BECLO-RHINO ALLERGY

Main information

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

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0899/017/002
  • Authorization date:
  • 10-11-2006
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995

MEDICINALPRODUCTS(LICENSINGANDSALE)REGULATIONS,1998

(S.I.No.142of1998)

PA0899/017/002

CaseNo:1025955

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

GoldshieldPharmaceuticalsLtd

NLATower,12-16AddiscombeRoad,Croydon,SurreyCRO0XT,England

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Beclo-RhinoAllergy50microgramAqueousNasalSpraySuspension

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom10/11/2006until09/11/2011.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 11/11/2006 CRN 1025955 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Beclo-RhinoAllergy50microgramAqueousNasalSpraySuspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

BeclometasoneDipropionate50microgramsperspray.

ForfulllistofExcipientsseesection6.1.

3PHARMACEUTICALFORM

NasalSpray,Suspension.

Aglassvialfittedwithameteringpumpandnasaltipcontaininganopaquewhitenasalspraysuspension.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthepreventionandtreatmentofseasonalallergicrhinitis.

4.2Posologyandmethodofadministration

1Spray=50µgbeclometasonedipropionate

Foradministrationbytheintra-nasalroute.

Adultsandtheelderly:Twospraysintoeachnostriltwicedaily=400µg/day.

Insomepatients,apreferreddosagemaybeonesprayintoeachnostrilthreeorfourtimesdaily.

Thetotaldailydoseshouldnotexceedeightsprays.

Formaximumtherapeuticbenefitregularuseisessential.Maximumbenefitmaynotbeobtainedinthefirstfewdoses,

andtheco-operationofpatientsisrequiredtoensurecompliancewitharegulardosageschedule.

Foruseinpatientsaged18yearsandover.

4.3Contraindications

Patientswithaknownhypersensitivitytoanyoftheingredients.

4.4Specialwarningsandprecautionsforuse

BeclometasoneAqueousNasalAllergySprayisnotspecificallycontra-indicatedinthepresenceofinfectionsofthe

nasalpassagesorparanasalsinuses,buttheseinfectionsshouldbetreatedappropriately.

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exercisedifthereisasuspicionthattheadrenalfunctionisimpaired.

Systemiceffectsmayoccurrarely.Theseeffectsincludehypothalamic-pituitary-adrenalsuppressionandgrowth

retardationinchildren.

Beclometasoneaqueousnasalallergyspraywillcontrolseasonalallergicrhinitisformostpatients,but,ifthereisan

abnormalheavychallengebysummerallergens,insomepatientsitmaybenecessarytogiveadditionaltreatment,

particularlytocontroleyeproblems.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nonestated.

4.6Pregnancyandlactation

Pregnancy

Thereisinadequateevidenceofsafetyinhumanpregnancy.Inanimalstheadministrationofcoricosteroidstopregnant

animalscancausefoetalabnormalitiesincludingcleftpalateandgrowthretardation.Thereisasmallriskthatsuch

effectscouldoccurtothehumanfoetus.However,theanimaleffectsoccurredafterrelativelyhighsystemicdosage:

whereas,directapplicationintra-nasallyprovidesminimalsystemicabsorption.

IfBeclometasoneaqueousnasalsprayisusedinpregnancy,therisktobenefitratiomustbeassessedagainstpossible

hazards.Itshouldbenotedthatbeclometasonedipropionatehasbeeninwidespreaduseformanyyearswithout

apparentill-effects.

Lactation

Althoughnospecificstudieshavebeenundertakenregardingthetransferofbeclometasonedipropionateintomilkof

lactatinganimals,itcanbeassumedthatitissecretedinmilk.However,thereislowpotentialforsignificantlevelsin

humanmilkfollowingdirectintra-nasaluseofbeclometasonedipropionate.

IfBeclometasoneaqueousnasalsprayisusedinbreastfeedingmothers,thetherapeuticbenefitsshouldbeweighed

againstthepossiblehazardstomotherandbaby.

4.7Effectsonabilitytodriveandusemachines

Nonestated

4.8Undesirableeffects

Rarecasesofnasalseptalperforationhaveoccurred.Drynessandirritationofthenoseandthroat,anunpleasanttaste

andsmell,andepistaxishaveoccurredrarely(aswiththeuseofnasalsprays).Therehavebeenrarecasesofraised

intra-ocularpressureandglaucoma.

4.9Overdose

Theonlyharmfuleffectofinhalationoflargeamountsofbeclometasonedipropionateinashortperiodoftimeis

suppressionofthehypothalamic-pituitary-adrenalfunction.Nospecialemergencytreatmentisrequired.Treatment

withBeclo-Rhinoshouldbecontinuedattheprescribed(recommended)dosebecausethehypothalamic-pituitaryl-

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Localsteroidalanti-inflammatoryagent

Beclometasonedipropionateexertsmarkedanti-inflammatoryactivityonthe

skinandnasalmucosa.

Theslowingeffectonthehypothalamic-pituitary-adrenalaxisfollowingadministrationviathenasalrouteisevident

onlyatdosesequaltoorgreaterthan8mgwhilstthelocaltherapeuticeffectisobviousatthemeandoseof400 µ

gper

dayinadults.Thedifferencebetweenthesedoselevelsandthemetabolicinactivationofthisproductaccountsforthe

lackofgeneralsideeffectsattherecommendeddailydosage.

5.2Pharmacokineticproperties

Beclometasonedipropionateisveryslightlyabsorbedbythenasalmucosa.Itismetabolisedintomonopropionateand

beclomethasone-alcoholintheliver,thenexcretedasinactivemetabolitesinbileandurine.

5.3Preclinicalsafetydata

Nonestated

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

GlucoseMonohydrate

MicrocrystallineCellulose/SodiumCarboxymethylCellulose

PhenylethylAlcohol

Polysorbate80

BenzalkoniumChloride

Waterforinjection

6.2Incompatibilities

Notapplicable

6.3ShelfLife

Aspackedforsale:24months

Afterfirstopening:3months

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Donotrefrigerateorfreeze.Keepthecontainerintheoutercarton.

6.5Natureandcontentsofcontainer

Glasstype&colour:TypeIIIamberglass

15mlglasssprayvial(100spray)

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6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements

7MARKETINGAUTHORISATIONHOLDER

GoldshieldPharmaceuticalsLtd

NLATower,12-16AddiscombeRoad

CroydonCROOXT

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA899/17/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFrstAuthorisation:10thNovember2006

Irish Medicines Board

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