FLEET MICRO ENEMA

Main information

  • Trade name:
  • FLEET MICRO ENEMA
  • Dosage:
  • 5 Milligram
  • Pharmaceutical form:
  • Rectal Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FLEET MICRO ENEMA
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0299/014/001
  • Authorization date:
  • 19-11-1996
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FleetMicro-enemaRectalSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each5mldosecontains:

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Rectalsolution

Slightopaquesolutionwithnoparticulatematterorturbidity.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetreatmentofoccasionalconstipationinbedriddenpatientsandgeriatrics.

Useinpaediatricsandobstetricsshouldonlybeundermedicalsupervision.

4.2Posologyandmethodofadministration

Adultsandchildrenaged3yearsandolder:AdministerthecontentsofoneFleetMicro-enemarectally15minutes

beforeeffectiswanted.

Lieonleftsidewithbothkneesbent,armsatrest.

Removeorangeprotectiveshield.

Withsteadypressure,gentlyinsertenemafulllengthintotherectumwithtippointingtowardsnavel.

Squeezetubeuntilcontentsareexpelled.

Discontinueuseifresistanceisencountered.Forcinganenemacanresultininjury.

4.3Contraindications

ItisadvisabletoavoidtheuseofFleetMicro-enemaincasesofhaemorrhoideruptionsandinpatientswith

inflammatoryboweldiseasesoranyacutegastrointestinalconditions.

Donotusewhenthereisahypersensitivitytotheactiveingredientsoranyoftheexcipients.

SodiumCitrate 450mg

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 26/10/2006 CRN 2029443 page number: 1

4.4Specialwarningsandprecautionsforuse

Excessiveusemaycausediarrhoeaandfluidlosswhichshouldbetreatedsymptomatically.

Frequentorprolongeduseofalaxativeformorethanoneweekmayresultindependence.

Rectalbleedingorfailuretohaveabowelmovementafteruseofalaxativemayindicateaseriousproblem.

InsuchcasesFleetMicro-enemashouldnotbeadministeredfurtherandadoctor’sadvicesought.

Thismedicinalproductcontainspropyleneglycolwhichmaycauseskinirritation.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Notapplicable.

4.6Pregnancyandlactation

Thereisnodataontoxicityinanimalsandman,thereforeshouldonlybeusedundermedicalsupervision.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Notapplicable.

4.9Overdose

Notapplicable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ItslaxativeactionisduetothecombinedactionofSodiumCitrate,whichactsbyretainingfluidinthebowelby

osmosisandbychangingthepatternofwaterdistributioninthefaecesandSodiumLaurylSulphoacetate,awetting

agent.

Effectivewithin5-15minutes.

5.2Pharmacokineticproperties

TheingredientscontainedinFleetMicro-enemaarenotabsorbedormetabolised,buteliminatedunchangedwiththe

faeces.

5.3Preclinicalsafetydata

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 26/10/2006 CRN 2029443 page number: 2

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Glycerol

SorbitolLiquid(non-crystallising)

PropyleneGlycol

Carbomer

Nozzlelubricant:whitesoftparaffin

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

FleetMicro-enemaisavailableinadisposable5mltube.Fingerguard,capandprotectivesheatharemadefromLDPE

whilethesoftpre-lubricatednozzle(Comfortip)ismadefromethylenevinylacetate.

The5mltubesareavailableinpacksizesof1,4,6and12.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

ECDeWitt&CompanyLimited

TudorRoad

ManorPark

Runcorn

Cheshire

WA71SZ

England

8MARKETINGAUTHORISATIONNUMBER

PA299/14/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:19November1996

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 26/10/2006 CRN 2029443 page number: 3

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 26/10/2006 CRN 2029443 page number: 4