DEQUADIN 0.25 MG LOZENGES

Main information

  • Trade name:
  • DEQUADIN 0.25 MG LOZENGES
  • Dosage:
  • 0.25 Milligram
  • Pharmaceutical form:
  • Lozenges
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DEQUADIN 0.25 MG LOZENGES
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0979/036/001
  • Authorization date:
  • 06-02-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Dequadin0.25mgLozenges

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachlozengecontains0.25mgdequaliniumchloride

Excipient: Sunsetyellow(E110)0.4mgperlozenge.

Sucrose998.925mgperlozenge.

LiquidGlucose50mgperlozenge.

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Lozenge.

Round,pale-orangelozenges.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthelocaltherapyofmostofthecommoninfectionsofthemouthandoropharynxincluding:vincentsangina,

pharyngitis,sorethroats,tonsillitis,stomatitis,aphthousulcers,thrush,glossitis.

4.2Posologyandmethodofadministration

Fororaladministration.

Adultsandchildrenover10years:

Onelozengetobesuckedevery2to3hours,uptoamaximumofeightinoneday.

Elderly:

Thereisnoneedfordosagereductioninelderly.

4.3Contraindications

Hypersensitivitytoanyoftheingredients.

4.4Specialwarningsandprecautionsforuse

Thelabelstates:

Keepallmedicinesoutofthereachofchildren.

Ifsymptomspersist,consultyourdoctor.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 27/12/2009 CRN 2076741 page number: 1

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noclinicallysignificantdruginteractionsknown.

4.6Pregnancyandlactation

ThesafetyofDequadinduringpregnancyandlactationhasnotbeenestablished,butitisconsideredahazard.

4.7Effectsonabilitytodriveandusemachines

Noadverseeffectsknown.

4.8Undesirableeffects

Occasionalhypersensitivityreactionsandsorenessofthetonguearepossible.

4.9Overdose

Overdosageshouldnotpresentaproblemotherthangastrointestinaldiscomfort.Treatmentshouldbesymptomatic.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Dequaliniumchlorideisaquanternaryammoniumantisepticactiveagainstmanygram-positiveandgram-negative

bacteria,yeastsandfungi.

5.2Pharmacokineticproperties

Notavailable.

5.3Preclinicalsafetydata

Therearenopreclinicalsafetydataofrelevancetotheconsumer.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sucrose

Citricacidmonohydrate

Liquidglucose

Saccharinsodium

Racemiccamphor

Magnesiumstearate

Gelatin

Sunsetyellow(E110)

Limeflavour

Peppermintoil

6.2Incompatibilities

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 27/12/2009 CRN 2076741 page number: 2

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

PVC/PVDCblisterstripssealedwithaluminiumfoilenclosedincardboardcartonstogivepacksof20or40lozenges.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

ReckittBenckiserIrelandLtd

7Riverwalk

CitywestBusinessCampus

Dublin24

8MARKETINGAUTHORISATIONNUMBER

PA0979/036/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:21October1986

Dateoflastrenewal:26August2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 27/12/2009 CRN 2076741 page number: 3