BECOTIDE EVOHALER

Main information

  • Trade name:
  • BECOTIDE EVOHALER
  • Dosage:
  • 250 Microgram
  • Pharmaceutical form:
  • Pressurised Inhalation Soln
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BECOTIDE EVOHALER
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1500/040/001
  • Authorization date:
  • 12-02-2010
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995,asamended

MedicinalProducts(ControlofPlacingontheMarket)Regulations,2007,asamended

PPA1500/040/001

CaseNo:2083758

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

ProfindWholesaleLtd.

Unit625,KilshaneAvenue,NorthwestBusinessPark,Dublin15,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

BecotideEvohaler250microgramsPressurisedInhalationSolution

theparticularsofwhicharesetoutintheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsasmaybespecifiedin

thesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom28/07/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

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Date Printed 28/07/2010 CRN 2083758 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BecotideEvohaler250microgramsPressurisedInhalationSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmetereddosecontains250microgramsbeclometasonediproprionate.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

PressurisedInhalationSolution

ProductimportedfromItaly:

Pressurisedaluminiumcontainerclosedwithameteringvalvecontainingapressurisedsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Severeasthmarequiresregularmedicalassessmentasdeathmayoccur.Patientswithsevereasthmahaveconstant

symptomsandfrequentexacerbations,withlimitedphysicalcapacity,andPEFvaluesbelow60%predictedatbaseline

withgreaterthan30%variability,usuallynotreturningentirelytonormalafterabronchodilator.Thesepatientswill

requirehighdoseinhaled(seedosageinstructions)ororalcorticosteroidtherapy.Suddenworseningofsymptomsmay

requireincreasedcorticosteroiddosagewhichshouldbeadministeredunderurgentmedicalsupervision.

Adults:-

Prophylacticmanagementin:-

Mildasthma(PEFvaluesgreaterthan80%predictedatbaselinewithlessthan20%variability):Patientsrequiring

intermittentsymptomaticbronchodilatorasthmamedicationonmorethananoccasionalbasis.

Moderateasthma(PEFvalues60-80%predictedatbaselinewith20-30%variability):Patientsrequiringregular

asthmamedicationandpatientswithunstableorworseningasthmaonotherprophylactictherapyorbronchodilator

alone.

Severeasthma(PEFvalueslessthan60%predictedatbaselinewithgreaterthan30%variability):Patientswithsevere

chronicasthma.

Children:-

Anychildwhorequiresprophylacticasthmamedication.

4.2Posologyandmethodofadministration

BecotideEvohalerisfororalinhalationuseonly.

Patientsshouldbemadeawareoftheprophylacticnatureoftherapywithinhaledbeclometasonedipropionateandthat

itshouldbetakenregularlyevenwhentheyareasymptomatic.

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Ifpatientsfindthatshort-actingreliefbronchodilatortreatmentbecomeslesseffectiveortheyneedmoreinhalations

thanusual,medicalattentionmustbesought.

Inpatientswhofindco-ordinationofapressurisedmetereddoseinhalerdifficult,aspacermaybeusedwithBecotide

Evohaler.

TheBabyhalerspacerdeviceisavailableforuseinyoungchildren.

Adultsandchildrenover12yearsofage:-

Patientsshouldbegivenastartingdoseofinhaledbeclometasonedipropionate,whichisappropriatefortheseverityof

theirdiseasebasedonthefollowingguidance:

Mildasthma:200to600microgramsperdayindivideddoses.

Moderateasthma:600to1000microgramsperdayindivideddoses.

Severeasthma:1000to2000microgramsperdayindivideddoses.

Thedosemaythenbeadjusteduntilcontrolisachievedorreducedtotheminimumeffectivedoseaccordingtothe

individualresponse.

Childrenover4yearsofage:-

Upto400microgramsperdayindivideddoses.

Childrenshouldbegivenastartingdoseofinhaledbeclometasonedipropionate,whichisappropriatefortheseverityof

theirdisease.

Thedosemaythenbeadjusteduntilcontrolisachievedorreducedtotheminimumeffectivedoseaccordingtothe

individualresponse.

Specialpatientgroups:-

Thereisnoneedtoadjustthedoseinelderlypatientsorinthosewithhepaticorrenalimpairment.

Testingtheinhaler

Beforeusingforthefirsttimeoriftheinhalerhasnotbeenusedforthreedaysormore:Removethemouthpiececover

bygentlysqueezingthesidesofthecover,shaketheinhalerwell,andreleaseonepuffintotheairtomakesurethatit

works.

Usingyourinhaler

Removethemouthpiececoverbygentlysqueezingthesidesofthecover.

Checktheinsideandoutsideoftheinhalerincludingthemouthpieceforthepresenceoflooseobjects.

Shaketheinhalerwelltoensurethatanylooseobjectsareremovedandthatthecontentsoftheinhalerareevenly

mixed.

Holdtheinhaleruprightbetweenfingersandthumbwithyourthumbonthebase,belowthemouthpiece.

Breatheoutasfarasiscomfortableandthenplacethemouthpieceinyourmouthbetweenyourteethandclose

yourlipsarounditbutdonotbiteit.

Justafterstartingtobreatheinthroughyourmouthpressdownonthetopoftheinhalertoreleasebeclometasone

dipropionatewhilestillbreathinginsteadilyanddeeply.

Whileholdingyourbreath,taketheinhalerfromyourmouthandtakeyourfingerfromthetopoftheinhaler.

Continueholdingyourbreathforaslongasiscomfortable.

Ifyouaretotakefurtherpuffskeeptheinhaleruprightandwaitabouthalfaminutebeforerepeatingsteps3to7.

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IMPORTANT:

Donotrushstages5,6and7.Itisimportantthatyoustarttobreatheinasslowlyaspossiblejustbeforeoperatingyour

inhaler.Practiceinfrontofamirrorforthefirstfewtimes.Ifyousee“mist”comingfromthetopofyourinhalerorthe

sidesofyourmouthyoushouldstartagainfromstage2.

Ifyourdoctorhasgivenyoudifferentinstructionsforusingyourinhaler,pleasefollowthemcarefully.Tellyourdoctor

ifyouhaveanydifficulties.

Cleaningtheinhaler

Theinhalershouldbecleanedatleastonceaweek:

Pullthemetalcanisteroutoftheplasticcasingoftheinhalerandremovethemouthpiececover.

Wipetheplasticcasingandmouthpiecewithadampcloth.

Leavetodryinawarmplace.Avoidexcessiveheat.

Replacethecanisterandmouthpiececover.

DONOTPUTTHEMETALCANISTERINTOWATER.

4.3Contraindications

BecotideEvohaleriscontra-indicatedinpatientswithahistoryofhypersensitivitytoanyofitscomponents.

4.4Specialwarningsandprecautionsforuse

Themanagementofasthmashouldfollowastepwiseprogramme,andpatientresponseshouldbemonitoredclinically

andbylungfunctiontests.

Increasinguseofshort-actinginhaledbeta-2-agoniststocontrolsymptomsindicatesdeteriorationofasthmacontrol.

Undertheseconditions,thepatient'stherapyplanshouldbereassessed.

Suddenandprogressivedeteriorationinasthmacontrolispotentiallylife-threateningandconsiderationshouldbegiven

toincreasingcorticosteroiddosage.Inpatientsconsideredatrisk,dailyflowmonitoringmaybeinstituted.

BecotideEvohalerisnotforuseinacuteattacksbutforroutinelong-termmanagement.Patientswillrequireafast-and

short-actinginhaledbronchodilatortorelieveacuteasthmaticsymptoms.

Patients'inhalertechniqueshouldbecheckedtomakesurethataerosolactuationissynchronisedwithinspirationof

breathforoptimumdeliveryofthedrugtothelungs.

Lackofresponseorsevereexacerbationsofasthmashouldbetreatedbyincreasingthedoseofinhaledbeclometasone

dipropionateand,ifnecessary,bygivingasystemicsteroidand/oranantibioticifthereisaninfection.

Systemiceffectsmayoccurwithanyinhaledcorticosteroid,particularlyathighdosesprescribedforlongperiods;these

effectsaremuchlesslikelytooccurthanwithoralcorticosteroids.PossiblesystemiceffectsincludeCushing’s

syndrome,Cushingoidfeatures,adrenalsuppression,growthretardationinchildrenandadolescents,decreaseinbone

mineraldensity,cataractandglaucoma.Itisimportant,therefore,thatthedoseofinhaledcorticosteroidistitratedto

thelowestdoseatwhicheffectivecontrolismaintained(seesection4.8UndesirableEffects).

Itisrecommendedthattheheightofchildrenreceivingprolongedtreatmentwithinhaledcorticosteroidisregularly

monitored.

Certainindividualscanshowgreatersusceptibilitytotheeffectsofinhaledcorticosteroidthandomostpatients.

Becauseofthepossibilityofimpairedadrenalresponse,patientstransferringfromoralsteroidtherapytoinhaled

beclometasonedipropionatetherapyshouldbetreatedwithspecialcareandadrenocorticalfunctionregularly

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Followingintroductionofinhaledbeclometasonedipropionate,withdrawalofsystemictherapyshouldbegradualand

patientsencouragedtocarryasteroidwarningcardindicatingthepossibleneedforadditionaltherapyintimesof

stress.

Similarlyreplacementofsystemicsteroidtreatmentwithinhaledtherapysometimesunmasksallergiessuchasallergic

rhinitisoreczemapreviouslycontrolledbythesystemicdrug.Theseallergiesshouldbesymptomaticallytreatedwith

antihistamineand/ortopicalpreparations,includingtopicalsteroids.

TreatmentwithBecotideEvohalershouldnotbestoppedabruptly.

Aswithallinhaledcorticosteroids,specialcareisnecessaryinpatientswithactiveorquiescentpulmonary

tuberculosis.

Patientsshouldbeadvisedthatthisproductcontainssmallamountsofethanolandglycerol.Atthenormaldosesthe

amountsofethanolandglycerolarenegligibleanddonotposearisktopatients.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

BecotideEvohalercontainsasmallamountofethanol.Thereisatheoreticalpotentialforinteractioninparticularly

sensitivepatientstakingdisulfiramormetronizadole.

4.6Pregnancyandlactation

ThereisinadequateevidenceofthesafetyofbeclometasonedipropionateorNorflurane(HFA134aor

Tetrafluoroethane)propellantinhumanpregnancy.

Inanimalreproductionstudieswithbeclometasonedipropionate,adverseeffectstypicalofpotentcorticosteroidsare

onlyseenathighsystemicexposurelevels;directinhaledapplicationensuresminimalsystemicexposure.

StudiesoftheeffectofNorflurane(HFA134a)onreproductivefunctionandembryo-foetaldevelopmentinanimals

haverevealednoclinicallyrelevantadverseevents.

NoclinicallyrelevantadverseeventshavebeenassociatedwiththeadministrationofNorflurane(HFA134a)

propellant.Thus,itisunlikelythattherewillbeanyadverseeffectsinhumans.

Administrationofdrugsduringpregnancyshouldonlybeconsiderediftheexpectedbenefittothemotherisgreater

thananypossiblerisktothefoetus.

Nospecificstudiesexaminingthetransferenceofbeclometasonedipropionateintothemilkoflactatinganimalshave

beenperformed.

Itisreasonabletoassumethatbeclomethasonedipropionateissecretedinmilkbutatthedosagesusedfordirect

inhalation,thereislowpotentialforsignificantlevelsinbreastmilk.

Theuseofbeclometasonedipropionateinmothersbreast-feedingtheirbabiesrequiresthatthetherapeuticbenefitsof

thedrugbeweighedagainstthepotentialhazardstothemotherandbaby.

4.7Effectsonabilitytodriveandusemachines

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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,commonanduncommoneventsweregenerallydetermined

fromclinicaltrialdata.Theincidenceinplaceboandcomparatorgrouphasnotbeentakenintoaccountinestimation

ofthesefrequencies.Rareandveryrareeventsweregenerallydeterminedfromspontaneousdata.

Infectionsandinfestations

Verycommon:Candidiasisofthemouthandthroat.

Candidiasisofthemouthandthroat(thrush)occursinsomepatients,theincidenceofwhichisincreasedwithdoses

greaterthan400microgramsbeclometasonedipropionateperday.PatientswithhighbloodlevelsofCandida

precipitins,indicatingapreviousinfection,aremostlikelytodevelopthiscomplication.Patientsmayfindithelpfulto

rinseouttheirmouthwithwaterafterusingtheinhaler.Symptomaticcandidiasiscanbetreatedwithtopicalanti-

fungaltherapywhilststillcontinuingwiththeBecotideEvohaler.

Immunesystemdisorders

Hypersensitivityreactionswiththefollowingmanifestationshavebeenreported:

Uncommon: Rashes,urticaria,pruritus,erythema.

Veryrare: Oedemaoftheeyes,face,lipsandthroat,respiratorysymptoms(dyspnoeaand/orbronchospasm)and

anaphylactoid/anaphylacticreactions.

Endocrinedisorders

Possiblesystemiceffectsinclude(seesection4.4SpecialWarningsandPrecautionsforUse):

Veryrare: Cushing’ssyndrome,Cushingoidfeatures,adrenalsuppression,growthretardationinchildrenand

adolescents,decreaseinbonemineraldensity,cataract,andglaucoma.

Psychiatricdisorders

Veryrare: Anxiety,sleepdisordersandbehaviouralchanges,includinghyperactivityandirritability

(predominantlyinchildren).

Respiratory,thoracicandmediastinaldisorders

Common: Hoarseness,throatirritation.

Insomepatientsinhaledbeclometasonedipropionatemaycausehoarsenessorthroatirritation.Itmay

behelpfultorinseoutthemouthwithwaterimmediatelyafterinhalation.Theuseofalargevolume

'spacer'devicemaybeconsidered.

Veryrare: Paradoxicalbronchospasm.

Aswithotherinhalationtherapy,paradoxicalbronchospasmmayoccurwithanimmediateincreaseinwheezingafter

dosing.Thisshouldbetreatedimmediatelywithafast-actinginhaledbronchodilator.BecotideEvohalershouldbe

discontinuedimmediately,thepatientassessed,andifnecessaryalternativetherapyinstituted.

4.9Overdose

Acuteinhalationofbeclometasonedipropionatedosesinexcessofthoserecommendedmayleadtotemporary

suppressionofadrenalfunction.Thisdoesnotneedemergencyactionasadrenalfunctionisrecoveredinafewdays,

asverifiedbyplasmacortisolmeasurements.

Howeverifhigherthanrecommendeddosageiscontinuedoverprolongedperiods,somedegreeofadrenalsuppression

mayresult.Monitoringofadrenalreservemaybenecessary.Incasesofbeclometasonedipropionateoverdose,

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Beclometasonedipropionateisapro-drugwithweakglucocorticoidreceptorbindingaffinity.Itishydrolysedvia

esteraseenzymestotheactivemetabolitebeclometasone-17-monopropionate(B-17-MP),whichhashightopicalanti-

inflammatoryactivity.

5.2Pharmacokineticproperties

Absorption

Whenadministeredviainhalation(viametereddoseinhaler),systemicabsorptionofunchangedbeclometasone

dipropionate(BDP)occursthroughthelungswithnegligibleoralabsorptionoftheswalloweddose.Thereisextensive

conversionofBDPtoitsactivemetaboliteB-17-MPwithinthelungpriortoabsorption.ThesystemicabsorptionofB-

MParisesfrombothlungdepositionandoralabsorptionoftheswalloweddose.Theabsolutebioavailabilityfollowing

inhalationisapproximately60%ofthenominaldoseforB-17-MP.BDPisabsorbedrapidlywithpeakplasma

concentrationsfirstbeingobserved(t

)at0.3h.B-17-MPappearsmoreslowlywithat

of1h.Thereisan

approximatelylinearincreaseinsystemicexposurewithincreasinginhaleddose.Whenadministeredorallythe

bioavailabilityofBDPisnegligiblebutpre-systemicconversiontoB-17-MPresultsinapproximately40%ofthedose

beingabsorbedasB-17-MP.

Metabolism

BDPisclearedveryrapidlyfromthesystemiccirculation,bymetabolismmediatedviaesteraseenzymesthatarefound

mosttissues.Themainproductofmetabolismistheactivemetabolite(B-17-MP).Minorinactivemetabolites,

beclometasone-21-monopropionate(B-21-MP)andbeclometasone(BOH)arealsoformedbutthesecontributelittletot

systemicexposure.

Distribution

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

Plasmaproteinbindingismoderatelyhigh(87%).

Elimination

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

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

thedosewasexcretedinthefaeceswithin96hoursmainlyasfreeandconjugatedpolarmetabolites.Approximately

12%ofthedosewasexcretedasfreeandconjugatedpolarmetabolitesintheurine.TherenalclearanceofBDPandits

metabolitesisnegligible.

5.3Preclinicalsafetydata

Preclinicalsafetystudiesindicatethatbeclometasonedipropionateshowsnegligiblesystemictoxicitywhen

administeredbytheinhaledroute.

Thenon-CFCpropellant,Norflurane(HFA134a),hasbeenshowntohavenotoxiceffectatveryhighvapour

concentrations,farinexcessofthoselikelytobeexperiencedbypatients,inawiderangeofanimalspeciesexposed

dailyforperiodsoftwoyears.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Norflurane(Hydrofluroralkane(HFA)134a)

EthanolAnhydrous

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6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Theshelf-lifeexpirydateofthisproductisthedateshownonthecontainerandoutercartonoftheproductonthe

marketinthecountryoforigin.

6.4Specialprecautionsforstorage

Thecanistercontainsapressurisedliquid.Donotexposetotemperaturehigherthan50°C.Donotpiercethecanister.

Donotrefrigerateorfreeze.

Donotstoreabove30°C.

Protectfromdirectsunlight.

Aswithmostinhaledmedicationsinpressurisedcontainers,thetherapeuticeffectofthismedicationmaydecrease

whenthecanisteriscold.

6.5Natureandcontentsofcontainer

Theinhalercomprisesanover-labelledaluminiumcanfittedwithameteringvalve,plasticactuator,anddustcap,and

placedinanover-labelledoutercarton.

Packsize:200metereddoses.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Patientsshouldbecarefullymonitoredintheproperuseoftheirinhaler

7PARALLELPRODUCTAUTHORISATIONHOLDER

ProfindWholesaleLtd

Unit625,KilshaneAvenue

NorthwestBusinessPark

Dublin15

Ireland

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1500/40/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:12 th

February2010

10DATEOFREVISIONOFTHETEXT

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