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FEXOFENADINE 180 MG FILM-COATED TABLETS

Active substance(s): FEXOFENADINE HYDROCHLORIDE

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Ref:

231-30-85846-W LEA FEXOFENADINE A/S TAB TUK
Version:

1

Trackwise Parent:

234437

PL Number(s),
MA Holder & Packer:
Reason for revision:

PL 00289/1030-31.
TEVA UK Limited Licence. Packed at Chanelle Medical, Ireland.
V1: Text update.

F. P. Code:
Pharma Code:
Third party code:
Fonts:
Base Font Size:

231-10-05571, 231-10-05581
TBC
LA4111
Univers
10 Pt

Dimensions:
L:
W:

300 mm
190 mm

18 November 2013
Child:

234445

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN C
BLACK

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
:HPXVWUHFHLYHDFRS\RIDQ\UG3DUW\6XSSOLHU·V3URRIEHIRUHDSSURYDOWRSULQWZLOOEHJUDQWHG

FEXOFENADINE 120 MG FILM-COATED
TABLETS
FEXOFENADINE 180 MG FILM-COATED
TABLETS
Fexofenadine hydrochloride
0!#+!'%,%!&,%4
).&/2-!4)/.&/24(%53%2

4ALKTOYOURDOCTORBEFOREYOUTAKE&EXOFENADINEIF
s 9OUAREGOINGTOTAKEANALLERGYTEST9OUMUST
STOPTAKINGTHISMEDICINETHREEDAYSBEFORETHE
TEST
Other medicines and Fexofenadine
4ELLYOURDOCTORORPHARMACISTIFYOUARETAKING
HAVERECENTLYTAKENORMIGHTTAKEANYOTHER
MEDICINES

Read all of this leaflet carefully before you start
using this medicine because it contains important
)TISESPECIALLYIMPORTANTTOTALKTOYOURDOCTOR
information for you
s +EEPTHISLEAFLET9OUMAYNEEDTOREADITAGAIN BEFOREYOUTAKE&EXOFENADINEIFYOUAREALSO
TAKINGANYOFTHEFOLLOWINGMEDICINES
s )FYOUHAVEANYFURTHERQUESTIONS ASKYOUR
s ERYTHROMYCIN ANANTIBIOTICUSEDTOTREATCERTAIN
DOCTORORPHARMACIST
s 4HISMEDICINEHASBEENPRESCRIBEDFORYOUONLY BACTERIALINFECTIONS
$ONOTPASSITONTOOTHERS)TMAYHARMTHEM s KETOCONAZOLE USEDTOTREATFUNGALINFECTIONS
s LOPINAVIRRITONAVIR USEDTOTREAT()6INFECTION
EVENIFTHEIRSIGNSOFILLNESSARETHESAMEAS
YOURS
4HESEMEDICINESINCREASETHEAMOUNTOF
s )FYOUGETANYOFTHESIDEEFFECTSTALKTOYOUR
DOCTORORPHARMACIST4HISINCLUDESANYPOSSIBLE &EXOFENADINEABSORBED ANDSOMAYINCREASEANY
SIDEEFFECTSNOTLISTEDINTHISLEAFLET3EESECTION SIDEEFFECTSYOUMAYSUFFER

).4()3,%!&,%4
)NDIGESTIONREMEDIESCONTAININGALUMINIUMAND
1. What Fexofenadine is and what it is used for
MAGNESIUMMAYAFFECTTHEACTIONOF&EXOFENADINE
2. What you need to know before you take
BYLOWERINGTHEAMOUNTOFDRUGABSORBED)FYOU
Fexofenadine
ARETAKINGANYSUCHINDIGESTIONREMEDIES ITIS
3. How to take Fexofenadine
RECOMMENDEDTHATYOULEAVEABOUT2 hours
4. Possible side effects of Fexofenadine
BETWEENTHETIMETHATYOUTAKE&EXOFENADINEAND
5. How to store Fexofenadine
YOURINDIGESTIONREMEDY
6. Contents of the pack and other information
Fexofenadine with food and drink
1 WHAT FEXOFENADINE IS AND WHAT IT &EXOFENADINESHOULDBETAKENWITHWATER

IS USED FOR
Pregnancy and breast-feeding
&EXOFENADINEHYDROCHLORIDE THEACTIVEINGREDIENT )FYOUAREPREGNANTORBREAST FEEDING THINKYOU
INYOURMEDICINE BELONGSTOTHEGROUPOF
MAYBEPREGNANTORAREPLANNINGTOHAVEABABY
MEDICINESKNOWNASANTIHISTAMINES
ASKYOURDOCTORORPHARMACISTFORADVICEBEFORE
TAKINGTHISMEDICINE
&EXOFENADINEMGTABLETSAREAPPROVEDFORTHE Pregnancy: 4AKE&EXOFENADINEDURINGPREGNANCY
RELIEFOFSYMPTOMSSUCHASSNEEZING RUNNING
ONLYIFYOURDOCTORCONSIDERSITTOBESTRICTLY
NOSEANDNOSEITCH EYEITCH TEARINGANDFLUSHING NECESSARY
WHICHTYPICALLYOCCURINCONNECTIONWITHHAYFEVER Breast-feeding)TISNOTRECOMMENDEDTOTAKE
ALLERGICRHINITIS 
&EXOFENADINEIFYOUAREBREAST FEEDING
&EXOFENADINEMGTABLETSAREAPPROVEDFORTHE
RELIEFOFSYMPTOMSSUCHASFLUSHING OEDEMAAND
ITCHING WHICHOCCURINCONNECTIONWITHTHE
ALLERGICSKINCONDITIONCALLEDCHRONICIDIOPATHIC
URTICARIA#)5 

2 WHAT YOU NEED TO KNOW BEFORE
YOU TAKE FEXOFENADINE

Driving and using machines
)TISUNLIKELYTHAT&EXOFENADINEWILLAFFECTYOUR
ABILITYTODRIVEORUSEMACHINES(OWEVER THERE
MAYBERAREEXCEPTIONS SOPLEASEENSURETHATYOU
AREALERTBEFOREDRIVINGORPERFORMINGTASKS
DEMANDINGYOURFULLATTENTION

3 HOW TO TAKE FEXOFENADINE

Do not take Fexofenadine if you:
!LWAYSTAKE&EXOFENADINEEXACTLYASYOURDOCTOR
s AREALLERGICHYPERSENSITIVE TOFEXOFENADINE
HASTOLDYOU#HECKWITHYOURDOCTOROR
HYDROCHLORIDEORANYOFTHEOTHERINGREDIENTSOF PHARMACISTIFYOUARENOTSURE
THISMEDICINE,ISTEDINSECTION 
Fexofenadine 120 mg Tablets: &ORRELIEFOF
4HEEFFICACYANDSAFETYOFFEXOFENADINE
SYMPTOMSOFHAYFEVERALLERGICRHINITIS 
HYDROCHLORIDEHASNOTBEENSTUDIEDINCHILDREN
4HERECOMMENDEDDOSEISONETABLETONCEDAILY
UNDER4HISMEDICINEISNOTRECOMMENDEDFOR FORADULTSANDCHILDRENYEARSANDOLDER
CHILDRENUNDERYEARSOFAGE

Fexofenadine 180 mg Tablets:&ORRELIEFOF
Warnings and precautions:
SYMPTOMSOFCHRONICIDIOPATHICURTICARIAALLERGIC
4ALKTOYOURDOCTORORPHARMACISTBEFORETAKING
SKINCONDITION 
&EXOFENADINEIFYOU
4HERECOMMENDEDDOSEISONETABLETONCEDAILYFOR
s AREELDERLY
ADULTSANDCHILDRENYEARSANDOLDER
s HAVEKIDNEYORLIVERPROBLEMS
s HAVEAHISTORYOFORONGOINGHEARTDISEASE
4AKETHETABLETSWITHWATER
BECAUSETAKINGTHISKINDOFMEDICINEMAYLEAD )FYOUTHINKTHEEFFECTSOF&EXOFENADINEARETOO
TOAFASTORIRREGULARHEARTBEAT
STRONGORTOOWEAK PLEASECONSULTYOURDOCTOROR
PHARMACIST

Ref:

231-30-85846-W LEA FEXOFENADINE A/S TAB TUK
Version:

1

Trackwise Parent:

PL Number(s),
MA Holder & Packer:
Reason for revision:

PL 00289/1030-31.
TEVA UK Limited Licence. Packed at Chanelle Medical, Ireland.
V1: Text update.

F. P. Code:
Pharma Code:
Third party code:
Fonts:
Base Font Size:

231-10-05571, 231-10-05581
TBC
LA4111
Univers
10 Pt

234437

Dimensions:
L:
W:

300 mm
190 mm

18 November 2013
Child:

234445

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN C
BLACK

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
:HPXVWUHFHLYHDFRS\RIDQ\UG3DUW\6XSSOLHU·V3URRIEHIRUHDSSURYDOWRSULQWZLOOEHJUDQWHG

s 4HEEXPIRYDATEREFERSTOTHELASTDAYOFTHAT
If you take more Fexofenadine than you should
MONTH
#ONTACTYOURDOCTOR EMERGENCYROOMOR
PHARMACISTIFYOUHAVETAKENMORE&EXOFENADINE s 4HISMEDICINALPRODUCTDOESNOTREQUIREANY
SPECIALSTORAGECONDITIONS
THANSTATEDINTHISLEAFLETORMORETHANYOUR
s $ONOTTHROWAWAYANYMEDICINESVIA
DOCTORHASPRESCRIBED3YMPTOMSOFOVERDOSE
WASTEWATERORHOUSEHOLDWASTE!SKYOUR
INCLUDEDIZZINESS FEELINGDROWSY FEELINGTIREDAND
PHARMACISTHOWTODISPOSEOFMEDICINESNO
ADRYMOUTH
LONGERREQUIRED4HESEMEASURESWILLHELPTO
PROTECTTHEENVIRONMENT
If you forget to take Fexofenadine
)FYOUFORGETTOTAKEADOSE TAKEITASSOONASYOU
REMEMBERITUNLESSITISNEARLYTIMEFORYOURNEXT 6 CONTENTS OF THE PACK AND OTHER
DOSE$ONOTTAKEADOUBLEDOSETOMAKEUPFORA
INFORMATION

FORGOTTENDOSE
What Fexofenadine contains:
)FYOUHAVEANYFURTHERQUESTIONSONTHEUSEOF
4HEACTIVESUBSTANCEISFEXOFENADINE
THISPRODUCT ASKYOURDOCTORORPHARMACIST
HYDROCHLORIDE
s %ACH&EXOFENADINEMGTABLETCONTAINSMG
4 POSSIBLE SIDE EFFECTS OF
OFFEXOFENADINEHYDROCHLORIDEEQUIVALENTTO
FEXOFENADINE
MGOFFEXOFENADINE
s 4HEOTHERINGREDIENTSAREMICROCRYSTALLINE
,IKEALLMEDICINES &EXOFENADINECANCAUSESIDE
CELLULOSE CROSCARMELLOSESODIUM MAIZESTARCH
EFFECTSALTHOUGHNOTEVERYBODYGETSTHEM
POVIDONE MAGNESIUMSTEARATE4HETABLETCOAT
4HESIDEEFFECTSDESCRIBEDBELOWHAVEBEEN
CONTAINSHYPROMELLOSE% TITANIUMDIOXIDE
EXPERIENCEDBYPEOPLETAKINGFEXOFENADINEAND
% MACROGOL MACROGOL IRON
THEYARELISTEDASEITHERCOMMON UNCOMMONOR
OXIDEYELLOW% ANDIRONOXIDERED% 
RARE
s %ACH&EXOFENADINEMGTABLETCONTAINSMG
Common MAYAFFECTUPTOINPEOPLE 
OFFEXOFENADINEHYDROCHLORIDEEQUIVALENTTO
s (EADACHE
MGOFFEXOFENADINE
s $ROWSINESS
s 4HEOTHERINGREDIENTSAREMICROCRYSTALLINE
s .AUSEA
CELLULOSE CROSCARMELLOSESODIUM MAIZESTARCH
s $RYMOUTH
POVIDONE MAGNESIUMSTEARATE4HETABLETCOAT
s $IZZINESS
CONTAINSHYPROMELLOSE% TITANIUMDIOXIDE
% MACROGOL MACROGOLANDIRON
Uncommon MAYAFFECTUPTOINPEOPLE 
OXIDEYELLOW% 
s &EELINGTIRED
s $IFFICULTYSLEEPING
What Fexofenadine looks like and contents of the
s .ERVOUSNESS
pack:
s 3LEEPDISTURBANCES
&EXOFENADINEMGTABLETSAREPEACHCOLOURED
s "ADDREAMS
OBLONG FILM COATEDTABLETS PLAINONBOTHSIDES
s )RREGULARANDORFASTHEARTBEAT
&EXOFENADINEMGTABLETSAREYELLOWCOLOURED
OBLONG FILM COATEDTABLETS PLAINONONESIDEWITH
Rare MAYAFFECTUPTOIN PEOPLE 
ACENTRALBREAK LINEONTHEOTHER
s !LLERGICSKINREACTIONSSUCHASECZEMA
s (IVESANDITCHING
&EXOFENADINECOMEINPACKSOF     
s 5NEXPECTEDSWELLINGOEDEMA
 ORTABLETS
s #HESTTIGHTNESS
.OTALLPACKSIZESMAYBEMARKETED
s 3HORTNESSOFBREATH

s &LUSHING
Marketing Authorisation Holder and Manufacturer
-ARKETING!UTHORISATIONHOLDER4%6!5+,IMITED
Not knownFREQUENCYCANNOTBEESTIMATEDFROM %ASTBOURNE ".!'
THEAVAILABLEDATA 
s $IARRHOEA
Company responsible for manufacture:
#HANELLE-EDICAL ,OUGHREA #O'ALWAY )RELAND
3EEKMEDICALADVICEIFSYMPTOMSOFANAPHYLACTIC
REACTIONSFOREXAMPLESWELLINGORDIFFICULTY
Product licence number(s)
BREATHING ORSERIOUSSKINREACTIONSOCCUR
&EXOFENADINEMG&ILM #OATED4ABLETS

0,
Reporting of side effects
&EXOFENADINEMG&ILM #OATED4ABLETS
)FYOUGETANYSIDEEFFECTS TALKTOYOURDOCTOR
0,
PHARMACISTORNURSE4HISINCLUDESANYPOSSIBLE

SIDEEFFECTSNOTLISTEDINTHISLEAFLET9OUCANALSO
This leaflet was last revised: October 2013
REPORTSIDEEFFECTSDIRECTLYVIATHE9ELLOW#ARD
3CHEMEATWWWMHRAGOVUKYELLOWCARD
"YREPORTINGSIDEEFFECTSYOUCANHELPPROVIDE
MOREINFORMATIONONTHESAFETYOFTHISMEDICINE

5 HOW TO STORE FEXOFENADINE
s Keep out of the sight and reach of children.
s $ONOTUSETHISMEDICINEAFTERTHEEXPIRYDATE
WHICHISSTATEDONTHECARTONANDBLISTER

 7
,!

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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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