FLETCHERS' PHOSPATE

Main information

  • Trade name:
  • FLETCHERS' PHOSPATE
  • Dosage:
  • 10%w/ v, 8%
  • Pharmaceutical form:
  • Enema
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FLETCHERS' PHOSPATE
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1161/007/001
  • Authorization date:
  • 28-03-2008
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA1161/007/001

CaseNo:2046426

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

TransferredfromPA0100/027/002.

ChemidexPharmaLimited

ChemidexHouse,EghamBusinessVillage,CrabtreeRoad,Egham,SurreyTW208RB,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Fletchers'PhosphateEnema

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom28/03/2008until22/06/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 29/03/2008 CRN 2046426 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Fletchers’PhosphateEnema

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Thesolutioncontains:

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Rectalsolution.

Aclear,colourlessliquid.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forevacuationofthecoloninconstipation,priortosurgicalanddiagnosticproceduresandinobstetricspriorto

delivery.

4.2Posologyandmethodofadministration

Forrectaluseonly.

Adults:Theusualdoseisoneenemaasrequired.

Children(over3years):Inproportionaccordingtobodyweight.

Children(under3years):Notrecommended.

4.3Contraindications

1.Useinpatientswithinflammatoryorulcerativeconditionsofthelargebowel,orinthosewithincreasedcolonic

absorptivecapacity.

2.Useinpatientswithacutegastro-intestinalconditions.

4.4Specialwarningsandprecautionsforuse

1.Prolongedusemayleadtoirritationoftheanalcanal.

2.Thisproductshouldbeusedwithgreatcautioninpatientsrequiringareducedsodiumintake,andelectrolyte

balanceshouldbemaintainedduringextendeduse.

3.Therehavebeenoccasionalreportsofvasovagalattacksoccurringinelderlypatientsfollowingtheadministration

ofphosphateenema.

Careshouldbetakennottouseundueforceinadministrationoftheenemaespeciallyinelderlyordebilitatedpatients

SodiumDihydrogenPhosphateDihydrate 10 %w/v

Irish Medicines Board

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Date Printed 29/03/2008 CRN 2046426 page number: 2

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown

4.6Pregnancyandlactation

Nospecialwarnings

4.7Effectsonabilitytodriveandusemachines

Notapplicable

4.8Undesirableeffects

Therehavebeenoccasionalreportsofapparentvasovagalattacksoccurringinelderlypatientsfollowingadministration

ofphosphateenema.

4.9Overdose

Therehavebeennocasesofoverdose.Intheeventofoverdosages,electrolytelevelsshouldbemonitoredandbalance

restoredwhereappropriate.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

TheactiveingredientsofFletchers’PhosphateEnemaaresodiumdihydrogenphosphatedihydrateanddisodium

phosphatedodecahydrate,bothofwhicharelaxatives.Theseactiveingredientsexerttheirlaxativeeffectsuponthe

lowerintestineviatheirosmoticpropertiesfollowingrectaladministration.

5.2Pharmacokineticproperties

Salinelaxativesarepoorlyandslowlyabsorbedfromtheintestinefollowingrectaladministration.SinceFletchers’

PhosphateEnemaispresentedasasingledoseenemaforrectaladministration,onlyminimalabsorptionislikelyto

occur.

5.3Preclinicalsafetydata

Therearenopreclinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

BenzalkoniumChloride

DisodiumEdetate

PurifiedWater

6.2Incompatibilities

Irish Medicines Board

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6.3ShelfLife

PVCBag: 1year

LDPEBottle: 3years

6.4Specialprecautionsforstorage

Donotstoreabove25 o

6.5Natureandcontentsofcontainer

1.Neutral,translucent,plasticisedPVCenemabagswithPVCnozzle,thelongtubeformhasaweldedtubebetween

thebagandnozzle.Individuallypackedinasealedpolypropylenebag.Packsize:128ml.

2.AnLDPEbottlewithaPVCorLDPEnozzle,rubbernon-returnvalve,andplasticovercap.Thenozzletobe

lubricatedwithWhiteSoftParaffinBP.Individuallypackedinacardboardcarton.Packsize:128ml.Thelong

tubeversionissuppliedwithaseparateapplicatorwithextensiontubeforattachmentbeforeuse.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

ChemidexPharmaLimited

ChemidexHouse

EghamBusinessVillage

CrabtreeRoad

Egham

Surrey

TW208RB

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA1161/7/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:23 rd

June1983

Dateoflastrenewal:23 rd

June2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 29/03/2008 CRN 2046426 page number: 4