DIFFLAM SPRAY

Main information

  • Trade name:
  • DIFFLAM SPRAY
  • Dosage:
  • 0.15 %w/ v
  • Pharmaceutical form:
  • Oromucosal Spray
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DIFFLAM SPRAY
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA0465/228/001
  • Authorization date:
  • 20-05-2011
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DifflamSpray,0.15%w/v,OromucosalSpray

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachpuff(175microlitres)contains262.5microgramsofbenzydaminehydrochloride(0.15%w/v).

Excipient(s):includesmethylparahydroxybenzoate(E218)andethanol

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Oromucosalspray

ProductimportedfromtheUK

Difflamsprayisametereddosespraycontainingaclear,colourlessoromucosalspraysolution

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asanadjunctinthesymptomaticreliefofpainfulinflammatoryconditionsofthethroatandmouth.

4.2Posologyandmethodofadministration

Fororomucosaladministration.

ADULTSANDELDERLY:4to8puffs,1½-3hourly.

CHILDREN(6-12):4puffs,1½-3hourly.

CHILDRENUNDER6:Onepufftobeadministeredper4kgbodyweight,uptoamaximumof4puffs,1½-3hourly.

Becauseofthesmallamountofdrugapplied,elderlypatientscanreceivethesamedoseasadults.

Thesprayshouldbedirectedontotheaffectedarea.Uninterruptedtreatmentshouldnotexceedsevendays,except

undermedicalsupervision.

4.3Contraindications

Useinpatientwithaknownhypersensitivity(egbronchospasm,rhinitis,urticaria)tothisproduct.

4.4Specialwarningsandprecautionsforuse

Avoidcontactwiththeeyes.

Iftheconditionisaggravatedornotimproveduseshouldcease.

Containsmethylparahydroxybenzoate(E218).Maycauseallergicreactions(possiblydelayed).

Irish Medicines Board

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Date Printed 25/05/2011 CRN 2067086 page number: 1

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Fertility,pregnancyandlactation

DifflamSprayshouldnotbeusedinpregnancyorlactationunlessconsideredessentialbythephysician.Thereisno

evidenceofateratogeniceffectinanimalstudies.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Benzydamineiswelltolerated;side-effectsareminor.Occasionally,oraltissuenumbnessor‘stinging’sensationsmay

occur.Thestinginghasbeenreportedtodisappearuponcontinuationofthetreatment,howeverifitpersistsitis

recommendedthattreatmentbediscontinued.Hypersensitivityreactionsoccurveryrarelybutmaybeassociatedwith

pruritusrash,urticaria,photodermatitisandoccasionallylaryngospasmorbronchospasm.

Inrarecasesanaphylacticreactionsmayoccurwhichcanbepotentiallylife-threatening.

4.9Overdose

Difflamisunlikelytocauseadversesystemiceffects,evenifaccidentalingestionshouldoccur.Nospecialmeasures

arerequired.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Benzydamineexertsananti-inflammatoryandanalgesicactionbystabilisingthecellularmembraneandinhibiting

prostaglandinsynthesis.

5.2Pharmacokineticproperties

Followingoraladministration,Benzydamineisrapidlyabsorbedfromthegastrointestinaltractandmaximumplasma

levelsreachedafter2-4hours.

AbouthalfoftheBenzydamineisexcretedunchangedviathekidneyatarateof10%ofthedosewithinthefirst24

hours.Theremainderismetabolised,mostlytoN-Oxide.

5.3Preclinicalsafetydata

Non-ClinicalDatarevealnospecialhazardsforhumansbasedonconventionalstudiesofsafetypharmacology,

repeatedtoxicity,genotoxicity,cardiogenicpotential,andtoxicitytoreproduction.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Purifiedwater

Glycerol

Saccharin

Irish Medicines Board

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Date Printed 25/05/2011 CRN 2067086 page number: 2

Ethanol

Methylparahydroxybenzoate

Mouthwashflavour52503/TFirmenich

Polysorbate20

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Theshelflifeexpirydateofthisproductshallbethedateshownonthecontainerandouterpackageoftheproductas

marketedinthecountryoforigin

6.4Specialprecautionsforstorage

Donotstoreabove30°C.Donotrefrigerateorfreeze

Storeintheoriginalpackage

6.5Natureandcontentsofcontainer

Difflamsprayispresentedinanoverlabelledboxcontaininga30mlHDPEbottlewitha170microlitremeteringvalve

spraypump.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Keepthebottleuprightduringuseandwhenstored

Afterusethenozzleshouldbewipedwithatissuetopreventblockage

7PARALLELPRODUCTAUTHORISATIONHOLDER

PCOManufacturingLtd

Unit10

AshbourneBusinessPark

Rath

Ashbourne

CountyMeath

Ireland

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA0465/228/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:20thMay2011

Irish Medicines Board

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Date Printed 25/05/2011 CRN 2067086 page number: 3