DELSYM

Main information

  • Trade name:
  • DELSYM Oral Suspension
  • Pharmaceutical form:
  • Oral Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DELSYM Oral Suspension
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1410/043/001
  • Authorization date:
  • 21-11-2008
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA1410/043/001

CaseNo:2043419

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

TransferredfromPA0021/066/001.

BayerLimited

TheAtrium,BlackthornRoad,Dublin18,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Delsym(ControlledRelease)30mg/5mlOralSuspension

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom21/11/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 21/11/2008 CRN 2043419 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Delsym(ControlledRelease)30mg/5mlOralSuspension.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each5mlofsuspensioncontainsdextromethorphanresincomplex*equivalentto30mgofdextromethorphan

hydrobromide.

*Dextromethorphanresincomplexascoateddextromethorphanpolistirexanduncoateddextromethorphanpolistirex.

Excipients:Each5mlcontainssucrose(granulatedsugar)600mg,sunsetyellow(E110)0.115mg,methyl

paradroxybenzoate(E218)7.5mg,propylparahydroxybenzoate(E216)1.5mgandhighfructosecornsyrup1.5g.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Prolongedreleaseoralsuspension

Uniformoralsuspensionofopaqueorangecolourandacharacteristicorangeodourandflavour.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetemporaryreliefofcoughduetominorthroatandbronchialirritationasmayoccurwiththe"commoncold"or

withinhaledirritants.

4.2Posologyandmethodofadministration

Fororaladministrationonly.Shakewellbeforeusing.Usethespoonprovided.

Adults:

1x5mlteaspoonfulevery12hours.Donotexceed3x5mlteaspoonfulin24hours.

Children:

6-12years:1x5mlteaspoonfulevery12hours.Donotexceed2x5mlteaspoonfulin24hours.

2-5years:halfx5mlteaspoonful(=2.5ml)every12hours.Donotexceed1x5mlteaspoonfulin24hours.

Childrenunder2years:

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4.3Contraindications

Useinpatientshypersensitivetotheactiveingredient.

Useinchildrenunder2yearsofage.

4.4Specialwarningsandprecautionsforuse

Delsymshouldonlybeusedundermedicalsupervisionforpersistentorchroniccoughsuchasoccurswithsmoking,

asthmaoremphysema,orwherecoughisaccompaniedbyexcessivesecretions.

Patientsexperiencinghighfever,rashorpersistentheadacheornoimprovementintheirconditionwithinsevendays,

shouldseekmedicaladvice.

Personswhoaretakingothermedicationsandareunderthecareofaphysician,shouldconsulttheirdoctorbefore

takingtheproduct.

Donotexceedtherecommendeddosageschedules.

Keepthisandallmedicinesoutofthereachofchildren.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

None.

4.6Pregnancyandlactation

Thisproductshouldnotbeusedduringpregnancyunlessconsideredessentialbythephysician.

4.7Effectsonabilitytodriveandusemachines

Delsymmaycausedrowsiness,ifaffecteddonotdriveoroperatemachineryandavoidalcohol.

4.8Undesirableeffects

Dextromethorphanoccasionallycausesdrowsiness,dizziness,excitation,mentalconfusion,gastrointestinal

disturbances,bronchoconstrictionanddyspnoea.

4.9Overdose

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Dextromethorphanisthedisomerofthecodeineanalogoflevorphanol;however,unlikethelisomer,ithasno

analgesicoraddictiveproperties.Thedrugactscentrallytoelevatethethresholdforcoughing.Itseffectivenessin

patientswithpathologicalcoughhasbeendemonstratedincontrolledstudies;itspotencyisnearlyequaltothatof

codeine.Comparedtocodeine,dextromethorphanproducesfewersubjectiveandgastrointestinalside-effects.In

therapeuticdosage,thedrugdoesnotinhibitciliaryactivity,anditsantitussiveeffectpersistfor5-6hours.Itstoxicity

isquitelow,butextremelyhighdosesmayproduceCNSdepression.

Dextromethorphaniswellabsorbedfromthegastrointestinaltract.Itismetabolisedintheliverandexcretedas

unchangeddextromethorphananddemethylatedmorphinancompounds.

5.2Pharmacokineticproperties

None.

5.3Preclinicalsafetydata

None.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Highfructosecornsyrup

Granulatedsugar(sucrose)

Propyleneglycol

Powderedtragancanthgum(E413)

Xanthangum(E415)

Methylp-hydroxybenzoate(E218)

Anhydrouscitricacid(E330)

Polysorbate80(E433)

Propylp-hydroxybenzoate(E216)

Orangeflavour

Sunsetyellow(E110)

Purifiedwater

Coateddextromethorphanpolistirex

(containingAmberliteIRP70(polacrilinpotassium),polyethyleneglycol300,vegetableoilandethylcellulose)

Uncoateddextromethorphanpolistirex

(containing,AmberliteIRP70sodiumwashed)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove30 o

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6.5Natureandcontentsofcontainer

Amberglassbottlesof89mlwithaplasticcap,presentedinanoutercarton.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

BayerLtd

TheAtrium

BlackthornRoad

Dublin18

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA1410/43/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorization:4 th

May1984

Dateoflastrenewal:11 th

November2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 21/11/2008 CRN 2043419 page number: 5