Orthostatichypotension

Gastrointestinaldisorders

Verycommon:Abdominalpain

Common:Drymouth,nausea,abdominaldistension,analdiscomfort,proctalgia

Uncommon:Vomiting,faecalincontinence

Frequencynotknown:Diarrhoea*,flatulence

*DiarrhoeaistheprimaryclinicaleffectofCitraFleet

Skinandsubcutaneoustissuedisorders

Frequencynotknown:Rash(includingerythematousandmaculo-papularrash),urticaria,pruritus,purpura

Generaldisordersandadministrationsiteconditions

Common:Thirst,fatigue

Frequencynotknown:Pain

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beenreportsofseizure/grandmalconvulsionwithoutassociatedhyponatraemia(see4.4and4.5).

4.9Overdose

NocasesofoverdosewithCitraFleet,orsimilarcombinationsofsodiumpicosulfateandmagnesiumcitrate,havebeen

reported.However,becauseofitsmodesofaction,anoverdoseofCitraFleetwouldbeexpectedtocauseprofuse

diarrhoeawithdehydrationandelectrolyteloss.Dehydrationcouldalsoleadtoorthostatichypotensionanddizziness.

Dehydrationandelectrolyteimbalancesshouldbecorrectedwithfluidandelectrolytesasnecessary.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

A06AB58-Sodiumpicosulfate,combinations.

TheactivecomponentsofCitraFleetaresodiumpicosulfate,astimulantcathartic,activelocallyinthecolon,and

magnesiumcitratewhichactsasanosmoticlaxativebyretainingmoistureinthecolon.Theactionisofapotent

'washingout'effectcombinedwithperistalticstimulationtoclearthebowelpriortoradiography,colonoscopyor

surgery.Theproductisnotintendedforuseasaroutinelaxative.

5.2Pharmacokineticproperties

Bothactivecomponentsarelocallyactiveinthecolon,andneitherisabsorbedinanydetectableamounts.

Inpatientswithseverelyreducedrenalfunction,accumulationofmagnesiuminplasmamayoccur.

5.3Preclinicalsafetydata

Prenataldevelopmentalstudiesinratsandrabbitsdidnotrevealanyteratogenicpotentialafteroraldosingof

sodiumpicosulfateupto100mg/kg/d,butembryotoxicityhadbeenobservedinbothspeciesatthisdoselevel.Inrats

dailydosesof10mg/kgduringlategestation(fetaldevelopment)andlactationreducedbodyweightsandsurvivalof

theoffspring.Maleandfemalefertilitywasnotaffectedbyoraldosesofsodiumpicosulfateupto100mg/kg.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Potassiumhydrogencarbonate

Saccharinsodium

LemonFlavour(lemonflavour,maltodextrin,tocopherolE307) .

6.2Incompatibilities

Notapplicable

6.3Shelflife

Unopenedsachets:30months.

Useimmediatelyafterreconstitution.

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Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Thepowderissuppliedinunitdosesachetscontaining15.08g.Sachetsarepackagedincartonsof2,50,100,200,500

and1000sachetsor50sachets(hospitalpack).Thesachetisacomplexformedbyapolyesterlayer,anintermediate

aluminiumlayerandaninternalpolyethylenelayer.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalandotherhandling

Directionsforreconstitution:

Reconstitutethecontentsofonesachetinacupofwater(approximately150ml).Theresultingsolutionappears

turbid.Stirfor2-3minutesanddrinkthesolution.Ifitbecomeshot,waituntilitcoolssufficientlytodrink.

7MARKETINGAUTHORISATIONHOLDER

LaboratoriosCasen-FleetS.L.U.

AutoviadeLogronokm13,300

50180Utebo

Zaragoza

Spain

8MARKETINGAUTHORISATIONNUMBER

PA1420/3/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:18April2008

Dateoflastrenewal:7June2010

10DATEOFREVISIONOFTHETEXT

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