DIARREST RF

Main information

  • Trade name:
  • DIARREST RF
  • Dosage:
  • 1/40/50/50 MG/5ml
  • Pharmaceutical form:
  • Oral Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DIARREST RF
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0185/036/001
  • Authorization date:
  • 27-11-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DiarrestOralSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Activeingredients:

Each5mlcontains:

Equivalenttoapproximately:

Forexcipientssee6.1.

3PHARMACEUTICALFORM

OralSolution

Strawcolouredliquidwithacreamsoda/orangeodour.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Adults:

Asanadjunctinthemanagementofacutediarrhoeatogetherwithappropriatefluidandelectrolytereplacement.

Inthesymptomaticcontrolofdiarrhoeaassociatedwithchronicinflammatoryboweldisease,e.g.Crohn'sdisease

andulcerativecolitis;asanadjuncttospecificmeasuressuchascorticosteroidsandsulphasalazine.Useinthese

conditionsshouldbeunderspecialistsupervision.

Intheadjunctiveshort-termcontrolofpostsurgicaldiarrhoea,includingileostomy.

Children:

Fortheoccasionaluseinthecontrolofintractablediarrhoeaunderspecialistsupervision.Sincepersistent

diarrhoeamaybeanindicatorofapotentiallyseriouscondition,theunderlyingcausemustalwaysbeinvestigated.

4.2Posologyandmethodofadminstration

Loperamidehydrochloride 1.0 mg

Potassiumchloride 40.0 mg

Sodiumchloride 50.0 mg

Sodiumcitrate 50.0 mg

Potassium 0.5 mmol/5ml

Sodium 1.4 mmol/5ml

Irish Medicines Board

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Date Printed 20/06/2006 CRN 2024590 page number: 1

DiarrestOralSolutionadministrationshouldbeaccompaniedbyanadequatedailyfluidintake.

Ifnoimprovementintheconditionofthepatientisseenwithintwodaysofcommencingtreatmentthenfurther

investigationintotheunderlyingcauseofthediarrhoeashouldbeperformed.

Adults,theelderlyandchildrenover12years:

Initiallytwotofour5mlspoonfulsshouldbetakenfollowedbytwo5mlspoonfulsthreetimesdaily.

Nomorethanten5mlspoonfulsofDiarrestOralSolutionshouldbetakendaily.

Childrenunder12years:

Notrecommended,exceptunderspecialistsupervisionforoccasionaluseinthecontrolofintractablediarrhoea.

Thedosagemayneedtobeadjustedforpatientswithhepaticimpairment.

4.3Contraindications

Aswithanyothermedicamentloperamideshouldnotbegiventopatientswhoexhibitahypersensitivityreaction.

Itshouldnotbeadministeredtochildrenlessthan12yearsofage.

Loperamideshouldnotbeusedinconditionswerethereisaneedforperistalsis,e.g.:

whenconstipationorileusispresent

whenabdominaldistensiondevelops

inpatientswithacuteulcerativecolitisorpseudomembranouscolitisassociatedwithbroadspectrumantibiotics

Loperamideshouldnotbeusedaloneincasesofacutedysentery.

4.4Specialwarningsandprecautionsforuse

Careshouldbetakenwhenadministeringloperamidetopatientswithhepaticdysfunctionbecauseofits

considerablefirst-passmetabolismintheliver.Inthecaseofliverdysfunction,relativeoverdosemayoccur.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nointeractionshavebeenreportedforloperamide.

4.6Pregnancyandlactation

Althoughstudiesinanimalshavenotcontainedanyreportsofteratogenicityforloperamide,itshouldnotbeused

inpregnancyasnospecificstudiesconcerningitseffectonthehumanfoetusareavailable.Althoughthe

concentrationsofloperamideexcretedinbreastmilkareextremelylow,itshouldonlybeadministeredtobreast

feedingmothersifconsideredessentialbythephysician.

4.7Effectsonabilitytodriveandusemachines

Irish Medicines Board

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Date Printed 20/06/2006 CRN 2024590 page number: 2

4.8Undesirableeffects

Reportedadverseeventshaveincludedparalyticileus(paralysisoftheintestinalmuscle),abdominalcrampsand

bloating.Loperamidemayalsocauseskinreactionsincludingurticaria,nausea,vomiting,constipation,tiredness,

drowsiness,dizzinessanddrymouth.

4.9Overdose

Loperamideoverdosagecancauseconstipation,ileus,miosis,muscularhypertonia,sleepinessandbradypnoea.These

effectscanbereversedusingtheopioidantagonistnaloxone.Patientsshouldbemonitoredforatleast48hoursafter

naloxoneadministration,especiallychildrenandpatientswithhepaticdysfunction.Gastriclavage,orinducedemesis

and/orenemaorlaxativesmayberecommended.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Loperamideisapiperidinederivativewithantidiarrhoealactivity.Itisusedinthemanagementofdiarrhoea.

Loperamidebindstoopioidreceptorsinthegutwall,inhibitingperistalsisandintestinalsecretions.

5.2Pharmacokineticproperties

Loperamideisnotwellabsorbedafteroraladministrationwithabout40%ofadoseabsorbedfromthegastro-intestinal

tract.Peakplasmaconcentrationsaredetectedabout4hoursafteringestion.Loperamideismainlymetabolisedinthe

liver.Eliminationisessentiallyviathefaecesthoughsomeloperamideisexcretedintheurine.Theeliminationhalf-life

is7-14hours.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Ethanol96%

Glycerol

Propyleneglycol

Sodiumpropylhydroxybenzoate(E217)

Sodiumethylhydroxybenzoate

Sodiummethylhydroxybenzoate(E219)

Saccharinsodium

Citricacidmonohydrate

Sunsetyellow(E110)

Creamsodaflavour

Orangeflavour

Purifiedwater

Each5mlspoonfulcontains36.3mgofsodium

6.2Incompatibilities

Irish Medicines Board

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Date Printed 20/06/2006 CRN 2024590 page number: 3

6.3ShelfLife

24months.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

6.5Natureandcontentsofcontainer

AmberglassbottleswithpolypropylenecapsandHighDensityPolyethylene(HDPE)containerswithpolyvinyl

chloride(PVC)capscontainingastrawcolouredliquidwithacreamsoda/orangeodourandflavour.

Packsizes:100,150and200ml.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

GalenLimited

SeagoeIndustrialEstate

Craigavon

BT635UA

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA185/36/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:27November1998

Dateoflastrenewal:27November2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 20/06/2006 CRN 2024590 page number: 4