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NASOBEC AQUEOUS 50 MICROGRAM NASAL SPRAY

Active substance(s): BECLOMETASONE DIPROPIONATE

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REG0062961

1

3
HOW TO USE NASOBEC AQUEOUS

231-30-83651-F LEA BECLOM (NASOBEC) 50MCG SPR TUK
Version 2.3

2

!LWAYSUSE.ASOBEC!QUEOUSEXACTLYASYOUR
beclometasone dipropionate
DOCTORHASTOLDYOU9OUSHOULDCHECKWITHYOUR
DOCTORORPHARMACISTIFYOUARENOTSURE
0!#+!'%,%!&,%4).&/2-!4)/.
4ELLYOURDOCTORIFYOUHAVEWATERYORITCHYEYES(E
&/24(%53%2
ORSHEMAYGIVEYOUANOTHERMEDICINETOTREATYOUR
Read all of this leaflet carefully before you start
EYES
using this medicine.
Always shake well before use. Only use in the nose.
s +EEPTHISLEAFLET9OUMAYNEEDTOREADITAGAIN
Do not swallow.
s )FYOUHAVEANYFURTHERQUESTIONS ASKYOUR
Adults (including the elderly) and Children
DOCTORORPHARMACIST
over six years old
s 4HISMEDICINEHASBEENPRESCRIBEDFORYOU$O
4HEUSUALDOSEISEITHER
NOTPASSITONTOOTHERS)TMAYHARMTHEM EVEN s 2 sprays into each nostril twice a day,ORIFYOU
IFTHEIRSYMPTOMSARETHESAMEASYOURS
PREFER
s )FYOUGETANYSIDEEFFECTS TALKTOYOURDOCTOR
s 1 spray into each nostril 3 or 4 times a day.
PHARMACISTORNURSE4HISINCLUDESANYPOSSIBLE
Do not use more than eight sprays
SIDEEFFECTSNOTLISTEDINTHISLEAFLET3EESECTION
(400 micrograms) in 24 hours.
9OUWILLONLYSTARTTOFEELBETTERAFTERYOUHAVE
).4()3,%!&,%4
BEENUSINGYOURMEDICINEFORAFEWDAYS
1. What Nasobec Aqueous is and what it is used for
/NCEYOURSYMPTOMSAREUNDERCONTROLYOUR
2. Before you use Nasobec Aqueous
DOCTORWILLCHANGEYOURDOSAGETOSPRAYINTO
3. How to use Nasobec Aqueous
EACHNOSTRILTWICEADAY
4. Possible side effects
)TISVERYIMPORTANTTOREDUCEYOURDOSEASSOON
5. How to store Nasobec Aqueous
ASYOURSYMPTOMSAREUNDERCONTROL
6. Further information
)FYOURSYMPTOMSTHENGETWORSE YOURDOSAGE
MAYTHENBEINCREASEDBACKTOTHESTARTINGDOSE
WHAT NASOBEC AQUEOUS IS AND
Do not use more than the recommended dose.
WHAT IT IS USED FOR
If you use high doses of Nasobec Aqueous
.ASOBEC!QUEOUSCONTAINSBECLOMETASONE
4HEREARETIMESWHENYOURDOCTORMAYNEEDTO
DIPROPIONATE WHICHISONEOFAGROUPOFMEDICINES
ADJUSTTHEDOSEOFTHESTEROIDYOUAREGIVENORTHE
CALLEDCORTICOSTEROIDS9OURMEDICINEHAS
WAYINWHICHYOUTAKEIT4HESETIMESARE
ANTI INFLAMMATORYPROPERTIES
s TIMESOFEXTREMESTRESS
.ASOBEC!QUEOUSISUSEDTOTREATANDPREVENTTHE
s DURINGADMISSIONTOHOSPITALAFTERASERIOUS
SYMPTOMSOFALLERGICREACTIONSTOPOLLENS
ACCIDENT INJURYORILLNESS
HAYFEVER HOUSEDUST ANDANIMALFUR SUCHASITCHY
s BEFOREORAFTERASURGICALOPERATION
ORRUNNYNOSEANDSNEEZING
)FYOUTHINKTHATANYOFTHESEAPPLYTOYOUWHILST
BEFORE YOU USE NASOBEC AQUEOUS
USING.ASOBEC!QUEOUS SPEAKTOYOURDOCTOROR
PHARMACIST
DO NOT use Nasobec Aqueous if you:
Children less than six years old
s AREALLERGICHYPERSENSITIVE TOBECLOMETASONE
s .ASOBEC!QUEOUSISNOTRECOMMENDEDFORUSE
DIPROPIONATEORANYOFTHEOTHERINGREDIENTSOF
INCHILDRENLESSTHANSIXYEARSOLD
THISMEDICINE
Before you use your nasal spray
Take special care with Nasobec Aqueous
 )FYOUAREUSINGYOURNASALSPRAYFORTHEFIRST
s 4ALKTOYOURDOCTORORPHARMACISTBEFOREUSING
TIME REMOVETHECLIPDIAGRAM! 
.ASOBEC!QUEOUSIFYOUHAVEANinfectionOR
ulcersINYOURNOSE ORYOUHAVERECENTLYHAD
A
surgeryORANinjuryTOYOURNOSE
Taking other medicines
s 0LEASETELLYOURDOCTORORPHARMACISTIFYOUARE
TAKINGORHAVERECENTLYTAKENANYOTHER
MEDICINES INCLUDINGMEDICINESOBTAINED
WITHOUTAPRESCRIPTION
Important information about some of the
 3HAKETHEBOTTLEGENTLYAND
ingredients of Nasobec Aqueous
THENREMOVETHEDUSTCAP B
s .ASOBEC!QUEOUSALSOINCLUDESTHEINGREDIENT
 (OLDTHEBOTTLEUPRIGHT
BENZALKONIUMCHLORIDE WHICHISANIRRITANTAND
WITHYOURTHUMBUNDER
MAYCAUSESKINREACTIONS
THEBOTTLEANDYOUR
Pregnancy and breast-feeding
INDEXFINGERANDMIDDLE
s )FYOUAREPREGNANT PLANNINGTOBECOME
FINGERONEITHERSIDEOF
PREGNANTORAREBREAST FEEDING ASKYOURDOCTOR
THENOZZLEDIAGRAM" 
FORADVICEBEFOREUSINGTHISMEDICINE
 4OMAKESUREYOURPUMPISWORKING TESTSPRAYIT
Driving and using machines
INTOTHEAIRBEFOREYOUUSEITFORTHEFIRSTTIME
s .ASOBEC!QUEOUSISNOTEXPECTEDTOAFFECTYOUR
ANDWHENEVERYOUHAVENOTUSEDITFORAWEEKOR
ABILITYTODRIVEOROPERATEMACHINERY
MORE(OLDTHEBOTTLEAWAYFROMYOUANDPRESS
DOWNUNTILYOUCANSEEAFINEMIST
Using your nasal spray
 'ENTLYBLOWYOURNOSE

NASOBECâ„¢ AQUEOUS
50 micrograms NASAL SPRAY

TEVA UK Ref:

1

Approved
POSSIBLE SIDE EFFECTS

,IKEALLMEDICINES .ASOBEC!QUEOUSCANCAUSE
SIDEEFFECTS ALTHOUGHNOTEVERYBODYGETSTHEM
s ANALLERGICREACTIONSWELLINGOFTHELIPS FACEOR
NECKLEADINGTOSEVEREDIFFICULTYINBREATHING
SHORTNESSOFBREATHORWHEEZING SKINRASHOR
HIVES 
4HISISAVERYSERIOUSBUTRARESIDEEFFECT9OUMAY
NEEDURGENTMEDICALATTENTIONORHOSPITALISATION
Immediately after you use your spray
s 9OUMAYSNEEZEALITTLE BUTTHISSOONSTOPS
s 6ERYOCCASIONALLYYOUMAYFINDYOUGETAN
UNPLEASANTTASTEORSMELL
Tell your doctor as soon as possible if you notice
any of the following side effects:

4

 #LOSEONENOSTRILBY
C
PRESSINGYOURFINGER
AGAINSTITANDPLACE
THENOZZLEOFTHE
SPRAYINYOUROTHER
NOSTRIL4ILTYOURHEAD
SLIGHTLYSOTHATTHE
BOTTLEISKEPTUPRIGHT
DIAGRAM# 
 "REATHEINTHROUGH
YOUROPENNOSTRILAND
ATTHESAMETIME PRESSTHENOZZLEONCEWITH
YOURFINGERSTORELEASETHESPRAY
 "REATHEOUTTHROUGHYOURMOUTH
 )FYOUNEEDTOUSEASECONDSPRAY REPEATSTEPS
AND
2EPEATSTEPS  AND WITHYOUROTHERNOSTRIL
After using your nasal spray
s 7IPETHENOZZLEWITHACLEANTISSUEANDPUTTHE
DUSTCAPBACKON
Cleaning your nasal spray
s 9OUSHOULDCLEANTHEPUMPATLEASTONCEAWEEK
TOSTOPITFROMGETTINGBLOCKEDUP'ENTLYPRESS
UPWARDSONTHEWHITECOLLARTOPULLTHENOZZLEOFF
DIAGRAM$
D
s 7ASHTHENOZZLEAND
DUSTCAPINWARM
WATER0UTTHEMINA
WARMPLACETODRY
BUTDONOTUSETOO
MUCHHEAT0UTTHE
NOZZLEANDDUSTCAP
BACKON
If you use more Nasobec
Aqueous than you should
)TISIMPORTANTTHATYOUTAKEYOURDOSEASSTATEDIN
THEh(OWTOUSEvSECTIONOFTHISLEAFLETORAS
ADVISEDBYYOURDOCTOR9OUSHOULDNOTEXCEEDTHE
RECOMMENDEDDOSEUSINGMOREORLESSMAYMAKE
YOURSYMPTOMSWORSE
)FYOUUSEMORETHANSPRAYSINHOURS TELLYOUR
DOCTORIMMEDIATELY
If you forget to use Nasobec Aqueous
)FYOUFORGETTOUSEYOURMEDICINEATTHERIGHTTIME
USEITASSOONASYOUREMEMBER ANDTHENCARRYON
ASBEFORE.EVERTAKETWODOSESTOGETHERTOMAKE
UPFORAFORGOTTENDOSE
If you stop using Nasobec Aqueous
$ONOTSTOPUSINGYOURMEDICINEWITHOUTTALKINGTO
YOURDOCTORFIRSTEVENIFYOUFEELBETTER
)FYOUHAVEANYFURTHERQUESTIONSONTHEUSEOFTHIS
PRODUCT ASKYOURDOCTORORPHARMACIST

Version:

HOW TO STORE NASOBEC AQUEOUS

FURTHER INFORMATION

Page 1 of 2

 &

What Nasobec Aqueous contains:
s 4HEACTIVEINGREDIENTISBECLOMETASONE
DIPROPIONATEANHYDROUS
s 4HEOTHERINGREDIENTSAREPHENYLETHYLALCOHOL
BENZALKONIUMCHLORIDE POLYSORBATE
MICROCRYSTALLINECELLULOSEANDCARMELLOSE
SODIUM GLUCOSEANHYDROUSANDPURIFIEDWATER
9OURMEDICINEMAYALSOCONTAINHYDROCHLORIC
ACIDTOADJUSTTHEP(
What Nasobec Aqueous looks like and contents of
the pack:
s .ASOBEC!QUEOUSISANASALSPRAY
s %ACHBOTTLEOF.ASOBEC!QUEOUSCONTAINS
SPRAYS
Marketing Authorisation Holder and Manufacturer
-ARKETINGAUTHORISATIONHOLDER
4%6!5+,IMITED %ASTBOURNE ".!'
#OMPANYRESPONSIBLEFORMANUFACTURE
4%6!#ZECH)NDUSTRIESSRO /PAVA #ZECH2EPUBLIC
This leaflet was last revised: -ARCH
0,

6

Keep out of the reach and sight of children.
+EEPYOURMEDICINEBELOWª#INTHEORIGINALCARTON
AWAYFROMLIGHT$ONOTPUTYOURMEDICINEINTHEFRIDGE
$ONOTUSE.ASOBEC!QUEOUSAFTERITHASBEENOPEN
FORMONTHSORAFTERTHEEXPIRYDATETHATISSTATED
ONTHEOUTERPACKAGING WHICHEVERISSOONER4HE
EXPIRYDATEREFERSTOTHELASTDAYOFTHATMONTH
-EDICINESSHOULDNOTBEDISPOSEDOFVIAWASTEWATER
ORHOUSEHOLDWASTE!SKYOURPHARMACISTHOWTO
DISPOSEOFMEDICINESNOLONGERREQUIRED4HESE
MEASURESWILLHELPTOPROTECTTHEENVIRONMENT

5

CommonAFFECTSLESSTHANINPEOPLE
s !DRYORPAINFULNOSEORTHROAT
s "ADNOSEBLEEDS
s -ILDALLERGICREACTIONSINCLUDINGSKINRASHESOR
REDNESS ITCHINGORWEALSLIKENETTLERASHORHIVES
Very rareAFFECTSLESSTHANIN PEOPLE
s (IGHPRESSUREINYOUREYETHATMAYCAUSEPAINOR
BLURREDVISION
s #LOUDINGOFTHELENSCATARACT
s $AMAGETOYOURNOSE
s 4HENOSESEPTUMTHEDIVIDINGPARTITIONINTHE
NOSE MAYBECOMEPERFORATED
4HEFOLLOWINGSIDEEFFECTSMAYOCCUR
s "LOODSTAINEDCRUSTSINTHENOSE
)TISIMPORTANTTOFOLLOWTHEDOSEINSTRUCTIONSSHOWN
IN3ECTION5SING.ASOBEC!QUEOUSATHIGHERDOSES
FORALONGTIMECANCAUSEANUMBEROFCHANGESIN
YOURBODY SUCHASCATCHINGINFECTIONSMOREEASILY
#HILDRENORADOLESCENTSWHOAREUSING.ASOBEC
!QUEOUSFORPROLONGEDPERIODSMAYGROWMORESLOWLY
ANDYOURDOCTORWILLWANTTOMONITORTHEIRGROWTH
Reporting of side effects
)FYOUGETANYSIDEEFFECTS TALKTOYOURDOCTOR
PHARMACISTORNURSE4HISINCLUDESANYPOSSIBLESIDE
EFFECTSNOTLISTEDINTHISLEAFLET9OUCANALSOREPORT
SIDEEFFECTSDIRECTLYVIATHE9ELLOW#ARD3CHEMEAT
WWWMHRAGOVUKYELLOWCARD
"YREPORTINGSIDEEFFECTSYOUCANHELPPROVIDEMORE
INFORMATIONONTHESAFETYOFTHISMEDICINE

13 March 2015

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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