Skip to Content

UK Edition. Click here for US version.

EXEMESTANE 25MG FILM COATED TABLETS

Active substance(s): EXEMESTANE

View full screen / Print PDF » Download PDF ⇩
Transcript
F. P. Code:
EAN Code:
Pharma Code:
Edge Code:
Third party code:
Fonts:

Dimensions:
L:
W:
D:
Foil Width:
Perforated:

300 mm
180 mm
N/A
N/A
N/A

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

PANTONE® GREEN
BLACK

Base Font Size:
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.
 
  
             

s )FYOUHAVEAHISTORYORARESUFFERINGFROMANY
CONDITIONWHICHAFFECTSTHESTRENGTHOFYOUR
BONES4HISISBECAUSEDRUGSOFTHISCLASS
0!#+!'%,%!&,%4).&/2-!4)/.&/24(%53%2
LOWERTHELEVELSOFFEMALEHORMONESANDTHIS
Read all of this leaflet carefully before you start
may lead to a loss of the mineral content of
taking this medicine because it contains
BONES WHICHMIGHTDECREASETHEIRSTRENGTH
important information for you.
9OUMAYHAVETOUNDERGOTESTSTOMEASURE
s Keep this leaflet. You may need to read it again.
YOURBONEDENSITYBEFOREANDDURING
s )FYOUHAVEANYFURTHERQUESTIONS ASKYOUR
TREATMENT9OURDOCTORCANGIVEYOUMEDICINE
doctor or pharmacist.
TOPREVENTORTREATTHEBONELOSS
s 4HISMEDICINEHASBEENPRESCRIBEDFORYOU
s "EFORETREATMENTWITH%XEMESTANEMG
ONLY$ONOTPASSITONTOOTHERS)TMAYHARM
&ILM #OATED4ABLETS YOURDOCTORMAYWANTTO
THEM EVENIFTHEIRSIGNSOFILLNESSARETHE
TAKEBLOODSAMPLESTOMEASUREYOURVITAMIN
same as yours.
$LEVELS4HISISBECAUSESEVEREVITAMIN$
s )FYOUGETANYSIDEEFFECTSTALKTOYOURDOCTOR
DEFICIENCYISCOMMONINWOMENWITHEARLY
ORPHARMACIST THISINCLUDESANYPOSSIBLESIDE
BREASTCANCER)NTHECASEOFLOWVITAMIN$
effects not listed in this leaflet. See section 4.
LEVELS YOURDOCTORWILLGIVEYOUSUPPLEMENT
7(!4)3).4()3,%!&,%4
therapy.
1. What Exemestane 25 mg Film-Coated Tablets Other medicines and Exemestane 25 mg
are and what they are used for
Film-Coated Tablets
2. What you need to know before you take
4ELLYOURDOCTORIFYOUARETAKING HAVERECENTLY
Exemestane 25 mg Film-Coated Tablets
TAKENORMIGHTTAKEANYOTHERMEDICINES
3. How to take Exemestane 25 mg Film-Coated
INCLUDINGMEDICINESOBTAINEDWITHOUTA
Tablets
prescription.
4. Possible side effects
5. How to store Exemestane 25 mg Film-Coated %XEMESTANEMG&ILM #OATED4ABLETSSHOULD
NOTBEGIVENATTHESAMETIMEASHORMONE
Tablets
REPLACEMENTTHERAPY(24 4HEFOLLOWING
6. Contents of the pack and other information
MEDICINESSHOULDBEUSEDCAUTIOUSLYWHEN
TAKING%XEMESTANEMG&ILM #OATED4ABLETS
EXEMESTANE 25 mg
1 WHAT
FILM-COATED TABLETS ARE AND WHAT ,ETYOURDOCTORKNOWIFYOUARETAKING
medicines such as:
THEY ARE USED FOR
s RIFAMPICINANANTIBIOTIC
Your medicine is called Exemestane 25 mg
s CARBAMAZEPINEORPHENYTOINANTI CONVULSANTS
&ILM #OATED4ABLETS
used to treat epilepsy)
%XEMESTANEMG&ILM #OATED4ABLETSBELONGS
s THEHERBALREMEDY3T*OHNSWORT(Hypericum
TOAGROUPOFMEDICINESKNOWNASAROMATASE
perforatum) ORPREPARATIONSCONTAININGIT
INHIBITORS4HESEDRUGSINTERFEREWITHA

EXEMESTANE
25 mg FILM-COATED TABLETS

SUBSTANCECALLEDAROMATASE WHICHISNEEDEDTO
MAKETHEFEMALESEXHORMONE OESTROGEN
ESPECIALLYINPOSTMENOPAUSALWOMEN2EDUCING
OESTROGENLEVELSINTHEBODYISAWAYOFTREATING
HORMONE DEPENDENTBREASTCANCER

Pregnancy, breast-feeding and fertility
$ONOTTAKE%XEMESTANEMG&ILM #OATED
4ABLETSIFYOUAREPREGNANTORBREAST FEEDING
)FYOUAREPREGNANTORTHINKYOUMIGHTBE TELL
your doctor.
%XEMESTANEMG&ILM #OATED4ABLETSAREUSED $ISCUSSCONTRACEPTIONWITHYOURDOCTORIFTHEREIS
TOTREATHORMONE DEPENDENTEARLYBREASTCANCER ANYPOSSIBILITYTHATYOUMAYBECOMEPREGNANT
INPOSTMENOPAUSALWOMENAFTERTHEYHAVE
Driving and using machines
COMPLETED YEARSOFTREATMENTWITHTHE
)FYOUFEELDROWSY DIZZYORWEAKWHILSTTAKING
medicine tamoxifen.
%XEMESTANEMG&ILM #OATED4ABLETS YOU
)TISALSOUSEDTOTREATHORMONE DEPENDENT
SHOULDNOTATTEMPTTODRIVEOROPERATEMACHINERY
ADVANCEDBREASTCANCERINPOSTMENOPAUSAL
TO TAKE EXEMESTANE 25 mg
WOMENWHENADIFFERENTHORMONALDRUG
3 HOW
FILM-COATED TABLETS
TREATMENTHASNOTWORKEDWELLENOUGH
!LWAYSTAKETHISMEDICINEEXACTLYASYOURDOCTOR
YOU NEED TO KNOW BEFORE
2 WHAT
HASTOLDYOU#HECKWITHYOURDOCTOROR
YOU TAKE EXEMESTANE 25 mg
PHARMACISTIFYOUAREUNSURE9OURDOCTORWILLTELL
FILM-COATED TABLETS
YOUHOWTOTAKETHISMEDICINEANDFORHOWLONG
Do not take Exemestane 25 mg Film-Coated
Adults and the elderly
Tablets
4HEUSUALDOSEISONEMGFILM COATEDTABLET
)FYOUAREORHAVEPREVIOUSLYBEENALLERGICTO
daily.
EXEMESTANETHEACTIVEINGREDIENTIN%XEMESTANE
%XEMESTANEMG&ILM #OATED4ABLETSSHOULD
MG&ILM #OATED4ABLETSORANYOFTHEOTHER
BETAKENBYMOUTHAFTERAMEALATAPPROXIMATELY
ingredients of this medicine (listed in section 6).
the same time each day.
s IFYOUHAVEnotALREADYBEENTHROUGH@THE
MENOPAUSE IEYOUARESTILLHAVINGYOUR
Use in children and adolescents
monthly period
4HISMEDICINEISNOTSUITABLEFORUSEINCHILDREN
s IFYOUAREPREGNANT LIKELYTOBEPREGNANTORIF and adolescents.
YOUAREBREAST FEEDING
If you take more Exemestane 25 mg
Warnings and precautions
Film-Coated Tablets than you should
Talk to your doctor or pharmacist before taking )FTOOMANYTABLETSARETAKENBYACCIDENT
Exemestane 25 mg Film-Coated Tablets
contact your doctor at once or go straight to the
s "EFORETREATMENTWITH%XEMESTANEMG
NEARESTHOSPITALCASUALTYDEPARTMENT3HOW
&ILM #OATED4ABLETS YOURDOCTORMAYWANTTO THEMTHEPACKOF%XEMESTANEMG
TAKEBLOODSAMPLESTOMAKESUREYOUHAVE
&ILM #OATED4ABLETS
reached the menopause
If you forget to take Exemestane 25 mg
s "EFORETAKING%XEMESTANEMG&ILM #OATED
Film-Coated Tablets
4ABLETS TELLYOURDOCTORIFYOUHAVEPROBLEMS
$ONOTTAKEADOUBLEDOSETOMAKEUPFORA
WITHYOURLIVERORKIDNEYS
forgotten dose.

F. P. Code:
EAN Code:
Pharma Code:
Edge Code:
Third party code:
Fonts:

Dimensions:
L:
W:
D:
Foil Width:
Perforated:

300 mm
180 mm
N/A
N/A
N/A

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

PANTONE® GREEN
BLACK

Base Font Size:
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.
 
  
             

)FYOUFORGETTOTAKEYOURFILM COATEDTABLET TAKE )FYOUHAVEANYBLOODTESTSDONE ITMAYBE
ITASSOONASYOUREMEMBER)FITISNEARLYTIME NOTICEDTHATTHEREARECHANGESINYOURLIVER
function. Changes in the amount of certain
FORTHENEXTDOSE TAKEITATTHEUSUALTIME
BLOODCELLSLYMPHOCYTES ANDPLATELETSBLOOD
If you stop taking Exemestane 25 mg
CELLSWHICHCAUSECLOTTING CIRCULATINGINYOUR
Film-Coated Tablets
BLOODMAYOCCUR ESPECIALLYINPATIENTSWITHA
$ONOTSTOPTAKINGYOURFILM COATEDTABLETSEVEN
pre-existing lymphopenia (reduced
IFYOUAREFEELINGWELL UNLESSYOURDOCTORTELLS
LYMPHOCYTESINTHEBLOOD 
YOU)FYOUHAVEANYFURTHERQUESTIONSONTHE
Reporting of side effects
USEOFTHISMEDICINE ASKYOURDOCTOROR
)FYOUGETANYSIDEEFFECTS TALKTOYOURDOCTOROR
pharmacist.
PHARMACIST4HISINCLUDESANYPOSSIBLESIDE
POSSIBLE
SIDE
EFFECTS
effects not listed in this leaflet. You can also
4
REPORTSIDEEFFECTSDIRECTLYVIATHE9ELLOW#ARD
,IKEALLMEDICINES THISMEDICINECANCAUSESIDE 3CHEMEATWWWMHRAGOVUKYELLOWCARD
EFFECTS ALTHOUGHNOTEVERYBODYGETSTHEM)N
"YREPORTINGSIDEEFFECTSYOUCANHELPPROVIDE
GENERAL THISMEDICINEISWELLTOLERATEDANDTHE more information on the safety of this medicine.
FOLLOWINGSIDEEFFECTSOBSERVEDINPATIENTS
TREATEDWITHTHISMEDICINEAREMAINLYMILDOR
TO STORE EXEMESTANE 25 mg
5 HOW
moderate in nature. Most of the side effects are
FILM-COATED TABLETS
ASSOCIATEDWITHASHORTAGEOFOESTROGENEG
Keep this medicine out of the sight and reach of
hot flushes).
children.
Very common side effects, (may affect more
Do not use this medicine after the expiry date
than 1 in 10 people):
WHICHISSTATEDONTHECARTONAFTER%80
s $IFFICULTYSLEEPING
4HEEXPIRYDATEREFERSTOTHELASTDAYOFTHAT
s (EADACHE
month.
s (OTFLUSHES
4HISMEDICINEDOESNOTREQUIREANYSPECIAL
s &EELINGSICK
storage conditions.
s )NCREASEDSWEATING
s -USCLEANDJOINTPAININCLUDINGOSTEOARTHRITIS $ONOTTHROWAWAYANYMEDICINESVIA
BACKPAIN ARTHRITISANDJOINTSTIFFNESS
WASTEWATERORHOUSEHOLDWASTE!SKYOUR
s 4IREDNESS
PHARMACISTHOWTOTHROWAWAYMEDICINESYOU
Common side effects, (may affect 1 in 10
people):
s ,OSSOFAPPETITE
s $EPRESSION
s $IZZINESS CARPALTUNNELSYNDROMEA
COMBINATIONOFPINSANDNEEDLES NUMBNESS
and pain affecting all of the hand except the
LITTLEFINGER IMPAIRMENTOFSENSATION
(paraesthesia)
s 3TOMACHACHE VOMITINGBEINGSICK
CONSTIPATION INDIGESTION DIARRHOEA
s 3KINRASH HAIRLOSS HIVES
s 4HINNINGOFBONESWHICHMIGHTDECREASETHEIR
STRENGTHOSTEOPOROSIS LEADINGTOBONE
FRACTURESBREAKSORCRACKS INSOMECASES
s 0AIN SWOLLENHANDSANDFEET
Uncommon side effects, (may affect up to 1 in
100 people):
s $ROWSINESS
s -USCLEWEAKNESS
s !LLERGICREACTIONSINCLUDINGRASH SWELLINGOF
THEFACE LIPS TONGUE ANDORTHROATWHICHMAY
CAUSEDIFFICULTYINBREATHINGORSWALLOWING
s )NCREASEDLIVERENZYMES INFLAMMATIONOFTHE
LIVERHEPATITIS ASSOCIATEDWITHFEELINGSICK
NAUSEA JAUNDICEYELLOWINGOFTHESKINAND
EYES ITCHING RIGHTSIDEDABDOMINALPAINAND
loss of appetite
s 3KINREACTIONWITHSMALLBLISTERSASSOCIATED
WITHFEVERACUTEGENERALISEDEXANTHEMATOUS
pustulosis)
s $ECREASEINTHENUMBEROFWHITEBLOODCELLS
(leucopenia)
s $ECREASEINTHENUMBEROFWHITEBLOODCELLS
WHICHMAKESINFECTIONMORELIKELY
Rare side effects, (may affect up to 1 in 1,000
people)
s $ECREASEINTHENUMBEROFBLOODPLATELETS
WHICHINCREASESRISKOFBLEEDINGANDBRUISING
Not known, (frequency cannot be estimated
from the available data)
s $ECREASEINTHENUMBEROFBLOODLYMPHOCYTES
TYPEOFWHITEBLOODCELLS 

NOLONGERUSE4HESEMEASURESWILLHELPTO
PROTECTTHEENVIRONMENT

6

CONTENTS OF THE PACK AND OTHER
INFORMATION

What Exemestane 25 mg Film-Coated Tablets
contain
4HEACTIVESUBSTANCEISEXEMESTANE%ACH
FILM COATEDTABLETCONTAINSMGEXEMESTANE
4HEOTHERINGREDIENTSARE
Tablet core:
-ANNITOL #OPOVIDONE #ROSPOVIDONE 3ILICIFIED
-ICROCRYSTALLINE#ELLULOSE 3ODIUM3TARCH
'LYCOLATE4YPE! -AGNESIUM3TEARATE
Film coating:
(YPROMELLOSE -ACROGOL 4ITANIUM$IOXIDE
What Exemestane 25 mg Film-Coated Tablets
look like and contents of the pack
7HITETOOFF WHITE ROUNDCOMPOUNDCUPTABLET
DEBOSSEDWITHhvONONESIDEANDPLAINON
THEREVERSE
%XEMESTANEMG&ILM #OATED4ABLETSARE
AVAILABLEINBLISTERPACKSOF
    X   "LISTERSOFOR
 FILM COATEDTABLETS
.OTALLPACKSIZESMAYBEMARKETED
Marketing Authorisation Holder and
Manufacturer
-ARKETING!UTHORISATION(OLDERIS4%6!5+
,IMITED "RAMPTON2OAD (AMPDEN0ARK
%ASTBOURNE %AST3USSEX ".!' 5NITED
Kingdom.
-ANUFACTURERIS%IR'EN0HARMA,TD
7ESTSIDE"USINESS0ARK /LD+ILMEADEN2OAD
7ATERFORD )RELAND
This leaflet was last revised in December 2013.
0,

 %

0000000000
000000

Expand view ⇕

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.

Hide