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VALSARTAN 40 MG CAPSULES

Active substance(s): VALSARTAN

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Transcript
TEVA UK Ref:

Version:

231-30-85580-E LEA VALSARTAN A/S CAP TUK

s SUDDENLOSSOFCONSCIOUSNESSSYNCOPE
s SPINNINGSENSATIONVERTIGO
s SEVERELYDECREASEDKIDNEYFUNCTION
SIGNSOFACUTERENALFAILURE
s MUSCLESPASMS ABNORMALHEART
RHYTHMSIGNSOFHYPERKALAEMIA
s BREATHLESSNESS DIFFICULTYBREATHING
WHENLYINGDOWN SWELLINGOFTHEFEET
ORLEGSSIGNSOFCARDIACFAILURE
s HEADACHE
s COUGH
s ABDOMINALPAIN
s NAUSEA
s DIARRHOEA
s TIREDNESS
s WEAKNESS
Frequency not known:
s ALLERGICREACTIONSWITHRASH ITCHINGAND
HIVESSYMPTOMSOFFEVER SWOLLEN
JOINTSANDJOINTPAIN MUSCLEPAIN
SWOLLENLYMPHNODESANDORFLU LIKE
SYMPTOMSMAYOCCURSIGNSOFSERUM
SICKNESS
s PURPLISH REDSPOTS FEVER ITCHINGSIGNS
OFINFLAMMATIONOFBLOODVESSELSALSO
CALLEDVASCULITIS
s UNUSUALBLEEDINGORBRUISINGSIGNS
OFTHROMBOCYTOPENIA
s MUSCLEPAINMYALGIA
s FEVER SORETHROATORMOUTHULCERSDUE
TOINFECTIONSSYMPTOMSOFALOWLEVEL
OFWHITEBLOODCELLSALSOCALLED
NEUTROPENIA
s DECREASEOFTHELEVELOFHAEMOGLOBIN
ANDDECREASEOFTHEPERCENTAGEOF
REDBLOODCELLSINTHEBLOODWHICH
CAN LEADTOANAEMIAINSEVERECASES
s INCREASEINTHELEVELOFPOTASSIUMIN
THEBLOODWHICHCAN TRIGGERMUSCLE
SPASMS ANDABNORMALHEARTRHYTHM
INSEVERECASES
s ELEVATIONOFLIVERFUNCTIONVALUES
WHICHCANINDICATELIVERDAMAGE
INCLUDINGANINCREASEOFBILIRUBININ
THEBLOODWHICHCAN TRIGGERYELLOW
SKINANDEYESINSEVERECASES
s INCREASEOFTHELEVELOFBLOODUREA
NITROGENANDINCREASEOFTHELEVELOF
SERUMCREATININEWHICHCANINDICATE
ABNORMALKIDNEYFUNCTION
s LOWLEVELOFSODIUMINTHEBLOODWHICH
CANTRIGGERTIREDNESS CONFUSION
MUSCLETWITCHINGANDORCONVULSIONS
INSEVERECASES 
4HEFREQUENCYOFSOMESIDEEFFECTSMAY
VARYDEPENDINGONYOURCONDITION&OR
EXAMPLE SIDEEFFECTSSUCHASDIZZINESS
ANDDECREASEDKIDNEYFUNCTIONWERESEEN
LESSFREQUENTLYINADULTPATIENTSTREATED
FORHIGHBLOODPRESSURETHANINADULT
PATIENTSTREATEDFORHEARTFAILUREORAFTER
ARECENTHEARTATTACK
3IDEEFFECTSINCHILDRENANDADOLESCENTS
ARESIMILARTOTHOSESEENINADULTS
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
ANYPOSSIBLESIDEEFFECTSNOTLISTEDIN
THISLEAFLET9OUCANALSOREPORTSIDEEFFECTS
DIRECTLYVIATHE9ELLOW#ARD3CHEMEAT
WWWMHRAGOVUKYELLOWCARD
"YREPORTINGSIDEEFFECTSYOUCANHELP

FOLD
LINE.

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

VALSARTAN 40 mg, 80 mg and
160 mg CAPSULES

PROVIDEMOREINFORMATIONONTHESAFETY
OFTHISMEDICINE

5

6

0ACKAGELEAFLET)NFORMATIONFORTHEUSER

How to store Valsartan Capsules

Keep this medicine out of the sight and
reach of children.
$ONOTUSETHISMEDICINEAFTERTHEEXPIRY
DATEWHICHISSTATEDONTHECARTONAND
BLISTERAFTER%804HEEXPIRYdate refers
TOTHELASTDAYOFTHATMONTH
$ONOTSTOREABOVEยช#3TOREINTHE
ORIGINALPACKAGEINORDERTOPROTECTFROM
MOISTURE
$ONOTTHROWAWAYANYMEDICINESVIA
WASTEWATERORHOUSEHOLDWASTE!SKYOUR
PHARMACISTHOWTOTHROWAWAYMEDICINES
YOUNOLONGERUSE4HESEMEASURESWILL
HELPPROTECTTHEENVIRONMENT

Contents of the pack and other
information

What Valsartan Capsules contain:
s 4HEACTIVESUBSTANCEISVALSARTAN
MG %ACHHARDCAPSULECONTAINS
MGOFVALSARTAN
MG %ACHHARDCAPSULECONTAINS
MGOFVALSARTAN
MG %ACHHARDCAPSULECONTAINS
MGOFVALSARTAN
s 4HEOTHERINGREDIENTSARESILICA
COLLOIDALANHYDROUS SODIUMSTARCH
GLYCOLATETYPE! CROSPOVIDONE
CELLULOSEMICROCRYSTALLINE MAIZESTARCH
ANDMAGNESIUMSTEARATEINSIDE THE
CAPSULE4HECAPSULESHELLISMADEOF
TITANIUMDIOXIDE GELATIN BLACKIRON
OXIDE MGANDMGSTRENGTHS
ONLYREDIRONOXIDE MGSTRENGTH
ONLYYELLOWIRONOXIDE4HEPRINTING
INKCONTAINSSHELLAC PROPYLENEGLYCOL
ANDBLACKIRONOXIDE
What Valsartan Capsules look like and
contents of the pack
s #APSULE HARD
s MGSTRENGTH(ARD GELATINCAPSULE
WITHGREYOPAQUEBODYANDCAP FILLED
WITHOFF WHITETOYELLOWISHPOWDER
WITHSMALLAGGLOMERATES IMPRINTED
6ONBODYANDCAP
s MGSTRENGTH(ARD GELATINCAPSULE
WITHGREYOPAQUEBODYANDFLESH
OPAQUECAP FILLEDWITHOFF WHITETO
YELLOWISHPOWDERWITHSMALL
AGGLOMERATES IMPRINTED6ONBODY
ANDCAP
s MGSTRENGTH(ARD GELATINCAPSULE
WITHGREYOPAQUEBODYANDFLESH
OPAQUECAP FILLEDWITHOFF WHITETO
YELLOWISHPOWDERWITHSMALL
AGGLOMERATES IMPRINTED6ONBODY
ANDCAP
4RANSPARENT06#0%06D#n!LUMINIUM
BLISTERPACKS
0ACKSIZES
MGCAPSULES      
   ANDCAPSULES
ANDMGCAPSULES   
     ANDCAPSULES
.OTALLPACKSIZESMAYBEMARKETED
Marketing Authorisation Holder and
Manufacturer
4%6!5+,IMITED %ASTBOURNE ".!'
5NITED+INGDOM
This leaflet was last revised in 09/2014
 %
0, 
X

22 December 2014

Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
s +EEPTHISLEAFLET9OUMAYNEEDTOREAD
it again.
s )FYOUHAVEANYFURTHERQUESTIONS ASK
YOURDOCTORORPHARMACIST
s 4HISMEDICINEHASBEENPRESCRIBEDFOR
YOUONLY$ONOTPASSITONTOOTHERS
)TMAYHARMTHEM EVENIFTHEIRSIGNS
OFILLNESSARETHESAMEASYOURS
s )FYOUGETANYSIDEEFFECTS TALKTOYOur
DOCTORORPHARMACIST4HISINCLUDES
ANYPOSSIBLESIDEEFFECTSNOTLISTEDIN
THISLEAFLET3EESECTION
WHATISINTHISLEAFLET

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

and in children and adolescents 6 to
18 years of age.(IGHBLOODPRESSURE
INCREASESTHEWORKLOADONTHEHEART
ANDARTERIES)FNOTTREATEDITCAN
DAMAGETHEBLOODVESSELSOFTHEBRAIN
HEART ANDKIDNEYS ANDMAYRESULTIN
aSTROKE HEARTFAILUREORKIDNEY
FAILURE(IGHBLOODPRESSUREINCREASES
THERISKOFHEARTATTACKS,OWERING
YOURBLOODPRESSUREREDUCESTHERISK
OFDEVELOPINGTHESEDISORDERS
s to treat adult patients after a recent
heart attack MYOCARDIALINFARCTION .
h2ECENTvHEREMEANSBETWEEN
HOURSANDDAYSAGO
s to treat symptomatic heart failure in
adult patients.6ALSARTANISUSEDWHEN
AGROUPOFMEDICINESCALLED
!NGIOTENSIN #ONVERTING%NZYME
!#% INHIBITORSAMEDICATIONTOTREAT
HEARTFAILURE CANNOTBEUSEDORITMAY
BEUSEDINADDITIONTO!#% INHIBITORS
WHENOTHERMEDICATIONSTOTREATHEART
FAILURECANNOTBEUSED(EARTFAILURE
SYMPTOMSINCLUDESHORTNESSOF
BREATHANDSWELLINGOFTHEFEETAND
LEGSOWINGTOFLUIDBUILD UP)TIS
CAUSEDWHENTHEHEARTMUSCLE
CANNOTPUMPBLOODSTRONGLYENOUGH
TOSUPPLYALLTHEBLOODNEEDED
THROUGHOUTTHEBODY
Valsartan 160 mg Capsules 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.(IGHBLOODPRESSURE
INCREASESTHEWORKLOADONTHEHEART
ANDARTERIES)FNOTTREATEDITCAN
DAMAGETHEBLOODVESSELSOFTHE
BRAIN HEART ANDKIDNEYS ANDMAY
RESULTINASTROKE HEARTFAILUREOR
KIDNEYFAILURE(IGHBLOODPRESSURE
INCREASESTHERISKOFHEARTATTACKS
,OWERINGYOURBLOODPRESSURETO
NORMALREDUCESTHERISKOF
DEVELOPINGTHESEDISORDERS
s to treat adult patients after a recent
heart attack MYOCARDIALINFARCTION .
h2ECENTvHEREMEANSBETWEEN
HOURSANDDAYS
s to treat symptomatic heart failure in
adult patients.6ALSARTANISUSEDWHEN
AGROUPOFMEDICINESCALLED
!NGIOTENSIN#ONVERTING%NZYME
!#% INHIBITORSAMEDICATIONTOTREAT
HEARTFAILURE CANNOTBEUSEDORITMAY
BEUSEDINADDITIONTO!#%INHIBITORS
WHENOTHERMEDICATIONSTOTREATHEART
FAILURECANNOTBEUSED(EARTFAILURE
SYMPTOMSINCLUDESHORTNESSOF
BREATH ANDSWELLINGOFTHEFEETAND
LEGSDUETOFLUIDBUILD UP)TISCAUSED
WHENTHEHEARTMUSCLECANNOTPUMP
BLOODSTRONGLYENOUGHTOSUPPLYALL
THEBLOODNEEDEDTHROUGHOUTTHE
BODY.

What Valsartan is and what it is
used for
6ALSARTANBELONGSTOACLASSOFMEDICINES
KNOWNAShANGIOTENSINIIRECEPTOR
ANTAGONISTSv WHICHHELPTOCONTROLHIGH
BLOODPRESSURE!NGIOTENSINII is a
SUBSTANCEINTHEBODYTHATCAUSESVESSELS
TOTIGHTEN THUSCAUSINGYOURBLOOD
PRESSURETOINCREASE6ALSARTANWORKSBY
BLOCKINGTHEEFFECTOFANGIOTENSINII. As
ARESULT BLOODVESSELSRELAXANDBLOOD
PRESSUREISLOWERED
Valsartan 40 mg Capsules can be used
for three different conditions:
s to treat high blood pressure in children
and adolescents 6 to 18 years of age.
(IGHBLOODPRESSUREINCREASESTHE
WORKLOADONTHEHEARTANDARTERIES)F
NOTTREATEDITCANDAMAGETHEBLOOD
VESSELSOFTHEBRAIN HEART ANDKIDNEYS
ANDMAYRESULTINASTROKE HEART
FAILURE ORKIDNEYFAILURE(IGHBLOOD
PRESSUREINCREASESTHERISKOFHEART
ATTACKS,OWERINGYOURBLOODPRESSURE
TONORMALREDUCESTHERISKOF
DEVELOPINGTHESEDISORDERS
s to treat adult patients after a recent
heart attack MYOCARDIALINFARCTION .
h2ECENTvHEREMEANSBETWEEN
HOURSANDDAYSAGO
s to treat symptomatic heart failure in
adult patients.6ALSARTANISUSEDWHENA
GROUPOFMEDICINESCALLED!NGIOTENSIN
#ONVERTING%NZYME!#% INHIBITORS
AMEDICATIONTOTREATHEARTFAILURE
CANNOT BEUSEDORITMAYBEUSEDIN
ADDITIONTO!#% INHIBITORSWHENOTHER
MEDICATIONSTOTREATHEARTFAILURE
CANNOTBEUSED(EARTFAILURESYMPTOMS 2 What you need to know before
you take Valsartan Capsules
INCLUDESHORTNESSOFBREATH AND
SWELLINGOFTHEFEETANDLEGSOWINGTO Do not take Valsartan Capsules if you:
FLUIDBUILD UP)TISCAUSEDWHENTHE s are allergicTOVALSARTANORANYOFTHE
HEARTMUSCLECANNOTPUMPBLOOD
OTHERINGREDIENTSOFTHISMEDICINE
STRONGLYENOUGHTOSUPPLYALLTHE
LISTEDINSECTION
BLOODNEEDEDTHROUGHOUTTHEBODY
s HAVEsevere liver disease
Valsartan 80 mg Capsules can be used s AREmore than 3 months pregnantIT
for three different conditions:
ISBETTERTOAVOID6ALSARTAN#APSULES
s to treat high blood pressure in adults
INEARLYPREGNANCY SEESECTION

1

0EEL(ERE4O/PEN

REG0142492

Version 0.3

Approved

Page 1 of 3

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

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2

TEVA UK Ref:

Version:

231-30-85580-E LEA VALSARTAN A/S CAP TUK

FOLD
LINE.

PAGE 2: LEFT HAND INSIDE FACE AFTER FOLDING AND TACKING

FAILURE WHICHAREKNOWNAS
Pregnancy, breast-feeding and fertility)
MINERALOCORTICOIDRECEPTORS
s HAVEDIABETESORIMPAIREDKIDNEY
ANTAGONISTS-2! FOREXAMPLE
FUNCTIONANDYOUARETREATEDWITHA
SPIRONOLACTONE EPLERENONE ORBETA
BLOODPRESSURELOWERINGMEDICINE
BLOCKERSFOREXAMPLEMETOPROLOL 
CONTAININGaliskiren.

9OURDOCTORMAYCHECKYOURKIDNEY
If any of these apply to you, do not take
FUNCTION BLOODPRESSURE ANDTHE
Valsartan Capsules.
AMOUNTOFELECTROLYTESEG
Warnings and precautions:
POTASSIUM INYOURBLOODATREGULAR
4ALKTOYOURDOCTORORPHARMACISTBEFORE INTERVALS3EEALSOINFORMATIONUNDER
TAKINGValsartanIFYOU
THEHEADINGh$ONOTTAKE6ALSARTANv
s HAVEliver disease
s HAVEsevere kidney diseaseORIFYOU If any of these apply to you, tell your
doctor
before you take Valsartan Capsules.
AREUNDERGOINGdialysis
s ARESUFFERINGFROMAnarrowing of the Other medicines and Valsartan
4ELLYOURDOCTORORPHARMACISTIFYOUARE
kidney artery
TAKING HAVERECENTLYTAKENORMIGHTTAKE
s HAVERECENTLYUNDERGONEKIDNEY
TRANSPLANTATIONreceived a new kidney) any OTHERMEDICINES
s ARETREATEDAFTERAHEARTATTACKORFOR 4HEEFFECTOFTHETREATMENTCANBE
HEARTFAILURE YOURDOCTORMAYcheck INFLUENCEDIF6ALSARTAN#APSULESARETAKEN
TOGETHERWITHCERTAINOTHERMEDICINES)T
your kidney function
s HAVEsevere heart disease other than MAYBENECESSARYTOCHANGETHEDOSE TO
TAKEOTHERPRECAUTIONS ORINSOMECASES
heart failure or heart attack
s ARETAKINGmedicines that increase the TOSTOPTAKINGONEOFTHEMEDICINES4HIS
amount of potassium in your blood. APPLIESTOBOTHPRESCRIPTIONAND
4HESEINCLUDEPOTASSIUMSUPPLEMENTS NON PRESCRIPTIONMEDICINES ESPECIALLY
SALTSUBSTITUTESCONTAININGPOTASSIUM s other medicines that lower blood
pressure ESPECIALLYWATERTABLETS
POTASSIUM SPARINGMEDICINESAND
DIURETICS
HEPARIN)TMAYBENECESSARYTOCHECK
s medicines that increase the amount
THEAMOUNTOFPOTASSIUMINYOUR
of potassium in your blood4HESE
BLOODATREGULARINTERVALS
INCLUDEPOTASSIUMSUPPLEMENTS
s IFYOUAREbelow 18 years of age and
POTASSIUMSPARINGMEDICINESAND
YOUTAKE6ALSARTANINCOMBINATION
HEPARIN
WITHOTHERMEDICINESTHATINHIBITTHE
RENINANGIOTENSINALDOSTERONESYSTEM s CERTAINTYPEOFpain killers called
non-steroidal anti-inflammatory
MEDICINESTHATLOWERBLOODPRESSURE
medicines.3!)$S
YOURDOCTORMAYCHECKYOURKIDNEY
FUNCTIONANDTHEAMOUNTOFPOTASSIUM s lithium AMEDICINEUSEDTOTREAT
SOMETYPESOFPSYCHIATRICILLNESS
INYOURBLOODATREGULARINTERVALS
s SUFFERFROMaldosteronism4HISISA
9OURDOCTORMAYNEEDTOCHANGEYOUR
DISEASEINWHICHYOURADRENALGLANDS DOSEANDORTAKEOTHERPRECAUTIONS
MAKETOOMUCHOFTHEHORMONE
s IFYOUARETAKINGAN!#% INHIBITOROR
ALDOSTERONE)FTHISAPPLIESTOYOU THE
ALISKIRENSEEALSOINFORMATIONUNDER
USEOF6ALSARTAN#APSULESISNOT
THEHEADINGS@$ONOTTAKE6ALSARTAN
RECOMMENDED
AND7ARNINGSANDPRECAUTIONS
s HAVElost a lot of fluid (dehydration) s IFYOUAREBEINGTREATEDWITHAN
CAUSEDBYDIARRHOEA VOMITING OR
!#% INHIBITORTOGETHERWITHCERTAIN
HIGHDOSESOFWATERTABLETSDIURETICS
OTHERMEDICINESTOTREATYOURHEART
s IFYOUHAVEEVEREXPERIENCEDSWELLING FAILURE WHICHAREKNOWNAS
OFTHETONGUEANDFACECAUSEDBYAN
MINERALOCORTICOIDRECEPTORANTAGONISTS
ALLERGICREACTIONCALLEDANGIOEDEMA
-2! FOREXAMPLESPIRONOLACTONE
WHENTAKINGANOTHERDRUGINCLUDING
EPLERENONE ORBETABLOCKERSFOR
!#%INHIBITORS TELLYOURDOCTOR)F
EXAMPLEMETOPROLOL 
THESESYMPTOMSOCCURWHENYOUARE In addition:
TAKING6ALSARTAN STOPTAKING6ALSARTAN s IFYOUAREBEINGTREATEDAFTERAHEART
IMMEDIATELYANDNEVERTAKEITAGAIN
ATTACK ACOMBINATIONWITH!#%
SEESECTION h0OSSIBLESIDEEFFECTSv 
INHIBITORSMEDICINESUSEDTOTREAT
s YOUMUSTTELLYOURDOCTORIFYOUTHINK
HEARTATTACK ISNOTRECOMMENDED
YOUare (or might become) pregnant.
Valsartan Capsules with food and drink
6ALSARTAN#APSULESARENOT
9OUCANTAKE6ALSARTAN#APSULESWITHOR
RECOMMENDEDINEARLYPREGNANCY AND
WITHOUTFOOD
MUSTNOTBETAKENIFYOUAREMORETHAN
MONTHSPREGNANT ASITMAYCAUSE Pregnancy, breast-feeding and fertility
SERIOUSHARMTOYOURBABYIFUSEDAT )FYOUAREPREGNANTORBREAST FEEDING
THATSTAGESEESECTION0REGNANCY THINKYOUMAYBEPREGNANTORARE
PLANNINGTOHAVEABABY ASKYOUR
breast-feeding and fertility).
s IFYOUARETAKINGANYOFTHEFOLLOWING DOCTORORPHARMACISTFORADVICEBEFORE
TAKINGTHISMEDICINE
MEDICINESUSEDTOTREATHIGHBLOOD
s 9OUMUSTTELLYOURDOCTORIFYOUTHINK
PRESSURE
THATYOUare (or might become)
s AN!#% INHIBITORFOREXAMPLE
pregnant9OURDOCTORWILLNORMALLY
ENALAPRIL LISINOPRIL RAMIPRIL IN
ADVISEYOUTOSTOPTAKING6ALSARTAN
PARTICULARIFYOUHAVEDIABETES
#APSULESBEFOREYOUBECOMEPREGNANT
relatedKIDNEYPROBLEMS
ORASSOONASYOUKNOWYOUARE
s ALISKIREN
PREGNANT ANDWILLADVISEYOUTOTAKE
s IFYOUAREBEINGTREATEDWITHAN
ANOTHERMEDICINEINSTEADOf 6ALSARTAN
!#% INHIBITORTOGETHERWITHCERTAIN
#APSULES6ALSARTAN#APSULESARENOT
OTHERMEDICINESTOTREATYOURHEART
RECOMMENDEDINEARLYPREGNANCY AND

REG0142492

Version 0.3

Approved

2

22 December 2014

PAGE 3: RIGHT HAND INSIDE FACE AFTER FOLDING AND TACKING

MUSTNOTBETAKENWHENMORETHAN
MONTHSPREGNANT ASITMAYCAUSE
SERIOUSHARMTOYOURBABYIFITUSED
AFTERTHETHIRDMONTHOFPREGNANCY
s 4ELLYOURDOCTORIFYOUAREBREAST
fEEDINGORABOUTTOSTARTBREAST FEEDING
6ALSARTAN#APSULESARENOT
RECOMMENDEDFORMOTHERSWHOARE
BREAST FEEDING ANDYOURDOCTORMAY
CHOOSEANOTHERTREATMENTFORYOUIF
YOUWISHTOBREAST FEED ESPECIALLYIF
YOURBABYISNEWBORN ORWASBORN
PREMATURELY
Driving and using machines
"EFOREYOUDRIVEAVEHICLE USETOOLSOR
OPERATEMACHINES ORCARRYOUTOTHER
aCTIVITIESTHATREQUIRECONCENTRATION MAKE
SUREYOUKNOWHOW6ALSARTAN#APSULES
AFFECTSYOU,IKEMANYOTHERMEDICINES
USEDTOTREATHIGHBLOODPRESSURE
6ALSARTAN#APSULESMAYCAUSEDIZZINESS
ANDAFFECTTHEABILITYTOCONCENTRATE

3

How to take Valsartan Capsules

!LWAYSTAKETHISMEDICINEEXACTLYASYOUR
DOCTORHASTOLDYOU#HECKWITHYOUR
DOCTORORPHARMACISTIFYOUARENOTSURE.
0EOPLEWITHHIGHBLOODPRESSUREOFTEN
DONOTNOTICEANYSIGNSOFTHISPROBLEM
-ANYMAYFEELQUITENORMAL4HISMAKES
ITALLTHEMOREIMPORTANTFORYOUTOKEEP
YOURAPPOINTMENTSWITHTHEDOCTOREVEN
IFYOUAREFEELINGWELL&ORDOSESNOT
REALISABLEPRACTICABLEWITHTHISSTRENGTH
OTHERSTRENGTHSANDPHARMACEUTICALFORMS
OFTHISMEDICINALPRODUCTAREAVAILABLE
Valsartan 80 mg and 160 mg capsules:
s Adults with high blood pressure:
4HERECOMMENDEDDOSEISMG
DAILY)NSOMECASESYOURDOCTORMAY
PRESCRIBEHIGHERDOSESEGMG
ORMG (ESHEMAYALSOCOMBINE
6ALSARTAN#APSULESWITHANADDITIONAL
MEDICINEEGADIURETIC 
Valsartan 40 mg, 80 mg and 160 mg
capsules:
s Use in children and adolescents (6 to
18 years of age) with high blood
pressure:
)NPATIENTSWHOWEIGHLESSTHANKG
THEUSUALDOSEISMGOFVALSARTAN
ONCEDAILY)NPATIENTSWHOWEIGHKG
ORMORETHEUSUALSTARTINGDOSEISMG
OFVALSARTANONCEDAILY)NSOMECASES
YOURDOCTORMAYPRESCRIBEHIGHER
DOSESTHEDOSECANBEINCREASEDTO
MGANDTOAMAXIMUMOFMG 
s Adult patients after a recent heart
attack:
!FTERAHEARTATTACKTHETREATMENTIS
GENERALLYSTARTEDASEARLYASAFTER
HOURS USUALLYATALOWDOSEOFMG
TWICEDAILY9OUMAYOBTAINTHEMG
DOSEBYDIVIDINGAMGVALSARTAN
TABLET9OURDOCTORWILLINCREASETHIS
DOSEGRADUALLYOVERSEVERALWEEKSTO
AMAXIMUMOFMGTWICEDAILY
4HEFINALDOSEDEPENDSONWHATYOU
ASANINDIVIDUALPATIENTCANTOLERATE
6ALSARTAN#APSULESCANBEGIVEN
TOGETHERWITHOTHERTREATMENTFOR
HEARTATTACKYOURDOCTORWILLDECIDE
WHICHTREATMENTISSUITABLEFORYOU
s Adult patients with heart failure:
4REATMENTSTARTSGENERALLYWITHMG
TWICEDAILY9OURDOCTORWILLINCREASE

THEDOSEGRADUALLYOVERSEVERALWEEKS
TOAMAXIMUMOFMGTWICEDAILY
4HEFINALDOSEDEPENDSONWHATYOU
ASANINDIVIDUALPATIENTCANTOLERATE
6ALSARTAN#APSULESCANBEGIVEN
TOGETHERWITHOTHERTREATMENTFOR
HEARTFAILUREYOURDOCTORWILLDECIDE
WHICHTREATMENTISSUITABLEFORYOU
9OUCANTAKE6ALSARTAN#APSULESWITHOR
WITHOUTFOOD3WALLOW6ALSARTAN#APSULES
WITHAGLASSOFWATER4AKE6ALSARTAN
#APSULESATABOUTTHESAMETIMEEACHDAY
If you take more Valsartan Capsules than
you should
)FYOUEXPERIENCEDIZZINESSANDORFAINTING
CONTACTYOURDOCTORIMMEDIATELY and lie
DOWN)FYOUHAVEACCIDENTALLYTAKEN
TOOMANYCAPSULESTHENCONTACTYOUR
DOCTOR PHARMACISTORHOSPITAL
If you forget to take Valsartan Capsules
)FYOUFORGETTOTAKEADOSETHENTAKEITAS
SOONASYOUREMEMBER(OWEVER IFITIS
ALMOSTTIMEFORYOURNEXTDOSE SKIPTHE
DOSEYOUMISSED$ONOTTAKEADOUBLE
DOSETOMAKEUPFORAFORGOTTENDOSE
If you stop taking Valsartan Capsules
3TOPPINGYOURTREATMENTWITH6ALSARTAN
#APSULESMAYCAUSEYOURDISEASETOGET
WORSE$ONOTSTOPTAKINGYOURMEDICINE
UNLESSYOURDOCTORTELLSYOUTO
If you have further questions on the use of
this medicine, ask your doctor or
pharmacist.

4

Possible side effects

,IKEALLMEDICINES THISMEDICINECAN
CAUSESIDEEFFECTS ALTHOUGHNOT
EVERYBODYGETSTHEM
4HESESIDEEFFECTSMAYOCCURWITHCERTAIN
FREQUENCIES WHICHAREDEFINEDASFOLLOWS
6ERYCOMMONMAYAFFECTMORETHAN
INPEOPLE
#OMMON
MAYAFFECTUPTOIN
PEOPLE
5NCOMMON MAYAFFECTUPTOIN
PEOPLE
2ARE
MAYAFFECTUPTOIN
 PEOPLE
6ERYRARE
MAYAFFECTUPTOIN
 PEOPLE
.OTKNOWN FREQUENCYCANNOTBE
ESTIMATEDFROMTHE
AVAILABLEDATA
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.
3IDEEFFECTSINCLUDE
Common
s DIZZINESS
s LOWBLOODPRESSUREWITHORWITHOUT
SYMPTOMSSUCHASDIZZINESSAND
FAINTINGWHENSTANDINGUP
s DECREASEDKIDNEYFUNCTIONSIGNSOF
RENALIMPAIRMENT 
Uncommon
s ANGIOEDEMASEESECTION3OME
SYMPTOMSNEEDIMMEDIATEMEDICAL
ATTENTION

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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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