package leaflet: information for the user betnovate cream · in this leaflet. see section 4. what...
TRANSCRIPT
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.
10000000147218
Pharma code Ref. No. 202
Pharma code Ref. No. 202
3
10000000147218
GSK-GBR-Barnard Castle-UKBAR
United Kingdom-GBR
Betnovate
N/A
JMF333
Offset
White Paper
1
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9.0pt
9.8pt
100%
9.0pt
No
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