Package Leaflet: Information for the User Pharma code ref ... · Read all of this leaflet carefully...

Pharma code ref. no: 7856

10000000110354

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.Do

notpassitontoothers.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 for Betnovatecontainsamedicinecalledbetamethasonevalerate.Itbelongstoagroupofmedicinescalledsteroidsthatreduceswellingandirritation.Betnovateisusedtohelpreducetherednessanditchinessofcertainskinproblems,suchaseczema,psoriasisanddermatitis.

2 What you need to know before you use Betnovate Do not use Betnovate:

• ifyouareallergic(hypersensitive)tobetamethasonevalerateoranyoftheotheringredientsofBetnovate(listedinSection6)

• onachildunder1year • totreatanyofthefollowingskinproblems,itcould

makethemworse: - acne - severeflushingofskinonandaroundyournose

(rosacea) - spottyredrasharoundyourmouth(perioral

dermatitis) - itchingaroundyourbackpassageorprivateparts - infectedskin(unlesstheinfectionisbeingtreated

withananti-infectivemedicineatthesametime) - itchyskinwhichisnotinflamed

Donotuseifanyoftheaboveapplytoyou.Ifyouarenotsure,talktoyourdoctororpharmacistbeforeusingBetnovate.Warnings and precautionsTalktoyourdoctororpharmacistbeforeusingBetnovateif:• youhavepreviouslyhadanallergic

reactionwithanothersteroid• youareapplyingthecreamunderan

airtightdressing,includingachild’snappy.Thesedressingsmakeiteasierfortheactiveingredienttopassthroughtheskin.Itispossibletoaccidentallyendupusingtoomuch.

• youhavepsoriasis,yourdoctorwillwanttoseeyoumoreoften.

• usingforachroniclegulcerasyoumaybeatincreasedriskoflocalallergicreactionorinfection.

• youareapplyingtoalargesurfacearea • youareapplyingthecreamonbrokenskinor

withintheskinfolds. • youareapplyingneareyesoroneyelids,as

cataractsorglaucomamayresultifthecreamrepeatedlyenterstheeye.

• youareapplyingtothinskinsuchasthefaceoronchildrenastheirskinisthinnerthanadultsandasaresultmayabsorblargeramounts.

• Dressingorbandagesshouldnotbeusedonchildrenoronthefacewherethecreamisapplied.

• Useonchildrenoronthefaceshouldbelimitedto5days.

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. • Donotusemorethantheamountprescribedfor

you. • Donotuseonlargeareasofthebodyforalong

time(suchaseverydayformanyweeksormonths)-unlessyourdoctortellsyouto.

• Thegermsthatcauseinfectionslikewarm,moistconditionsunderbandagesordressingssoalwayscleantheskinbeforeafreshdressingisputon.

• Ifyouareapplyingthecreamonsomeoneelsemakesureyouwashyourhandsafteruseorweardisposableplasticgloves.

• Ifyourskinproblemdoesnotimprovein 2to4weeks,talktoyourdoctor.

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

gentlyrubintotheskinuntilithasalldisappeared.YoucanmeasurehowmuchBetnovatetousewithyourfingertip.Forchildrenyouwillneedtouselesscreambutstilluseanadultfingertomeasureoutthefingertipunit.Thispictureshowsonefingertipunit.

3 Unlessyouaremeanttoapplythecreamtoyourhandsasapartofthetreatment,washthemagainafterusingthecream.

For an adult

Package Leaflet: Information for the User

Betnovate® Creambetamethasone valerate

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Phar

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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

FrontBack

including buttocks

1-2 years 1 ½ 1 ½ 2 2 3

3-5 years 1 ½ 2 3 3 3 ½

6-10 years 2 2 ½ 4 ½ 3 ½ 5

• Donotuseitonchildrenunder1yearofage • Itisespeciallyimportantinchildrennottoexceed

theprescribedamount. • Acourseoftreatmentforachildshouldnot

normallylastmorethan5days-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,irritationoritching

wherethecreamisapplied. Very rare(mayaffectupto1in10,000people) • anincreasedriskofinfection • anallergicskinreactionwherethecreamisapplied • rash,itchybumpyskinorrednessoftheskin • thinninganddrynessofyourskinanditmayalso

damageorwrinklemoreeasily • stretchmarksmaydevelop • veinsunderthesurfaceofyourskinmaybecome

morenoticeable

• anincreaseorreductioninhairgrowthorhairlossandchangesinskincolour

• weightgain,roundingoftheface. • delayedweightgainorslowingofgrowthin

children • bonescanbecomethin,weakandbreakeasily • cloudylensintheeye(cataract)orincreased

pressureineye(glaucoma) • increasedbloodsugarlevelsorsugarintheurine • highbloodpressure

Reporting of side effectsIfyougetanysideeffects,talktoyourdoctororpharmacist.Thisincludesanypossiblesideeffectsnotlistedinthisleaflet.YoucanalsoreportsideeffectsdirectlyviatheYellowCardSchemeat: www.mhra.gov.uk/yellowcard.Byreportingsideeffectsyoucanhelpprovidemoreinformationonthesafetyofthismedicine.

5 How to store Betnovate • Keepoutofthesightandreachofchildren. • Donotusethismedicineaftertheexpirydate

whichisstatedonthetubeorcartonafter(Exp).Theexpirydatereferstothelastdayofthatmonth.

• Donotstoreabove25ºC. • Donotthrowawaymedicinesviawastewateror

householdwaste.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,whichcontainseither30or100gofcream.Marketing Authorisation Holder and ManufacturerProductLicenceheldbyGlaxoWellcomeUKLtd,StockleyParkWest,Uxbridge,MiddlesexUB111BTManufacturedbyGlaxoWellcomeOperations,BarnardCastle,DurhamDL128DTIfyouhaveanyquestionsorarenotsureaboutanything,askyourdoctororpharmacistwhowilladviseyou.Youmaybeabletofindoutmoreinformationfrombooksinpubliclibraries.Other formats:TolistentoorrequestacopyofthisleafletinBraille,largeprintoraudiopleasecall,freeofcharge:

08001985000(UKOnly)Pleasebereadytogivethefollowinginformation:Product name: Betnovate CreamReferencenumber10949/0014ThisisaserviceprovidedbytheRoyalNationalInstituteofBlindPeople.This leaflet was last revised in:July2013BetnovateisaregisteredtrademarkoftheGlaxoSmithKlinegroupofcompanies.©2013GlaxoSmithKlinegroupofcompanies. Allrightsreserved.

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