CASACOL EXPECTORANT SYRUP

Main information

  • Trade name:
  • CASACOL EXPECTORANT SYRUP
  • Dosage:
  • 20/ 100/ 200 MG/ 5ml
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CASACOL EXPECTORANT SYRUP
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1721/001/001
  • Authorization date:
  • 23-06-2011
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CasacolExpectorantSyrup,

Methoxyphenaminehydrochloride,20mg/5ml

Guaiphenesin,100mg/5ml

SodiumCitrate,200mg/5ml

2QUALITATIVEANDQUANTITATIVECOMPOSITION

AlsocontainsSorbitol(E420),Ponceau4R(E124),Nipasept[methyl(E218),ethyl(E214)andpropyl(E216)

Hydroxybenzoate]

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Syrup.

Apaleredstrawcolouredliquidwithafaintodourofcherry,containedinanamberglassbottle.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Indicatedinthetreatmentofcoughandcongestionassociatedwiththecommoncold,bronchitis,etc

Childrenaged6-12years:Casacolisindicatedforsecondlineuseonly.

4.2Posologyandmethodofadministration

(a)Adults:

Oneortwo5mlspoonfuls3to4timesdaily.

(b)Childrenaged6to12years: 5ml 3to4timesdaily.

Maximumdailydose:20mlsyrup.

Notmorethan4dosesshouldbegiveninany24hours.Donotexceedstateddose.

Useinchildrenagedbetween6-12yearsshouldbeunderthesupervisionofahealthcareprofessional

(doctor/pharmacist).Thedurationofuseshouldberestrictedtonomorethan5days.

Each5mlcontains:

Methoxyphenaminehydrochloride 20 mg

Guaiphenesin 100 mg

Irish Medicines Board

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4.3Contraindications

Coronarythrombosis,hypertension,hyperthyroidism,closed-angleglaucomaandurinaryretention.

Concurrenttreatmentwithmonoamineoxidaseinhibitors,orwithin10daysofstoppingsuchtreatment.

Concurrenttreatmentwithothersympathomimeticdrugs.

Sensitivitytotheactiveingredientsorotherproductexcipients(seesection6.1.)

Inpatientstakinganyothermedicineforcoughandcold.

Childrenundertheageof6years.

4.4Specialwarningsandprecautionsforuse

1.Thispreparationshouldbeusedwithcautioninpatientswithorganicheartdiseaseorwhoarereceiving

digitalistherapy.

2.Thepreparationmayprecipitateurinaryretention.

3.Patientswithprostatichypertrophymayhaveincreaseddifficultywithmicturition.

4.Thisproductmayactasacerebralstimulantgivingrisetoinsomnia,nervousness,tremorandepileptiform

convulsions.

5.Thephysicianofpharmacistshouldreassurehimselfthatsympathomimeticcontainingpreparationsarenot

simultaneousadministeredbyseveralroutesi.e.orallyandtopically(nasal,auralandeyepreparations).

6.Patientswithrarehereditaryproblemsoffructoseintoleranceshouldnottakethismedicine.

7.Thispreparationshouldbeusedwithcautioninpatientswithporphyriabecauseguiaphenesinhasbeenshown

tobeporphyrinogenicinanimals.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Concomitantuseofthisproductwithsympathomimeticagents,suchasdecongestants,tricyclicantidepressants,

appetitesuppressantsandamphetamine-likepsychostimulantsorwithMonoamineOxidaseinhibitorswhichinterfere

withthecatabolismofsympathomimeticamines,mayoccasionallycauseariseinbloodpressure.

TheuseofCasacolinpatientscurrentlyreceivingorwhohavereceivedwithin10daysmonoamineoxidaseinhibitors

iscontraindicated(seesection4.3).

Thisproductshouldbeusedwithcautioninpatientsreceivingdigitalistherapy,beta-adrenergicblockers,guanethidine,

resperine,methyldopaoranti-hypertensiveagents.

Citratesaltstakenorallycanenhancetheabsorptionofaluminiumfromthegastrointestinaltract.Patientswithimpared

renalfunctionareparticularlysusceptibletoaluminiumaccumulationandshouldavoidcitratecontainingoral

preparations.

Concurrentusewithhalogenatedanaestheticagentssuchaschloroform,cyclopropane,halothane,enfluraneor

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4.6Fertility,pregnancyandlactation

TherearenoadequatedatafromtheuseofCasacolinpregnantorlactatingwomen.Casacolshouldnotbeusedduring

pregnancyunlessclearlynecessary.

4.7Effectsonabilitytodriveandusemachines

Casacoldoesnotnormallyproduceanyeffectsonabilitytodriveorusemachines.

4.8Undesirableeffects

Casacolmayoccasionallygiverisetocentralnervoussystemstimulation,e.g.insomnia,nervousness,tremorand

epileptiformconvulsions.

Inadditionallergicreactions,urticaria,skinrashes(withorwithoutirritation),itching,gastro-intestinaldiscomfortand

urinaryretentionmayoccur.

CasacolcontainstheactiveingredientsmethoxyphenamineHCl,guaiphenesinandsodiumcitrate.Methoxiphenamine

isasympathomimeticmixed-actingagentandthefollowingadditionaladversereactionshavebeenreportedforother

sympathomimetics:tachycardia,impairedcirculationtotheextremities,hypertension,andcardiacarrhythmias.

Guaiphenesin,hasbeenreportedtocausegastro-intestinaldiscomfort,nauseaandvomiting,andoccasionallyrash,

urticaria,dizzinessandheadache.

4.9Overdose

TheeffectsofacutetoxicityfromCasacolmayincludegastro-intestinaldiscomfort,nausea,vomiting,irritability,

restlessness,tremor,convulsions,palpitations,hypertensionanddifficultywithmicturition.Necessarymeasuresshould

betakentomaintainandsupportrespirationandcontrolconvulsions.Gastriclavageshouldbeperformedifindicated.

Catheterisationofthebladdermaybenecessaryifindicated.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup–ATCR05CA03,expectorants,excludingcombinationswithcoughsuppressants.

Methoxyphenaminehydrochlorideisasympathomimeticagentwithpreferentialactivityonbeta-2receptors.

Guaiphenesinisanexpectorantthatreducestheviscosityoftenacioussputum.

MechanismofAction

Methoxyphenaminehydrochlorideisadirectactingsympathomimeticagentwitharelativelyselectiveactiononbeta-2

adrenoceptors.Stimulationofbeta-2 adrenoceptorsresultsinbronchodilation.

5.2Pharmacokineticproperties

GeneralCharacteristicsoftheActiveSubstances

MethoxyphenaminehydrochlorideismetabolisedinthelivertoO-desmethylmethoxyphenamine,N-

desmethylmethoxyphenamine,and5-hydroxymethoxyphenamine.ThisismediatedatleastinpartbyanNADPH

dependentCP

system.

Guaiphenesinisreadilyabsorbedfromthegastrointestinaltractandisreadilymetabolisedandexcretedintheurine.The

majorurinarymetaboliteisbeta-(2-methoxyphenoxy)lacticacid.Guaiphenesinhasaplasmahalf-lifeofonehour.

Sodiumcitrateismetabolised,followingabsorption,tosodiumbicarbonateandintheabsenceofadeficitofbicarbonatein

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5.3Preclinicalsafetydata

Notrelevant.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Propyleneglycol

Saccharinsodium

Nipasept(methyl(E218),ethyl(E214)andpropyl(E216)hydroxybenzoate)

Linctusflavour

Ponceau4R(E124)

Sorbitol

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3Shelflife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Donotrefrigerateorfreeze.

6.5Natureandcontentsofcontainer

AmberglassbottlewithROPPcap,containing125mlor300mlsyrup.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

PhoenixHealthcareLtd

Unit3NorthernCrossBusinessPark

Finglas

Dublin11

8MARKETINGAUTHORISATIONNUMBER

PA1721/1/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:23 rd

May1979

Dateoflastrenewal:1 st

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10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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