package leaflet: information for the user betnovate cream · in this leaflet. see section 4. what...

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keepthisleaflet.Youmayneedtoreaditagain. • Ifyouhaveanyfurtherquestions,askyourdoctoror

pharmacist. • Thismedicinehasbeenprescribedforyouonly.Donotpass

itontoothers.Itmayharmthem,eveniftheirsignsofillnessarethesameasyours.

• Ifyougetanysideeffects,talktoyourdoctororpharmacist.Thisincludesanypossiblesideeffectsnotlistedinthisleaflet.Seesection4.

What is in this leaflet 1 WhatBetnovateisandwhatitisusedfor 2 WhatyouneedtoknowbeforeyouuseBetnovate 3 HowtouseBetnovate 4 Possiblesideeffects 5 HowtostoreBetnovate 6 Contentsofthepackandotherinformation

1 What Betnovate is and what it is used forBetnovatecontainsamedicinecalledbetamethasonevalerate.Itbelongstoagroupofmedicinescalledsteroidsthatreduceswellingandirritation.Betnovateisusedtohelpreducetherednessanditchinessofcertainskinproblems,suchaseczema,psoriasisanddermatitis.

2 What you need to know before you use Betnovate

Do not use Betnovate: • ifyouareallergic(hypersensitive)tobetamethasone

valerateoranyoftheotheringredientsofBetnovate(listedinsection6)

• onachildunder1year • totreatanyofthefollowingskinproblems,itcouldmake

themworse:

- acne - severeflushingofskinonandaroundyournose(rosacea) - spottyredrasharoundyourmouth(perioraldermatitis) - itchingaroundyourbackpassageorprivateparts - infectedskin(unlesstheinfectionisbeingtreatedwithan

anti-infectivemedicineatthesametime) - itchyskinwhichisnotinflamedDonotuseifanyoftheaboveapplytoyou.Ifyouarenotsure,talktoyourdoctororpharmacistbeforeusingBetnovate.Warnings and precautionsTalktoyourdoctororpharmacistbeforeusingBetnovateif:• youhavepreviouslyhadanallergicreactionwithanothersteroid

• youareapplyingthecreamunderanairtightdressing,includingachild’snappy.Thesedressingsmakeiteasierfortheactiveingredienttopassthroughtheskin.Itispossibletoaccidentallyendupusingtoomuch.

• youhavepsoriasis,yourdoctorwillwanttoseeyoumoreoften.

• usingforachroniclegulcerasyoumaybeatincreasedriskoflocalallergicreactionorinfection.

• youareapplyingtoalargesurfacearea• youareapplyingthecreamonbrokenskinorwithintheskinfolds.

• youareapplyingneareyesoroneyelids,ascataractsorglaucomamayresultifthecreamrepeatedlyenterstheeye.

• youhaveaninfectionoftheskinasthiswillneedtobetreated• youareapplyingtothinskinsuchasthefaceoronchildrenastheirskinisthinnerthanadultsandasaresultmayabsorblargeramounts.

• Dressingorbandagesshouldnotbeusedonchildrenoronthefacewherethecreamisapplied.

• Useonchildrenoronthefaceshouldbelimitedto5days.Contactyourdoctorifyouexperienceblurredvisionorothervisualdisturbances.Ifthisproductcomesintocontactwithdressings,clothingandbeddingthefabriccanbeeasilyignitedwithanakedflame.Youshouldkeepawayfromfirewhenusingthisproduct.Ifyouarenotsureifanyoftheaboveapplytoyou,talktoyourdoctororpharmacistbeforeusingthismedicine.Other medicines and BetnovateTellyourdoctororpharmacistifyouaretaking,haverecentlytakenormighttakeanyothermedicine,especiallyifyouaretakingritonaviranditraconazolemedications.Pregnancy and breast-feeding and fertilityIfyouarepregnantorarebreast-feeding,thinkyoumaybepregnantorareplanningtohaveababy,askyourdoctororpharmacistforadvicebeforetakingthismedicine.Betnovate Cream contains chloroscresol and cetostearyl alcoholBetnovatecreamcontainschlorocresolwhichmaycauseallergicreactionsandcetostearylalcoholwhichmaycauselocalskinreactions(e.g.contactdermatitis).

3 How to use BetnovateAlwaysusethismedicineexactlyasyourdoctorhastoldyou.Checkwithyourdoctororpharmacistifyouarenotsure.Using this medicine

• YouusuallyapplyBetnovateonceortwiceaday.Thismaybereducedasyourskinbeginstogetbetter.

• Thiscreamisforuseonyourskinonly. • Donotusemorethantheamountprescribedforyou. • Donotuseonlargeareasofthebodyforalongtime

(suchaseverydayformanyweeksormonths)-unlessyourdoctortellsyouto.

• Thegermsthatcauseinfectionslikewarm,moistconditionsunderbandagesordressingssoalwayscleantheskinbeforeafreshdressingisputon.

• Ifyouareapplyingthecreamonsomeoneelsemakesureyouwashyourhandsafteruseorweardisposableplasticgloves.

• Ifyourskinproblemdoesnotimprovein2to4weeks,talktoyourdoctor.

Guidance on how to apply the cream 1 Washyourhands. 2 Applyathinlayertotheaffectedarea(s)andgentlyrub

intotheskinuntilithasalldisappeared.YoucanmeasurehowmuchBetnovatetousewithyourfingertip.For

childrenyouwillneedtouselesscreambutstilluseanadultfingertomeasureoutthefingertipunit.Thispictureshowsonefingertipunit.

3 Unlessyouaremeanttoapplythecreamtoyourhandsasapartofthetreatment,washthemagainafterusingthecream.

For an adult

Donotworryifyoufindyouneedalittlemoreorlessthanthis.Itisonlyaroughguide.For a child aged 1 – 10

Number of fingertip units needed

Child’s age Face and neck

Arm and hand

Leg and foot Front Back 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.

• Itisespeciallyimportantinchildrennottoexceedtheprescribedamount.

• Acourseoftreatmentforachildshouldnotnormallylastmorethan5days-unlessyourdoctorhastoldyoutouseitforlonger.

If you have psoriasisIfyouhavethickpatchesofpsoriasisonyourelbowsorknees,yourdoctormaysuggestapplyingthecreamunderanairtightdressing.Itwillonlybeatnighttohelpthecreamtostartworking.Afterashortperiodoftimeyouwillthenapplythecreamasnormal.If you apply Betnovate to your faceYoushouldonlyapplythecreamtoyourfaceifyourdoctortellsyouto.Itshouldnotbeusedformorethan5days,astheskinonyourfacethinseasily.Do not let the cream get into your eyes.If you use more Betnovate than you shouldIfyouapplytoomuchorifaccidentallyswallowed,itcouldmakeyouill.Talktoyourdoctororgotothehospitalassoonaspossible.If you forget to use Betnovate Ifyouforgettoapplyyourcream,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,youdevelopageneralisedrashoryourskinbecomesswollenduringtreatment.YoumaybeallergictoBetnovate,haveaninfectionorneedothertreatment.

• youhavepsoriasisandgetraisedbumpswithpusundertheskin.Thiscanhappenveryrarelyduringoraftertreatmentandisknownaspustularpsoriasis.

Other side effects you may notice when using Betnovate include:

Common: mayaffectupto1in10people • afeelingofburning,pain,irritationoritchingwherethe

creamisapplied. Very rare: mayaffectupto1in10,000people • anincreasedriskofinfection • anallergicskinreactionwherethecreamisapplied • rash,itchybumpyskinorrednessoftheskin • thinninganddrynessofyourskinanditmayalsodamage

orwrinklemoreeasily • stretchmarksmaydevelop • bloodvesselsunderthesurfaceofyourskinmaybecome

morenoticeable • anincreaseorreductioninhairgrowthorhairlossand

changesinskincolour • weightgain,roundingoftheface. • delayedweightgainorslowingofgrowthinchildren • bonescanbecomethin,weakandbreakeasily • cloudylensintheeye(cataract)orincreased

pressureineye(glaucoma) • adecreaseinthelevelofthehormonecortisol

inyourblood • increasedbloodsugarlevelsorsugarintheurine • highbloodpressure Not Known: frequencycannotbeestimatedfromtheavailabledata

• blurredvisionReporting of side effectsIfyougetanysideeffects,talktoyourdoctororpharmacist.Thisincludesanypossiblesideeffectsnotlistedinthisleaflet.YoucanalsoreportsideeffectsdirectlyviatheYellowCardSchemeat: www.mhra.gov.uk/yellowcardorsearchforMHRAYellowCardintheGooglePlayorAppleAppStore.Byreportingsideeffectsyoucanhelpprovidemoreinformationonthesafetyofthismedicine.

Betnovate Creambetamethasone valerate

Package leaflet: Information for the user

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5 How to store Betnovate • Keepthismedicineoutofthesightandreachofchildren. • Donotusethismedicineaftertheexpirydatewhichis

statedonthetubeorcartonafter(EXP).Theexpirydatereferstothelastdayofthatmonth.

• Donotstoreabove25ºC. • Donotthrowawaymedicinesviawastewaterorhousehold

waste.Askyourpharmacisthowtothrowawaymedicinesyounolongeruse.Thesemeasureswillhelpprotecttheenvironment.

6 Contents of the pack and other information What Betnovate cream contains

• Theactiveingredientisbetamethasonevalerate.Each1gcontains1mgofbetamethasone(0.1%w/w)asvalerate.Theotheringredientsarechlorocresol,cetomacrogol1000,cetostearylalcohol,whitesoftparaffin,liquidparaffin,sodiumacidphosphate,phosphoricacid,sodiumhydroxideandpurifiedwater.

What Betnovate looks like and contents of the packWithineachcartonisatubewithaplasticscrewcap,whichcontainseither30gor100gofcream.Marketing Authorisation Holder and ManufacturerMarketing Authorisation HolderGlaxoWellcomeUKLtd,StockleyParkWest,Uxbridge,Middlesex,UB111BTManufacturerGlaxoWellcomeOperations,BarnardCastle,Durham,DL128DTOther formats:TolistentoorrequestacopyofthisleafletinBraille,largeprintoraudiopleasecall,freeofcharge:

08001985000(UKOnly)Pleasebereadytogivethefollowinginformation:Product name: Betnovate CreamReferencenumber 10949/0014ThisisaserviceprovidedbytheRoyalNationalInstituteofBlindPeople.This leaflet was last revised in: August 2017.TrademarksareownedbyorlicensedtotheGSKgroupofcompanies©2017GSKgroupofcompaniesoritslicensor.

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