FLEET READY-TO-USE ENEMA

Main information

  • Trade name:
  • FLEET READY-TO-USE ENEMA
  • Dosage:
  • 21.4/9.4 Grams
  • Pharmaceutical form:
  • Rectal Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FLEET READY-TO-USE ENEMA
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1420/002/001
  • Authorization date:
  • 08-02-2008
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FleetReady-touse21.4g/9.4gEnema

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each118mldosedeliverstheequivalentof21.4g(18.1%w/v)SodiumDihydrogenPhosphateDihydrateand9.4g

(8.0%w/v)DisodiumPhosphateDodecahydrate.

Contains4.4gSodiumper118mldelivereddose.

Excipients:contains70mgbenzalkoniumchlorideper118mldelivereddose.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

RectalSolution(Enema)

Clear,colourless,odourlesssolution,freefromprecipitateandturbidity.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Foruseinthereliefofoccasionalconstipation.

Forusewherebowelcleansingisrequired,suchasbeforeandafterlowerbowelsurgery,deliveryandpost

partum,beforeproctoscopy,sigmoidoscopyandbeforeradiologicalexaminationsofthelowerbowel.

4.2Posologyandmethodofadministration

Posology

Adults,ElderlyandChildrenover12yearsold:1bottle(118mldelivereddose)nomorethanoncedailyorasdirected

byaphysician

Childrenaged3yearstolessthan12years:Asdirectedbyaphysician.

Donotadministertochildrenunder3yearsofage

Methodofadministration

Forrectaluseonly:

Lieonleftsidewithbothkneesbent,armsatrest.

Removeorangeprotectiveshield.

Withsteadypressure,gentlyinsertenemaComfortipintoanuswithnozzlepointingtowardsnavel.

Squeezebottleuntilnearlyallliquidisexpelled.

Discontinueuseifresistanceisencountered.Forcingtheenemacanresultininjury.

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Generally,2to5minutesaresufficienttoobtainthedesiredeffect.Ifdelayeddiscontinuefurtheruseandconsulta

physician

Foroccasionalconstipationrectalenemasaretobeusedtoprovideshort-termreliefonly.

4.3Contraindications

FleetReady-to-UseEnemaiscontraindicatedinpatientswith:

Hypersensitivitytoactiveingredientsortoanyoftheexcipientsoftheproduct.

Conditionscausingdecreasedgastricmotility,e.g.,

Suspectedintestinalobstruction.

Paralyticileus.

Anorectalstenosis.

Imperforateanus.

Congenitaloracquiredmegacolon.

Hirschsprung’sDisease.

Undiagnosedgastrointestinalpathology,e.g.,

symptomsofappendicitis,intestinalperforationoractiveinflammatoryboweldisease.

Undiagnosedrectalbleeding.

Congestiveheartfailure.

Dehydrationandgenerallyinallcaseswhereabsorptioncapacityisincreasedoreliminationcapacityis

decreased.

Childrenunder3yearsofage.

4.4Specialwarningsandprecautionsforuse

DonotuseFleetReady-to-useenemawhennausea,vomitingorabdominalpainispresentunlessdirectedbya

physician.

Patientsshouldbeadvisedtoexpectliquidstoolsandshouldbeencouragedtodrinkclearliquidstohelpprevent

dehydration.

Usewithcautionin:elderlyordebilitatedpatientsandinpatientswithuncontrolledarterialhypertension,ascites,heart

disease,rectalmucosalchanges(ulcers,fissures),colostomyorpre-existingelectrolyteimbalanceashypocalcaemia,

hypokalaemia,hyperphosphataemia,hypernatraemiaandacidosismayoccur.Whereelectrolytedisordersaresuspected

andinpatientswhomayexperiencehyperphosphataemia,electrolytelevelsshouldbemonitoredbeforeandafter

administrationofFleetReady-to-UseEnema.

Theproductshouldbeusedwithcautioninpatientswithabnormalrenalfunction.Wheretheclinicalbenefitis

expectedtooutweightheriskofhyperphosphataemia

RepeatedandprolongeduseofFleetReady-to-UseEnemaisnotrecommendedasitmaycausehabituation.Unless

directedbyaphysician,FleetReady-to-useenemashouldnotbeusedformorethantwoweeks.

RectalbleedingorfailureinbowelevacuationafterusingFleetReady-to-UseEnema(evacuationoccurswithin5

minutesofadministration)mayindicateaseriouscondition.Nofurtheradministrationsshouldbegivenandthe

conditionofthepatientshouldbeassessedbyaphysician.

FleetReady-to-UseEnemashouldbeadministeredfollowingtheinstructionsforuseandhandling(seesection4.2).

Patientsshouldbewarnedtostopadministrationifresistanceisfeltbecauseforcedadministrationmaycauselocal

damage.

Thismedicinecontainsbenzalkoniumchloridewhichisanirritantandmaycauseskinreactions.

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Usewithcautioninpatientstakingcalciumchannelblockers,diuretics,lithiumtreatmentorothermedicationsthat

mightaffectelectrolytelevelsashyperphosphataemia,hypocalcaemia,hypokalaemia,hypernatraemicdehydrationand

acidosismayoccur.

Ashypernatraemiaisassociatedwithlowerlithiumlevels,concomitantuseofFleetRTUEnemaandlithiumtherapy

couldleadtoafallinserumlithiumlevelswithalesseningofeffectiveness.

4.6Fertility,pregnancyandlactation

Asthereisnorelevantdataavailabletoevaluatethepotentialforfoetalmalformationorotherfoetotoxiceffectswhen

administeredduringpregnancyFleetReady-to-UseEnemashouldonlybeusedasdirectedbyaphysicianatthetimeof

deliveryorpostpartum.

Assodiumphosphatemaypassintothebreastmilk,itisadvisedthatbreastmilkisexpressedanddiscardedforupto

24hoursafterreceivingtheFleetReady-to-UseEnema.

4.7Effectsonabilitytodriveandusemachines

Notrelevant.

4.8Undesirableeffects

AdversereactionstoFleetReady-to-UseEnemaarenotknown(cannotbeestimatedfromtheavailabledata)andare

presentedbelowbySystemOrganClassandPreferredterm.

IMMUNESYSTEMDISORDERS Hypersensitivity

e.g.urticaria,pruritus

METABOLISMANDNUTRITION

DISORDERS Dehydration

Hyperphosphataemia

Hypocalcaemia

Hypokalaemia

Hypernatraemia

Metabolicacidosis

GASTROINTESTINALDISORDERS Nausea

Vomiting

Abdominalpain

Abdominaldistension

Diarrhoea

Gastrointestinalpain

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IncontactwithskinFleetReady-to-UseEnemamaycauserectalirritation,blistering,stinging,pruritus,orpain.

4.9Overdose

TherehavebeenfatalitieswhenFleetReady-to-useEnemahasbeenadministeredinexcessivedosesorretained,used

inchildrenorusedinobstructedpatients.

Hyperphosphataemia,hypocalcaemia,hypernatraemia,hypernatraemiadehydration,acidosisandtetanymayoccurin

overdoseorretention.

Recoveryfromthetoxiceffectscannormallybeachievedbyrehydration.Inseverecasescorrectionofelectrolyte

changesbyprovidingcalciumandmagnesiumsalts(10%calciumgluconate)whilepromotingeliminationof

exogenousphosphorusandtheuseofdialysisshouldbeconsidered.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCclassification:A06AG01Sodiumphosphateenema.

FleetReady-to-UseEnemawillactasasalinelaxativewhenadministeredbytherectalroute.Fluidaccumulationinthe

lowerbowelproducesdistensionandpromotesperistalsisandbowelmovementwithonlytherectum,sigmoidandpart

orallofthedescendingcolonbeingevacuated.

5.2Pharmacokineticproperties

Colonicabsorptionisprobablyminimal,butithasbeenreportedthatasymptomatichyperphosphataemiaupto2–3

timesabovenormalphosphoruslevelsoccursinnearly25%ofindividualswithnormalrenalfunctionafter

administrationofORALsodiumphosphatecontainingcolonicpreparations.Undernormalconditionsthegreatest

phosphorusabsorptionoccursinthesmallbowelwhichisneverreachedfromrectaladministration.

5.3Preclinicalsafetydata

INJURY,POISONINGAND

PROCEDURALCOMPLICATIONS Blister

GENERALDISORDERSAND

ADMINISTRATIONSITE

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

DisodiumEdetate

BenzalkoniumChloride

PurifiedWater

Nozzlelubricant:WhiteSoftParaffin

6.2Incompatibilities

Notapplicable.

6.3Shelflife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25ºC.

Donotrefrigerate.

6.5Natureandcontentsofcontainer

FleetReady-to-UseEnemaissuppliedina133mldisposableLDPEsqueezebottle,fittedwithaLDPEcap,

neoprene/isoprenefree-latexvalveandasoftpre-lubricatedComfortip(ethylenevinylacetate),whichiscoveredbya

protectiveLDPEshielduntiluse.

Thebottlecontains133mlofFleetReady-to-UseEnema,whichgivesadelivereddoseof118ml.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

LaboratoriosCasen-FleetS.L.U.

AutoviadeLogro ñokm13,300

50180 Utebo

Zaragoza

Spain

8MARKETINGAUTHORISATIONNUMBER

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:16February1995

Dateoflastrenewal:16February2010

10DATEOFREVISIONOFTHETEXT

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