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Read all of this leaflet carefully before you start using this medicine because it contains important information for you.• Keepthisleaflet.Youmayneedtoreaditagain.• Ifyouhaveanyfurtherquestions,askyourdoctor
orpharmacist.• Thismedicinehasbeenprescribedforyouonly.
Donotpassitontoothers.Itmayharmthem,eveniftheirsignsofillnessarethesameasyours.
• Ifyougetanysideeffects,talktoyourdoctororpharmacist.Thisincludesanypossiblesideeffectsnotlistedinthisleaflet.Seesection4.
What is in this leaflet:1 WhatBetnovateisandwhatitisusedfor2 WhatyouneedtoknowbeforeyouuseBetnovate3 HowtouseBetnovate4 Possiblesideeffects5 HowtostoreBetnovate6 Contentsofthepackandotherinformation
1 What Betnovate is and what it is used forBetnovatecontainsamedicinecalledbetamethasonevalerate.Itbelongstoagroupofmedicinescalledsteroids.Ithelpstoreduceswellingandirritation.Betnovateisusedtohelpreducetherednessanditchinessofcertainskinproblems,suchaseczema,psoriasisanddermatitis.
2 What you need to know before you use BetnovateDo not use Betnovate:• ifyouareallergic(hypersensitive)to
betamethasonevalerateoranyoftheotheringredientsofBetnovate(listedinSection6)
• onachildunder1year• totreatanyofthefollowingskinproblems,it
couldmakethemworse:- acne- severeflushingofskinonandaroundyour
nose(rosacea)- spottyredrasharoundyourmouth(perioral
dermatitis)- itchingaroundyourbackpassage
orprivateparts- infectedskin(unlesstheinfection
isbeingtreatedwithananti-infectivemedicineatthesametime)
- itchyskinwhichisnotinflamedDonotuseifanyoftheaboveapplytoyou.Ifyouarenotsure,talktoyourdoctororpharmacistbeforeusingBetnovate.Warnings and precautionsTalktoyourdoctororpharmacistbeforeusingBetnovateif:• youhavepreviouslyhadanallergic
reactionwithanothersteroid• youareapplyingtheointmentunder
anairtightdressing,includingachild’snappy.Thesedressingsmakeiteasierfortheactiveingredienttopassthroughtheskin.Itispossibletoaccidentallyendupusingtoomuch.
• youhavepsoriasis,yourdoctorwillwanttoseeyoumoreoften.
• usingforachroniclegulcerasyoumaybeatincreasedriskoflocalallergicreactionorinfection.
• youareapplyingtoalargesurfacearea• youareapplyingtheointmentonbrokenskinor
withintheskinfolds.• youareapplyingneareyesoroneyelids,as
cataractsorglaucomamayresultiftheointmentrepeatedlyenterstheeye.
• youareapplyingtothinskinsuchasthefaceoronchildrenastheirskinisthinnerthanadultsandasaresultmayabsorblargeramounts.
• Dressingorbandagesshouldnotbeusedonchildrenoronthefacewheretheointmentisapplied.
• Useonchildrenoronthefaceshouldbelimitedto5days.
Ifyouarenotsureifanyoftheaboveapplytoyou,talktoyourdoctororpharmacistbeforeusingthismedicine.Other medicines and BetnovateTellyourdoctororpharmacistifyouaretaking,haverecentlytakenormighttakeanyothermedicine,especiallyifyouaretakingritonaviranditraconazolemedications.Pregnancy and breast-feeding and fertilityIfyouarepregnantorarebreast-feeding,thinkyoumaybepregnantorareplanningtohaveababy,askyourdoctororpharmacistforadvicebeforetakingthismedicine.
3 How to use BetnovateAlwaysusethismedicineexactlyasyourdoctorhastoldyou.Checkwithyourdoctororpharmacistifyouarenotsure.Using this medicine• YouusuallyapplyBetnovateonceortwiceaday.
Thismaybereducedasyourskinbeginstogetbetter.
• Thisointmentisforuseonyourskinonly.• Donotusemorethantheamountprescribedforyou.• Donotuseonlargeareasofthebodyforalong
time(suchaseverydayformanyweeksormonths)-unlessyourdoctortellsyouto.
• Thegermsthatcauseinfectionslikewarm,moistconditionsunderbandagesordressingssoalwayscleantheskinbeforeafreshdressingisputon.
• Ifyouareapplyingtheointmentonsomeoneelsemakesureyouwashyourhandsafteruseorweardisposableplasticgloves.
• Ifyourskinproblemdoesnotimprovein2to4weeks,talktoyourdoctor.
Guidance on how to apply the ointment1 Washyourhands.2 Applyathinlayertotheaffectedarea(s)andgently
rubintotheskinuntilithasalldisappeared.YoucanmeasurehowmuchBetnovatetousewithyourfingertip.Forchildrenyouwillneedtouselessointmentbutstilluseanadultfingertomeasureoutthefingertipunit.Thispictureshowsonefingertipunit.
3 Unlessyouaremeanttoapplytheointmenttoyourhandsasapartofthetreatment,washthemagainafterusingtheointment.
For an adult
Donotworryifyoufindyouneedalittlemoreorlessthanthis.Itisonlyaroughguide.
Package Leaflet: Information for the User
Betnovate® Ointmentbetamethasone valerate
Pharma Code Ref: 7871
4
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GSK-GBR-Barnard Castle-UKBAR
United Kingdom-GBR
Betnovate
1
K
JMF032
FRONTPAGE 1 OF 2
For a child aged 1 – 10
Number of fingertip units needed
Child’s age
Face and neck
Arm and hand
Leg and foot
FrontBack
including buttocks
1-2 years 1½ 1½ 2 2 3
3-5 years 1½ 2 3 3 3½
6-10 years 2 2½ 4½ 3½ 5
• Donotuseitonchildrenunder1yearofage.• Itisespeciallyimportantinchildrennottoexceed
theprescribedamount.• Acourseoftreatmentforachildshouldnot
normallylastmorethan5days-unlessyourdoctorhastoldyoutouseitforlonger.
If you have psoriasisIfyouhavethickpatchesofpsoriasisonyourelbowsorknees,yourdoctormaysuggestapplyingtheointmentunderanairtightdressing.Itwillonlybeatnighttohelptheointmenttostartworking.Afterashortperiodoftimeyouwillthenapplytheointmentasnormal.If you apply Betnovate to your faceYoushouldonlyapplytheointmenttoyourfaceifyourdoctortellsyouto.Itshouldnotbeusedformorethan5days,astheskinonyourfacethinseasily.Do not let the ointment get into your eyes.If you use more Betnovate than you shouldIfyouapplytoomuchorifaccidentallyswallowed,itcouldmakeyouill.Talktoyourdoctororgotothehospitalassoonaspossible.If you forget to use Betnovate Ifyouforgettoapplyyourointment,applyitassoonasyouremember.Ifitisclosetothetimeyouarenextmeanttoapplyit,waituntilthistime.If you stop using Betnovate IfyouuseBetnovateregularlymakesureyoutalktoyourdoctorbeforeyoustopusingitasyourconditionmaygetworseifstoppedsuddenly.Ifyouhaveanyfurtherquestionsontheuseofthismedicine,askyourdoctororpharmacist.
4 Possible side effectsLikeallmedicines,thismedicinecancausesideeffects,althoughnoteverybodygetsthem.Stop using Betnovate and tell your doctor immediately if:• youfindthatyourskinconditiongetsworse,you
developageneralisedrashoryourskinbecomesswollenduringtreatment.YoumaybeallergictoBetnovate,haveaninfectionorneedothertreatment.
• youhavepsoriasisandgetraisedbumpswithpusundertheskin.Thiscanhappenveryrarelyduringoraftertreatmentandisknownaspustularpsoriasis.
Other side effects you may notice when using Betnovate include:Common(mayaffectupto1in10people)• afeelingofburning,pain,irritationoritching
wheretheointmentisapplied.Very rare(mayaffectupto1in10,000people)• anincreasedriskofinfection• anallergicskinreactionwheretheointmentis
applied• rash,itchybumpyskinorrednessoftheskin• thinninganddrynessofyourskinanditmayalso
damageorwrinklemoreeasily• stretchmarksmaydevelop
• veinsunderthesurfaceofyourskinmaybecomemorenoticeable
• anincreaseorreductioninhairgrowthorhairlossandchangesinskincolour
• weightgain,roundingoftheface• delayedweightgainorslowingofgrowthin
children• bonescanbecomethin,weakandbreakeasily• cloudylensintheeye(cataract)orincreased
pressureineye(glaucoma)• increasedbloodsugarlevelsorsugarintheurine• highbloodpressureReporting of side effectsIfyougetanysideeffects,talktoyourdoctororpharmacist.Thisincludesanypossiblesideeffectsnot listedinthisleaflet.YoucanalsoreportsideeffectsdirectlyviatheYellowCardSchemeat:www.mhra.gov.uk/yellowcard.Byreportingsideeffectsyoucanhelpprovidemoreinformationonthesafetyofthismedicine.
5 How to store Betnovate• Keepoutofthesightandreachofchildren.• Donotusethismedicineaftertheexpirydate
whichisstatedonthetubeorcartonafter(Exp).Theexpirydatereferstothelastdayofthatmonth.
• Donotstoreabove30°C.• Donotthrowawaymedicinesviawastewateror
householdwaste.Askyourpharmacisthowtothrowawaymedicinesyounolongeruse.Thesemeasureswillhelpprotecttheenvironment.
6 Contents of the pack and other informationWhat Betnovate ointment contains• Theactiveingredientisbetamethasonevalerate.
Each1gcontains1mgofbetamethasone(0.1% w/w)asvalerate.
• Theotheringredientsareliquidparaffinandwhitesoftparaffin.
What Betnovate looks like and contents of the packWithineachcartonisatubewithaplasticscrewcap,whichcontainseither30or100gofointment.Marketing Authorisation Holder and ManufacturerProductLicenceheldbyGlaxoWellcomeUKLtd,StockleyParkWest,Uxbridge,MiddlesexUB111BTManufacturedbyGlaxoWellcomeOperations,BarnardCastle,DurhamDL128DTIfyouhaveanyquestionsorarenotsureaboutanything,askyourdoctororpharmacistwhowilladviseyou.Youmaybeabletofindoutmoreinformationfrombooksinpubliclibraries.Other formats:TolistentoorrequestacopyofthisleafletinBraille,largeprintoraudiopleasecall,freeofcharge:
08001985000(UKOnly)Pleasebereadytogivethefollowinginformation:Product name: Betnovate OintmentReferencenumber 10949/0020ThisisaserviceprovidedbytheRoyalNationalInstituteofBlindPeople.This leaflet was last revised in:July2013BetnovateisaregisteredtrademarkoftheGlaxoSmithKlinegroupofcompanies.©2013GlaxoSmithKlinegroupofcompanies.Allrightsreserved.
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Co
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1
4
10000000110356
GSK-GBR-Barnard Castle-UKBAR
United Kingdom-GBR
Betnovate
1
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JMF032
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