betnovate-lotion patient leaflet | euroclinix · baby, ask your doctor or pharmacist for advice...
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Read all of this leaflet carefully before you start using this medicine because it contains important information for you.• Keepthisleaflet.Youmayneedtoreadit
again.• Ifyouhaveanyfurtherquestions,askyour
doctororpharmacist.• Thismedicinehasbeenprescribedforyou
only.Donotpassitontoothers.Itmayharmthem,eveniftheirsignsofillnessarethesameasyours.
• Ifyougetanysideeffects,talktoyourdoctororpharmacist.Thisincludesanypossiblesideeffectsnotlistedinthisleaflet.Seesection4.
What is in this leaflet:1 WhatBetnovateisandwhatitisusedfor2 Whatyouneedtoknowbeforeyouuse
Betnovate3 HowtouseBetnovate4 Possiblesideeffects5 HowtostoreBetnovate6 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)to
betamethasonevalerateoranyoftheotheringredientsofBetnovate(listedinSection6)
• onachildunder1year• totreatanyofthefollowingskin
problems,itcouldmakethemworse: - acne - severeflushingofskinonandaround
yournose(rosacea) - spottyredrasharoundyourmouth
(perioraldermatitis) - itchingaroundyourbackpassageor
privateparts - infectedskin(unlesstheinfectionisbeing
treatedwithananti-infectivemedicineatthesametime)
- itchyskinwhichisnotinflamedDonotuseifanyoftheaboveapplytoyou.Ifyouarenotsure,talktoyourdoctororpharmacistbeforeusingBetnovate.Warnings and precautionsTalktoyourdoctororpharmacistbeforeusingBetnovateif:• youhavepreviouslyhadanallergicreaction
withanothersteroid• youareapplyingthelotionunderanairtight
dressing,includingachild’snappy.Thesedressingsmakeiteasierfortheactiveingredienttopassthroughtheskin.Itispossibletoaccidentallyendupusingtoomuch.
• youhavepsoriasis,yourdoctorwillwanttoseeyoumoreoften.
• usingforachroniclegulcerasyoumaybeatincreasedriskoflocalallergicreactionorinfection.
• youareapplyingtoalargesurfacearea• youareapplyingthelotiononbrokenskinor
withintheskinfolds.• youareapplyingneareyesoroneyelids,as
cataractsorglaucomamayresultifthelotionrepeatedlyenterstheeye.
• youareapplyingtothinskinsuchasthefaceoronchildrenastheirskinisthinnerthanadultsandasaresultmayabsorblargeramounts.
• Dressingorbandagesshouldnotbeusedonchildrenoronthefacewherethelotionisapplied.
• Useonchildrenoronthefaceshouldbelimitedto5days.
Ifyouarenotsureifanyoftheaboveapplytoyou,talktoyourdoctororpharmacistbeforeusingthismedicine.Other medicines and BetnovateTellyourdoctororpharmacistifyouaretaking,haverecentlytakenormighttakeanyothermedicine,especiallyifyouaretakingritonaviranditraconazolemedications.Pregnancy and breast-feeding and fertilityIfyouarepregnantorarebreast-feeding,thinkyoumaybepregnantorareplanningtohaveababy,askyourdoctororpharmacistforadvicebeforetakingthismedicine.Betnovate Lotion contains cetostearyl alcoholBetnovateLotioncontainscetostearylalcoholwhichmaycauselocalskinreactions(e.g.contactdermatitis).
3 How to use BetnovateAlwaysusethismedicineexactlyasyourdoctorhastoldyou.Checkwithyourdoctororpharmacistifyouarenotsure.Using this medicine• YouusuallyapplyBetnovateonceor
twiceaday.Thismaybereducedasyourskinbeginstogetbetter.
• Thislotionisforuseonyourskinonly.• Donotusemorethantheamountprescribed
foryou.• Donotuseonlargeareasofthebodyfora
longtime(suchaseverydayformanyweeksormonths)-unlessyourdoctortellsyouto.
• Thegermsthatcauseinfectionslikewarm,moistconditionsunderbandagesordressingssoalwayscleantheskinbeforeafreshdressingisputon.
• Ifyouareapplyingthelotiononsomeoneelsemakesureyouwashyourhandsafteruseorweardisposableplasticgloves.
• Ifyourskinproblemdoesnotimprovein2to4weeks,talktoyourdoctor.
Guidance on how to apply the lotion1 Washyourhands.2 Gentlyrubasmallamountoflotionintothe
skinuntilithasalldisappeared.3 Unlessyouaremeanttoapplythelotionto
yourhandsasapartofthetreatment,washthemagainafterusingthelotion.
Package Leaflet: Information for the User
Betnovate® Lotionbetamethasone valerate
12000000102881
4
12000000102881
GSK-ContractMfg-Eur-Deu-Germany-Aspen-Bad Oldesloe
United Kingdom-GBR
Betnovate
1
K
BE07_148X297
Aspen Bad OldesloeAdditional Information Panel
Replacement: 12000000100953
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For a child• Donotuseitonchildrenunder1yearofage.• Itisespeciallyimportantinchildrennotto
exceedtheprescribedamount.Thesmallerthechildthelesslotionyouwillneedtouse.
• Acourseoftreatmentforachildshouldnotnormallylastmorethan5daysunlessyourdoctorhastoldyoutouseitforlonger.
If you have psoriasisIfyouhavethickpatchesofpsoriasisonyourelbowsorknees,yourdoctormaysuggestapplyingthelotionunderanairtightdressing.Itwillonlybeatnighttohelpthelotiontostartworking.Afterashortperiodoftimeyouwillthenapplythelotionasnormal.If you apply Betnovate to your faceYoushouldonlyapplythelotiontoyourfaceifyourdoctortellsyouto.Itshouldnotbeusedformorethan5days,astheskinonyourfacethinseasily.Do not let the lotion get into your eyes.If you use more Betnovate than you shouldIfyouapplytoomuchorifaccidentallyswallowed,itcouldmakeyouill.Talktoyourdoctororgotothehospitalassoonaspossible.If you forget to use Betnovate Ifyouforgettoapplyyourlotion,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,irritationor
itchingwherethelotionisapplied.Very rare(mayaffectupto1in10,000people)• anincreasedriskofinfection• anallergicskinreactionwherethelotionis
applied• rash,itchybumpyskinorrednessoftheskin• thinninganddrynessofyourskinanditmay
alsodamageorwrinklemoreeasily• stretchmarksmaydevelop• veinsunderthesurfaceofyourskinmay
becomemorenoticeable• anincreaseorreductioninhairgrowthor
hairlossandchangesinskincolour• weightgain,roundingoftheface• delayedweightgainorslowingofgrowthin
children• bonescanbecomethin,weakandbreakeasily• cloudylensintheeye(cataract)orincreased
pressureineye(glaucoma)• increasedbloodsugarlevelsorsugarinthe
urine• highbloodpressure
Reporting of side effectsIfyougetanysideeffects,talktoyourdoctororpharmacist.Thisincludesanypossiblesideeffectsnotlistedinthisleaflet.YoucanalsoreportsideeffectsdirectlyviatheYellowCardSchemeat:www.mhra.gov.uk/yellowcard.Byreportingsideeffectsyoucanhelpprovidemoreinformationonthesafetyofthismedicine.
5 How to store Betnovate • Keepoutofthesightandreachofchildren.• Donotusethismedicineaftertheexpiry
datewhichisstatedonthebottleorcartonafter(Exp).Theexpirydatereferstothelastdayofthatmonth.
• Donotstoreabove25°C.• Donotthrowawaymedicinesvia
wastewaterorhouseholdwaste.Askyourpharmacisthowtothrowawaymedicinesyounolongeruse.Thesemeasureswillhelpprotecttheenvironment.
6 Contents of the pack and other information
What Betnovate Lotion contains• Theactiveingredientisbetamethasone
valerate.Each10mlcontains0.01mlofbetamethasone(0.1%w/w)asvalerate.
• Theotheringredientsaremethylhydroxybenzoate,xanthangum,cetostearylalcohol,liquidparaffin,isopropylalcohol,glycerol,cetomacrogol1000,sodiumcitrate,citricacidandpurifiedwater.
What Betnovate looks like and contents of the packWithineachcartonisaplasticbottlewithanozzleandcapthatcontains100mloflotion.Marketing Authorisation Holder and ManufacturerProductLicenceheldbyGlaxoWellcomeUKLtd,StockleyParkWest,Uxbridge,MiddlesexUB111BTManufacturedbyAspenBadOldesloeGmbHIndustriestrasse32-3623843BadOldesloeGermanyIfyouhaveanyquestionsorarenotsureaboutanything,askyourdoctororpharmacistwhowilladviseyou.Youmaybeabletofindoutmoreinformationfrombooksinpubliclibraries.Other formats:TolistentoorrequestacopyofthisleafletinBraille,largeprintoraudiopleasecall,freeofcharge:
08001985000(UKOnly)Pleasebereadytogivethefollowinginformation:Product name: Betnovate LotionReferencenumber 10949/0044ThisisaserviceprovidedbytheRoyalNationalInstituteofBlindPeople.
This leaflet was last revised in: July2013BetnovateisaregisteredtrademarkoftheGlaxoSmithKlinegroupofcompanies.©2013GlaxoSmithKlinegroupofcompanies.Allrightsreserved.
12000000102881
4
12000000102881
GSK-ContractMfg-Eur-Deu-Germany-Aspen-Bad Oldesloe
United Kingdom-GBR
Betnovate
1
K
BE07_148X297
Aspen Bad OldesloeAdditional Information Panel
Replacement: 12000000100953
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