DEQUACAINE LOZENGES, BENZOCAINE 10 MG, DEQUALINIUM

Main information

  • Trade name:
  • DEQUACAINE LOZENGES, BENZOCAINE 10 MG, DEQUALINIUM
  • Dosage:
  • 0.25 Milligram
  • Pharmaceutical form:
  • Lozenges
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DEQUACAINE LOZENGES, BENZOCAINE 10 MG, DEQUALINIUM
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0979/035/001
  • Authorization date:
  • 06-02-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DequacaineLozenges

Benzocaine10mg

Dequaliniumchloride0.25mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachlozengecontains0.25mgdequaliniumchlorideand10mgbenzocaine

Excipients:

Sorbitol(E420)

Sugarbase(consistingofglucoseandsucrose)2.6g/lozenge.

Forfulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Lozenge.

Round,yellowlozenges.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthereliefofseveresorethroatsandforthereliefofpainanddiscomfortintheoralcavityassociatedwith

superficialinfectionoftheoropharynxorwithdentalprocedures.

4.2Posologyandmethodofadministration

Adultsandchildrenover12years:

Onelozengetobesuckedslowlyeverytwohoursasrequired.Notmorethan8lozengestobetakeninany24hours.

Childrenunder12years:

Notsuitable.

Elderly:

Thereisnoneedfordosagereductioninelderly.

4.3Contraindications

Patientssensitivetoanyoftheingredientsortopara-aminobenzoicacidanditsderivatives.

Patientswithlowplasmacholinesteraseconcentrations.

4.4Specialwarningsandprecautionsforuse

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sufferfromMyastheniaGravis.

Thelabelstates:

Warning:Donotexceedthestateddose.Keepallmedicinesoutofthereachofthechildren.Ifsymptomspersistorare

accompaniedbyfever,headache,nauseaorvomitingconsultyourdoctor.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Dequacaineiscontraindicatedinthosepatientstakinganticholinesterases.

Benzocaineismetabolisedtopara-aminobenzoicacidandDequacainemaythereforeantagonisetheeffectsof

sulphonamides.

4.6Pregnancyandlactation

ThesafetyofDequacaineduringpregnancyandlactationhasnotbeenestablished.Aslocalanaestheticcancrossthe

placenta,itisrecommendedthatthisproductisnottakenduringpregnancy.Noinformationontheuseofthisproduct

inlactationisavailableanditisrecommendedthatDequacaineisnottakenwhilebreastfeeding.

4.7Effectsonabilitytodriveandusemachines

Noadverseeffectsknown.

4.8Undesirableeffects

Dequacainemayoccasionallycausehypersensitivityreactions.Methaemoglobinaemiahasoccasionallybeenreported

followingtheuseofbenzocaine.

4.9Overdose

Symptomsofoverdosageincludingyawning,restlessness,excitement,nervousness,dizziness,nystagmus,tinnitus,

blurredvision,nausea,vormitting,muscletwitching,tremorsandconvulsions.Excitationmaybetransientand

followedbydepressionwithdrowsiness,respiratoryfailureandcoma.Theremaybesimultaneouseffectsonthe

cardiovascularsystemwithmyocardialdepressionandperipheralvasodilation,resultinginhypertension,arrhythmias

andcardiacarrest.Mayalsocausemethaemoglobinaemia.

Treatmentconsistessentiallyofmaintainingthecirculationandrespirationandcontrollingconvulsions.Thecirculation

maybemaintainedwithinfusionsofplasmaorsuitableelectrolytesolutions.

Convulsionsmaybecontrolledwiththeinfusionsofplasmaorsuitableelectrolytesolution.Convulsionsmaybe

controlledbytheintravenousadministrationofdiazepam.

Ifnecessary,suxamethoniumtogetherwithendotrachealintubationandartificialrespirationmaybeusedifconvulsions

persists.

Metahemoglobinaemiamaybetreatedbyintravenousadministraionof1-4mg/kgmethyleneblueinjection.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Benzocaineisalocalanaestheticoftheestertype.Dequaliniumchlorideisaquartenaryammoniumantisepticactive

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5.2Pharmacokineticproperties

Benzocaineisreadilyabsorbedthroughmucousmembranesandishydrolysedbyesterasesintheplasmaandtoalesser

extentintheliver.

5.3Preclinicalsafetydata

Therearenopreclinicalsafetydataofrelevancetotheconsumer.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumsaccharin

Levomenthol

Racemiccamphor

Peppermintoil

Benzylalcohol

Sorbitol(E420)

Sugarbase(sucroseandglucose)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove30°C

6.5Natureandcontentsofcontainer

PVC/PVDCblisterstripssealedwithaluminiumfoilenclosedincardboardcartonstogiveapackof24lozenges.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

ReckittBenckiserIrelandLtd

7Riverwalk

CitywestBusinessCampus

Dublin24

8MARKETINGAUTHORISATIONNUMBER

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 27July1987

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