BETNOVATE SCALP APPLICATION

Main information

  • Trade name:
  • BETNOVATE SCALP APPLICATION
  • Dosage:
  • 0.1 %v/w
  • Pharmaceutical form:
  • Cutaneous Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BETNOVATE SCALP APPLICATION
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1447/059/001
  • Authorization date:
  • 22-12-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BetnovateScalpApplication0.1%w/wCutaneousSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

ContainsBetamethasoneValerateequivalentto0.1%w/wBetamethasone

Forfulllistofexcipientsseesection6.1

3PHARMACEUTICALFORM

Cutaneoussolution.

ImportedfromGreece

Acolourless,hazyslightlyviscousliquid.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Betamethasonevalerateisatopicalcorticosteroidusedinthemanagementofsteroid-responsivedermatosesofthe

scalp,suchaspsoriasis,seborrhoeacapitisandinflammationassociatedwithseveredandruff.

4.2Posologyandmethodofadministration

AsmallquantityofBetnovateScalpApplicationshouldbeappliedtothescalpnightandmorninguntilimprovementis

noticeable.Itmaythenbepossibletosustainimprovementbyapplyingonceaday,orevenlessfrequently.

4.3Contraindications

Useinthepresenceofuntreatedinfectionsofbacterial,viral,tuberculousorfungalorigin.

Hypersensitivitytothepreparation.

Dermatosesinchildrenunderoneyearofage,includingdermatitisandnapkineruptions.

Useinacnevulgaris,rosaceaorinperioraldermatoses.

4.4Specialwarningsandprecautionsforuse

Prolongeduseofuninterruptedocclusion(includingnapkin)orusewithextensiveocclusivedressingsmaysuppress

adrenocorticalfunction.

Continuoustreatmentforlongerthanthreeweeksonuseofocclusion(includingnapkins)shouldbeavoidedinpatients

undertheageofthreeyearsbecauseofthepossibilityofadrenocorticalsuppressionorofgrowthsuppression,systemic

absorptionandhypercorticism.

Caremustbetakentokeepthepreparationawayfromtheeyes.

Donotusenearanakedflame.

Betnovatepreparationsareusuallywelltolerated,butifsignsofhypersensitivityappear,applicationshouldstop

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Long-termcontinuoustopicaltherapyshouldbeavoidedwherepossible,particularlyininfantsandchildren,asadrenal

suppressioncanoccurevenwithoutocclusion.

Topicalcorticosteroidsmaybehazardousinpsoriasisforanumberofreasons,includingreboundrelapses,

developmentoftolerances,riskofgeneralisedpustularpsoriasisanddevelopmentoflocalorsystemictoxicitydueto

impairedbarrierfunctionoftheskin.Ifusedinpsoriasiscarefulpatientsupervisionisimportant.

Appropriateantimicrobialtherapyshouldbeusedwhenevertreatinginflammatorylesionswhichhavebecomeinfected.

Anyspreadofinfectionrequireswithdrawaloftopicalcorticosteroidstherapyandsystemicadministrationof

antibacterialagents.Bacterialinfectionisencouragedbythewarm,moistconditionsinducedbyocclusivedressings,

andsotheskinshouldbecleansedbeforeafreshdressingisapplied.

Therehavebeenafewreportsintheliteratureofthedevelopmentofcataractsinpatientswhohavebeenusing

corticosteroidsforprolongedperiodsoftime.Althoughitisnotpossibletoruleoutsystemiccorticosteroidsasaknown

factor,prescribersshouldbeawareofthepossibleroleofcorticosteroidsincataractdevelopment.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nonereported.

4.6Fertility,pregnancyandlactation

Topicalcorticosteroidshaveinducedteratogeniceffectsinanimals.Similareffectshavenotbeenconclusively

demonstratedwithuseduringpregnancyinhumanbeings.However,thisproductshouldnotbeusedinpregnancyor

lactationunlessconsideredessentialbythephysicianandonlyfortheshortestperiodpossible.

4.7Effectsonabilitytodriveandusemachines

Nonereported.

4.8Undesirableeffects

Adverseeventsarelistedbelowbysystemorganclassandfrequency.Frequenciesaredefinedas:verycommon

(1/10),common(1/100and<1/10),uncommon(1/1000and<1/100),rare(1/10,000and<1/1000)andveryrare

(<1/10,000)includingisolatedreports.Verycommon,commonanduncommoneventsweregenerallydeterminedfrom

clinicaltrialdata.Thebackgroundratesinplaceboandcomparatorgroupswerenottakenintoaccountwhenassigning

frequencycategoriestoadverseeventsderivedfromclinicaltrialdata,sincetheseratesweregenerallycomparableto

thoseintheactivetreatmentgroup.Rareandveryrareeventsweregenerallydeterminedfromspontaneousdata.

Immunesystemdisorders

Veryrare: *Hypersensitivity.

Ifsignsof*hypersensitivityappear,applicationshouldstopimmediately.

Endocrinedisorders

Veryrare: *Featuresofhypercortisolism.

*Aswithothercorticosteroids,prolongeduseoflargeamountsortreatmentofextensiveareas,canresultinsufficient

systemicabsorptiontoproducethe*featuresofhypercortisolism.Thiseffectismorelikelytooccurininfantsand

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Skinandsubcutaneoustissuedisorders

Common: *Localskinburningand*pruritus.

Veryrare: *Localatrophicchanges,allergiccontactdermatitis,pustularpsoriasis.

*Localatrophymayoccurafterprolongedtreatment.

Inveryrareinstances,treatmentofpsoriasiswithcorticosteroid(oritswithdrawal)isthoughttohaveprovokedthe

pustularformofthedisease.

4.9Overdose

Acuteoverdosageisveryunlikelytooccur,however,inthecaseofchronicoverdosageormisusethefeaturesof

hypercortisolismmayappearandinthissituationtopicalsteroidsshouldbediscontinuedgraduallyundermedical

supervisionbecauseoftheriskofadrenalinsufficiency.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

BetamethasoneValerateisanactivecorticosteroidwithtopicalanti-inflammatoryactivity.

5.2Pharmacokineticproperties

Theextentofpercutaneousabsorptionoftopicalcorticosteroidsisdeterminedbymanyfactorsincludingthevehicle,the

integrityoftheepidermalbarrier,andtheuseofocclusivedressings.

Topicalcorticosteroidscanbeabsorbedfromnormalintactskin.Inflammationand/orotherdiseaseprocessesintheskin

increasepercutaneousabsorption.Occlusivedressingssubstantiallyincreasethepercutaneousabsorptionoftopical

corticosteroids.

Onceabsorbedthroughtheskin,topicalcorticosteroidsarehandledthroughpharmacokineticpathwayssimilarto

systematicallyadministeredcorticosteroids.Corticosteroidsareboundtoplasmaproteinsinvaryingdegrees.

Corticosteroidsaremetabolizedprimarilybytheliverandarethenexcretedbythekidneys.

5.3Preclinicalsafetydata

Noadditionaldata.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Carbomer

IsoproylAlcohol

Sodiumhydroxide

Purifiedwater

6.2Incompatibilities

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6.3Shelflife

Theshelflifeexpirydateofthisproductshownonthebottlelabelandoutercartonoftheproductasmarketedinthe

countryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25°C

Storeintheoriginalpackage

6.5Natureandcontentsofcontainer

BetnovateScalpApplicationissuppliedin50mlbottleswithnozzlesinanover-labelledcarton.

6.6Specialprecautionsfordisposalandotherhandling

Nospecialrequirements

7PARALLELPRODUCTAUTHORISATIONHOLDER

G&ALicensingLimited

Ballymurray

Co.Roscommon

Ireland

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1447/059/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:22 nd

December2009

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