BECONASE AQUEOUS NASAL SPRAY

Main information

  • Trade name:
  • BECONASE AQUEOUS NASAL SPRAY
  • Dosage:
  • 50 Microgram
  • Pharmaceutical form:
  • Nasal Spray Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BECONASE AQUEOUS NASAL SPRAY
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1473/016/001
  • Authorization date:
  • 24-04-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PPA1473/016/001

CaseNo:2059693

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

McDowellPharmaceuticals

4AltonaRoad,Lisburn,N.Ireland,BT275QB

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Beconase50microgramsAqueousNasalSpray

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom24/04/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

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PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Beconase50microgramsAqueousNasalSpray

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each100mgspraycontainsbeclomethasonedipropionatemonohydrateequivalentto50microgramsof

beclomethasonedipropionate.

Excipients:Containsbenzalkoniumchloride

Forafulllistofexcipients,see6.1.

3PHARMACEUTICALFORM

Nasalspray,suspension(shortterm:Nasalspray)

ProductimportedfromtheUK:

Anaqueous,white,opaque,suspension.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Fortheprophylaxisandtreatmentofperennialandseasonalallergicandvasomotorrhinitis.

Beconasecansignificantlydelaytherecurrenceofnasalpolypsafternasalpolypectomy.Wherepolypsdorecur,

Beconasecansuppresstheirincreaseinsize.

4.2Posologyandmethodofadministration

Beconaseisforadministrationbytheintranasalrouteonly.

AdultsandChildrenover6yearsofage:

Twoapplicationstoeachnostriltwicedaily.Insomepatientsasingleapplicationintoeachnostrilthreeorfourtimes

dailymaybepreferred.

Thetotaldailydoseshouldnotusuallyexceed400micrograms(8sprays).

Childrenunder6years:

Thereisinsufficientclinicaldatatorecommenduse.

BeconaseAqueousNasalSprayhasadustcapwhichprotectsthenozzleandkeepsitclean.Remembertotakethisoff

beforeusingthespray.Replacethedustcapafteruse.

Anewspray,oronewhichhasnotbeenusedforafewdays,maynotworkthefirsttime.Youmayneedto'prime'the

bottlebypumpingthesprayafewtimesuntilafinemistisproduced.Todothis,holdthebottleasshown.Putyour

forefingerandmiddlefingereithersideofthenozzleandyourthumbunderneaththebottle.Keepingyourthumbstill,

pressdownwithyourfingerstopumpthespray.

Holdthenozzlepointingawayfromyouwhileyouaredoingthis.

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NEVERtrytounblockitorenlargethetinysprayholewithapinorothersharpobjectbecausethiswilldestroythe

spraymechanism.

Tocleanthespray:

1.Takethedustcapoff.

2.Pressupwardsonthewhitecollartoreleasethenozzle.

3.Soakthenozzleanddustcapinwarmwaterforafewminutesandthenrinseunderarunningtap.

4.Shakeofftheexcesswaterandallowtodryinawarm,NOTHOTplace.

5.Re-fitthenozzle.

6.'Prime'thebottleifnecessarybypumpingthesprayafewtimesuntilthefinemistisproduced.

Yournasalsprayshouldbecleanedatleastonceaweekormoreifitgetsblocked.

Usingthespray:

1.Shakethebottleandremovethedustcap.

2.Blowyournosegently.

3.Closeonenostrilasshownandputthenozzleintheothernostril.Tiltyourheadforwardslightlyandkeepthe

bottleupright.Holdthebottleasshown.

4.Starttobreatheinslowlythroughyournose.WHILEYOUAREBREATHINGINsquirtasprayoffinemistinto

yournostrilbypressingdownfirmlywithyourfingers.

5.Breatheoutthroughyourmouth.Repeatstep4totakeasecondsprayinthesamenostril.

6.Removethenozzlefromthisnostrilandbreatheoutthroughyourmouth.

7.Repeatsteps3to6fortheothernostril.

Afterusingthespray:

Wipethenozzlecarefullywithacleantissueorhandkerchief,andreplacethedustcap.

4.3Contraindications

BeconaseAqueousNasalSprayiscontraindicatedinpatientswithahypersensitivitytoanyofitscomponents.

4.4Specialwarningsandprecautionsforuse

Theuseofbeclomethasonedipropionatelocallyinthenasopharynxmayresultinthedevelopmentoflocalmonilial

infections.

Theuseofthepreparationshouldbeavoidedinthepresenceofuntreatedinfections.

Ifpatientsareonsystemiccorticosteroidtherapy,greatcareshouldbetakenduringthetransferofthepatienttosmall

beclomethasonetherapyincasethereisimpairmentofadrenalfunction.

Occasionallysneezingattacksmayfollowuse.

Infectionsofthenasalpassagesandparanasalsinusesshouldbeappropriatelytreatedbutdonotconstituteaspecific

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Ifrecommendeddosesofintranasalbeclomethasoneareexceededorifindividualsareparticularlysensitiveor

predisposedbyvirtueofrecentsystemicsteroidtherapies,systemiceffectsmayoccur,includingreductioningrowth

velocity.

AlthoughBeconaseAqueousNasalSpraywillcontrolseasonalallergicrhinitisinmostcases,anabnormallyheavy

challengeofsummerallergensmayincertaininstancesnecessitateappropriateadditionaltherapyparticularlytocontrol

eyesymptoms.

Forfulltherapeuticbenefit,regularusageisessential.

Particularcareshouldbetakentominimiseuseoftopicalcorticosteroidsinpatientswithimmunosuppression.

Experienceofthesafetyoflong-termuseoftopicalcorticosteroidsisnotyetestablished.

Particularcautionisrequiredinpatientswithahistoryof,orexistenttuberculosis.

Cataractshavebeenassociatedwithsystemicsteroidtherapy.Therehavebeenrarereportsofcataractsdevelopingin

patientswhohavebeenusingintranasalorinhaledcorticosteroidsforprolongedperiods,althoughtogethercauses,

includingexposuretosystemicsteroids,cannotbeexcluded.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Notapplicable.

4.6Pregnancyandlactation

Administrationofdrugsduringpregnancyshouldonlybeconsiderediftheexpectedbenefittothemotherisgreater

thananypossiblerisktothefoetus.

Thereisinadequateevidenceofsafetyofbeclomethasonedipropionateinhumanpregnancy.Inanimalreproduction

studies,adverseeffectstypicalofpotentcorticosteroidsareonlyseenathighsystemicexposurelevels;directintranasal

applicationensuresminimalsystemicexposure.

Lactation:

Nospecificstudiesexaminingthetransferenceofbeclomethasonedipropionateintothemilkoflactatinganimalshave

beenperformed.Itisreasonabletoassumethatbeclomethasonedipropionateissecretedinmilkbutatthedosagesused

fordirectintranasalapplication,thereislowpotentialforsignificantlevelsinbreastmilk.Theuseofbeclomethasone

dipropionateinmothersbreast-feedingtheirbabiesrequirethatthetherapeuticbenefitsofthedrugbeweighedagainst

thepotentialhazardstothemotherandbaby.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Adverseeventsarelistedbelowbysystemorganclassandfrequency.Frequenciesaredefinedas:verycommon(1/10),

common(1/100and<1/10),uncommon(1/1000and<1/100),rare(1/10,000and<1/1000)andveryrare(<1/10,000)

includingisolatedreports.Verycommon,commonanduncommoneventsweregenerallydeterminedfromclinicaltrial

data.Rareandveryrareeventsweregenerallydeterminedfromspontaneousdata.Inassigningadverseevent

frequencies,thebackgroundratesinplacebogroupswerenottakenintoaccount,sincetheseratesweregenerally

comparabletothoseintheactivetreatmentgroup.

Immunesystemdisorders

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andthroat,anaphylactoid/anaphylacticreactions,bronchospasm.

Nervoussystemdisorders

Common:Unpleasanttaste,unpleasantsmell.

Aswithothernasalsprays,unpleasanttasteandsmellhavebeenreported.

Eyedisorders

Veryrare:Glaucoma,raisedintraocularpressure,cataract.

Respiratory,thoracicandmediastinaldisorders

Common:Epistaxis,nasaldryness,nasalirritation,throatdryness,throatirritation.

Veryrare:Nasalseptalperforation.

Aswithothernasalsprays,drynessandirritationofthenoseandthroat,andepistaxishavebeenreported.Nasalseptal

perforationhasalsobeenreportedfollowingtheuseofintranasalcorticosteroids.

4.9Overdose

Theonlyharmfuleffectthatfollowsinhalationoflargeramountsofthedrugoverashortperiodissuppressionof

hypothalamic-pituitary-adrenal(HPA)function.Nospecificemergencyactionneedbetaken.TreatmentwithBeconase

AqueousNasalSprayshouldbecontinuedattherecommendeddose.HPAfunctionrecoversinadayortwo.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Followingtopicaladministrationbeclomethasone17,21-dipropionate(BDP)producespotentanti-inflammatoryand

vaso-constrictoreffects.

BDPisapro-drugwithweakglucocorticoidreceptorbindingaffinity.Itishydrolysedviaesteraseenzymestothe

activemetabolitebeclomethasone-17-monopropionate(B-17-MP),whichhashightopicalanti-inflammatoryactivity.

Beclomethasonedipropionateoffersapreventativebackgroundtreatmentforhayfeverwhentakenpriortoallergen

challenge.Afterwhichwithregularuse,BDPcancontinuetopreventallergysymptomsfromre-appearingbyreducing

thesensitivityofnasalmembranes.

5.2Pharmacokineticproperties

Absorption

FollowingintranasaladministrationofBDPthesystemicabsorptionwasassessedbymeasuringtheplasma

concentrationsofitsactivemetaboliteB-17-MP,forwhichtheabsolutebioavailabilityfollowingintranasal

administrationis44%.

FollowingoraladministrationofBDPthesystemicabsorptionwasalsoassessedbymeasuringtheplasma

concentrationsofitsactivemetaboliteB-17-MP,forwhichtheabsolutebioavailabilityfollowingoraladministrationis

41%.

Metabolism

BDPisclearedveryrapidlyfromthecirculationandplasmaconcentrationsareundetectable(<50pg/ml)following

oralorintranasaldosing.Metabolismismediatedviaesteraseenzymesfoundinmosttissues.Themainproductof

metabolismistheactivemetabolite(B-17-MP).

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formedbutthesecontributelittletosystemicexposure.

Distribution

Thetissuedistributionatsteady-stateforBDPismoderate(20l)butmoreextensiveforB-17-MP(424l).Plasma

proteinbindingismoderatelyhigh(87%).

Elimination

TheeliminationofBDPandB-17-MParecharacterisedbyhighplasmaclearance(150and120l/h)withcorresponding

terminaleliminationhalf-livesof0.5hand2.7h.FollowingoraladministrationoftritiatedBDP,approximately60%of

thedosewasexcretedinthefaeceswithin96hoursmainlyasfreeandconjugatedpolarmetabolites.Approximately

12%ofthedosewasexcretedasfreeandconjugatedpolarmetabolitesintheurine.TherenalclearanceofBDPandits

metabolitesisnegligible.

5.3Preclinicalsafetydata

Thereisnoadditionalinformationofrelevancetotheprescriber.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumcarboxymethylcellulose

Microcrystallinecellulose

Dextrose

Benzalkoniumchloride

Phenylethylalcohol

Polysorbate80

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Theshelf-lifeexpirydateofthisproductshallbethedateshownonthecontainerandouterpackageoftheproducton

themarketinthecountryoforigin

Discard3monthsafterfirstusingspray.

6.4Specialprecautionsforstorage

Donotstoreabove30°C.

Donotrefrigerate.

Keepcontainerintheoutercartontoprotectfromlight.

6.5Natureandcontentsofcontainer

A30mlpolypropylenebottlefittedwithatamper-resistantmeteringatomisingpumpinanover-labelledoutercarton.

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6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements

7ParallelProductAuthorisationHolder

McDowellPharmaceuticals

4AltonaRoad

Lisburn

N.Ireland

BT275QB

8ParallelProductAuthorisationNumber

PPA1473/16/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:24thApril2009

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