FLIXONASE AQUEOUS NASAL SPRAY
Active substance: FLUTICASONE PROPIONATE MICRONISED
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FRONT PAGE
Package Leaflet: Information For The User
1 What Flixonase is and what it is used for
FlixonaseAqueousNasalSpray(calledFlixonaseinthis leaflet)containsamedicinecalledfluticasonepropionate. Thisbelongstoagroupofmedicinescalledsteroids(also calledcortico-steroids). Steroidsworkbyreducinginflammation. Theyreduceswellingandirritationinyournose. Thishelpstorelieveitching,sneezingandyourblocked orrunnynose. Flixonaseisusedtopreventandtreat: Inflammationintheliningofyournose(rhinitis)dueto seasonalallergies,suchasHayfever. Inflammationintheliningofyournose(rhinitis)dueto yearround(perennial)allergies,suchasanimalallergies.
Aqueous Nasal Spray
fluticasone propionate 50 micrograms
Pregnancy and breast-feeding Talktoyourdoctorbeforeusingthismedicineifyouare pregnant,mightbecomepregnant,orarebreast-feeding. Driving and using machines Flixonaseisnotlikelytoaffectyoubeingabletodriveor useanytoolsormachines. Important information about some of the ingredients of Flixonase Flixonasecontainsbenzalkoniumchloridewhichmaycause problemswithyourbreathing(bronchospasm).
Preparing your spray
Eachsprayhasadustcapwhichprotectsthenozzle andkeepsitclean.Remembertotakethisoffbefore usingthespray. Anewspray(oronethathasnotbeenusedforafew days),maynotworkfirsttime.Youneedtoprime thespraybypumpingthesprayafewtimesuntila finemistisproduced. 1 Holdthebottleas shownandmake sureitispointed awayfromyou. 2 Putyourforefinger andmiddlefinger onthecollareither sideofthenozzle andputyourthumb underneaththe bottle. 3 Keepyourthumb still,andpress downwithyour fingerstopumpthe spray. Ifthespraydoesnotworkandyouthinkitmaybe blocked,youwillneedtocleanit.Pleaseseethe sectionbelow,Cleaning your spray. Nevertrytounblockorenlargethetinysprayhole withapinorothersharpobject.Thiswilldamage thewaythesprayworks.
3 How to use Flixonase
AlwaysuseFlixonaseexactlyasyourdoctorhastoldyou. Youshouldcheckwithyourdoctororpharmacistifyouare notsure. Do not use in children under 4 years old Onlyuseinyournose,contactwitheyesshouldbeavoided. Ittakesafewdaysforthismedicinetowork.Sokeepusingit, even though you may not feel better straight away. Usethesprayeveryday. How much to use - adults and children (aged 12 and over) Theusualstartingdoseis2spraysintoeachnostrilonce aday,preferablyinthemorning. Themostyouwoulduseover24hoursisnormally 8sprays(4sprayspernostril). Asyoubecomebetter,yourdoctormayaskyoutousea lowerdose-onesprayintoeachnostrilonceaday. Ifyoursymptomsthengetworse,yourdosemaybe increasedbacktothestartingdose. How much to use - children aged 4 to 11 years Theusualstartingdoseisonesprayintoeachnostril onceaday,preferablyinthemorning Themostyouwoulduseover24hoursisnormally 4sprays(2sprayspernostril) If you use high doses of Flixonase Youmayneedextrasteroids: intimesofextremestress duringadmissiontohospitalafteraseriousaccidentor injury beforeasurgicaloperation. Yourdoctormaygiveyouextrasteroidmedicationsuchas tabletsoraninjection.
Read all of this leaflet carefully before you start using this medicine. Keepthisleaflet.Youmayneedtoreaditagain. Ifyouhaveanyfurtherquestions,askyourdoctoror pharmacist. Thismedicinehasbeenprescribedforyou.Donotpassit ontoothers.Itmayharmthem,eveniftheirsymptoms arethesameasyours. Ifanyofthesideeffectsgetsserious,orifyounotice anysideeffectsnotlistedinthisleaflet,pleasetellyour doctororpharmacist. In this leaflet: 1 WhatFlixonaseisandwhatitisusedfor 2 BeforeyouuseFlixonase 3 HowtouseFlixonase 4 Possiblesideeffects 5 HowtostoreFlixonase 6 Furtherinformation
2 Before you take Flixonase
Do not use Flixonase if: Youareallergic(hypersensitive)tofluticasonepropionate oranyoftheotheringredientsofFlixonaseAqueousNasal Spray(listedinsection6:Furtherinformation). Take special care with Flixonase Ifyouhaveeverhadanoperationonyournose Ifyouhaveaninfectioninyournose Ifyouareunsureiftheaboveapplytoyou,talktoyour doctororpharmacistbeforeusingFlixonase. Taking other medicines Pleasetellyourdoctorifyouaretakingorhaverecently takenanyothermedicines,includingmedicinesobtained withoutaprescription.Thisincludesherbalmedicines. Checkwithyourdoctororpharmacistbeforeusingyour medicineif: youhavehadsteroidsforalongtime,eitherasan injectionorbyyourmouth youaretakingatypeofantiviralmedicineknownasa proteaseinhibitor(e.g.ritonavir) youaretakingcertainmedicinesusedtotreatfungal infections(e.g.ketoconazole). Taking Flixonase with food and drink YoucanuseFlixonaseatanytimeofday,withorwithout food.
Please turn over the page
10000000109350 PHARMA CODE N 4274
BACK PAGE
Using your spray
1 Shakethebottleandtakeoffthedustcap. 2 Blowyournosegently. 3 Closeonenostril withyourfingeras shown,andputthe nozzleintheother nostril.Tiltyourhead forwardslightly andkeepthebottle upright.Holdthe bottleasshown. 4 Starttobreathein slowlythroughyour nose.Whileyouare breathinginpress downfirmlyonthe collarwithyourfingers. Asprayoffinemistwillgointoyournostril. 5 Breatheoutthroughyourmouth. 6 Repeatstep4touseasecondsprayinthesame nostril. 7 Removethenozzlefromthisnostrilandbreathe outthroughyourmouth. 8 Repeatsteps3to6foryourothernostril. 9 Afterusingyourspray,wipethenozzlecarefully withacleantissueorhandkerchief,andreplace thedustcap.
Cleaning your spray
Cleanyoursprayatleastonceaweek,ormoreoften ifitgetsblocked. 1 Takethedustcapoff bygentlysqueezingthe ribbedsidesbetween yourfingerandthumb andliftingitoff.Donot twistitoff. 2 Pullupwardsonthe whitecollartoremove thenozzle. 3 Soakthenozzleand dustcapinwarmwater forafewminutes. 4 Thenrinseundera runningtap. 5 Shakeofftheexcess waterandletthemdry inawarmplace. 6 Putthenozzlebackonthespray. 7 Primethebottleasdescribedinthesection above,Preparing your spray. If you forget to use Flixonase Ifyoumissadose,justusethenextdosewhenitisdue. If you use more Flixonase than you should Tellyourdoctorifyouusemorethanyouweretoldto. Itisimportantthatyoutakeyourdoseasstatedonthe pharmacistslabelorasadvisedbyyourdoctor.Youshould useonlyasmuchasyourdoctorrecommends;usingmore orlessmaymakeyoursymptomsworse. If you stop taking Flixonase Donotstoptreatmentevenifyoufeelbetter,unlessyour doctortellsyoutostop.Ifyoudostop,thesymptomsmay comeback. Ifyouhaveanyfurtherquestionsontheuseofthisproduct, askyourdoctororpharmacist.
4 Possible side effects
Likeallmedicines,Flixonasecancausesideeffects,although noteverybodygetsthem.Thefollowingsideeffectsmay happenwiththismedicine:
Allergic reactions: get a doctors help straight away AsmallnumberofpeoplegetallergicreactionstoFlixonase, whichcandevelopintoamoreserious,evenlife-threatening problemifnottreated.Symptomsinclude: becomingverywheezy,coughingorhavingdifficulty withbreathing suddenlyfeelingweakorlight-headed(whichmaylead tocollapseorlossofconsciousness) swellingaroundtheface,mouthortongue skinrashesorredness. Ifthishappens,tellyourdoctorstraightaway-youmay need urgent medical treatment. AllergicreactionstoFlixonaseareveryrare(Theseaffectless than1in10,000people). Immediately after you use your spray Youmaysneezealittle,butthissoonstops. Veryoccasionallyyoumayfindyougetanunpleasant tasteorsmell. Tell your doctor as soon as possible if you notice any of the following side effects: Othersideeffectsinclude: Very common (affectsmorethan1in10people) Nosebleeds. Common (affectslessthan1in10people) Headache. Unpleasanttaste. Unpleasantsmell. Adryorpainfulnoseorthroat. Very rare(affectslessthan1in10,000people) Skinreaction-whichcanrangefromred,itchyrash andblotchestoamoresevereskinreactionsuchasdry, crackedandpeelingskin. Problemswithyoureyessuchaspainorblurredvision. Damagetoyournose. Veryrarely,thenormalproductionofsteroidsinyourbody maybeaffected.Thisismorelikelytohappenifyouuse highdosesforalongtime.Yourdoctorwillhelpstopthis happeningbymakingsureyouusethelowestdoseofsteroid whichcontrolsyoursymptoms.Inchildrenthissideeffectcan rarelycausethemtogrowmoreslowlythanothers.Children whoreceivethistreatmentforalongperiodoftimewillhave theirheightcheckedregularlybytheirdoctor. Ifyounoticeanysideeffectsnotlistedinthisleaflettell yourdoctorassoonaspossible.
5 How to store Flixonase
Keepoutofthereachandsightofchildren. Protectfromfrostandlight. Donotstoreabove30C. Donotputinarefrigerator. DonotuseFlixonaseaftertheexpirydatewhichisstated onthelabelandcartonafterEXP.Theexpirydaterefers tothelastdayofthatmonth. Ifyouaretoldtostoptakingthismedicinereturnany unusedspraytoyourpharmacisttobedestroyed. Medicinesshouldnotbedisposedofviawastewaterorhousehold waste.Askyourpharmacisthowtodisposeofmedicinesnolonger required.Thesemeasureswillhelptoprotecttheenvironment.
6 Further Information
What Flixonase Aqueous Nasal Spray contains Theactivesubstanceisfluticasonepropionate Theotheringredientsaremicrocrystallinecellulose,sodium carboxymethylcellulose,dextrose,polysorbate80,purified waterandthepreservativesbenzalkoniumchlorideand phenylethylalcohol.Theseotheringredientsareneededto makeastablesuspensionwhichwillnotgooff. What Flixonase Aqueous Nasal Spray looks like and contents of the pack Eachambercolouredglassbottledelivers150sprays.Each spraycontains50microgramsoffluticasonepropionate. Marketing Authorisation Holder GlaxoWellcomeUKLtd,TradingasAllenandHanburys, StockleyParkWest,Uxbridge,Middlesex,UB111BT Manufacturer GlaxoWellcomeSA,ArandadeDuero,Burgos,Spain Otherformats: TolistentoorrequestacopyofthisleafletinBraille,large printoraudiopleasecall,freeofcharge: Pleasebereadytogivethefollowinginformation: Product name Flixonase Aqueous Nasal Spray Referencenumber 10949/0036 ThisisaserviceprovidedbytheRoyalNationalInstituteoftheBlind. Leaflet date: August 2012 FlixonaseisatrademarkoftheGlaxoSmithKlinegroupofcompanies. 2012GlaxoSmithKlinegroupofcompanies
08001985000(UKOnly)
10000000109350
PHARMA CODE N 4274
Package Leaflet: Information For The User
1 What Flixonase is and what it is used for
FlixonaseAqueousNasalSpray(calledFlixonaseinthis leaflet)containsamedicinecalledfluticasonepropionate. Thisbelongstoagroupofmedicinescalledsteroids(also calledcortico-steroids). Steroidsworkbyreducinginflammation. Theyreduceswellingandirritationinyournose. Thishelpstorelieveitching,sneezingandyourblocked orrunnynose. Flixonaseisusedtopreventandtreat: Inflammationintheliningofyournose(rhinitis)dueto seasonalallergies,suchasHayfever. Inflammationintheliningofyournose(rhinitis)dueto yearround(perennial)allergies,suchasanimalallergies.
Aqueous Nasal Spray
fluticasone propionate 50 micrograms
Pregnancy and breast-feeding Talktoyourdoctorbeforeusingthismedicineifyouare pregnant,mightbecomepregnant,orarebreast-feeding. Driving and using machines Flixonaseisnotlikelytoaffectyoubeingabletodriveor useanytoolsormachines. Important information about some of the ingredients of Flixonase Flixonasecontainsbenzalkoniumchloridewhichmaycause problemswithyourbreathing(bronchospasm).
Preparing your spray
Eachsprayhasadustcapwhichprotectsthenozzle andkeepsitclean.Remembertotakethisoffbefore usingthespray. Anewspray(oronethathasnotbeenusedforafew days),maynotworkfirsttime.Youneedtoprime thespraybypumpingthesprayafewtimesuntila finemistisproduced. 1 Holdthebottleas shownandmake sureitispointed awayfromyou. 2 Putyourforefinger andmiddlefinger onthecollareither sideofthenozzle andputyourthumb underneaththe bottle. 3 Keepyourthumb still,andpress downwithyour fingerstopumpthe spray. Ifthespraydoesnotworkandyouthinkitmaybe blocked,youwillneedtocleanit.Pleaseseethe sectionbelow,Cleaning your spray. Nevertrytounblockorenlargethetinysprayhole withapinorothersharpobject.Thiswilldamage thewaythesprayworks.
3 How to use Flixonase
AlwaysuseFlixonaseexactlyasyourdoctorhastoldyou. Youshouldcheckwithyourdoctororpharmacistifyouare notsure. Do not use in children under 4 years old Onlyuseinyournose,contactwitheyesshouldbeavoided. Ittakesafewdaysforthismedicinetowork.Sokeepusingit, even though you may not feel better straight away. Usethesprayeveryday. How much to use - adults and children (aged 12 and over) Theusualstartingdoseis2spraysintoeachnostrilonce aday,preferablyinthemorning. Themostyouwoulduseover24hoursisnormally 8sprays(4sprayspernostril). Asyoubecomebetter,yourdoctormayaskyoutousea lowerdose-onesprayintoeachnostrilonceaday. Ifyoursymptomsthengetworse,yourdosemaybe increasedbacktothestartingdose. How much to use - children aged 4 to 11 years Theusualstartingdoseisonesprayintoeachnostril onceaday,preferablyinthemorning Themostyouwoulduseover24hoursisnormally 4sprays(2sprayspernostril) If you use high doses of Flixonase Youmayneedextrasteroids: intimesofextremestress duringadmissiontohospitalafteraseriousaccidentor injury beforeasurgicaloperation. Yourdoctormaygiveyouextrasteroidmedicationsuchas tabletsoraninjection.
Read all of this leaflet carefully before you start using this medicine. Keepthisleaflet.Youmayneedtoreaditagain. Ifyouhaveanyfurtherquestions,askyourdoctoror pharmacist. Thismedicinehasbeenprescribedforyou.Donotpassit ontoothers.Itmayharmthem,eveniftheirsymptoms arethesameasyours. Ifanyofthesideeffectsgetsserious,orifyounotice anysideeffectsnotlistedinthisleaflet,pleasetellyour doctororpharmacist. In this leaflet: 1 WhatFlixonaseisandwhatitisusedfor 2 BeforeyouuseFlixonase 3 HowtouseFlixonase 4 Possiblesideeffects 5 HowtostoreFlixonase 6 Furtherinformation
2 Before you take Flixonase
Do not use Flixonase if: Youareallergic(hypersensitive)tofluticasonepropionate oranyoftheotheringredientsofFlixonaseAqueousNasal Spray(listedinsection6:Furtherinformation). Take special care with Flixonase Ifyouhaveeverhadanoperationonyournose Ifyouhaveaninfectioninyournose Ifyouareunsureiftheaboveapplytoyou,talktoyour doctororpharmacistbeforeusingFlixonase. Taking other medicines Pleasetellyourdoctorifyouaretakingorhaverecently takenanyothermedicines,includingmedicinesobtained withoutaprescription.Thisincludesherbalmedicines. Checkwithyourdoctororpharmacistbeforeusingyour medicineif: youhavehadsteroidsforalongtime,eitherasan injectionorbyyourmouth youaretakingatypeofantiviralmedicineknownasa proteaseinhibitor(e.g.ritonavir) youaretakingcertainmedicinesusedtotreatfungal infections(e.g.ketoconazole). Taking Flixonase with food and drink YoucanuseFlixonaseatanytimeofday,withorwithout food.
Please turn over the page
10000000109350 PHARMA CODE N 4274
BACK PAGE
Using your spray
1 Shakethebottleandtakeoffthedustcap. 2 Blowyournosegently. 3 Closeonenostril withyourfingeras shown,andputthe nozzleintheother nostril.Tiltyourhead forwardslightly andkeepthebottle upright.Holdthe bottleasshown. 4 Starttobreathein slowlythroughyour nose.Whileyouare breathinginpress downfirmlyonthe collarwithyourfingers. Asprayoffinemistwillgointoyournostril. 5 Breatheoutthroughyourmouth. 6 Repeatstep4touseasecondsprayinthesame nostril. 7 Removethenozzlefromthisnostrilandbreathe outthroughyourmouth. 8 Repeatsteps3to6foryourothernostril. 9 Afterusingyourspray,wipethenozzlecarefully withacleantissueorhandkerchief,andreplace thedustcap.
Cleaning your spray
Cleanyoursprayatleastonceaweek,ormoreoften ifitgetsblocked. 1 Takethedustcapoff bygentlysqueezingthe ribbedsidesbetween yourfingerandthumb andliftingitoff.Donot twistitoff. 2 Pullupwardsonthe whitecollartoremove thenozzle. 3 Soakthenozzleand dustcapinwarmwater forafewminutes. 4 Thenrinseundera runningtap. 5 Shakeofftheexcess waterandletthemdry inawarmplace. 6 Putthenozzlebackonthespray. 7 Primethebottleasdescribedinthesection above,Preparing your spray. If you forget to use Flixonase Ifyoumissadose,justusethenextdosewhenitisdue. If you use more Flixonase than you should Tellyourdoctorifyouusemorethanyouweretoldto. Itisimportantthatyoutakeyourdoseasstatedonthe pharmacistslabelorasadvisedbyyourdoctor.Youshould useonlyasmuchasyourdoctorrecommends;usingmore orlessmaymakeyoursymptomsworse. If you stop taking Flixonase Donotstoptreatmentevenifyoufeelbetter,unlessyour doctortellsyoutostop.Ifyoudostop,thesymptomsmay comeback. Ifyouhaveanyfurtherquestionsontheuseofthisproduct, askyourdoctororpharmacist.
4 Possible side effects
Likeallmedicines,Flixonasecancausesideeffects,although noteverybodygetsthem.Thefollowingsideeffectsmay happenwiththismedicine:
Allergic reactions: get a doctors help straight away AsmallnumberofpeoplegetallergicreactionstoFlixonase, whichcandevelopintoamoreserious,evenlife-threatening problemifnottreated.Symptomsinclude: becomingverywheezy,coughingorhavingdifficulty withbreathing suddenlyfeelingweakorlight-headed(whichmaylead tocollapseorlossofconsciousness) swellingaroundtheface,mouthortongue skinrashesorredness. Ifthishappens,tellyourdoctorstraightaway-youmay need urgent medical treatment. AllergicreactionstoFlixonaseareveryrare(Theseaffectless than1in10,000people). Immediately after you use your spray Youmaysneezealittle,butthissoonstops. Veryoccasionallyyoumayfindyougetanunpleasant tasteorsmell. Tell your doctor as soon as possible if you notice any of the following side effects: Othersideeffectsinclude: Very common (affectsmorethan1in10people) Nosebleeds. Common (affectslessthan1in10people) Headache. Unpleasanttaste. Unpleasantsmell. Adryorpainfulnoseorthroat. Very rare(affectslessthan1in10,000people) Skinreaction-whichcanrangefromred,itchyrash andblotchestoamoresevereskinreactionsuchasdry, crackedandpeelingskin. Problemswithyoureyessuchaspainorblurredvision. Damagetoyournose. Veryrarely,thenormalproductionofsteroidsinyourbody maybeaffected.Thisismorelikelytohappenifyouuse highdosesforalongtime.Yourdoctorwillhelpstopthis happeningbymakingsureyouusethelowestdoseofsteroid whichcontrolsyoursymptoms.Inchildrenthissideeffectcan rarelycausethemtogrowmoreslowlythanothers.Children whoreceivethistreatmentforalongperiodoftimewillhave theirheightcheckedregularlybytheirdoctor. Ifyounoticeanysideeffectsnotlistedinthisleaflettell yourdoctorassoonaspossible.
5 How to store Flixonase
Keepoutofthereachandsightofchildren. Protectfromfrostandlight. Donotstoreabove30C. Donotputinarefrigerator. DonotuseFlixonaseaftertheexpirydatewhichisstated onthelabelandcartonafterEXP.Theexpirydaterefers tothelastdayofthatmonth. Ifyouaretoldtostoptakingthismedicinereturnany unusedspraytoyourpharmacisttobedestroyed. Medicinesshouldnotbedisposedofviawastewaterorhousehold waste.Askyourpharmacisthowtodisposeofmedicinesnolonger required.Thesemeasureswillhelptoprotecttheenvironment.
6 Further Information
What Flixonase Aqueous Nasal Spray contains Theactivesubstanceisfluticasonepropionate Theotheringredientsaremicrocrystallinecellulose,sodium carboxymethylcellulose,dextrose,polysorbate80,purified waterandthepreservativesbenzalkoniumchlorideand phenylethylalcohol.Theseotheringredientsareneededto makeastablesuspensionwhichwillnotgooff. What Flixonase Aqueous Nasal Spray looks like and contents of the pack Eachambercolouredglassbottledelivers150sprays.Each spraycontains50microgramsoffluticasonepropionate. Marketing Authorisation Holder GlaxoWellcomeUKLtd,TradingasAllenandHanburys, StockleyParkWest,Uxbridge,Middlesex,UB111BT Manufacturer GlaxoWellcomeSA,ArandadeDuero,Burgos,Spain Otherformats: TolistentoorrequestacopyofthisleafletinBraille,large printoraudiopleasecall,freeofcharge: Pleasebereadytogivethefollowinginformation: Product name Flixonase Aqueous Nasal Spray Referencenumber 10949/0036 ThisisaserviceprovidedbytheRoyalNationalInstituteoftheBlind. Leaflet date: August 2012 FlixonaseisatrademarkoftheGlaxoSmithKlinegroupofcompanies. 2012GlaxoSmithKlinegroupofcompanies
08001985000(UKOnly)
10000000109350
PHARMA CODE N 4274
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
