BETNOVATE SCALP APPLICATION

Main information

  • Trade name:
  • BETNOVATE SCALP APPLICATION
  • Dosage:
  • 0.1 %w/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:
  • PPA0465/142/001A
  • Authorization date:
  • 12-11-2004
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BetnovateScalpApplication0.1%w/wCutaneousSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Containsbetamethasonevalerateequivalentto0.1%w/wofbetamethasone.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Cutaneoussolution

ProductimportedfromGreece:

Acolourless,hazy,slightlyviscousliquid.

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.

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Betnovatepreparationsareusuallywelltolerated,butifsignsofhypersensitivityappear,applicationshouldstop

immediately.Exacerbationofsymptomsmayoccur.

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

NoneKnown.

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,commonanduncommoneventsweregenerallydeterminedfromclinicaltrial

data.Thebackgroundratesinplaceboandcomparatorgroupswerenottakenintoaccountwhenassigningfrequency

categoriestoadverseeventsderivedfromclinicaltrialdata,sincetheseratesweregenerallycomparabletothoseinthe

activetreatmentgroup.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,postularpsoriasis.

*Localatrophymayoccurafterprolongedtreatment.

Inveryrareinstances,treatmentofpsoriasiswithcorticosteroid(oritswithdrawal)isthoughttohaveprovokedthe

pustularformofthedisease.

4.9Overdose

Acuteoverdosageisveryunlikelytooccur,however,inthecaseofchronicoverdosageormisuse,thefeaturesof

hypercorticisolismmayappearandinthissituationtopicalsteroidsshouldbediscontinuedgraduallyundermedical

supervisionbecauseoftheriskofadrenalinsufficiency.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

BetamethasoneValerateisanactivecorticosteroidwithtopicalanti-inflammatoryactivity.

5.2Pharmacokineticproperties

Theextentofpercutaneousabsorptionoftopicalcorticosteroidsisdeterminedbymanyfactorsincludingthevehicle,

theintegrityoftheepidermalbarrier,andtheuseofocclusivedressings.

Topicalcorticosteroidscanbeabsorbedfromnormalintactskin.Inflammationand/orotherdiseaseprocessesinthe

skinincreasepercutaneousabsorption.Occlusivedressingssubstantiallyincreasethepercutaneousabsorptionof

topicalcorticosteroids.

Onceabsorbedthroughtheskin,topicalcorticosteroidsarehandledthroughpharmacokineticpathwayssimilarto

systematicallyadministeredcorticosteroids.Corticosteroidsareboundtoplasmaproteinsinvaryingdegrees.

Corticosteroidsaremetabolizedprimarilybytheliverandarethenexcretedbythekidneys.

5.3Preclinicalsafetydata

Noadditionaldata.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Carbomer

Isopropylalcohol

Sodiumhydroxide

PurifiedWater

6.2Incompatibilities

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6.3Shelflife

Theshelf-lifeexpirydateofthisproductisthedateshownonthecontainerandouterpackageoftheproductonthe

marketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

Plasticbottlesof50mlsolutioncontainedinanoutercardboardcarton.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7PARALLELPRODUCTAUTHORISATIONHOLDER

PCOManufacturing

Unit10,AshbourneBusinessPark

Rath

Ashbourne

Co.Meath

Ireland

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA465/142/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:12November2004

Dateoflastrenewal:12November2009

10DATEOFREVISIONOFTHETEXT

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