BETNELAN

Main information

  • Trade name:
  • BETNELAN Tablets 500mcg Microgram
  • Dosage:
  • 500mcg Microgram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BETNELAN Tablets 500mcg Microgram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0365/066/001
  • Authorization date:
  • 27-10-1993
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0365/066/001

CaseNo:2062927

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

UCBPharmaLimited

208BathRoad,Slough,BerkshireSL13WE,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Betnelan500microgramTablets.

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom22/07/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

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PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Betnelan500microgramTablets.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains500micrograms(0.5mg)betamethasone.

Excipients:contains97mglactosepertablet.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Tablet.

Small,whiteflattabletengraved‘BetnelanEvans’ononesideandscoredonthereverse.

Thescorelineisonlytofacilitatebreakingforeaseofswallowingandnottodivideintoequaldoses.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Betamethasoneisaglucocorticosteroidwhichisabouteighttotentimesasactiveasprednisoloneonaweight-for-

weightbasis.

Awidevarietyofdiseasesmaysometimesrequirecorticosteroidtherapy.Someoftheprincipalindicationsare:

Bronchialasthma,severehypersensitivityreactions,anaphylaxis;rheumatoidarthritis,systemiclupuserythematosus,

dermatomyositis,mixedconnectivetissuedisease(excludingsystemicsclerosis),polyarteritisnodosa;inflammatory

skindisorders,includingpemphigusvulgaris,bullouspemphigoidandpyodermagangrenosum;minimalchange

nephroticsyndrome,acuteinterstitialnephritis;ulcerativecolitis,Crohn'sdisease;sarcoidosis;rheumaticcarditis;

haemolyticanaemia(auto-immune),acutelymphoblasticandchroniclymphocyticleukaemias.,malignantlymphoma,

multiplemyeloma,idiopathicthrombocytopeniapurpura;immuno-suppressionintransplantation.

4.2Posologyandmethodofadministration

Thelowestdosagethatwillproduceanacceptableresultshouldbeused;whenitispossibletoreducethedosage,this

mustbeaccomplishedinstages.Duringprolongedtherapy,dosagemayneedtobeincreasedtemporarilyduring

periodsofstressorinexacerbationofillness(seeSpecialWarningsandPrecautionsforUse).

Adults:

Thedoseusedwilldependuponthedisease,itsseverity,andtheclinicalresponseobtained.Thefollowingregimens

areforguidanceonly.

Short-termtreatment:

2to3mgdailyforthefirstfewdays,subsequentlyreducingthedailydosageby250or500micrograms(0.25or

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Rheumatoidarthritis:

500micrograms(0.5mg)to2mgdaily.Formaintenancetherapythelowesteffectivedosageisused.

Mostotherconditions:

1.5to5mgdailyforonetothreeweeks,thenreducingtotheminimumeffectivedosage.

Largerdosesmaybeneededformixedconnectivetissuediseasesandulcerativecolitis.

Children:

Aproportionoftheadultdosagemaybeused(e.g.75%attwelveyears,50%atsevenyearsand25%atoneyear)but

clinicalfactorsmustbegivendueconsideration(seeSpecialWarningsandPrecautionsforUse).

4.3Contraindications

Systemicinfections,unlessspecificanti-infectivetherapyisemployed.Hypersensitivitytoanycomponentsofthe

tablet.Useinpatientswithpepticulceroracutepsychosis.

4.4Specialwarningsandprecautionsforuse

APatientInformationLeafletshouldbesuppliedwiththisproduct.

Undesirableeffectsmaybeminimisedbyusingthelowesteffectivedosefortheminimumperiodandbyadministering

thedailyrequirementasasinglemorningdose,orasasinglemorningdoseonalternatedayswheneverpossible.

Frequentpatientreviewisrequiredtoappropriatelytitratethedoseagainstdiseaseactivity(seePosologyandMethod

ofAdministration).

Cautionisadvisedwiththeuseofcorticosteroidsinpatientswithhypothyroidismormyasthemagravis.

Cautionisadvisedwiththeuseofcorticosteroidsinpatientswhohavesufferedarecentmyocardialinfarctionbecause

oftheriskofmyocardialrupture.

Suppressionoftheinflammatoryresponseandimmunefunctionincreasesthesusceptibilitytoinfectionsandtheir

severity.Theclinicalpresentationmayoftenbeatypicalandseriousinfectionssuchassepticaemiaandtuberculosis

maybemaskedandmayreachanadvancedstagebeforebeingrecognised.

Chickenpoxisofparticularconcernsincethisnormallyminorillnessmaybefatalinimmunosuppressedpatients.

Patients(orparentsofchildren)withoutadefinitehistoryofchickenpoxshouldbeadvisedtoavoidclosepersonal

contactwithchickenpoxorherpeszosterandifexposedtheyshouldseekurgentmedicalattention.Passive

immunisationwithvaricella/zosterimmunoglobulin(VZIG)isneededbyexposednon-immunepatientswhoare

receivingsystemiccorticosteroidsorwhohaveusedthemwithintheprevious3months;thisshouldbegivenwithin10

daysofexposuretochickenpox.Ifadiagnosisofchickenpoxisconfirmed,theillnesswarrantsspecialistcareand

urgenttreatment.Corticosteroidsshouldnotbestoppedandthedosemayneedtobeincreased.

Livevaccinesshouldnotbegiventoindividualswithimpairedimmuneresponsiveness.Theantibodyresponseto

othervaccinesmaybediminished.

Patientsshouldbeadvisedtotakeparticularcaretoavoidexposuretomeaslesandtoseekimmediatemedicaladviceif

exposureoccurs.Prophylaxiswithintramuscularnormalimmunoglobulinmaybeneeded.

Adrenalsuppression:

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Inpatientswhohavereceivedmorethanphysiologicaldosesofsystemiccorticosteroids(approximately1mg

betamethasoneorequivalent)forgreaterthan3weeks,withdrawalshouldnotbeabrupt.Howdosereductionshould

becarriedoutdependslargelyonwhetherthediseaseislikelytorelapseasadoseofsystemiccorticosteroidsis

reduced.Clinicalassessmentofdiseaseactivitymaybeneededduringwithdrawal.Ifthediseaseisunlikelytorelapse

onwithdrawalofsystemiccorticosteroidsbutthereisuncertaintyabouthypothalamic-pituitary-adrenal(HPA)

suppression,thedoseofsystemiccorticosteroidmaybereducedrapidlytophysiologicaldoses.Onceadailydose

equivalentto1mgbetamethasoneisreached,dosereductionshouldbeslowertoallowtheHPA-axistorecover.

Abruptwithdrawalofsystemiccorticosteroidtreatment,whichhascontinuedupto3weeksisappropriateifitis

consideredthatthediseaseisunlikelytorelapse.Abruptwithdrawalofdosesofupto6mgdailyofbetamethasone,or

equivalentfor3weeksisunlikelytoleadtoclinicallyrelevantHPA-axissuppression,inthemajorityofpatients.In

thefollowingpatientgroups,gradualwithdrawalofsystemiccorticosteroidtherapyshouldbeconsideredevenafter

courseslasting3weeksorless:

Patientswhohavehadrepeatedcoursesofsystemiccorticosteroids,particularlyiftakenforgreaterthan3weeks,

Whenashortcoursehasbeenprescribedwithinoneyearofcessationoflong-termtherapy(monthsoryears),

Patientswhohavereasonsforadrenocorticalinsufficiencyotherthanexogenouscorticosteroidstherapy,

Patientsreceivingdosesofsystemiccorticosteroidgreaterthan6mgdailyofbetamethasone(orequivalent),

Patientsrepeatedlytakingdosesintheevening.

Duringprolongedtherapyanyintercurrentillness,traumaorsurgicalprocedurewillrequireatemporaryincreasein

dosage;ifcorticosteroidshavebeenstoppedfollowingprolongedtherapytheymayneedtobetemporarilyre-

introduced.

Specialprecautions:

Particularcareisrequiredwhenconsideringtheuseofsystemiccorticosteroidsinpatientswiththefollowing

conditionsandfrequentpatientmonitoringisnecessary.

Osteoporosis(post-menopausalfemalesareparticularlyatrisk).

Hypertensionorcongestiveheartfailure.

Existingorprevioushistoryofsevereaffectivedisorders(especiallyprevioussteroidpsychosis).

Diabetesmellitus(orafamilyhistoryofdiabetes).

Historyoftuberculosis.

Glaucoma(orafamilyhistoryofglaucoma).

Previouscorticosteroid-inducedmyopathy.

Liverfailure-bloodlevelsofcorticosteroidmaybeincreased,(aswithotherdrugswhicharemetabolisedinthe

liver).

Renalinsufficiency.

Epilepsy.

Pepticulceration.

Patientsshouldcarry'steroidtreatment'cardswhichgiveclearguidanceontheprecautionstobetakentominimiserisk

andwhichprovidedetailsofprescriber,drug,dosageandthedurationoftreatment.

Patients/andorcarersshouldbewarnedthatpotentiallyseverepsychiatricadversereactionsmayoccurwithsystemic

steroids(seesection4.8).Symptomstypicallyemergewithinafewdaysorweeksofstartingtreatment.Risksmaybe

higherwithhighdoses/systemicexposure(seealsosection4.5pharmacokineticinteractionsthatcanincreasetherisk

ofsideeffects),althoughdoselevelsdonotallowpredictionoftheonset,type,severityordurationofreactions.Most

reactionsrecoveraftereitherdosereductionorwithdrawal,althoughspecifictreatmentsmaybenecessary.

Patients/carersshouldbeencouragedtoseekmedicaladviceifworryingpsychologicalsymptomsdevelop,especiallyif

depressedmoodorsuicidalideationissuspected.Patients/carersshouldalsobealerttopossiblepsychiatric

disturbancesthatmayoccureitherduringorimmediatelyafterdosetapering/withdrawalofsystemicsteroids,although

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Particularcareisrequiredwithconsideringtheuseofsystemiccorticosteroidsinpatientswithexistingorprevious

historyofsevereaffectivedisordersinthemselvesorintheirfirstdegreerelatives.Thesewouldincludedepressiveor

manic-depressiveillnessandprevioussteroidpsychosis.

Useinchildren:

Cautionisadvisedinchildrenastheyaremoresusceptibletosystemictoxicityfrombetamethasone.

Corticosteroidscausedose-relatedgrowthretardationininfancy,childhoodandadolescence,whichmaybe

irreversible.Treatmentshouldbelimitedtotheminimumdosagefortheshortestpossibletime.Inordertominimise

suppressionoftheHPAaxisandgrowthretardation,considerationshouldbegiventoadministrationofasingledose

onalternatedays.

Useintheelderly:

Thecommonadverseeffectsofsystemiccorticosteroidsmaybeassociatedwithmoreseriousconsequencesinoldage,

especiallyosteoporosis,hypertension,hypokalaemia,diabetes,susceptibilitytoinfectionandthinningoftheskin.

Closeclinicalsupervisionisrequiredtoavoidlife-threateningreactions.

Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactasedeficiencyorglucose-galactose

malabsorptionshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Steroidsmayreducetheeffectsofanticholinesterasesinmyastheniagravis,cholecystographicX-raymediaandnon-

steroidalanti-inflammatoryagents.

Rifampicin,rifabutin,carbamazepine,phenobarbitone,phenytoin,primidone,aminoglutethimideandephedrine

enhancethemetabolismofcorticosteroids;thusthecorticosteroidtherapeuticeffectmaybereduced.

Thedesiredeffectsofhypoglycaemicagents(includinginsulin),anti-hypertensivesanddiureticsareantagonisedby

corticosteroids,andthehypokalaemiceffectsofacetazolamide,loopdiuretics,thiazidediureticsandcarbenoxoloneare

enhanced.

Theefficacyofcoumarinanticoagulantsmaybeenhancedbyconcurrentcorticosteroidtherapyandclosemonitoringof

theINRorprothrombintimeisrequiredtoavoidspontaneousbleeding.

Therenalclearanceofsalicylatesisincreasedbycorticosteroidsandsteroidwithdrawalmayresultinsalicylate

intoxication.

Concurrentuseofcorticosteroidsandfluoroquinolonesmayresultinincreasedriskoftendonrupture.

Quetiapinemayresultindecreasedlevelsofcorticosteroids.

Corticosteroidsmayenhancethemetabolismoftretinoinresultingindecreasedlevelsoftretinoin.

Theriskofhypokalaemiaisincreasedwiththeophylline,ulcerhealingdrugssuchascarbenoxoloneandantifungals

suchasamphotericinB.

Increasedtoxicitymayresultifhypokalaemiaoccursinpatientsoncardiacglycosides.

Ritonavirandoralcontraceptivesmayresultinincreasedplasmaconcentrationsorcorticosteroids.

Theeffectofcorticosteroidsmaybereducedfor3-4daysaftermifepristone.

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AnincreaseintheincidenceofgastrointestinalbleedingmayoccurifNSAIDSaretakenconcomitantlywith

corticosteroids.

Corticosteroidsmayantagonisetheeffectsofneuromuscularblockingdrugssuchasvecuronium.

4.6Pregnancyandlactation

Pregnancy

Theabilityofcorticosteroidstocrosstheplacentavariesbetweenindividualdrugs,however,betamethasonereadily

crossestheplacenta.Administrationofcorticosteroidstopregnantanimalscancauseabnormalitiesoffoetal

developmentincludingcleftpalate,intra-uterinegrowthretardationandeffectsonbraingrowthanddevelopment.

Thereisnoevidencethatcorticosteroidsresultinanincreasedincidenceofcongenitalabnormalities,suchascleft

palate/lipinman.However,whenadministeredforprolongedperiodsorrepeatedlyduringpregnancy,corticosteroids

mayincreasetheriskofintra-uterinegrowthretardation.Hypoadrenalismmay,intheory,occurintheneonate

followingprenatalexposuretocorticosteroidsbutusuallyresolvesspontaneouslyfollowingbirthandisrarely

clinicallyimportant.Hypertrophiccardiomyopathyandgastroesophagealrefluxhavebeenassociatedwithinutero

exposuretobetamethasone.

Aswithalldrugs,corticosteroidsshouldonlybeprescribedwhenthebenefitstothemotherandchildoutweighthe

risks.Whencorticosteroidsareessentialhowever,patientswithnormalpregnanciesmaybetreatedasthoughthey

wereinthenon-gravidstate.Patientswithpre-eclampsiaorfluidretentionrequireclosemonitoring.

Betamethasone,systemicallyadministeredtoawomanduringpregnancymayresultinatransientsuppressionofthe

foetalheartrateparametersandbiophysicalactivitiesthatarewidelyusedfortheassessmentoffoetalwell–being.

Thesecharacteristicscanincludeareductioninfoetalbreathingmovements,bodymovementsandheartrate.

Lactation

Corticosteroidsmaypassintobreastmilk,althoughnodataareavailableforbetamethasone.Infantsofmotherstaking

highdosesofsystemiccorticosteroidsforprolongedperiodsmayhaveadegreeofadrenalsuppression.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Theincidenceofpredictableundesirableeffects,includinghypothalamic-pituitary-adrenal(HPA)axissuppression,

correlateswiththerelativepotencyofthedrug,dosage,timingofadministrationandthedurationoftreatment(see

SpecialWarningsandPrecautionsforUse).

Bloodandlymphaticsystemdisorders:Leucocytosis

Immunesystemdisorders:

Increasedsusceptibilitytoandseverityofinfectionswithsuppressionofclinicalsymptomsandsigns,opportunistic

infections,recurrenceofdormanttuberculosis(seeSpecialWarningsandPrecautionsforUse).

Endocrinedisorders:

Suppressionofthehypothalamic-pituitary-adrenalaxis,growthsuppressionininfancy,childhoodandadolescence,

menstrualirregularityandamenorrhoea.Cushingoidfacies,hirsutism,weightgain,impairedcarbohydratetolerance

withincreasedrequirementsforantidiabetictherapy.Negativeproteinandcalciumbalance.Increasedappetite.

Sodiumandwaterretention,potassiumloss,hypokalaemicalkalosis.

Neuropsychiatric:

Awiderangeofpsychiatricreactionsincludingaffectivedisorder(suchasirritable,euphoric,depressedandlabile

moodandsuicidalthoughts),psychoticreactionsincludingmania,delusions,hallucinationsandaggravationof

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confusionandamnesiahavebeenreported.Reactionsarecommonanymayoccurinbothadultsandchildren.In

adults,thefrequencyofseverereactionshasbeenestimatedtothe5-6%.Psychologicaleffectshavebeenreportedon

withdrawalofcorticosteroids;thefrequencyisunknown.

Psychologicaldependence.Increasedintra-cranialpressurewithpapilloedemainchildren(pseudotumourcerebri),

usuallyaftertreatmentwithdrawal.Aggravationofepilepsy.

Eyedisorders:

Increasedintra-ocularpressure,glaucoma,papilloedema,posteriorsubcapsularcataracts,cornealorscleralthinning,

exacerbationofophthalmicviralorfungaldiseases.

Vasculardisorders:

Thrombo-embolism,hypertension.

Gastrointestinaldisorders:

Abdominaldistension,oesophagealulceration,nausea,dyspepsia,pepticulcerationwithperforationandhaemorrhage,

acutepancreatitis,candidiasis.

Skinandsubcutaneoustissuedisorders:

Impairedhealing,skinatrophy,bruising,telangiectasia,striae,acne,Stevens-Johnsonsyndrome.

Musculoskeletal,connectivetissuedisorders:

Osteoporosis,vertebralandlongbonefractures,avascularosteonecrosis,tendonrupture,proximalmyopathy.

Generaldisordersandadministrationsiteconditions:

Hypersensitivityincludinganaphylaxis,hasbeenreported.

Withdrawalsymptomsandsigns:

Toorapidareductionofcorticosteroiddosagefollowingprolongedtreatmentcanleadtoacuteadrenalinsufficiency,

hypotensionanddeath(seeSpecialWarningsandPrecautionsforUse).

A‘withdrawalsyndrome’mayalsooccur,includingfever,myalgia,arthralgia,rhinitis,conjunctivitis,painfulitchy

skinnodulesandlossofweight.

4.9Overdose

Treatmentisunlikelytobeneededincasesofacuteoverdosage.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCode:H02AB01

Betamethasoneisaglucocorticoidwhichisabouteighttotentimesasactiveasprednisoloneonaweight-for-weight

basis.

5.2Pharmacokineticproperties

Corticosteroidsareboundtoplasmaproteinsinvaryingdegrees.Corticosteroidsaremetabolisedprimarilyintheliver

andarethenexcretedbythekidneys.

5.3Preclinicalsafetydata

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactose

MaizeStarch

Gelatin

MagnesiumStearate

6.2Incompatibilities

Notapplicable

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove30°C.Storeintheoriginalcontainertoprotectfromlight.

6.5Natureandcontentsofcontainer

Tubularglassvialwithapolyurethanesnap-plugclosurecontaining100tablets

Tamperevidentpolypropylenecontainerwithapolyurethanefoamwadandalowdensitypolyethylenelidcontaining

500tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

UCBPharmaLimited

208BathRoad

Slough

Berkshire

SL13WE

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA0365/066/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1978

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10DATEOFREVISIONOFTHETEXT

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