EXPUTEX 250MG / 5ML ORAL SOLUTION

Main information

  • Trade name:
  • EXPUTEX 250MG / 5ML ORAL SOLUTION
  • Dosage:
  • 250 MG/5ml
  • Pharmaceutical form:
  • Oral Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EXPUTEX 250MG / 5ML ORAL SOLUTION
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0488/014/001
  • Authorization date:
  • 17-02-1995
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Exputex250mg/5mlOralSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each5mlofliquidcontains250mgofCarbocisteine.

Excipients:Containssunsetyellow(E110),parahydroxybenzoates(E215,E217,E219),ethanol,andsaltscontaining

sodium.

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

OralSolution.

Aviscous,orangecolouredliquidwithanodourofcondensedmilkandorange.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asamucolyticadjunctforrespiratorytractdisorderscharacterisedbyexcessiveorviscousmucous.

4.2Posologyandmethodofadministration

Fororaladministration

Adults

Theusualdoseisthree5mlspoonfulsthreetimesdailyinitially,reducingtotwo5mlspoonfulsthreetimesdailywhen

asatisfactoryresponsehasbeenobtained.

Children

6-12years: Theusualdoseisone5mlspoonful(250mg)twotothreetimesdaily.

2-5years: Theusualdoseishalfa5mlspoonful(125mg)twotothreetimesdaily.

Under2years:Notrecommended.

4.3Contraindications

UseinpatientswithaknownhypersensitivitytocarbocisteineortoanyoftheexcipientsinExputex.

Useinpatientswithknownactivepepticulceration.

4.4Specialwarningsandprecautionsforuse

Becauseofthepossibleeffectsonthemucousglandsofthestomach,thisproductshouldbeusedwithcautionin

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Exputexcontainsapproximately100mgsodiumper15mldose.Tobetakenintoconsiderationbypatientsona

controlledsodiumdiet.

Exputexcontainsparahydroxybenzoateswhichmaycauseallergicreactions(possiblydelayed).

ExputexcontainssunsetyellowFCF(E110)whichmaycauseallergicreactions.

Exputexcontainssmallamountsofethanol,lessthan100mgperdose.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nonelisted.

4.6Fertility,pregnancyandlactation

Thisproductshouldnotbeusedduringpregnancyunlessconsideredessentialbythephysician.

4.7Effectsonabilitytodriveandusemachines

Nonelisted.

4.8Undesirableeffects

Sideeffectsincludenausea,headache,gastrointestinalupsetandskinrash.

4.9Overdose

Thereisnoexperienceofoverdosingwiththisproductandseriouseffectsarenotexpected.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup: Mucolytic

ATCCode: RO5CB03

Carbocisteineisamucolyticagent.

5.2Pharmacokineticproperties

Carbocisteineisabsorbedfromthegastrointestinaltractandexcretedintheurineasunchangeddrugandmetabolites.

5.3Preclinicalsafetydata

Nonelisted.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Ethanol96%

Saccharinsodium

SunsetyellowFCF(E110)

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Sodiumpropylparahydroxybenzoate(E217)

Sodiummethylparahydroxybenzoate(E219)

Citricacidmonohydrate

Sodiumhydroxide

Carmellosesodium

Glycerol

Levomenthol

Orangeflavour17.40.7040

CondensedmilkflavourF7047

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Twoyears.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

Storethebottleintheoriginalcartoninordertoprotectfromlight.

Onceopenedusewithinonemonth.

6.5Natureandcontentsofcontainer

Amberglassbottlewithpolypropylenecapsasclosures.

Packsizes:100ml,200ml,300ml.

Aspoonwitha2.5mland5mlmeasureissuppliedwithallpacksofthisproduct.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

MonmouthPharmaceuticalsLtd,

HampshireInternationalBusinessPark,

Chineham,

Basingstoke,

Hampshire,

RG248EP,

UnitedKingdom.

8MARKETINGAUTHORISATIONNUMBER

PA488/14/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:20December1985

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10DATEOFREVISIONOFTHETEXT

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Date Printed 07/12/2011 CRN 2085729 page number: 4