Download - Betnovate-lotion Patient Leaflet | euroClinix · baby, ask your doctor or pharmacist for advice before taking this medicine. Betnovate Lotion contains cetostearyl alcohol Betnovate

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Page 1: Betnovate-lotion Patient Leaflet | euroClinix · baby, ask your doctor or pharmacist for advice before taking this medicine. Betnovate Lotion contains cetostearyl alcohol Betnovate

TYPE SIZE: 9/10HORIZONTAL SCALE: 100%

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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Page 2: Betnovate-lotion Patient Leaflet | euroClinix · baby, ask your doctor or pharmacist for advice before taking this medicine. Betnovate Lotion contains cetostearyl alcohol Betnovate

TYPE SIZE: 9/10HORIZONTAL SCALE: 100%

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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