BECLO-RHINO AQUEOUS 50 Mcg/Dose Nasal Spray Suspension

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
BECLOMETASONE DIPROPIONATE
Available from:
Mercury Pharmaceuticals Ltd
INN (International Name):
BECLOMETASONE DIPROPIONATE
Dosage:
50 Mcg/Dose
Pharmaceutical form:
Nasal Spray Suspension
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization number:
PA0899/017/001
Authorization date:
2009-05-13

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Beclo-Rhino50microgramAqueousNasalSpraySuspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

BeclomethasoneDipropionate50microgramsperspray.

Forexcipientssee6.1.

3PHARMACEUTICALFORM

Nasalspraysuspension

Aglassvialfittedwithameteredpumpandnasaltipcontaininganopaquewhitenasalspraysuspension.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Fortheprophylaxisandtreatmentofperennialandseasonalallergicrhinitis,includinghayfeverandvasomotor

rhinitis.

Inflammatoryrhinitis,especiallyeosinophil-inducedrhinitis.

4.2Posologyandmethodofadministration

1Spray=50mgbeclomethasonedipropionate.

Foradministrationbytheintra-nasalroute.

Adultsandtheelderly:Twospraysintoeachnostriltwicedaily=400micrograms/day.Insomepatients,apreferred

dosagemaybeonesprayintoeachnostrilthreeorfourtimesdaily.

Thetotaldailydoseshouldnotexceedeightsprays.

Formaximumtherapeuticbenefitregularuseisessential.Maximumbenefitmaynotbeobtainedinthefirstfewdoses,

andtheco-operationofpatientsisrequiredtoensurecompliancewitharegulardosageschedule.

Children:(over6years).Asforadultsandtheelderly.Usebychildrenunder6yearsofageisnotrecommended

becauseofinsufficientclinicaldata.

4.3Contraindications

Patientswithaknownhypersensitivitytoanyoftheingredients.

4.4Specialwarningsandprecautionsforuse

BeclomethasoneAqueousNasalSprayisnotspecificallycontra-indicatedinthepresenceofinfectionsofthenasal

passagesorparanasalsinuses,buttheseinfectionsshouldbetreatedappropriately.Whenpatientsaretransferredfrom

systemicsteroidtherapytoBeclomethasoneaqueousnasalspray,careshouldbeexercisedifthereisasuspicionthat

Irish Medicines Board

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Date Printed 28/09/2006 CRN 2028334 page number: 1

Systemiceffectsmayoccurrarely.Theseeffectsincludehypothalamic-pituitary-adrenalsuppressionandgrowth

retardationinchildren.

Beclomethasoneaqueousnasalspraywillcontrolseasonalallergicrhinitisformostpatients,but,ifthereisanabnormal

heavychallengebysummerallergens,insomepatientsitmaybenecessarytogiveadditionaltreatment,particularlyto

controleyeproblems.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nonestated.

4.6Pregnancyandlactation

Pregnancy

Thereisinadequateevidenceofsafetyinhumanpregnancy.Inanimalstheadministrationofcorticosteroidstopregnant

animalscancausefoetalabnormalitiesincludingcleftpalateandgrowthretardation.Thereisasmallriskthatsuch

effectscouldoccurtothehumanfoetus.However,theanimaleffectsoccurredafterrelativelyhighsystemicdosage

whereas,directapplicationintra-nasallyprovidesminimalsystemicabsorption.

IfBeclomethasoneaqueousnasalsprayisusedinpregnancy,therisktobenefitratiomustbeassessedagainstpossible

hazards.Itshouldbenotedthatbeclomethasonedipropionatehasbeeninwidespreaduseformanyyearswithout

apparentill-effects.

Lactation

Althoughnospecificstudieshavebeenundertakenregardingthetransferofbeclomethasonedipropionateintomilkof

lactatinganimals,itcanbeassumedthatitissecretedinmilk.However,thereislowpotentialforsignificantlevelsin

humanmilkfollowingdirectintra-nasaluseofbeclomethasonedipropionate.

IfBeclomethasoneaqueousnasalsprayisusedinbreastfeedingmothers,thetherapeuticbenefitsshouldbeweighed

againstthepossiblehazardstomotherandbaby.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Rarecasesofnasalseptalperforationhaveoccurred.Drynessandirritationofthenoseandthroat,anunpleasanttaste

andsmell,andepistaxishaveoccurredrarely(aswiththeuseofnasalsprays).Therehavebeenrarecasesofraised

intra-ocularpressureandglaucoma.

4.9Overdose

Theonlyharmfuleffectofinhalationoflargeamountsofbeclomethasonedipropionateinashortperiodoftimeis

suppressionofthehypothalamic-pituitary-adrenalfunction.Nospecialemergencytreatmentisrequired.Treatment

withBeclomethasonedipropionateshouldbecontinuedattheprescribed(recommended)dosebecausethe

hypothalamicpituitary-adrenalfunctionrecoversinadayortwo.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Localsteroidalanti-inflammatoryagent.

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Theslowingeffectonthehypothalamic-pituitary-adrenalaxisfollowingadministrationviathenasalrouteisevident

onlyatdosesequaltoorgreaterthan8mgwhilstthelocaltherapeuticeffectisobviousatthemeandoseof400mcgin

adults.Thedifferencebetweenthesedoselevelsandthemetabolicinactivationofthisproductaccountsforthelackof

generalsideeffectsattherecommendeddailydosage.

5.2Pharmacokineticproperties

Beclomethasonedipropionateisveryslightlyabsorbedbythenasalmucosa.Itismetabolisedintomonopropionateand

beclomethasone-alcoholintheliver,thenexcretedasinactivemetabolitesinbileandurine.

5.3Preclinicalsafetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

GlucoseMonohydrate

Microcrystallinecellulose

SodiumCarboxymethylCellulose

Phenylethylalcohol

Polysorbate80

Benzalkoniumchloride

WaterforInjection

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Aspackagedforsale24months.

Afterfirstopening3months.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

Donotrefrigerateorfreeze.

Keepthecontainerintheoutercarton.

6.5Natureandcontentsofcontainer

15mlTypeIIIamberglassspraybottle(100spray).

27mlTypeIIIamberglassspraybottle(200spray).

Bothwithmeteredpumpandnasaltip.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

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7MARKETINGAUTHORISATIONHOLDER

GoldshieldPharmaceuticalsLtd

NLATower

CroydonCR00XT

England

8MARKETINGAUTHORISATIONNUMBER

PA899/17/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:14May1999

Dateoflastrenewal:14May2004

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 28/09/2006 CRN 2028334 page number: 4

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