BECLO-RHINO AQUEOUS

Main information

  • Trade name:
  • BECLO-RHINO AQUEOUS
  • Dosage:
  • 50 Mcg/ Dose
  • Pharmaceutical form:
  • Nasal Spray Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BECLO-RHINO AQUEOUS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0899/017/001
  • Authorization date:
  • 14-05-1999
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

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

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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

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