BECONASE HAYFEVER

Main information

  • Trade name:
  • BECONASE HAYFEVER
  • Dosage:
  • 50 Mcg/ Dose
  • Pharmaceutical form:
  • Nasal Spray Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BECONASE HAYFEVER
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0678/092/001
  • Authorization date:
  • 17-09-1999
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BeconaseHayfevernasalspray50microgramsperspray

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each100mgspraycontainsbeclometasonedipropionatemonohydrateequivalentto50microgramsBeclometasone

DipropionatePh.Eur.

Excipients:Each100mgspraycontainsbenzalkoniumchloridesolutionequivalenttobenzalkoniumchloride20

micrograms.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Nasalspray,suspension

Anaqueouswhiteopaquesuspensioninaplasticbottlefittedwithameteringatomisingpumpandnasalapplicator.

4CLINICALPARTICULARS

4.1TherapeuticIndications

BeconaseHayfeverpreventsandrelievesnasalcongestion,sneezingandarunny,itchynoseduetohayfeverand

otherseasonalallergicconditions.Oncenasalcongestionisclearedthepressureandpainaroundtheeyesisalso

reduced.

4.2Posologyandmethodofadministration

Regularusageisessentialforfulltherapeuticbenefit.BeconaseHayfeverquicklystartstobringreliefandreduce

swellinginthenosealthoughitmaytakeafewdaystobuilduptoitsmaximumeffect.

Adults18yearsofageandover:

Therecommendeddoseistwoapplicationsintoeachnostriltwicedaily.

Totaldailyadministrationshouldnotexceed8applications(400mcg).

Ifthereisnoresponseafter14daysoftreatment,medicaladviceshouldbesought.

BeconaseHayfeverisfornasaluseonly.

Donotusecontinuouslyforlongerthan3monthswithoutconsultingyourdoctor.

4.3Contraindications

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4.4Specialwarningsandprecautionsforuse

InfectionsofthenasalpassagesandparanasalsinusesshouldbeappropriatelytreatedbutBeconaseHayfever

therapyneednotbestopped.

CaremustbetakenwhiletransferringpatientsfromsystemicsteroidtreatmenttoBeconaseHayfeverifthereisany

reasontosupposethattheiradrenalfunctionisimpaired.

Systemiceffectsincludingreductioningrowthvelocitymayrarelyoccurwithexcessiveuseoftheproduct.

AlthoughBeconaseHayfeverwillcontrolseasonalallergicrhinitisinmostcases,additionaltherapymaybeneeded

tocontroleyesymptomsinthepresenceofabnormallyheavyallergenchallenges.

MedicaladviceshouldbesoughtbeforeusingBeconaseHayfeverinthecaseofrecentinjuryorsurgerytothenose,

orproblemswithulcerationinthenose.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noknowninteractionswithotherdrugsandalcoholhavebeenobserved.

4.6Pregnancyandlactation

Insufficientdataisavailabletoassessthepossibleriskoftheuseofbeclometasonedipropionateinpregnantor

lactatingwomen.BeconaseHayfevershouldthereforenotbetakenduringpregnancyandlactationwithout

consultingaphysician.

4.7Effectsonabilitytodriveandusemachines

Beclometasonedipropionateisunlikelytoproduceaneffectontheabilitytodriveorusemachines.

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,commonanduncommoneventsweregenerallydeterminedfrom

clinicaltrialdata.Rareandveryrareeventsweregenerallydeterminedfromspontaneousdata.Inassigningadverse

eventsfrequencies,thebackgroundratesinplacebogroupsweretakenintoaccount,sincetheseratesweregenerally

comparabletothoseintheactivetreatmentgroup.

Immunesystemdisorders

Veryrare:Hypersensitivereactionsincludingrashes,urticaria,pruritis,erythemaandoedemaoftheeyes,face,lipsand

throat,anaphylactoid/anaphylacticreactions,bronchospasm.

Nervoussystemdisorders

Common:Unpleasanttaste,unpleasantsmell.

Aswithothernasalsprays,unpleasanttasteandsmellshavebeenreported.

Eyedisorders

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Respiratory,thoracicandmediastinaldisorders

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

Veryrare:Nasalseptalperforation.

Aswithothernasalsprays,drynessandirritationofthenoseandthroat,andepistaxishavebeenreported.Nasalseptal

perforationhasalsobeenreportedfollowingtheuseofintranasalcorticosteroids.

4.9Overdose

Theonlyharmfuleffectthatfollowsinhalationoflargeramountsofthedrugoverashortperiodissuppressionof

hypothalamic-pituitary-adrenal(HPA)function.Nospecialemergencyactionneedbetaken.Treatmentwith

BeconaseHayfevershouldbecontinuedattherecommendeddose.HPAfunctionrecoversinadayortwo.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Followingtopicaladministrationbeclomethasone17,21-dipropionate(BDP)producespotentanti-inflammatoryand

vaso-constrictoreffects.

BDPisapro-drugwithweakglucocorticoidreceptorbindingaffinity.Itishydrolysedviaesteraseenzymestothe

activemetabolitebeclomethasone-17-monopropionate(B-17-MP),whichhashightopicalanti-inflammatory

activity.

Beclomethasonedipropionateoffersapreventativebackgroundtreatmentforhayfeverwhentakenpriortoallergan

challenge.

Afterwhichwithregularuse,BDPcancontinuetopreventallergysymptomsfromre-appearingbyreducingthe

sensitivityofnasalmembranes.

5.2Pharmacokineticproperties

Absorption

FollowingintranasaladministrationofBDP,thesystemicabsorptionwasassessedbymeasuringtheplasma

concentrationsofitsactivemetaboliteB-17-MP,forwhichtheabsolutebioavailabilityfollowingintranasal

administrationis44%

FollowingoraladministrationofBDPthesystemicabsorptionwasalsoassessedbymeasuringtheplasma

concentrationofitsactivemetaboliteB-17-MP,forwhichtheabsolutebioavailabilityfollowingoraladministrationis

Metabolism

BDPisclearedveryrapidlyfromthecirculationandplasmaconcentrationsareundetectable(<50pg/ml)followingoral

orintranasaldosing.Metabolismismeditatedviaesteraseenzymesfoundinmosttissues.Themainproductof

metabolismistheactivemetabolite(B-17-MP).Minorinactivemetabolites,beclomethasone-21-monopropionate(B-

21-MP)andbeclomethasone(BOH),arealsoformedbutthesecontributelittletosystemicexposure.

Distribution

Thetissuedistributionatsteady-stateforBDPismoderate(201)butmoreextensiveforB-17-MP(4241).Plasma

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Elimination

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

terminaleliminationhalf-livesof0.5hand2.7h.FollowingoraladmininstrationoftrititatedBDP,approximately60%

ofthedosewasexcretedinthefaeceswithin96hoursmainlyasfreeandconjugatedpolarmetabolites.Approximately

12%ofthedosewasexcretedasfreeandconjugatedpolarmetabolitesintheurine.TherenalclearanceofBDPandits

metabolitesisnegligible.

5.3Preclinicalsafetydata

Nodataincluded.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Microcrystallinecellulose

Carboxymethylcellulosesodium

Glucoseanhydrous

Polysorbate80

Purifiedwater

Benzalkoniumchloride

Phenylethylalcohol

6.2Incompatibilities

Nonereported.

6.3ShelfLife

Twoyears.

Discardthreemonthsafterfirstusingthespray.

6.4Specialprecautionsforstorage

Donotstoreabove30 °

C.Donotrefrigerate.

Keepcontainerinoutercartoninordertoprotectfromlight.

6.5Natureandcontentsofcontainer

BeconaseHayfeverissuppliedinaplasticbottlefittedwithametering,atomisingpumpandnasalapplicator.Each

20mlpolypropylenecontainerprovidesapproximately100meteredsprays.Each30mlpolypropylenecontainer

providesapproximately180meteredsprays.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

YourBeconaseHayfeversprayhasadustcapwhichprotectsthenozzleandkeepsitclean.

Remembertotakeitoffbeforeusingthespray(Picture1).

Anewspray,oronewhichhasnotbeenusedforafewdays,maynotworkthefirsttime.Youmayneedto“prime”the

bottlebypumpingthesprayafewtimesuntilafinemistisproduced.Todothisholdthebottleasshown.Putyour

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Keepingyourthumbstill,pressdownwithyourfingerstopumpthespray(Picture2).Holdthenozzlepointingaway

fromyouwhileyouaredoingthis.

Ifthespraystilldoesn’tworkandyouthinkitmaybeblocked,cleanitasdescribedbelow.

NEVERtrytounlockitorenlargethetinysprayholewithapinorothersharpobjectbecausethiswilldestroythe

spraymechanism.

Usingthespray:

1.Shakethebottleandremovethedustcap.

2.Blowyournosegently.

3.Closeonenostrilasshownandputthenozzleintheothernostril.Tiltyourheadforwardslightlyandkeepthe

bottleupright.Holdthebottleasshown(Picture3).

4.Starttobreatheinslowlythroughyournose.WHILEYOUAREBREATHINGINsquirtasprayoffinemistinto

yournostrilbypressingdownfirmlyonthecollarwithyourfingers(Picture4).

5.Breatheoutthroughyourmouth.Repeatstep4totakeasecondsprayinthesamenostril.

6.Removethenozzlefromthisnostrilandbreatheoutthroughyourmouth.

7.Repeatsteps3to6fortheothernostril.

AFTERUSINGTHESPRAYWIPETHENOZZLECAREFULLYWITHACLEANTISSUEOR

HANDKERCHIEF,ANDREPLACETHEDUSTCAP.

Tocleanthespray:

1.Takethedustcapoff.

2.Pullupwardsonthewhitecollartoremovethenozzle.

3.Soakthenozzleanddustcapinwarmwaterforafewminutes,andthenrinseunderarunningtap.

4.Shakeofftheexcesswaterandallowtodryinawarm,NOTHOT,place.

5.Re-fitthenozzle.

6.“Prime”thebottleifnecessarybypumpingthesprayafewtimesuntilafinemistisproduced.

YOURNASALSPRAYSHOULDBECLEANEDATLEASTONCEAWEEK,ORMOREOFTENIFITGETS

BLOCKED.

7MARKETINGAUTHORISATIONHOLDER

GlaxoSmithKlineConsumerHealthcare(Ireland)Limited

StonemasonsWay

Rathfarnham

Dublin16

8MARKETINGAUTHORISATIONNUMBER

PA678/92/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:17September1999

Dateoflastrenewal:17September2009

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 20/10/2010 CRN 2090290 page number: 5