BETNESOL-N 0.01% W/W, 3500 IU/ML EYE OINTMENT

Main information

  • Trade name:
  • BETNESOL-N 0.01% W/W, 3500 IU/ML EYE OINTMENT
  • Dosage:
  • 0.1/0.5%w/ %v/v
  • Pharmaceutical form:
  • Eye Ointment
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BETNESOL-N 0.01% W/W, 3500 IU/ML EYE OINTMENT
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0365/046/002
  • Authorization date:
  • 13-08-1993
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0365/046/002

CaseNo:2077742

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

UCBPharmaLimited

208BathRoad,Slough,BerkshireSL13WE,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Betnesol-N0.1%/0.5%EyeOintment

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom10/02/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 11/02/2010 CRN 2077742 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Betnesol-N0.1%/0.5%EyeOintment

2QUALITATIVEANDQUANTITATIVECOMPOSITION

BetamethasoneSodiumPhosphate0.10%w/w

NeomycinSulphate0.50%w/w(equivalentto3500IU/g)

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Eyeointment

Asmoothoff-whitetranslucentointment.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Fortheshort-termtreatmentofsteroidresponsiveinflammatoryconditionsoftheeyewhenprophylacticantibiotic

treatmentisalsorequired,afterexcludingthepresenceofviralandfungaldisease.

4.2Posologyandmethodofadministration

Adults(includingtheelderly)andchildren

Thefrequencyofdosingdependsontheclinicalresponse.Ifthereisnoclinicalresponsewithin7daysoftreatment,the

ointmentshouldbediscontinued.

Treatmentshouldbethelowesteffectivedosefortheshortestpossibletime.Normally,Betnesol-NOintmentshould

notbegivenformorethan7days,unlessunderexpertsupervision.Aftermoreprolongedtreatment(over6to8

weeks),theointmentshouldbewithdrawnslowlytoavoidrelapse.

Anextrusionoftheointmentabout1/4inchlongmaybeintroducedbeneaththelowerlidtwoorthreetimesdaily

and/oratnight.

4.3Contraindications

Viral,fungal,tuberculousorpurulentconditionsoftheeye.Useiscontraindicatedifglaucomaispresentorherpetic

keratitis(e.g.dendriticulcer)isconsideredapossibility.Useoftopicalsteroidsinthelatterconditioncanleadtoan

extensionoftheulcerandmarkedvisualdeterioration.

Hypersensitivitytotheactivesubstanceortoanyoftheexcipients.

4.4Specialwarningsandprecautionsforuse

Irish Medicines Board

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Topicalcorticosteroidsshouldneverbegivenforanundiagnosedredeyeasinappropriateuseispotentiallyblinding.

Treatmentwithcorticosteroid/antibioticcombinationsshouldnotbecontinuedformorethan7daysintheabsenceof

anyclinicalimprovement,sinceprolongedusemayleadtooccultextensionofinfectionduetothemaskingeffectof

thesteroid.Prolongedusemayalsoleadtoskinsensitisationandtheemergenceofresistantorganisms.

Prolongedusemayleadtotheriskofadrenalsuppressionininfants.

Treatmentwithcorticosteroidpreparationsshouldnotberepeatedorprolongedwithoutregularreviewtoexclude

raisedintraocularpressure,cataractformationorunsuspectedinfections.

Aminoglycosideantibioticsmaycauseirreversible,partialortotaldeafnesswhengivensystemicallyorwhenapplied

topicallytoopenwoundsordamagedskin.Thiseffectisdoserelatedandisenhancedbyrenalorhepaticimpairment.

Althoughthiseffecthasnotbeenreportedfollowingtopicalocularuse,thepossibilityshouldbeconsideredwhenhigh

dosetopicaltreatmentisgiventosmallchildrenorinfants.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nonerelevanttotopicaluse.

4.6Pregnancyandlactation

Safetyforuseinpregnancyandlactationhasnotbeenestablished.Thereisinadequateevidenceofsafetyinhuman

pregnancy.Topicaladministrationofcorticosteroidstopregnantanimalscancauseabnormalitiesoffoetaldevelopment

includingcleftpalateandintrauterinegrowthretardation.Theremaythereforebeaverysmallriskofsucheffectsinthe

humanfoetus.

Thereisariskoffoetalototoxicityifaminoglycosideantibioticpreparationsareadministeredduringpregnancy.

4.7Effectsonabilitytodriveandusemachines

Maycausetransientblurringofvisiononinstillation.Patientsshouldbewarnednottodriveoroperatehazardous

machineryunlessvisionisclear.

4.8Undesirableeffects

Hypersensitivityreactions,usuallyofthedelayedtype,mayoccurleadingtoirritation,burning,stinging,itchingand

dermatitis.

Topicalcorticosteroidusemayresultincornealulceration,increasedintraocularpressureleadingtoopticnerve

damage,reducedvisualacuityandvisualfielddefects.

Intensiveorprolongeduseoftopicalcorticosteroidsmayleadtoformationofposteriorsubcapsularcataracts.

Inthosediseasescausingthinningofthecorneaorsclera,corticosteroidtherapymayresultinthinningoftheglobe

leadingtoperforation.

Mydriasis,ptosisandepithelialpunctatekeratitisandglaucomahavealsobeenreportedfollowingophthalmicuseof

corticosteroids.

4.9Overdose

Long-termintensivetopicalusemayleadtosystemiceffects.

Irish Medicines Board

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCode:S01CA05.

Betamethasoneisaglucocorticoidwhichhastopicalanti-inflammatoryactivity.Neomycinisabroadspectrum

aminoglycosideantibiotic.

5.2Pharmacokineticproperties

Notapplicableastheointmentisappliedtopicallytotheeye.

5.3Preclinicalsafetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Whitesoftparaffin

Liquidparaffin

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

6.4Specialprecautionsforstorage

Donotstoreabove25 °

C.Donotrefrigerateorfreeze.

6.5Natureandcontentsofcontainer

Collapsiblealuminiumtubeswithfine-boreextendednozzletubefittedwithanaturalpolyethylenecapcontaining3

gramsofointment.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Unopened: 24months.

Irish Medicines Board

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7MARKETINGAUTHORISATIONHOLDER

UCBPharmaLimited

208BathRoad

Slough

Berkshire

SL13WE

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA365/46/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:13August1993

Dateoflastrenewal:13August2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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