CLICKHALER BECLOMETASONE

Main information

  • Trade name:
  • CLICKHALER BECLOMETASONE
  • Dosage:
  • 50 mg Microgram
  • Pharmaceutical form:
  • Powder for Inhalation
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CLICKHALER BECLOMETASONE
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0486/002/001
  • Authorization date:
  • 07-09-1999
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0486/002/001

CaseNo:2050241

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

InnovataBiomedLtd

1MereWay,Ruddington,Nottingham,NG116JS,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

ClickhalerBeclometasone50micrograms.Inhalationpowder.

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom17/06/2008until29/10/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 20/06/2008 CRN 2050241 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

ClickhalerBeclometasone50micrograms.Inhalationpowder.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmeteredactuationof1.3mgcontains50microgramsofbeclometasonedipropionateanddelivers45micrograms

ofbeclometasonedipropionate.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Inhalationpowder.

Whitefree-flowingpowder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

BeclometasoneDipropionateisindicatedforthecontrolofpersistentasthma.

4.2Posologyandmethodofadministration

Theproductisintendedfororalinhalationonly.ForoptimumresultsClickhalerBeclometasoneshouldbeused

regularly.

Theinitialdoseshouldbeappropriatetotheseverityofthediseaseandthemaintenancedosetitratedtothelowestdose

atwhicheffectivecontrolofasthmaisachieved.

Adults:

Theinitialdoseforpatientswithmildasthmais200to400microgramsperday;thismaybeincreasedto800

microgramsperdayifrequired.

Forpatientswithmoderateasthmaandsevereasthmatheinitialdosecanbe800to1600microgramsperday,increased

to2000microgramsinseverecases.Thenormalmaximumdailydoseforadultsis2000micrograms.

Themaintenancedoseisnormally200to400microgramstwicedaily.Ifnecessarythedosemaybeincreasedto1600

to2000microgramsperdaydividedintotwotofourdosesandbereducedlaterwhenasthmaisstabilised.

Childrenaged6-12years:

Upto100micrograms2to4timesdailyaccordingtotheclinicalresponse.

Normallythemaximumdailydoseinchildrenis400µg.Howeversomecasesofsevereasthmamaynotbecontrolled

andhigherdosesmayberequiredinlinewithinternationalguidelines.Oncetheasthmaiscontrolled,thedoseof

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WhentransferringapatienttoClickhalerBeclometasonefromotherdevices,treatmentshouldbeindividualisedtaking

intoconsiderationtheactiveingredientandmethodofadministration.

4.3Contraindications

ClickhalerBeclometasoneiscontra-indicatedinpatientswithhypersensitivity(allergy)tobeclometasonedipropionate

ortotheexcipient(see6.1ListofExcipients).

4.4Specialwarningsandprecautionsforuse

Patientsshouldbeinstructedintheproperuseoftheinhaler.Theyshouldalsobemadeawareoftheprophylactic

natureoftherapywithClickhalerBeclometasoneandthattheyshoulduseitregularly,everyday,evenwhentheyare

asymptomatic.Beclometasonedipropionateisnotsuitableforthetreatmentofanacuteasthmaattack.

Increasinguseofbronchodilators,inparticularshort-actinginhaled

-agonists,torelievesymptomsindicates

deteriorationofasthmacontrol.Ifpatientsfindthatshort-actingreliefbronchodilatortreatmentbecomeslesseffective,

ortheyneedmoreinhalationsthanusual,medicalattentionmustbesought.Inthissituationpatientsshouldbe

reassessedandconsiderationgiventotheneedforincreasedanti-inflammatorytherapy(e.g.higherdosesofinhaled

corticosteroidsoracourseoforalcorticosteroids).Severeexacerbationsofasthmamustbetreatedinthenormalway.

Systemiceffectsofinhaledcorticosteroidsmayoccur,particularlyathighdosesprescribedforprolongedperiods.

Possiblesystemiceffectsincludeadrenalsuppression,growthretardationinchildrenandadolescents,decreaseinbone

mineraldensity,cataractandglaucoma.

Itisimportantthereforethatthedoseofinhaledsteroidsistitratedtothelowestdoseatwhicheffectivecontrolof

symptomsisachieved.

Itisrecommendedthattheheightofchildrenreceivingprolongedtreatmentwithinhaledsteroidsisregularly

monitored.Ifgrowthisslowed,therapyshouldbereviewedwiththeaimofreducingthedoseofinhaledcorticosteroid

ifpossible,tothelowestdoseatwhicheffectivecontrolofsymptomsisachieved.

Dosesinexcessof1500microgramsperdaymayinduceadrenalsuppression.Insuchpatientstherisksofdeveloping

adrenalsuppressionshouldbebalancedagainstthetherapeuticadvantages,andprecautionsshouldbetakentoprovide

systemicsteroidcoverinsituationsofstressorelectivesurgery.

Thetransfertoinhaledbeclometasonedipropionateofpatientswhohavebeentreatedwithsystemicsteroidsforlong

periodsoftime,orathighdose,needsspecialcareandsubsequentmanagementasrecoveryfromimpaired

adrenocorticalfunctionisslow.Withthesepatientsadrenocorticalfunctionshouldbemonitoredregularlyandtheir

doseofsystemicsteroidreducedcautiously.Gradualwithdrawalofthesystemicsteroidshouldcommenceafterabout

oneweek.Reductionsindosage,appropriatetothelevelofmaintenancesystemicsteroid,shouldbeintroducedatnot

lessthanweeklyintervals.

Somepatientsmayfeelunwellinanon-specificwayduringwithdrawalofthesystemicsteroid.Theyshouldbe

encouragedtoperseverewiththeinhaledbeclometasonedipropionate,unlessthereareobjectivesignsofadrenal

insufficiency.

Patientswhohavebeentransferredfromoralsteroidswhoseadrenocorticalfunctionisimpairedshouldcarryasteroid

warningcardindicatingthattheymayneedsupplementarysystemicsteroidsduringperiodsofstress,e.g.worsening

asthmaattacks,chestinfections,majorintercurrentillness,surgery,traumaetc.

Replacementofsystemicsteroidtreatmentwithinhaledtherapysometimesunmasksallergiessuchasallergicrhinitis

oreczemapreviouslycontrolledbythesystemicdrug.

Inthecaseofmassivemucussecretionintherespiratorytract,de-obstructionandashortcourseoforalsteroidsmaybe

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Specialcareisnecessaryinpatientswithactiveorquiescentpulmonarytuberculosisandinpatientswithviral,bacterial

andfungalinfectionsoftheeye,mouthorrespiratorytract.Inthecaseofbacterialinfectionoftherespiratorytract

adequateantibioticco-medicationmayberequired.

TreatmentwithClickhalerBeclometasoneespeciallyathighdosesshouldnotbestoppedabruptly.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Duetotheverylowplasmaconcentrationachievedafterinhaleddosing,clinicallysignificantdruginteractionsarein

generalunlikely.Careshouldbetakenwhenco-administeringknownstrongCYP3A4inhibitors(e.g.ketoconazole,

itraconazole,nelfinavir,ritonavir)asthereisapotentialforincreasedsystemicexposuretobeclometasone.

4.6Pregnancyandlactation

Pregnancy:Thereareinsufficientdataregardingthesafetyofbeclomethasonedipropionateduringhumanpregnancy.

Systemicadministrationofrelativelyhighdosesofcorticosteroidstopregnantanimalscancauseabnormalitiesof

foetaldevelopmentincludingcleftpalateandintra-uterinegrowthretardation.Theremaythereforebeaverysmallrisk

ofsucheffectsinthehumanfoetus.Becausebeclomethasonedipropionateisdelivereddirectlytothelungsbythe

inhaledrouteitavoidsthehighlevelofexposurethatoccurswhencorticosteroidsaregivenbysystemicroutes.

Theuseofbeclometasonedipropionateinpregnancyrequiresthatthepossiblebenefitsofthedrugbeweighedagainst

thepossiblehazards.Itshouldbenotedthatthedrughasbeeninwidespreaduseformanyyearswithoutapparentill

consequence.

Lactation:Itisreasonabletoassumethatbeclometasonedipropionateissecretedinmilk,butatthedosagesusedfor

directinhalationthereislowpotentialforsignificantlevelsinbreastmilk.

Theuseofbeclometasonedipropionateinmothersbreastfeedingtheirbabiesrequiresthatthetherapeuticbenefitsof

thedrugbeweighedagainstthepotentialhazardstothemotherandbaby.

4.7Effectsonabilitytodriveandusemachines

Noneknown

4.8Undesirableeffects

Candidiasisofthemouthandthroat(thrush)mayoccurinsomepatients,whichcanbetreatedwhilststillcontinuing

withClickhalerBeclometasone.Hoarsenessmayalsooccur.Itmaybehelpfultorinseoutthemouththoroughlywith

waterimmediatelyafterinhalation.

Aswithotherinhalationtherapy,thepotentialforparadoxicalbronchospasmshouldbekeptinmind.Ifitoccurs,the

preparationshouldbediscontinuedimmediatelyand,ifnecessary,alternativetherapyinstituted.

Systemiceffectsofinhaledcorticosteroidsmayoccur,particularlyathighdosesprescribedforprolongedperiods.

Thesemayincludeadrenalsuppression,growthretardationinchildrenandadolescents,decreaseinbonemineral

density,cataractandglaucomaandeasybruisingoftheskin.

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4.9Overdose

AcuteInhalationofalargeamountofthedrugoverashortperiodmayleadtotemporarysuppressionofadrenal

function.Noemergencyactionisrequired.Treatmentwithbeclometasonedipropionatebyinhalationshouldbe

continuedatadosesufficienttocontrolasthma;adrenalfunctionrecoversinafewdaysandcanbeverifiedby

measuringplasmacortisol.

ChronicUseofexcessivedosesofinhaledbeclometasonedipropionateoveraprolongedperiodmaycauseadrenal

suppressionandadegreeofatrophyoftheadrenalcortex.Transfertoamaintenancedoseofasystemicsteroidmaybe

requireduntiltheconditionisstabilised.Treatmentwithinhaledbeclometasonedipropionateshouldthenbecontinued

atadosesufficienttocontrolasthma.

Ifhigherthanapproveddosesarecontinuedoverprolongedperiods,significantadrenalsuppressionandadrenalcrisis

arepossible.Presentingsymptomsofadrenalcrisismayinitiallybenon-specificandincludeanorexia,abdominalpain,

weightloss,tiredness,headache,nausea,vomiting.Hypoglycaemiawithdecreasedconsciousnessand/orconvulsions

isatypicalsymptom.Situationswhichcouldpotentiallytriggeracuteadrenalcrisisincludeexposuretotrauma,

surgery,infectionoranyrapidreductionindosage.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCcode:R03BA01.Otheranti-asthmatics,inhalants,glucocorticoids.

Beclometasonedipropionategivenbyinhalationhasaglucocorticoidanti-inflammatoryactionwithinthelungs.

Theexactmechanismresponsibleforthisanti-inflammatoryeffectisunknown.

5.2Pharmacokineticproperties

Absorptionfromthegastrointestinaltractisslowandbioavailabilityislow,suggestingthatmostoftheabsorbeddrug

ismetabolisedduringitsfirstpassagethroughtheliver.Sincethedoseoforalbeclometasonedipropionateneededto

suppressplasmacortisolisgreaterthanthatrequiredbyinhalation,thissuggeststhattheportionabsorbedfromthe

lungsismainlyresponsibleforanysystemiceffects.

5.3Preclinicalsafetydata

Studiesinanumberofanimalspecies,includingrats,rabbitsanddogs,haveshownnounusualtoxicityduringacute

experiments.Theeffectsofbeclometasonedipropionateinproducingsignsofglucocorticoidexcessduringchronic

administrationbyvariousroutesaredoserelated.Teratogenicitytestinghasshowncleftpalateinmice,aswithother

glucocorticoids.Beclometasonedipropionateisnon-genotoxicanddemonstratesnooncogenicpotentialinlifetime

studieswithrats.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate(whichcontainsmilkproteins)

6.2Incompatibilities

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6.3ShelfLife

2years

6monthswhenremovedfromthefoilpouch.

6.4Specialprecautionsforstorage

Donotstoreabove30°C.Storeinadryplace.

6.5Natureandcontentsofcontainer

Aplasticinhalerdeviceincorporatingameteringpumpandamouthpieceenclosedwithina

polyester/aluminium/polyethyleneheat-sealedsachet.Each50micrograminhalercontains200actuations.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Removemouthpiececoverfromtheinhaler.

Shaketheinhalerwell.

Holdtheinhaleruprightwiththumbonthebaseandfingeronthepushbutton.Pressthedosingbuttondown

firmly–onceonly.

Breatheoutasfarasiscomfortable.

Note:donotblowintothedeviceatanytime.

Placemouthpieceinyourmouth.Closelipsfirmlyaroundit(donotbiteit).

Breatheinthroughyourmouthsteadilyanddeeply,todrawthemedicineintoyourlungs.

Holdyourbreath,taketheinhalerfromyourmouthandcontinueholdingyourbreathforabout5seconds.

Forthesecondpuff,keeptheinhaleruprightandrepeatsteps2-7

Replacethemouthpiececover.

7MARKETINGAUTHORISATIONHOLDER

InnovataBiomedLtd

1MereWay

Ruddington

Nottingham,NG116JS

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA486/2/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:7 th

Irish Medicines Board

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Dateoflastrenewal: 30 th

October2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 20/06/2008 CRN 2050241 page number: 7