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VALSARTAN 160MG FILM-COATED TABLETS

Active substance(s): VALSARTAN

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TEVA UK Ref:

Version:

231-30-88210-D LEA VALSARTAN A/S TABS TUK

s MUSCLEPAINMYALGIA
s FEVER SORETHROATORMOUTHULCERSDUETO
INFECTIONSSYMPTOMSOFLOWLEVELOFWHITE
BLOODCELLSALSOCALLEDNEUTROPENIA
s DECREASEOFLEVELOFHAEMOGLOBINAND
DECREASEOFTHEPERCENTAGEOFREDBLOOD
CELLSINTHEBLOODWHICHCANLEADTO
ANAEMIAINSEVERECASES
s INCREASEOFLEVELOFPOTASSIUMINTHEBLOOD
WHICHCANTRIGGERMUSCLESPASMSAND
ABNORMALHEARTRHYTHMINSEVERECASES
s ELEVATIONOFLIVERFUNCTIONVALUESWHICH
CANINDICATELIVERDAMAGE INCLUDINGAN
INCREASEOFBILIRUBININTHEBLOODWHICH
CANTRIGGERYELLOWSKINANDEYESINSEVERE
CASES
s INCREASEOFLEVELOFBLOODUREANITROGEN
ANDINCREASEOFLEVELOFSERUMCREATININE
WHICHCANINDICATEABNORMALKIDNEY
FUNCTION
s LOWLEVELOFSODIUMINTHEBLOODWHICH
CANTRIGGERTIREDNESS CONFUSION MUSCLE
TWITCHINGANDORCONVULSIONSINSEVERE
CASES 

3IDEEFFECTSINCHILDRENANDADOLESCENTSARE
SIMILARTOTHOSESEENINADULTS
If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.
Reporting of side effects
)FYOUGETANYSIDEEFFECTS TALKTOYOUR
DOCTOR PHARMACISTORNURSE4HISINCLUDES
ANYPOSSIBLESIDEEFFECTSNOTLISTEDINTHIS
LEAFLET9OUCANALSOREPORTSIDEEFFECTS
DIRECTLYVIATHE9ELLOW#ARD3CHEMEAT
WWWMHRAGOVUKYELLOWCARD
"YREPORTINGSIDEEFFECTSYOUCANHELP
PROVIDEMOREINFORMATIONONTHESAFETYOF
THISMEDICINE

5

HOW TO STORE VALSARTAN

Keep this medicine out of the sight and
reach of children.
$ONOTUSETHISMEDICINEAFTERTHEEXPIRY
DATEWHICHISSTATEDONTHECARTONANDBLISTER
AFTER%804HEEXPIRYDATEREFERSTOTHELAST
DAYOFTHATMONTH.
$ONOTSTOREABOVEยช#3TOREINTHE
ORIGINALPACKAGEINORDERTOPROTECTFROM
MOISTURE
$ONOTUSE6ALSARTANIFYOUNOTICETHATTHE
PACKISDAMAGEDORSHOWSSIGNSOF
TAMPERING
$ONOTTHROWAWAYANYMEDICINESVIA
WASTEWATERORHOUSEHOLDWASTE!SKYOUR
PHARMACISTHOWTOTHROWAWAYMEDICINES
YOUNOLONGERUSE4HESEMEASURESWILLHELP
PROTECTTHEENVIRONMENT

6

What Valsartan looks like and contents of
the pack
6ALSARTANMG&ILM COATED4ABLETSARE
YELLOW OVAL SHAPED FILM COATEDTABLETS
SCOREDONONESIDEANDDEBOSSEDWITHh6v
ONONESIDEOFTHESCORELINEANDhvON
THEOTHERSIDEOFTHESCORELINE!VAILABLEIN
PACKSIZESOF        
  ANDFILM COATEDTABLETS
(OSPITALPACK X X AND
X FILM COATEDTABLETS
6ALSARTANMG&ILM COATED4ABLETSARE
PINK OVAL SHAPED FILM COATEDTABLETS
SCOREDONONESIDEANDDEBOSSEDWITHh6v
ONONESIDEOFTHESCORELINEANDhvON
THEOTHERSIDEOFTHESCORELINE!VAILABLEIN
PACKSIZESOF        
 ANDFILM COATEDTABLETS(OSPITAL
PACKFILM COATEDTABLETS#ALENDARPACK
OFANDTABLETS
6ALSARTANMG&ILM COATED4ABLETSARE
YELLOW OVAL SHAPED FILM COATEDTABLETS
SCOREDONONESIDEANDDEBOSSEDWITHh6v
ONONESIDEOFTHESCORELINEANDhvON
THEOTHERSIDEOFTHESCORELINE!VAILABLEIN
PACKSIZESOF        
 ANDFILM COATEDTABLETS(OSPITAL
PACKFILM COATEDTABLETS#ALENDARPACK
OFANDTABLETS
6ALSARTANMG&ILM COATED4ABLETSARE
PURPLE OVAL SHAPED FILM COATEDTABLETS
SCOREDONONESIDEANDDEBOSSEDWITHh6v
ONONESIDEOFTHESCORELINEANDhvON
THEOTHERSIDEOFTHESCORELINE!VAILABLEIN
PACKSIZESOF        
     FILM COATEDTABLETS
(OSPITALPACK X XANDX
FILM COATEDTABLETS
.OTALLPACKSIZESMAYBEMARKETED
Marketing Authorisation Holder and
Manufacturer
-ARKETING!UTHORISATION(OLDERIS
4EVA5+,IMITED %ASTBOURNE ".!'
5NITED+INGDOM
Manufacturer is:
4EVA0HARMACEUTICAL7ORKS0RIVATE,IMITED
#OMPANY 0ALLAGIUT $EBRECEN
This leaflet was last revised in 09/2014.
0,  

CONTENTS OF THE PACK AND
OTHER INFORMATION

What Valsartan contains
s 4HEACTIVESUBSTANCEISVALSARTAN
MG%ACHFILM COATEDTABLETCONTAINS
MGOFVALSARTAN
MG%ACHFILM COATEDTABLETCONTAINS
MGOFVALSARTAN
MG%ACHFILM COATEDTABLETCONTAINS
MGOFVALSARTAN
MG%ACHFILM COATEDTABLETCONTAINS
MGOFVALSARTAN

 $
X

PAGE 1: AFTER FOLDING FRONT FACE (INSIDE OF REEL AFTER FOLDING AND TACKING)

of age.(IGHBLOODPRESSUREINCREASESTHE
WORKLOADONTHEHEARTANDARTERIES)FNOT
TREATEDITCANDAMAGETHEBLOODVESSELSOF
THEBRAIN HEART ANDKIDNEYS ANDMAY
RESULTINASTROKE HEARTFAILURE ORKIDNEY
FAILURE(IGHBLOODPRESSUREINCREASESTHE
RISKOFHEARTATTACKS,OWERINGYOURBLOOD
PRESSURETONORMALREDUCESTHERISKOF
DEVELOPINGTHESEDISORDERS
s to treat adult patients after a recent heart
0!#+!'%,%!&,%4).&/2-!4)/.
attack (myocardial infarction).h2ECENTv
&/24(%53%2
HEREMEANSBETWEENHOURSAND
Read all of this leaflet carefully before you
DAYS
start taking this medicine because it
s to treat symptomatic heart failure in adult
contains important information for you.
patients.6ALSARTANISUSEDWHENAGROUP
s +EEPTHISLEAFLET9OUMAYNEEDTOREADIT
OFMEDICINESCALLED!NGIOTENSIN
AGAIN
#ONVERTING%NZYME!#% INHIBITORSA
s )FYOUHAVEANYFURTHERQUESTIONS ASKYOUR
MEDICATIONTOTREATHEARTFAILURE CANNOT
DOCTORORPHARMACIST
BEUSEDORITMAYBEUSEDINADDITIONTO
s 4HISMEDICINEHASBEENPRESCRIBEDFORYOU
!#% INHIBITORSWHENOTHERMEDICATIONSTO
ONLY$ONOTPASSITONTOOTHERS)TMAY
TREATHEARTFAILURECANNOTBEUSED(EART
HARMTHEM EVENIFTHEIRSYMPTOMSARE
FAILURESYMPTOMSINCLUDESHORTNESSOF
THESAMEASYOURS
BREATH ANDSWELLINGOFTHEFEETANDLEGS
s )FYOUGETANYSIDEEFFECTS TALKTOYOUR
DUETOFLUIDBUILD UP)TISCAUSEDWHENTHE
DOCTORORPHARMACIST4HISINCLUDESANY
HEARTMUSCLECANNOTPUMPBLOODSTRONGLY
POSSIBLESIDEEFFECTSNOTLISTEDINTHIS
ENOUGHTOSUPPLYALLTHEBLOODNEEDED
LEAFLET3EESECTION
THROUGHOUTTHEBODY

VALSARTAN 40 mg
FILM-COATED TABLETS
VALSARTAN 80 mg
FILM-COATED TABLETS
VALSARTAN 160 mg
FILM-COATED TABLETS
VALSARTAN 320 mg
FILM-COATED TABLETS

7(!4)3).4()3,%!&,%4

Valsartan 160 mg Film-coated Tablets can be
used for three different conditions:
s to treat high blood pressure in adults and
in children and adolescents 6 to 18 years
of age. (IGHBLOODPRESSUREINCREASESTHE
WORKLOADONTHEHEARTANDARTERIES)FNOT
TREATEDITCANDAMAGETHEBLOODVESSELSOF
THEBRAIN HEART ANDKIDNEYS ANDMAY
RESULTINASTROKE HEARTFAILURE ORKIDNEY
FAILURE(IGHBLOODPRESSUREINCREASESTHE
1 WHAT VALSARTAN IS AND WHAT IT
RISKOFHEARTATTACKS,OWERINGYOURBLOOD
IS USED FOR
PRESSURETONORMALREDUCESTHERISKOF
6ALSARTANBELONGSTOACLASSOFMEDICINES
DEVELOPINGTHESEDISORDERS
KNOWNASANGIOTENSINIIRECEPTORANTAGONIST s to treat adult patients after a recent heart
WHICHHELPTOCONTROLHIGHBLOODPRESSURE
attack (myocardial infarction).h2ECENTv
!NGIOTENSINIIISASUBSTANCEINTHEBODY
HEREMEANSBETWEENHOURSAND
THATCAUSESVESSELSTOTIGHTEN THUSCAUSING
DAYS
YOURBLOODPRESSURETOINCREASE
s to treat symptomatic heart failure in adult
6ALSARTANWORKSBYBLOCKINGTHEEFFECTOF
patients.6ALSARTANISUSEDWHENAGROUP
ANGIOTENSINII!SARESULT BLOODVESSELS
OFMEDICINESCALLED!NGIOTENSIN
RELAXANDBLOODPRESSUREISLOWERED
#ONVERTING%NZYME!#% INHIBITORSA
MEDICATIONTOTREATHEARTFAILURE CANNOT
Valsartan 40 mg Film-coated Tablets can be
BEUSEDORITMAYBEUSEDINADDITIONTO
used for three different conditions:
!#%INHIBITORSWHENOTHERMEDICATIONTO
s to treat high blood pressure in children
and adolescents 6 to 18 years of age(IGH TREATHEARTFAILURECANNOTBEUSED(EART
FAILURESYMPTOMSINCLUDESHORTNESSOF
BLOODPRESSUREINCREASESTHEWORKLOADON
BREATH ANDSWELLINGOFTHEFEETANDLEGS
THEHEARTANDARTERIES)FNOTTREATEDITCAN
DUETOFLUIDBUILD UP)TISCAUSEDWHENTHE
DAMAGETHEBLOODVESSELSOFTHEBRAIN
HEARTMUSCLECANNOTPUMPBLOODSTRONGLY
HEART ANDKIDNEYS ANDMAYRESULTINA
ENOUGHTOSUPPLYALLTHEBLOODNEEDED
STROKE HEARTFAILURE ORKIDNEYFAILURE
THROUGHOUTTHEBODY.
(IGHBLOODPRESSUREINCREASESTHERISKOF
HEARTATTACKS,OWERINGYOURBLOOD
Valsartan 320 mg Film-coated Tablets can be
PRESSURETONORMALREDUCESTHERISKOF
used
DEVELOPINGTHESEDISORDERS
s to treat high blood pressure in adults and
s to treat adult patients after a recent heart
in children and adolescents 6 to 18 years
attack (myocardial infarction)h2ECENTv
of age.(IGHBLOODPRESSUREINCREASESTHE
HEREMEANSBETWEENHOURSAND
WORKLOADONTHEHEARTANDARTERIES)FNOT
DAYS
TREATEDITCANDAMAGETHEBLOODVESSELSOF
s to treat symptomatic heart failure in adult
THEBRAIN HEART ANDKIDNEYS ANDMAY
patients.6ALSARTANISUSEDWHENAGROUP
RESULTINASTROKE HEARTFAILURE ORKIDNEY
OFMEDICINESCALLED!NGIOTENSIN
FAILURE(IGHBLOODPRESSUREINCREASESTHE
#ONVERTING%NZYME!#% INHIBITORSA
RISKOFHEARTATTACKS,OWERINGYOURBLOOD
MEDICATIONTOTREATHEARTFAILURE CANNOT
PRESSURETONORMALREDUCESTHERISKOF
BEUSEDORITMAYBEUSEDINADDITIONTO
DEVELOPINGTHESEDISORDERS
!#% INHIBITORSWHENOTHERMEDICATIONSTO
2 WHAT YOU NEED TO KNOW
TREATHEARTFAILURECANNOTBEUSED(EART
BEFORE YOU TAKE VALSARTAN
FAILURESYMPTOMSINCLUDESHORTNESSOF
BREATH ANDSWELLINGOFTHEFEETANDLEGS
Do not take Valsartan
DUETOFLUIDBUILD UP)TISCAUSEDWHENTHE s IFYOUAREallergic TOVALSARTANORANYOF
HEARTMUSCLECANNOTPUMPBLOODSTRONGLY
THEOTHERINGREDIENTSOFTHISMEDICINE
ENOUGHTOSUPPLYALLTHEBLOODNEEDED
LISTEDINSECTION
THROUGHOUTTHEBODY
s IFYOUHAVEsevere liver disease

1. What Valsartan is and what it is used for
2. What you need to know before you take
Valsartan
3. How to take Valsartan
4. Possible side effects
5. How to store Valsartan
6. Contents of the pack and other
information

Valsartan 80 mg Film-coated Tablets can be
used for three different conditions:
s to treat high blood pressure in adults and
in children and adolescents 6 to 18 years

s IFYOUAREmore than 3 months pregnant
ITISALSOBETTERTOAVOID6ALSARTANINEARLY
PREGNANCY SEESECTION0REGNANCY
BREAST FEEDINGANDFERTILITY
0EEL(ERE4O/PEN

0HARMACODE

4HEFREQUENCYOFSOMESIDEEFFECTSMAY
VARYDEPENDINGONYOURCONDITION&OR
EXAMPLE SIDEEFFECTSSUCHASDIZZINESS AND
DECREASEDKIDNEYFUNCTION WERESEENLESS
FREQUENTLYINADULTPATIENTSTREATEDWITHHIGH
BLOODPRESSURETHANINADULTPATIENTSTREATED
FORHEARTFAILUREORAFTERARECENTHEARTATTACK

s 4HEOTHERINGREDIENTSARECOLLOIDAL
ANHYDROUSSILICA SODIUMSTARCHGLYCOLATE
TYPE! CROSPOVIDONE MICROCRYSTALLINE
CELLULOSE MAIZESTARCH MAGNESIUM
STEARATE HYPROMELLOSE MACROGOL
TITANIUMDIOXIDE% TALC MGAND
MGYELLOWIRONOXIDE% MG
ANDMGREDIRONOXIDE%
MGREDIRONOXIDE% INDIGOTINE
% SUNSETYELLOW&#&% 

16 September 2014

Top of page cut-off to middle of registration mark = 44 mm

FOLD
LINE.

PAGE 4: AFTER FOLDING REAR FACE (OUTSIDE OF REEL AFTER FOLDING AND TACKING)

1

TEVA UK Ref:

Version:

231-30-88210-D LEA VALSARTAN A/S TABS TUK

PAGE 2: LEFT HAND INSIDE FACE AFTER FOLDING AND TACKING

s IFYOUHAVEDIABETESORIMPAIREDKIDNEY
FUNCTIONANDYOUARETREATEDWITHABLOOD
PRESSURELOWERINGMEDICINECONTAINING
aliskiren
If any of these apply to you, do not take
Valsartan.
Warnings and precautions
4ALKTOYOURDOCTORORPHARMACISTBEFORE
TAKING6ALSARTAN
s IFYOUHAVELIVERDISEASE
s IFYOUHAVEASEVEREKIDNEYDISEASEORIF
YOUAREUNDERGOINGDIALYSIS
s IFYOUARESUFFERINGFROMANARROWINGOF
THEKIDNEYARTERY
s IFYOUHAVERECENTLYHADAKIDNEY
TRANSPLANTATIONRECEIVEDANEWKIDNEY
s IFYOUARETREATEDAFTERAHEARTATTACKORFOR
HEARTFAILURE YOURDOCTORMAYCHECKYOUR
KIDNEYFUNCTION
s IFYOUHAVESEVEREHEARTDISEASEOTHER
THANHEARTFAILUREORHEARTATTACK
s IFYOUARETAKINGMEDICINESTHATINCREASE
THEAMOUNTOFPOTASSIUMINYOURBLOOD
4HESEINCLUDEPOTASSIUMSUPPLEMENTSOR
SALTSUBSTITUTESCONTAININGPOTASSIUM
POTASSIUM SPARINGMEDICINESAND
HEPARIN)TMAYBENECESSARYTOCHECKTHE
AMOUNTOFPOTASSIUMINYOURBLOODAT
REGULARINTERVALS
s IFYOUAREBELOWYEARSOFAGEANDYOU
TAKE6ALSARTANINCOMBINATIONWITHOTHER
MEDICINESTHATINHIBITTHERENIN
ANGIOTENSINALDOSTERONESYSTEM
MEDICINESTHATLOWERBLOODPRESSURE
YOURDOCTORMAYCHECKYOURKIDNEY
FUNCTIONANDTHEAMOUNTOFPOTASSIUMIN
YOURBLOODATREGULARINTERVALS
s IFYOUSUFFERFROMALDOSTERONISM4HISISA
DISEASEINWHICHYOURADRENALGLANDS
MAKETOOMUCHOFTHEHORMONE
ALDOSTERONE)FTHISAPPLIESTOYOU THEUSE
OF6ALSARTANISNOTRECOMMENDED
s IFYOUHAVELOSTALOTOFFLUIDDEHYDRATION
CAUSEDBYDIARRHOEA VOMITING ORHIGH
DOSESOFWATERTABLETSDIURETICS
s IFYOUHAVEEVEREXPERIENCEDSWELLINGOF
THETONGUEANDFACECAUSEDBYANALLERGIC
REACTIONCALLEDANGIOEDEMAWHENTAKING
ANOTHERDRUGINCLUDING!#%INHIBITORS
TELLYOURDOCTOR)FTHESESYMPTOMSOCCUR
WHENYOUARETAKING6ALSARTAN STOPTAKING
6ALSARTANIMMEDIATELYANDNEVERTAKEIT
AGAIN SEESECTION0OSSIBLESIDE
EFFECTS 
s YOUMUSTTELLYOURDOCTORIFYOUTHINKYOU
AREORMIGHTBECOME PREGNANT6ALSARTAN
ISNOTRECOMMENDEDINEARLYPREGNANCY
ANDMUSTNOTBETAKENIFYOUAREMORE
THANMONTHSPREGNANT ASITMAYCAUSE
SERIOUSHARMTOYOURBABYIFUSEDATTHAT
STAGESEESECTION0REGNANCY
BREAST FEEDINGANDFERTILITY 
s IFYOUARETAKINGANYOFTHEFOLLOWING
MEDICINESUSEDTOTREATHIGHBLOOD
PRESSURE
s AN!#% INHIBITORFOREXAMPLEENALAPRIL
LISINOPRIL RAMIPRIL INPARTICULARIFYOU
HAVEDIABETES RELATEDKIDNEYPROBLEMS
s ALISKIREN
)NADDITIONFOR6ALSARTANMG MGAND
MGFILMCOATEDTABLETS
s IFYOUAREBEINGTREATEDWITHAN
!#% INHIBITORTOGETHERWITHCERTAINOTHER
MEDICINESTOTREATYOURHEARTFAILURE
WHICHAREKNOWNASMINERALOCORTICOID
RECEPTORSANTAGONISTS-2! FOREXAMPLE
SPIRONOLACTONE EPLERENONE ORBETA
BLOCKERSFOREXAMPLEMETOPROLOL
s 9OURDOCTORMAYCHECKYOURKIDNEY
FUNCTION BLOODPRESSURE ANDTHEAMOUNT
OFELECTROLYTESEGPOTASSIUM INYOUR
BLOODATREGULARINTERVALS
3EEALSOINFORMATIONUNDERTHEHEADING@$O
NOTTAKE;6ALSARTAN=g

If any of these apply to you, tell your doctor
before you take Valsartan.
Other medicines and Valsartan
4ELLYOURDOCTORORPHARMACISTIFYOUARE
TAKING HAVERECENTLYTAKENORMIGHTTAKE
ANYOTHERMEDICINES
4HEEFFECTOFTHETREATMENTCANBE
INFLUENCEDIF6ALSARTANISTAKENTOGETHERWITH
CERTAINOTHERMEDICINES)TMAYBENECESSARY
TOCHANGETHEDOSE TOTAKEOTHER
PRECAUTIONS ORINSOMECASESTOSTOPTAKING
ONEOFTHEMEDICINES4HISAPPLIESTOBOTH
PRESCRIPTIONANDNON PRESCRIPTION
MEDICINES ESPECIALLY
s other medicines that lower blood
pressure,ESPECIALLYwater tablets
DIURETICS
s medicines that increase the amount of
potassiumINYOURBLOOD4HESEINCLUDE
POTASSIUMSUPPLEMENTSORSALTSUBSTITUTES
CONTAININGPOTASSIUM POTASSIUM SPARING
MEDICINESANDHEPARIN
s certain type of pain killersCALLED
NON STEROIDALANTI INFLAMMATORY
MEDICINES(NSAIDs)
s lithium AMEDICINEUSEDTOTREATSOME
TYPESOFPSYCHIATRICILLNESS
9OURDOCTORMAYNEEDTOCHANGEYOURDOSE
ANDORTOTAKEOTHERPRECAUTIONS
)FYOUARETAKINGAN!#% INHIBITOROR
ALISKIRENSEEALSOINFORMATIONUNDERTHE
HEADINGS@$ONOTTAKE;6ALSARTAN=AND
@7ARNINGSANDPRECAUTIONS 
In addition for Valsartan 40 mg, 80 mg and
160 mg Film-coated Tablets:
s IFYOUAREBEINGtreated after a heart
attack,ACOMBINATIONWITHACE inhibitors
AMEDICATIONTOTREATHEARTATTACK ISNOT
RECOMMENDED
s IFYOUAREBEINGTREATEDWITHAN!#%
INHIBITORTOGETHERWITHCERTAINOTHER
MEDICINESTOTREATYOURHEARTFAILURE
WHICHAREKNOWNASMINERALOCORTICOID
RECEPTORSANTAGONISTS-2! FOREXAMPLE
SPIRONOLACTONE EPLERENONE ORBETA
BLOCKERSFOREXAMPLEMETOPROLOL 
Valsartan with food and drink
9OUCANTAKE6ALSARTANWITHORWITHOUTFOOD
Pregnancy, breast-feeding and fertility
)FYOUAREPREGNANTORBREAST FEEDING THINK
YOUMAYBEPREGNANTORAREPLANNINGTO
HAVEABABY ASKYOURDOCTORORPHARMACIST
FORADVICEBEFORETAKINGTHISMEDICINE
!SKYOURDOCTORORPHARMACISTFORADVICE
BEFORETAKINGANYMEDICINE
s You must tell your doctor if you think you
are (or might become) pregnant9OUR
DOCTORWILLNORMALLYADVISEYOUTOSTOP
TAKING6ALSARTANBEFOREYOUBECOME
PREGNANTORASSOONASYOUKNOWYOUARE
PREGNANT ANDWILLADVISEYOUTOTAKE
ANOTHERMEDICINEINSTEADOF6ALSARTAN
6ALSARTANISNOTRECOMMENDEDINEARLY
PREGNANCY ANDMUSTNOTBETAKENWHEN
MORETHANMONTHSPREGNANT ASITMAY
CAUSESERIOUSHARMTOYOURBABYIFITIS
USEDAFTERTHETHIRDMONTHOFPREGNANCY
s Tell your doctor if you are breast-feeding
or about to start breast-feeding.6ALSARTAN
ISNOTRECOMMENDEDFORMOTHERSWHOARE
BREAST FEEDING ANDYOURDOCTORMAY
CHOOSEANOTHERTREATMENTFORYOUIFYOU
WISHTOBREAST FEED ESPECIALLYIFYOUR
BABYISNEWBORN ORWASBORN
PREMATURELY
Driving and using machines
"EFOREYOUDRIVEAVEHICLE USETOOLSOR
OPERATEMACHINES ORCARRYOUTOTHER
ACTIVITIESTHATREQUIRECONCENTRATION MAKE
SUREYOUKNOWHOW6ALSARTANAFFECTSYOU

FOLD
LINE.

1

16 September 2014

PAGE 3: RIGHT HAND INSIDE FACE AFTER FOLDING AND TACKING

,IKEMANYOTHERMEDICINESUSEDTOTREAT
HIGHBLOODPRESSURE 6ALSARTANMAYINRARE
CASESCAUSEDIZZINESSANDAFFECTTHEABILITY
TOCONCENTRATE

ASYOUREMEMBER(OWEVER IFITISALMOST
TIMEFORYOURNEXTDOSE SKIPTHEDOSEYOU
MISSED$ONOTTAKEADOUBLEDOSETOMAKE
UPFORAFORGOTTENDOSE

Valsartan 320 mg Film-coated Tablets
CONTAINSSUNSETYELLOW&#&% 
4HISMEDICINALPRODUCTCONTAINSSUNSET
YELLOW&#&% ANDMAYCAUSEALLERGIC
REACTIONS

If you stop taking Valsartan
3TOPPINGYOURTREATMENTWITH6ALSARTANMAY
CAUSEYOURDISEASETOGETWORSE$ONOT
STOPTAKINGYOURMEDICINEUNLESSYOUR
DOCTORTELLSYOUTO

3

HOW TO TAKE VALSARTAN

!LWAYSTAKETHISMEDICINEEXACTLYASYOUR
DOCTORHASTOLDYOU#HECKWITHYOURDOCTOR
ORPHARMACISTIFYOUARENOTSURE0EOPLE
WITHHIGHBLOODPRESSUREOFTENDONOTNOTICE
ANYSIGNSOFTHISPROBLEM-ANYMAYFEEL
QUITENORMAL4HISMAKESITALLTHEMORE
IMPORTANTFORYOUTOKEEPYOUR
APPOINTMENTSWITHTHEDOCTOREVENIFYOU
AREFEELINGWELL
Valsartan 80 mg, 160 mg and 320 mg
Film-coated Tablets:
Adults with high blood pressure:4HE
RECOMMENDEDDOSEISMGDAILY)NSOME
CASESYOURDOCTORMAYPRESCRIBEHIGHER
DOSESEGMGORMG (EMAYALSO
COMBINE6ALSARTANWITHANADDITIONAL
MEDICINEEGADIURETIC 
Valsartan 40 mg, 80 mg, 160 mg and
320 mg Film-coated Tablets:
Use in children and adolescents (6 to
18 years of age) with high blood
pressure:)NPATIENTSWHOWEIGHLESSTHAN
KGTHEUSUALDOSEISMGOFVALSARTAN
ONCEDAILY)NPATIENTSWHOWEIGHKGOR
MORETHEUSUALSTARTINGDOSEISMGOF
VALSARTANONCEDAILY)NSOMECASESYOUR
DOCTORMAYPRESCRIBEHIGHERDOSESTHE
DOSECANBEINCREASEDTOMGANDTOA
MAXIMUMOFMG 
Valsartan 40 mg, 80 mg and 160 mg
Film-coated Tablets:
Adult patients after a recent heart
attack:!FTERAHEARTATTACKTHETREATMENTIS
GENERALLYSTARTEDASEARLYASAFTERHOURS
USUALLYATALOWDOSEOFMGTWICEDAILY
9OUOBTAINTHEMGDOSEBYDIVIDINGTHE
MGTABLET9OURDOCTORWILLINCREASETHIS
DOSEGRADUALLYOVERSEVERALWEEKSTOA
MAXIMUMOFMGTWICEDAILY4HEFINAL
DOSEDEPENDSONWHATYOUASANINDIVIDUAL
PATIENTCANTOLERATE
6ALSARTANCANBEGIVENTOGETHERWITHOTHER
TREATMENTFORHEARTATTACK ANDYOURDOCTOR
WILLDECIDEWHICHTREATMENTISSUITABLEFOR
YOU

)FYOUHAVEANYFURTHERQUESTIONSONTHEUSE
OFTHISMEDICINE ASKYOURDOCTOROR
PHARMACIST

4

POSSIBLE SIDE EFFECTS

,IKEALLMEDICINES THISMEDICINECANCAUSE
SIDEEFFECTS ALTHOUGHNOTEVERYBODYGETS
THEM
4HESESIDEEFFECTSMAYOCCURWITHCERTAIN
FREQUENCIES WHICHAREDEFINEDASFOLLOWS
6ERYCOMMONMAYAFFECTMORETHANIN
PEOPLE
#OMMON
MAYAFFECTUPTOIN
PEOPLE
5NCOMMON MAYAFFECTUPTOIN
PEOPLE
2ARE
MAYAFFECTUPTOIN
PEOPLE
6ERYRARE
MAYAFFECTUPTOIN 
PEOPLE
.OTKNOWN
FREQUENCYCANNOTBE
ESTIMATEDFROMTHEAVAILABLE
DATA
Some symptoms need immediate medical
attention:
9OUMAYEXPERIENCESYMPTOMSOF
ANGIOEDEMAASPECIFICALLERGICREACTION
SUCHAS
s SWOLLENFACE LIPS TONGUEORTHROAT
s DIFFICULTYINBREATHINGORSWALLOWING
s HIVES ITCHING
If you get any of these, see a doctor
immediately.
Side effects include:
Common:
s DIZZINESS
s LOWBLOODPRESSUREWITHORWITHOUT
SYMPTOMSSUCHASDIZZINESSANDFAINTING
WHENSTANDINGUP
s DECREASEDKIDNEYFUNCTIONSIGNSOFRENAL
IMPAIRMENT 

Uncommon:
s ANGIOEDEMASEESECTION@3OMESYMPTOMS
NEEDIMMEDIATEMEDICALATTENTION
s SUDDENLOSSOFCONSCIOUSNESSSYNCOPE
s SPINNINGSENSATIONVERTIGO
Adult patients with heart failure:
s SEVERELYDECREASEDKIDNEYFUNCTIONSIGNS
4REATMENTSTARTSGENERALLYWITHMGTWICE
OFACUTERENALFAILURE
DAILY9OURDOCTORWILLINCREASETHEDOSE
s MUSCLESPASMS ABNORMALHEARTRHYTHM
GRADUALLYOVERSEVERALWEEKSTOAMAXIMUM
SIGNSOFHYPERKALAEMIA
OFMGTWICEDAILY4HEFINALDOSE
s BREATHLESSNESS DIFFICULTYBREATHINGWHEN
DEPENDSONWHATYOUASANINDIVIDUAL
LYINGDOWN SWELLINGOFTHEFEETORLEGS
PATIENTCANTOLERATE
SIGNSOFCARDIACFAILURE
6ALSARTANCANBEGIVENTOGETHERWITHOTHER s HEADACHE
TREATMENTFORHEARTFAILURE ANDYOURDOCTOR s COUGH
WILLDECIDEWHICHTREATMENTISSUITABLEFOR
s ABDOMINALPAIN
YOU
s NAUSEA
9OUCANTAKE6ALSARTANWITHORWITHOUTFOOD s DIARRHOEA
s TIREDNESS
3WALLOW6ALSARTANWITHAGLASSOFWATER
4AKE6ALSARTANATABOUTTHESAMETIMEEACH s WEAKNESS
DAY
Not known:
4HETABLETCANBEDIVIDEDINTOEQUALDOSES
s ALLERGICREACTIONSWITHRASH ITCHINGAND
HIVES ORSYMPTOMSOFFEVER SWOLLEN
If you take more Valsartan than you should
JOINTSANDJOINTPAIN MUSCLEPAIN SWOLLEN
)FYOUEXPERIENCESEVEREDIZZINESSANDOR
LYMPHNODESANDORFLU LIKESYMPTOMS
FAINTING CONTACTYOURDOCTORIMMEDIATELY
MAYOCCURSIGNSOFSERUMSICKNESS
ANDLIEDOWN)FYOUHAVEACCIDENTALLYTAKEN
s PURPLISH REDSPOTS FEVER ITCHINGSIGNSOF
TOOMANYTABLETS CONTACTYOURDOCTOR
INFLAMMATIONOFBLOODVESSELSALSOCALLED
PHARMACIST ORHOSPITAL
VASCULITIS
If you forget to take Valsartan
s UNUSUALBLEEDINGORBRUISINGSIGNSOF
)FYOUFORGETTOTAKEADOSE TAKEITASSOON
THROMBOCYTOPENIA

TEVA UK Ref:

231-30-91402-C LEA VALSARTAN A/S TAB TUK
VALSARTAN 40 mg FILM-COATED
TABLETS
VALSARTAN 80 mg FILM-COATED
TABLETS
VALSARTAN 160 mg FILM-COATED
TABLETS
VALSARTAN 320 mg FILM-COATED
TABLETS
0!#+!'%,%!&,%4).&/2-!4)/.&/24(%53%2

Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
s +EEPTHISLEAFLET9OUMAYNEEDTOREADIT
AGAIN
s )FYOUHAVEANYFURTHERQUESTIONS ASKYOUR
DOCTORORPHARMACIST
s 4HISMEDICINEHASBEENPRESCRIBEDFORYOU
ONLY$ONOTPASSITONTOOTHERS)TMAYHARM
THEM EVENIFTHEIRSYMPTOMSARETHESAMEAS
YOURS
s )FYOUGETANYSIDEEFFECTS TALKTOYOURDOCTOR
ORPHARMACIST4HISINCLUDESANYPOSSIBLESIDE
EFFECTSNOTLISTEDINTHISLEAFLET3EESECTION
7(!4)3).4()3,%!&,%4

1. What Valsartan is and what it is used for
2. What you need to know before you take
Valsartan
3. How to take Valsartan
4. Possible side effects
5. How to store Valsartan
6. Contents of the pack and other information

1

WHAT VALSARTAN IS AND WHAT IT IS
USED FOR

6ALSARTANBELONGSTOACLASSOFMEDICINESKNOWN
ASANGIOTENSINIIRECEPTORANTAGONIST WHICHHELP
TOCONTROLHIGHBLOODPRESSURE!NGIOTENSINIIIS
ASUBSTANCEINTHEBODYTHATCAUSESVESSELSTO
TIGHTEN THUSCAUSINGYOURBLOODPRESSURETO
INCREASE6ALSARTANWORKSBYBLOCKINGTHEEFFECT
OFANGIOTENSINII!SARESULT BLOODVESSELSRELAX
ANDBLOODPRESSUREISLOWERED
Valsartan 40 mg Film-coated Tablets can be
used for three different conditions:
s to treat high blood pressure in children and
adolescents 6 to 18 years of age(IGHBLOOD
PRESSUREINCREASESTHEWORKLOADONTHEHEART
ANDARTERIES)FNOTTREATEDITCANDAMAGETHE
BLOODVESSELSOFTHEBRAIN HEART ANDKIDNEYS
ANDMAYRESULTINASTROKE HEARTFAILURE OR
KIDNEYFAILURE(IGHBLOODPRESSUREINCREASES
THERISKOFHEARTATTACKS,OWERINGYOURBLOOD
PRESSURETONORMALREDUCESTHERISKOF
DEVELOPINGTHESEDISORDERS
s to treat adult patients after a recent heart
attack (myocardial infarction)h2ECENTvHERE
MEANSBETWEENHOURSANDDAYS
s to treat symptomatic heart failure in adult
patients.6ALSARTANISUSEDWHENAGROUPOF
MEDICINESCALLED!NGIOTENSIN#ONVERTING
%NZYME!#% INHIBITORSAMEDICATIONTOTREAT
HEARTFAILURE CANNOTBEUSEDORITMAYBE
USEDINADDITIONTO!#% INHIBITORSWHENOTHER
MEDICATIONSTOTREATHEARTFAILURECANNOTBE
USED(EARTFAILURESYMPTOMSINCLUDE
SHORTNESSOFBREATH ANDSWELLINGOFTHEFEET
ANDLEGSDUETOFLUIDBUILD UP)TISCAUSED
WHENTHEHEARTMUSCLECANNOTPUMPBLOOD
STRONGLYENOUGHTOSUPPLYALLTHEBLOOD
NEEDEDTHROUGHOUTTHEBODY
Valsartan 80 mg Film-coated Tablets can be
used for three different conditions:
s to treat high blood pressure in adults and in
children and adolescents 6 to 18 years of age.
(IGHBLOODPRESSUREINCREASESTHEWORKLOAD
ONTHEHEARTANDARTERIES)FNOTTREATEDITCAN
DAMAGETHEBLOODVESSELSOFTHEBRAIN HEART
ANDKIDNEYS ANDMAYRESULTINASTROKE HEART
FAILURE ORKIDNEYFAILURE(IGHBLOODPRESSURE
INCREASESTHERISKOFHEARTATTACKS,OWERING
YOURBLOODPRESSURETONORMALREDUCESTHE
RISKOFDEVELOPINGTHESEDISORDERS
s to treat adult patients after a recent heart
attack (myocardial infarction).h2ECENTvHERE
MEANSBETWEENHOURSANDDAYS
s to treat symptomatic heart failure in adult
patients.6ALSARTANISUSEDWHENAGROUPOF
MEDICINESCALLED!NGIOTENSIN#ONVERTING
%NZYME!#% INHIBITORSAMEDICATIONTOTREAT
HEARTFAILURE CANNOTBEUSEDORITMAYBE
USEDINADDITIONTO!#% INHIBITORSWHENOTHER
MEDICATIONSTOTREATHEARTFAILURECANNOTBE
USED(EARTFAILURESYMPTOMSINCLUDE
SHORTNESSOFBREATH ANDSWELLINGOFTHEFEET
ANDLEGSDUETOFLUIDBUILD UP)TISCAUSED
WHENTHEHEARTMUSCLECANNOTPUMPBLOOD
STRONGLYENOUGHTOSUPPLYALLTHEBLOOD
NEEDEDTHROUGHOUTTHEBODY
Valsartan 160 mg Film-coated Tablets can be
used for three different conditions:
s to treat high blood pressure in adults and in
children and adolescents 6 to 18 years of age.
(IGHBLOODPRESSUREINCREASESTHEWORKLOAD
ONTHEHEARTANDARTERIES)FNOTTREATEDITCAN
DAMAGETHEBLOODVESSELSOFTHEBRAIN HEART
ANDKIDNEYS ANDMAYRESULTINASTROKE HEART
FAILURE ORKIDNEYFAILURE(IGHBLOODPRESSURE
INCREASESTHERISKOFHEARTATTACKS,OWERING
YOURBLOODPRESSURETONORMALREDUCESTHE
RISKOFDEVELOPINGTHESEDISORDERS
s to treat adult patients after a recent heart
attack (myocardial infarction).h2ECENTvHERE
MEANSBETWEENHOURSANDDAYS
s to treat symptomatic heart failure in adult
patients.6ALSARTANISUSEDWHENAGROUPOF
MEDICINESCALLED!NGIOTENSIN#ONVERTING
%NZYME!#% INHIBITORSAMEDICATIONTOTREAT
HEARTFAILURE CANNOTBEUSEDORITMAYBE
USEDINADDITIONTO!#%INHIBITORSWHENOTHER
MEDICATIONTOTREATHEARTFAILURECANNOTBE
USED(EARTFAILURESYMPTOMSINCLUDE
SHORTNESSOFBREATH ANDSWELLINGOFTHEFEET
ANDLEGSDUETOFLUIDBUILD UP)TISCAUSED
WHENTHEHEARTMUSCLECANNOTPUMPBLOOD
STRONGLYENOUGHTOSUPPLYALLTHEBLOOD
NEEDEDTHROUGHOUTTHEBODY

Version:

1

16 September 2014

If any of these apply to you, do not take
Valsartan.
Warnings and precautions
4ALKTOYOURDOCTORORPHARMACISTBEFORETAKING
6ALSARTAN
s IFYOUHAVELIVERDISEASE
s IFYOUHAVEASEVEREKIDNEYDISEASEORIFYOU
AREUNDERGOINGDIALYSIS
s IFYOUARESUFFERINGFROMANARROWINGOFTHE
KIDNEYARTERY
s IFYOUHAVERECENTLYHADAKIDNEY
TRANSPLANTATIONRECEIVEDANEWKIDNEY
s IFYOUARETREATEDAFTERAHEARTATTACKORFOR
HEARTFAILURE YOURDOCTORMAYCHECKYOUR
KIDNEYFUNCTION
s IFYOUHAVESEVEREHEARTDISEASEOTHERTHAN
HEARTFAILUREORHEARTATTACK
s IFYOUARETAKINGMEDICINESTHATINCREASETHE
AMOUNTOFPOTASSIUMINYOURBLOOD4HESE
INCLUDEPOTASSIUMSUPPLEMENTSORSALT
SUBSTITUTESCONTAININGPOTASSIUM
POTASSIUM SPARINGMEDICINESANDHEPARIN)T
MAYBENECESSARYTOCHECKTHEAMOUNTOF
POTASSIUMINYOURBLOODATREGULARINTERVALS
s IFYOUAREBELOWYEARSOFAGEANDYOUTAKE
6ALSARTANINCOMBINATIONWITHOTHERMEDICINES
THATINHIBITTHERENINANGIOTENSINALDOSTERONE
SYSTEMMEDICINESTHATLOWERBLOODPRESSURE
YOURDOCTORMAYCHECKYOURKIDNEYFUNCTION
ANDTHEAMOUNTOFPOTASSIUMINYOURBLOODAT
REGULARINTERVALS
s IFYOUSUFFERFROMALDOSTERONISM4HISISA
DISEASEINWHICHYOURADRENALGLANDSMAKE
TOOMUCHOFTHEHORMONEALDOSTERONE)FTHIS
APPLIESTOYOU THEUSEOF6ALSARTANISNOT
RECOMMENDED
s IFYOUHAVELOSTALOTOFFLUIDDEHYDRATION
CAUSEDBYDIARRHOEA VOMITING ORHIGHDOSES
OFWATERTABLETSDIURETICS
s IFYOUHAVEEVEREXPERIENCEDSWELLINGOFTHE
TONGUEANDFACECAUSEDBYANALLERGICREACTION
CALLEDANGIOEDEMAWHENTAKINGANOTHERDRUG
INCLUDING!#%INHIBITORS TELLYOURDOCTOR)F
THESESYMPTOMSOCCURWHENYOUARETAKING
6ALSARTAN STOPTAKING6ALSARTANIMMEDIATELY
ANDNEVERTAKEITAGAIN SEESECTION
0OSSIBLESIDEEFFECTS 
s YOUMUSTTELLYOURDOCTORIFYOUTHINKYOUARE
ORMIGHTBECOME PREGNANT6ALSARTANISNOT
RECOMMENDEDINEARLYPREGNANCY ANDMUST
NOTBETAKENIFYOUAREMORETHANMONTHS
PREGNANT ASITMAYCAUSESERIOUSHARMTO
YOURBABYIFUSEDATTHATSTAGESEESECTION
0REGNANCY BREAST FEEDINGANDFERTILITY 
s IFYOUARETAKINGANYOFTHEFOLLOWING
MEDICINESUSEDTOTREATHIGHBLOODPRESSURE
s AN!#% INHIBITORFOREXAMPLEENALAPRIL
LISINOPRIL RAMIPRIL INPARTICULARIFYOUHAVE
DIABETES RELATEDKIDNEYPROBLEMS
s ALISKIREN
)NADDITIONFOR6ALSARTANMG MGAND
MGFILMCOATEDTABLETS
s IFYOUAREBEINGTREATEDWITHAN!#% INHIBITOR
TOGETHERWITHCERTAINOTHERMEDICINESTOTREAT
YOURHEARTFAILURE WHICHAREKNOWNAS
MINERALOCORTICOIDRECEPTORSANTAGONISTS
-2! FOREXAMPLESPIRONOLACTONE
EPLERENONE ORBETABLOCKERSFOREXAMPLE
METOPROLOL
s 9OURDOCTORMAYCHECKYOURKIDNEYFUNCTION
BLOODPRESSURE ANDTHEAMOUNTOF
ELECTROLYTESEGPOTASSIUM INYOURBLOODAT
REGULARINTERVALS
3EEALSOINFORMATIONUNDERTHEHEADING@$ONOT
TAKE;6ALSARTAN=
If any of these apply to you, tell your doctor
before you take Valsartan.
Other medicines and Valsartan
4ELLYOURDOCTORORPHARMACISTIFYOUARETAKING
HAVERECENTLYTAKENORMIGHTTAKEANYOTHER
MEDICINES
4HEEFFECTOFTHETREATMENTCANBEINFLUENCEDIF
6ALSARTANISTAKENTOGETHERWITHCERTAINOTHER
MEDICINES)TMAYBENECESSARYTOCHANGETHE
DOSE TOTAKEOTHERPRECAUTIONS ORINSOME
CASESTOSTOPTAKINGONEOFTHEMEDICINES4HIS
APPLIESTOBOTHPRESCRIPTIONAND
NON PRESCRIPTIONMEDICINES ESPECIALLY
s other medicines that lower blood pressure,
ESPECIALLYwater tabletsDIURETICS
s medicines that increase the amount of
potassiumINYOURBLOOD4HESEINCLUDE
POTASSIUMSUPPLEMENTSORSALTSUBSTITUTES
CONTAININGPOTASSIUM POTASSIUM SPARING
MEDICINESANDHEPARIN
s certain type of pain killersCALLEDNON STEROIDAL
ANTI INFLAMMATORYMEDICINES(NSAIDs)
s lithium AMEDICINEUSEDTOTREATSOMETYPES
OFPSYCHIATRICILLNESS
9OURDOCTORMAYNEEDTOCHANGEYOURDOSE
ANDORTOTAKEOTHERPRECAUTIONS
)FYOUARETAKINGAN!#% INHIBITORORALISKIREN
SEEALSOINFORMATIONUNDERTHEHEADINGS@$O
NOTTAKE;6ALSARTAN=AND@7ARNINGSAND
PRECAUTIONS 
In addition for Valsartan 40 mg, 80 mg and 160 mg
Film-coated Tablets:
s IFYOUAREBEINGtreated after a heart attack,A
COMBINATIONWITHACE inhibitors A
MEDICATIONTOTREATHEARTATTACK ISNOT
RECOMMENDED
s IFYOUAREBEINGTREATEDWITHAN!#% INHIBITOR
TOGETHERWITHCERTAINOTHERMEDICINESTOTREAT
YOURHEARTFAILURE WHICHAREKNOWNAS
MINERALOCORTICOIDRECEPTORSANTAGONISTS
-2! FOREXAMPLESPIRONOLACTONE
EPLERENONE ORBETABLOCKERSFOREXAMPLE
METOPROLOL 
Valsartan with food and drink
9OUCANTAKE6ALSARTANWITHORWITHOUTFOOD
Pregnancy, breast-feeding and fertility
)FYOUAREPREGNANTORBREAST FEEDING THINKYOU
MAYBEPREGNANTORAREPLANNINGTOHAVEABABY
ASKYOURDOCTORORPHARMACISTFORADVICEBEFORE
TAKINGTHISMEDICINE

!SKYOURDOCTORORPHARMACISTFORADVICEBEFORE
TAKINGANYMEDICINE
Valsartan 320 mg Film-coated Tablets can be used s You must tell your doctor if you think you are
s to treat high blood pressure in adults and in
(or might become) pregnant9OURDOCTORWILL
children and adolescents 6 to 18 years of age.
NORMALLYADVISEYOUTOSTOPTAKING6ALSARTAN
(IGHBLOODPRESSUREINCREASESTHEWORKLOAD
BEFOREYOUBECOMEPREGNANTORASSOONAS
ONTHEHEARTANDARTERIES)FNOTTREATEDITCAN
YOUKNOWYOUAREPREGNANT ANDWILLADVISE
DAMAGETHEBLOODVESSELSOFTHEBRAIN HEART
YOUTOTAKEANOTHERMEDICINEINSTEADOF
ANDKIDNEYS ANDMAYRESULTINASTROKE HEART
6ALSARTAN6ALSARTANISNOTRECOMMENDEDIN
FAILURE ORKIDNEYFAILURE(IGHBLOODPRESSURE
EARLYPREGNANCY ANDMUSTNOTBETAKENWHEN
INCREASESTHERISKOFHEARTATTACKS,OWERING
MORETHANMONTHSPREGNANT ASITMAYCAUSE
YOURBLOODPRESSURETONORMALREDUCESTHE
SERIOUSHARMTOYOURBABYIFITISUSEDAFTER
RISKOFDEVELOPINGTHESEDISORDERS
THETHIRDMONTHOFPREGNANCY
s
Tell your doctor if you are breast-feeding or
2 WHAT YOU NEED TO KNOW
about to start breast-feeding.6ALSARTANISNOT
BEFORE YOU TAKE VALSARTAN
RECOMMENDEDFORMOTHERSWHOARE
Do not take Valsartan
BREAST FEEDING ANDYOURDOCTORMAYCHOOSE
s IFYOUAREallergic TOVALSARTANORANYOFTHE
ANOTHERTREATMENTFORYOUIFYOUWISHTO
OTHERINGREDIENTSOFTHISMEDICINELISTEDIN
BREAST FEED ESPECIALLYIFYOURBABYIS
SECTION
NEWBORN ORWASBORNPREMATURELY
s IFYOUHAVEsevere liver disease
s IFYOUAREmore than 3 months pregnant ITIS Driving and using machines
"EFOREYOUDRIVEAVEHICLE USETOOLSOROPERATE
ALSOBETTERTOAVOID6ALSARTANINEARLY
MACHINES ORCARRYOUTOTHERACTIVITIESTHAT
PREGNANCY SEESECTION0REGNANCY
REQUIRECONCENTRATION MAKESUREYOUKNOWHOW
BREAST FEEDINGANDFERTILITY
6ALSARTANAFFECTSYOU
s IFYOUHAVEDIABETESORIMPAIREDKIDNEY
FUNCTIONANDYOUARETREATEDWITHABLOOD
,IKEMANYOTHERMEDICINESUSEDTOTREATHIGH
PRESSURELOWERINGMEDICINECONTAINING
BLOODPRESSURE 6ALSARTANMAYINRARECASES
aliskiren
CAUSEDIZZINESSANDAFFECTTHEABILITYTO
CONCENTRATE

TEVA UK Ref:

Version:

231-30-91402-C LEA VALSARTAN A/S TAB TUK
1

16 September 2014

s ELEVATIONOFLIVERFUNCTIONVALUESWHICHCAN
INDICATELIVERDAMAGE INCLUDINGANINCREASE
OFBILIRUBININTHEBLOODWHICHCANTRIGGER
YELLOWSKINANDEYESINSEVERECASES
s INCREASEOFLEVELOFBLOODUREANITROGENAND
INCREASEOFLEVELOFSERUMCREATININEWHICH
3 HOW TO TAKE VALSARTAN
CANINDICATEABNORMALKIDNEYFUNCTION
!LWAYSTAKETHISMEDICINEEXACTLYASYOUR
s LOWLEVELOFSODIUMINTHEBLOODWHICHCAN
DOCTORHASTOLDYOU#HECKWITHYOURDOCTOROR
TRIGGERTIREDNESS CONFUSION MUSCLETWITCHING
PHARMACISTIFYOUARENOTSURE0EOPLEWITHHIGH
ANDORCONVULSIONSINSEVERECASES 
BLOODPRESSUREOFTENDONOTNOTICEANYSIGNSOF
THISPROBLEM-ANYMAYFEELQUITENORMAL4HIS 4HEFREQUENCYOFSOMESIDEEFFECTSMAYVARY
MAKESITALLTHEMOREIMPORTANTFORYOUTOKEEP DEPENDINGONYOURCONDITION&OREXAMPLE SIDE
EFFECTSSUCHASDIZZINESS ANDDECREASEDKIDNEY
YOURAPPOINTMENTSWITHTHEDOCTOREVENIFYOU
FUNCTION WERESEENLESSFREQUENTLYINADULT
AREFEELINGWELL
PATIENTSTREATEDWITHHIGHBLOODPRESSURETHAN
Valsartan 80 mg, 160 mg and 320 mg
INADULTPATIENTSTREATEDFORHEARTFAILUREORAFTER
Film-coated Tablets:
ARECENTHEARTATTACK
Adults with high blood pressure:4HE
3IDEEFFECTSINCHILDRENANDADOLESCENTSARE
RECOMMENDEDDOSEISMGDAILY)NSOME
SIMILARTOTHOSESEENINADULTS
CASESYOURDOCTORMAYPRESCRIBEHIGHERDOSES
EGMGORMG (EMAYALSOCOMBINE If any of the side effects gets serious, or if you
6ALSARTANWITHANADDITIONALMEDICINEEGA
notice any side effects not listed in this leaflet,
DIURETIC 
please tell your doctor or pharmacist.
Valsartan 320 mg Film-coated Tablets CONTAINS
SUNSETYELLOW&#&% 
4HISMEDICINALPRODUCTCONTAINSSUNSETYELLOW
&#&% ANDMAYCAUSEALLERGICREACTIONS

Valsartan 40 mg, 80 mg, 160 mg and 320 mg
Film-coated Tablets:
Use in children and adolescents (6 to 18
years of age) with high blood pressure:)N
PATIENTSWHOWEIGHLESSTHANKGTHEUSUAL
DOSEISMGOFVALSARTANONCEDAILY)NPATIENTS
WHOWEIGHKGORMORETHEUSUALSTARTING
DOSEISMGOFVALSARTANONCEDAILY)NSOME
CASESYOURDOCTORMAYPRESCRIBEHIGHERDOSES
THEDOSECANBEINCREASEDTOMGANDTOA
MAXIMUMOFMG 

Reporting of side effects
)FYOUGETANYSIDEEFFECTS TALKTOYOURDOCTOR
PHARMACISTORNURSE4HISINCLUDESANYPOSSIBLE
SIDEEFFECTSNOTLISTEDINTHISLEAFLET9OUCANALSO
REPORTSIDEEFFECTSDIRECTLYVIATHE9ELLOW#ARD
3CHEMEATWWWMHRAGOVUKYELLOWCARD
"YREPORTINGSIDEEFFECTSYOUCANHELPPROVIDE
MOREINFORMATIONONTHESAFETYOFTHISMEDICINE

5

HOW TO STORE VALSARTAN

Valsartan 40 mg, 80 mg and 160 mg Film-coated
Tablets:
Adult patients after a recent heart attack:
!FTERAHEARTATTACKTHETREATMENTISGENERALLY
STARTEDASEARLYASAFTERHOURS USUALLYATA
LOWDOSEOFMGTWICEDAILY9OUOBTAINTHE
MGDOSEBYDIVIDINGTHEMGTABLET9OUR
DOCTORWILLINCREASETHISDOSEGRADUALLYOVER
SEVERALWEEKSTOAMAXIMUMOFMGTWICE
DAILY4HEFINALDOSEDEPENDSONWHATYOUASAN
INDIVIDUALPATIENTCANTOLERATE
6ALSARTANCANBEGIVENTOGETHERWITHOTHER
TREATMENTFORHEARTATTACK ANDYOURDOCTORWILL
DECIDEWHICHTREATMENTISSUITABLEFORYOU

Keep this medicine out of the sight and reach of
children.
$ONOTUSETHISMEDICINEAFTERTHEEXPIRYDATE
WHICHISSTATEDONTHECARTONANDBLISTERAFTER
%804HEEXPIRYDATEREFERSTOTHELASTDAYOFTHAT
MONTH
$ONOTSTOREABOVEยช#3TOREINTHEORIGINAL
PACKAGEINORDERTOPROTECTFROMMOISTURE
$ONOTUSE6ALSARTANIFYOUNOTICETHATTHEPACK
ISDAMAGEDORSHOWSSIGNSOFTAMPERING
$ONOTTHROWAWAYANYMEDICINESVIA
WASTEWATERORHOUSEHOLDWASTE!SKYOUR
PHARMACISTHOWTOTHROWAWAYMEDICINESYOU
NOLONGERUSE4HESEMEASURESWILLHELPPROTECT
Adult patients with heart failure:4REATMENT THEENVIRONMENT
STARTSGENERALLYWITHMGTWICEDAILY9OUR
OF THE PACK AND
6 CONTENTS
DOCTORWILLINCREASETHEDOSEGRADUALLYOVER
OTHER INFORMATION
SEVERALWEEKSTOAMAXIMUMOFMGTWICE
DAILY4HEFINALDOSEDEPENDSONWHATYOUASAN What Valsartan contains
INDIVIDUALPATIENTCANTOLERATE
s 4HEACTIVESUBSTANCEISVALSARTAN
6ALSARTANCANBEGIVENTOGETHERWITHOTHER
MG%ACHFILM COATEDTABLETCONTAINS
TREATMENTFORHEARTFAILURE ANDYOURDOCTORWILL
MGOFVALSARTAN
DECIDEWHICHTREATMENTISSUITABLEFORYOU
MG%ACHFILM COATEDTABLETCONTAINS
MGOFVALSARTAN
9OUCANTAKE6ALSARTANWITHORWITHOUTFOOD
MG%ACHFILM COATEDTABLETCONTAINS
3WALLOW6ALSARTANWITHAGLASSOFWATER
MGOFVALSARTAN
4AKE6ALSARTANATABOUTTHESAMETIMEEACHDAY
MG%ACHFILM COATEDTABLETCONTAINS
4HETABLETCANBEDIVIDEDINTOEQUALDOSES
MGOFVALSARTAN
If you take more Valsartan than you should
s 4HEOTHERINGREDIENTSARECOLLOIDALANHYDROUS
)FYOUEXPERIENCESEVEREDIZZINESSANDORFAINTING
SILICA SODIUMSTARCHGLYCOLATETYPE!
CONTACTYOURDOCTORIMMEDIATELYANDLIEDOWN)F CROSPOVIDONE MICROCRYSTALLINECELLULOSE
YOUHAVEACCIDENTALLYTAKENTOOMANYTABLETS
MAIZESTARCH MAGNESIUMSTEARATE
CONTACTYOURDOCTOR PHARMACIST ORHOSPITAL
HYPROMELLOSE MACROGOL TITANIUMDIOXIDE
% TALC MGANDMGYELLOWIRON
If you forget to take Valsartan
OXIDE% MGANDMGREDIRON
)FYOUFORGETTOTAKEADOSE TAKEITASSOONAS
OXIDE% MGREDIRONOXIDE%
YOUREMEMBER(OWEVER IFITISALMOSTTIMEFOR
INDIGOTINE% SUNSETYELLOW&#&% 
YOURNEXTDOSE SKIPTHEDOSEYOUMISSED$O
NOTTAKEADOUBLEDOSETOMAKEUPFORA
What Valsartan looks like and contents of the
FORGOTTENDOSE
pack
If you stop taking Valsartan
6ALSARTANMG&ILM COATED4ABLETSAREYELLOW
3TOPPINGYOURTREATMENTWITH6ALSARTANMAY
OVAL SHAPED FILM COATEDTABLETS SCOREDONONE
CAUSEYOURDISEASETOGETWORSE$ONOTSTOP
SIDEANDDEBOSSEDWITHh6vONONESIDEOFTHE
TAKINGYOURMEDICINEUNLESSYOURDOCTORTELLS
SCORELINEANDhvONTHEOTHERSIDEOFTHE
YOUTO
SCORELINE!VAILABLEINPACKSIZESOF   
)FYOUHAVEANYFURTHERQUESTIONSONTHEUSEOF        AND
FILM COATEDTABLETS(OSPITALPACK X
THISMEDICINE ASKYOURDOCTORORPHARMACIST
X ANDX FILM COATEDTABLETS

4
6ALSARTANMG&ILM COATED4ABLETSAREPINK
,IKEALLMEDICINES THISMEDICINECANCAUSESIDE OVAL SHAPED FILM COATEDTABLETS SCOREDONONE
SIDEANDDEBOSSEDWITHh6vONONESIDEOFTHE
EFFECTS ALTHOUGHNOTEVERYBODYGETSTHEM
SCORELINEANDhvONTHEOTHERSIDEOFTHE
4HESESIDEEFFECTSMAYOCCURWITHCERTAIN
SCORELINE!VAILABLEINPACKSIZESOF   
FREQUENCIES WHICHAREDEFINEDASFOLLOWS
      ANDFILM COATED
6ERYCOMMON MAYAFFECTMORETHANIN
TABLETS(OSPITALPACKFILM COATEDTABLETS
PEOPLE
#ALENDARPACKOFANDTABLETS
#OMMON
MAYAFFECTUPTOINPEOPLE
5NCOMMON
MAYAFFECTUPTOINPEOPLE 6ALSARTANMG&ILM COATED4ABLETSAREYELLOW
OVAL SHAPED FILM COATEDTABLETS SCOREDONONE
2ARE
MAYAFFECTUPTOIN
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PEOPLE
SCORELINEANDhvONTHEOTHERSIDEOFTHE
6ERYRARE
MAYAFFECTUPTOIN 
SCORELINE!VAILABLEINPACKSIZESOF   
PEOPLE
.OTKNOWN
FREQUENCYCANNOTBEESTIMATED       ANDFILM COATED
TABLETS(OSPITALPACKFILM COATEDTABLETS
FROMTHEAVAILABLEDATA
#ALENDARPACKOFANDTABLETS
Some symptoms need immediate medical
6ALSARTANMG&ILM COATED4ABLETSAREPURPLE
attention:
9OUMAYEXPERIENCESYMPTOMSOFANGIOEDEMA OVAL SHAPED FILM COATEDTABLETS SCOREDONONE
SIDEANDDEBOSSEDWITHh6vONONESIDEOFTHE
ASPECIFICALLERGICREACTION SUCHAS
SCORELINEANDhvONTHEOTHERSIDEOFTHE
s SWOLLENFACE LIPS TONGUEORTHROAT
SCORELINE!VAILABLEINPACKSIZESOF   
s DIFFICULTYINBREATHINGORSWALLOWING
          
s HIVES ITCHING
FILM COATEDTABLETS(OSPITALPACK X
If you get any of these, see a doctor
XANDXFILM COATEDTABLETS
immediately.
POSSIBLE SIDE EFFECTS

Side effects include:

.OTALLPACKSIZESMAYBEMARKETED

Common:
s DIZZINESS
s LOWBLOODPRESSUREWITHORWITHOUTSYMPTOMS
SUCHASDIZZINESSANDFAINTINGWHENSTANDING
UP
s DECREASEDKIDNEYFUNCTIONSIGNSOFRENAL
IMPAIRMENT 

Marketing Authorisation Holder and
Manufacturer
-ARKETING!UTHORISATION(OLDERIS
4EVA5+,IMITED %ASTBOURNE ".!' 5NITED
+INGDOM

Manufacturer is:
4EVA0HARMACEUTICAL7ORKS0RIVATE,IMITED
#OMPANY 0ALLAGIUT $EBRECEN
Uncommon:
s ANGIOEDEMASEESECTION@3OMESYMPTOMS
This leaflet was last revised in 09/2014.
NEEDIMMEDIATEMEDICALATTENTION
0,  
s SUDDENLOSSOFCONSCIOUSNESSSYNCOPE
s SPINNINGSENSATIONVERTIGO
s SEVERELYDECREASEDKIDNEYFUNCTIONSIGNSOF
ACUTERENALFAILURE
s MUSCLESPASMS ABNORMALHEARTRHYTHMSIGNS
OFHYPERKALAEMIA
s BREATHLESSNESS DIFFICULTYBREATHINGWHEN
LYINGDOWN SWELLINGOFTHEFEETORLEGSSIGNS
OFCARDIACFAILURE
s HEADACHE
s COUGH
s ABDOMINALPAIN
s NAUSEA
s DIARRHOEA
s TIREDNESS
s WEAKNESS
Not known:
s ALLERGICREACTIONSWITHRASH ITCHINGANDHIVES
ORSYMPTOMSOFFEVER SWOLLENJOINTSANDJOINT
PAIN MUSCLEPAIN SWOLLENLYMPHNODES
ANDORFLU LIKESYMPTOMSMAYOCCURSIGNSOF
SERUMSICKNESS
s PURPLISH REDSPOTS FEVER ITCHINGSIGNSOF
INFLAMMATIONOFBLOODVESSELSALSOCALLED
VASCULITIS
s UNUSUALBLEEDINGORBRUISINGSIGNSOF
THROMBOCYTOPENIA
s MUSCLEPAINMYALGIA
s FEVER SORETHROATORMOUTHULCERSDUETO
INFECTIONSSYMPTOMSOFLOWLEVELOFWHITE
BLOODCELLSALSOCALLEDNEUTROPENIA
s DECREASEOFLEVELOFHAEMOGLOBINAND
DECREASEOFTHEPERCENTAGEOFREDBLOODCELLS
INTHEBLOODWHICHCANLEADTOANAEMIAIN
SEVERECASES
s INCREASEOFLEVELOFPOTASSIUMINTHEBLOOD
WHICHCANTRIGGERMUSCLESPASMSAND
ABNORMALHEARTRHYTHMINSEVERECASES

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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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