FLEET PHOSPHO-SODA 24.4G/ 10.8G ORAL SOLUTION

Main information

  • Trade name:
  • FLEET PHOSPHO-SODA 24.4G/ 10.8G ORAL SOLUTION
  • Dosage:
  • 24.4/ 10.8 Grams
  • Pharmaceutical form:
  • Oral Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FLEET PHOSPHO-SODA 24.4G/10.8G ORAL SOLUTION
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1420/001/001
  • Authorization date:
  • 19-10-2007
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FleetPhospho-soda24.4g/10.8gOralsolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each45mlbottlecontains5.0gsodium.

FleetPhospho-sodacontainsaverysmallamountofethanol.Lessthan100mgperdose

Forafulllistofexcipients,seeSection6.1.

3PHARMACEUTICALFORM

Oralsolution

Clearcolourlesssolutionwithaginger-lemonodour,freefromprecipitationandturbidity.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asabowelcleanserinpreparingthepatientforcolonsurgery,orforpreparingthecolonforx-rayorforendoscopic

examination.

Bowelcleansingagentsarenottobeconsideredastreatmentsforconstipation.

4.2Posologyandmethodofadministration

AdultsOnly:Nottobegiventochildrenundertheageof18years.

Elderlypatients:AsforAdults.

ThetakingofFleetPhospho-soda24.4g/10.8gOralsolutionshouldbestartedthedaybeforethehospitalappointment.

Forhospitalappointmentsbefore12noonthedosageinstructionsformorningappointmentsshouldbefollowedandfor

appointmentsafter12noonthedosageinstructionsforanafternoonappointmentshouldbefollowed.

ORNING A PPOINTMENT :

Daybeforeappointment

7am–Inplaceofbreakfastdrinkatleastonefullglassof“clearliquid”orwater,moreifdesired.

“Clearliquids”includewater,clearsoup,strainedfruitjuiceswithoutpulp,blackteaorblackcoffee,clearcarbonated

andnon-carbonatedsoftdrinks.

Dose–Straightafterwards,dilute45mlinhalfaglass(120ml)coldwater.Drinkthissolutionfollowedbyonefull

per45mldose per1ml

Sodiumdihydrogenphosphatedihydrate 24.4g 0.542g

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Drinkasmuchextraliquidsaspossibletoreplacethefluidslostduringbowelmovements.

1pmlunch–Inplaceoflunchdrinkatleastthreefullglasses(720ml)of“clearliquid”orwater,moreifdesired.

7pmsupper–Inplaceofsupperdrinkatleastonefullglassof“clearliquid”orwater,moreifdesired.

Dose–Straightafterwards,dilute45mlinhalfaglass(120ml)coldwater.Drinkthissolutionfollowedbyonefull

glass(240ml)coldwater,moreifdesired.

Additionalwateror“clearliquids”maybetakenupuntilmidnightifnecessary.

Drinkinglargeamountsofclearliquidsalsohelpsensurethatthebowelwillbecleanfortheprocedure.

FTERNOONAPPOINTMENT :

Daybeforeappointment

1pmlunch–Alightsnackmaybetaken.Afterlunch,nomoresolidfoodmustbetakenuntilafterthehospital

appointment.

7pmsupper–Inplaceofsupperdrinkatleastonefullglassof“clearliquid”orwater,moreifdesired.

Dose–Straightafterwards,dilute45mlinhalfaglass(120ml)coldwater.Drinkthissolutionfollowedbyonefull

glass(240ml)coldwater,moreifdesired.

Drinkasmuchextraliquidsaspossibletoreplacethefluidslostduringbowelmovements.

Duringtheevening,drinkatleastthreefullglassesofwateror“clearliquid”beforegoingtobed.

Dayofappointment

7ambreakfast–Inplaceofbreakfastdrinkatleastonefullglassof“clearliquid”orwater,moreifdesired.

Dose–Straightafterwards,dilute45mlinhalfaglass(120ml)coldwater.Drinkthissolutionfollowedbyonefull

glass(240ml)coldwater

Drinkasmuchextraliquidsaspossibletoreplacethefluidslostduringbowelmovements.Drinkinglargeamountsof

clearliquidsalsohelpsensurethatthebowelwillbecleanfortheprocedure.

Morewateror“clearliquid”maybetakenupuntil8am.

Thisproductnormallyproducesabowelmovementin½to6hours.

Aftertheprocedure:

Inordertoreplacefluidlostduringthepreparationfortheprocedurepatientsshouldbeencouragedtodrinkplentyof

fluidafterwards.

4.3Contraindications

Donotuse:

Inchildrenundertheageof18years.

Whennausea,vomitingorabdominalpainarepresent.

Thereisahypersensitivitytotheactiveingredientsoranyofexcipients.

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Clinicallysignificantimpairmentofrenalfunction;

Primaryhyperparathyroidismassociatedwithhypercalcaemia

Congestiveheartfailure;

Ascites;

Knownorsuspectedgastrointestinalobstruction;

Megacolon(congenitaloracquired);

Perforation;

Ileus;

Activeinflammatoryboweldisease.

FleetPhospho-soda24.4g/10.8gOralsolutionshouldnotbeusedincombinationwithotherlaxativeproducts

containingsodiumphosphate

4.4Specialwarningsandprecautionsforuse

Dehydration

Thisproductusuallyworkswithin½to6hours.Iftherehasbeennobowelmovementwithin6hoursoftakingFleetPhospho-

soda,instructthepatienttostopuseandcontactadoctorimmediatelyasdehydrationcouldoccur.

Patientsshouldbewarnedtoexpectfrequent,liquidstools.Patientsshouldbeencouragedtodrinkasmuchliquidaspossibleto

helppreventdehydration.Inadequatefluidintakewhenusinganyeffectivepurgativemayleadtoexcessivefluidlosspossibly

producingdehydrationandhypovolemia.Dehydrationandhypovolemiafrompurgationmaybeexacerbatedbyinadequateoral

fluidintake,nausea,vomiting,lossofappetite,oruseofdiuretics,angiotensinconvertingenzymeinhibitors(ACE-Is),angiotensin

receptorblockers(ARBS),andnon-steroidalanti-inflammatorydrugs(NSAIDs)andmaybeassociatedwithacuterenalfailure.

Therehavebeenrarereportsofacuterenalfailurewithpurgatives,includingsodiumphosphatesandPEG-3350.

Patientswithconditionsthatmaypredisposetodehydrationorthosetakingmedications

whichmaydecreaseglomerularfiltrationrate,shouldbeassessedforhydrationstatuspriortouseofpurgativepreparationsand

managedappropriately.

Nephrocalcinosis

Nephrocalcinosisassociatedwithacuterenalfailureanddepositsofcalcium-phosphatecrystalsintherenaltubuleshasbeen

rarelyreportedinpatientsusingsodiumphosphatesforbowelcleansing;Nephrocalcinosisisaseriousadverseeventthatmay

resultinpermanentrenalfunctionimpairmentandtherequirementoflong-termdialysis.Themajorityofthesereportsoccurredin

elderlyfemalepatientstakingdrugstotreathypertensionorotherdrugproducts,suchasdiureticsorNSAIDs,thatmayresultin

dehydration.

CareshouldbetakentoprescribeFleetPhospho-sodaperrecommendationswithaparticularattentiontoknowncontraindications

andadequatehydration.

Atriskpatients

Usewithcautioninpatientswithanincreasedriskforunderlyingrenalimpairment,pre-existingelectrolytedisturbances,

FleetPhospho-soda24.4g/10.8gOralsolutionhasbeenrarelyassociatedwithsevereand

potentiallyfatalcasesofelectrolytedisordersinelderlypatients.Thebenefit/riskratioof

FleetPhospho-soda24.4g/10.8gOralsolutionneedstobecarefullyconsideredbefore

initiatingtreatmentinthisat-riskpopulation.

SpecialattentionshouldbetakenwhenprescribingFleetPhospho-soda24.4g/10.8gOral

solutiontoanypatientwithregardtoknowncontraindicationsandtheimportanceof

adequatehydrationand,inat-riskpopulations(seebelowandsections4.2and4.3.),the

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hypertensionorotherconditionsinwhichthepatientsaretakingproductsthatmayresultindehydration,seebelow),hypotension

withclinicalimpactorassociatedwithhypovolaemia,heartdisease,acutemyocardialinfarction,unstableangina,orwith

debilitatedorelderlypatients.Intheseat-riskpatients,considerobtainingbaselineandpost-treatmentsodium,potassium,

calcium,chloride,bicarbonate,phosphate,bloodureanitrogenandcreatininevalues.

Electrolytedisorders

Thereisariskofelevatedserumlevelsofsodiumandphosphateanddecreasedlevelsofcalciumandpotassium;consequently

hypernatraemia,hyperphosphataemia,hypocalcaemia,hypokalaemia,andacidosismayoccur.

SlightQTintervalprolongationmayrarelyoccurasaresultofelectrolyteimbalancessuchashypocalcaemiaorhypokalaemia.

Thesechangesareclinicallyinsignificant.

Hypomotility

Usewithcautioninpatientswithhypomotilitydisordersorwhohavehadgastro-intestinalsurgeryorhaveothermedical

conditionspredisposingthemtohypomotilitydisorders.Ifthepatienthashadacolostomyorileostomy,ormustkeeptoasalt-

freediet,thepreparationmustbeusedwithcaution,sinceadisturbanceofelectrolytebalance,dehydrationoradisturbanceof

acidbalancemayarise.

Lesions

Singleormultipleaphthoid-likepunctiformlesionslocatedintherectosigmoidregionhavebeenobservedbyendoscopy.These

wereeitherlymphoidfolliclesordiscreteinflammatoryinfiltratesorepithelialcongestions/changesrevealedbythecolonic

preparation.Theseabnormalitiesarenotclinicallysignificantanddisappearspontaneouslywithoutanytreatment.

Sodiumcontent

FleetPhospho-sodacontains5.0gsodiumineach45mldose.Considerationshouldthereforebegiventothepotentialharmto

patientsrequiringalow-sodiumdiet.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Usewithcautioninpatientstakingcalciumchannelblockers,diuretics,lithiumtreatmentorothermedicationsthat

mightaffectelectrolytelevelsashyperphosphataemia,hypocalcaemia,hypokalaemia,hypernatraemicdehydrationand

acidosismayoccur.

DuringtheintakeofFleetPhospho-soda24.4g/10.8gOralsolutiontheabsorptionofdrugsfromthegastrointestinal

tractmaybedelayedorevencompletelyprevented.Theefficacyofregularlytakenoraldrugs(e.g.oralcontraceptives,

antiepilepticdrugs,antidiabetics,antibiotics)maybereducedorcompletelyabsent.Cautionisalsoadvisedwhen

takingmedicinesknowntoprolongtheQTinterval.

Usewithcautioninpatientswhoaretakingparathyroidhormonemedications.

4.6Fertility,pregnancyandlactation

ForFleetPhospho-soda24.4g/10.8gOralsolution,noclinicaldataonexposedpregnanciesandnodatafromanimal

studieswithrespecttoeffectsonpregnancy,embryonal/fetaldevelopment,parturitionandpostnataldevelopmentare

available.Thepotentialriskforhumansisunknown.FleetPhospho-soda24.4g/10.8gOralsolutionshouldnotbeused

duringpregnancyunlessclearlynecessary.

ItisnotknownwhetherFleetPhospho-soda24.4g/10.8gOralsolutionisexcretedinhumanmilk.Assodium

phosphatemaypassintothebreastmilk,itisadvisedthatbreastmilkisexpressedanddiscardedfromthefirstdoseto

24hoursaftertheseconddoseofthebowelcleansingsolution.Womenshouldnotbreast-feedtheirinfantsuntil24

hoursafterreceivingtheseconddoseofFleetPhospho-soda24.4g/10.8gOralsolution.

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FleetPhospho-soda24.4g/10.8gOralsolutionmaycausedizziness,probablyasaresultofdehydration,andthismay

haveamildtomoderateeffectontheabilitytodriveorusemachinery.

4.8Undesirableeffects

Thefollowingadversereactionswerereportedwithfrequenciescorrespondingto:Verycommon(1/10),Common

(1/100,<1/10),Uncommon(1/1,000,<1/100),Rare(1/10,000,<1/1,000),Veryrare(1/10,000).Withineach

frequencygrouping,undesirableeffectsarepresentedinorderofdecreasingseriousness.

IMMUNESYSTEMDISORDERS

Veryrare

Hypersensitivity

METABOLISMANDNUTRITIONDISORDERS

Uncommon

Dehydration

Veryrare

Hyperphosphataemia

Hypocalcaemia

Hypokalaemia

Hypernatraemia

Metabolicacidosis

Tetany

NERVOUSSYSTEMDISORDERS

Verycommon

Dizziness

Common

Headache

Veryrare

Lossofconsciousness

Paraesthesia

CARDIACDISORDERS

Veryrare

Myocardialinfarction

Arrhythmia

VASCULARDISORDERS

Veryrare

Hypotension

GASTROINTESTINALDISORDERS

Verycommon

Diarrhoea

Abdominalpain

Abdominaldistension

Nausea

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4.9Overdose

Therehavebeenfatalcasesofhyperphosphataemiawithconcomitanthypocalcaemia,hypernatraemiaandacidosis

whenFleetPhospho-soda24.4g/10.8gOralsolutionhasbeenusedinexcessivedoses,giventochildrenortoobstructed

patients.

Patientsexperiencingoverdosehavepresentedthefollowingsymptoms:dehydration,hypotension,tachycardia,

bradycardia,tachypnoea,cardiacarrest,shock,respiratoryfailure,dyspnoea,convulsions,ileusparalytic,anxiety,

pain.Overdosescanleadtoelevatedserumlevelsofsodiumandphosphateanddecreasedlevelsofcalciumand

potassium.Inthosecases,hypernatremia,hyperphosphatemia,hypocalcemia,hypokalemia,andacidosismayoccur.

TherearealsodocumentedcasesofcompleterecoveryfromoverdosesinbothchildrenaccidentallygivenFleet

Phospho-soda24.4g/10.8gOralsolution,andalsoinpatientswithobstruction,oneofwhomreceivedasix-fold

overdose.

Recoveryfromthetoxiceffectofexcessingestioncannormallybeachievedbyrehydration,thoughtheintravenous

administrationof10%calciumgluconatemaybenecessary.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

A06AD–Osmoticallyactinglaxative.

Vomiting

Colonoscopiaabnormal(Singleormultipleaphthoid-likepunctiformlesions

locatedintherectosigmoidregionthatarenotclinicallysignificantanddisappear

spontaneouslywithoutanytreatment)

SKINANDSUBCUTANEOUSTISSUEDISORDERS

Veryrare

Dermatitisallergic

MUSCULOSKELETALANDCONNECTIVETISSUEDISORDERS

Veryrare

Musclecramp

RENALANDURINARYDISORDERS

Rare

Nephrocalcinosis

Veryrare

Renalfailureacute

Renalfailurechronic

GENERALDISORDERSANDADMINISTRATIONSITECONDITIONS

Verycommon

Chills

Asthenia

Common

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retentioninthelumenofthesmallintestine.Fluidaccumulationintheileumproducesdistensionand,inturn,

promotesperistalsisandbowelevacuation.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

NoanimalstudiesonreproductiontoxicityhavebeenconductedwithFleetPhospho-soda24.4g/10.8gOralsolution.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Glycerol

SaccharinSodium

SodiumBenzoate(E211)

GingerLemonFlavour*

PurifiedWater

*GingerLemonFlavour:

OleoresinGinger

Alcohol

OilLemon

PartiallyDeterpenatedOilLemon

CitricAcid

Water

6.2Incompatibilities

Notapplicable.

6.3Shelflife

3years.

Onceopeneduseimmediately.Discardanyunusedportion.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

FleetPhospho-soda24.4g/10.8gOralsolutionissuppliedincartonscontaining2x45mlor100x45ml(hospitalpack)

polyethylenebottleswithpolypropylene,aluminiumfoil-linedscrewcaps.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalandotherhandling

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7MARKETINGAUTHORISATIONHOLDER

LaboratoriosCasen-FleetS.L.U.

AutoviadeLogronokm13,300

50180Utebo

Zaragoza

Spain

8MARKETINGAUTHORISATIONNUMBER

PA1420/1/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:06February1998

Dateoflastrenewal:30April2010

10DATEOFREVISIONOFTHETEXT

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