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VALSARTAN 80MG FILM COATED TABLETS

Active substance(s): VALSARTAN / VALSARTAN

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TEVA UK Ref:

Version:

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

s MUSCLE PAIN MYALGIA
s FEVER SORE THROAT OR MOUTH ULCERS DUE TO
INFECTIONS SYMPTOMS OF LOW LEVEL OF WHITE
BLOOD CELLS ALSO CALLED NEUTROPENIA
s DECREASE OF LEVEL OF HAEMOGLOBIN AND
DECREASE OF THE PERCENTAGE OF RED BLOOD
CELLS IN THE BLOOD WHICH CAN LEAD TO
ANAEMIA IN SEVERE CASES
s INCREASE OF LEVEL OF POTASSIUM IN THE BLOOD
WHICH CAN TRIGGER MUSCLE SPASMS AND
ABNORMAL HEART RHYTHM IN SEVERE CASES
s ELEVATION OF LIVER FUNCTION VALUES WHICH
CAN INDICATE LIVER DAMAGE INCLUDING AN
INCREASE OF BILIRUBIN IN THE BLOOD WHICH
CAN TRIGGER YELLOW SKIN AND EYES IN SEVERE
CASES
s INCREASE OF LEVEL OF BLOOD UREA NITROGEN
AND INCREASE OF LEVEL OF SERUM CREATININE
WHICH CAN INDICATE ABNORMAL KIDNEY
FUNCTION
s LOW LEVEL OF SODIUM IN THE BLOOD WHICH
CAN TRIGGER TIREDNESS CONFUSION MUSCLE
TWITCHING ANDOR CONVULSIONS IN SEVERE
CASES 

3IDE EFFECTS IN CHILDREN AND ADOLESCENTS ARE
SIMILAR TO THOSE SEEN IN ADULTS
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
)F YOU GET ANY SIDE EFFECTS TALK TO YOUR
DOCTOR PHARMACIST OR NURSE4HIS INCLUDES
ANY POSSIBLE SIDE EFFECTS NOT LISTED IN THIS
LEAFLET9OU CAN ALSO REPORT SIDE EFFECTS
DIRECTLY VIA THE9ELLOW #ARD 3CHEME AT
WWWMHRAGOVUKYELLOWCARD
"Y REPORTING SIDE EFFECTS YOU CAN HELP
PROVIDE MORE INFORMATION ON THE SAFETY OF
THIS MEDICINE

5

HOW TO STORE VALSARTAN

Keep this medicine out of the sight and
reach of children.
$O NOT USE THIS MEDICINE AFTER THE EXPIRY
DATE WHICH IS STATED ON THE CARTON AND BLISTER
AFTER %804HE EXPIRY DATE REFERS TO THE LAST
DAY OF THAT MONTH.
$O NOT STORE ABOVE ยช# 3TORE IN THE
ORIGINAL PACKAGE IN ORDER TO PROTECT FROM
MOISTURE
$O NOT USE 6ALSARTAN IF YOU NOTICE THAT THE
PACK IS DAMAGED OR SHOWS SIGNS OF
TAMPERING
$O NOT THROW AWAY ANY MEDICINES VIA
WASTEWATER OR HOUSEHOLD WASTE !SK YOUR
PHARMACIST HOW TO THROW AWAY MEDICINES
YOU NO LONGER USE4HESE MEASURES WILL HELP
PROTECT THE ENVIRONMENT

6

What Valsartan looks like and contents of
the pack
6ALSARTAN  MG &ILM COATED4ABLETS ARE
YELLOW OVAL SHAPED FILM COATED TABLETS
SCORED ON ONE SIDE AND DEBOSSED WITH h6v
ON ONE SIDE OF THE SCORE LINE AND hv ON
THE OTHER SIDE OF THE SCORE LINE !VAILABLE IN
PACK SIZES OF         
   AND  FILM COATED TABLETS
(OSPITAL PACK    X    X  AND
  X  FILM COATED TABLETS
6ALSARTAN  MG &ILM COATED4ABLETS ARE
PINK OVAL SHAPED FILM COATED TABLETS
SCORED ON ONE SIDE AND DEBOSSED WITH h6v
ON ONE SIDE OF THE SCORE LINE AND hv ON
THE OTHER SIDE OF THE SCORE LINE !VAILABLE IN
PACK SIZES OF         
  AND  FILM COATED TABLETS (OSPITAL
PACK  FILM COATED TABLETS #ALENDAR PACK
OF  AND  TABLETS
6ALSARTAN  MG &ILM COATED4ABLETS ARE
YELLOW OVAL SHAPED FILM COATED TABLETS
SCORED ON ONE SIDE AND DEBOSSED WITH h6v
ON ONE SIDE OF THE SCORE LINE AND hv ON
THE OTHER SIDE OF THE SCORE LINE !VAILABLE IN
PACK SIZES OF         
  AND  FILM COATED TABLETS (OSPITAL
PACK  FILM COATED TABLETS #ALENDAR PACK
OF  AND  TABLETS
6ALSARTAN  MG &ILM COATED4ABLETS ARE
PURPLE OVAL SHAPED FILM COATED TABLETS
SCORED ON ONE SIDE AND DEBOSSED WITH h6v
ON ONE SIDE OF THE SCORE LINE AND hv ON
THE OTHER SIDE OF THE SCORE LINE !VAILABLE IN
PACK SIZES OF         
      FILM COATED TABLETS
(OSPITAL PACK   X   X  AND  X 
FILM COATED TABLETS
.OT ALL PACK SIZES MAY BE MARKETED
Marketing Authorisation Holder and
Manufacturer
-ARKETING !UTHORISATION (OLDER IS
4EVA 5+ ,IMITED %ASTBOURNE ". !'
5NITED +INGDOM
Manufacturer is:
4EVA 0HARMACEUTICAL 7ORKS 0RIVATE ,IMITED
#OMPANY 0ALLAGI UT   $EBRECEN
This leaflet was last revised in 09/2014.
0,     

CONTENTS OF THE PACK AND
OTHER INFORMATION

What Valsartan contains
s 4HE ACTIVE SUBSTANCE IS VALSARTAN
 MG %ACH FILM COATED TABLET CONTAINS
 MG OF VALSARTAN
 MG %ACH FILM COATED TABLET CONTAINS
 MG OF VALSARTAN
 MG %ACH FILM COATED TABLET CONTAINS
 MG OF VALSARTAN
 MG %ACH FILM COATED TABLET CONTAINS
 MG OF VALSARTAN

 $
 X 

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

of age. (IGH BLOOD PRESSURE INCREASES THE
WORKLOAD ON THE HEART AND ARTERIES )F NOT
TREATED IT CAN DAMAGE THE BLOOD VESSELS OF
THE BRAIN HEART AND KIDNEYS AND MAY
RESULT IN A STROKE HEART FAILURE OR KIDNEY
FAILURE (IGH BLOOD PRESSURE INCREASES THE
RISK OF HEART ATTACKS ,OWERING YOUR BLOOD
PRESSURE TO NORMAL REDUCES THE RISK OF
DEVELOPING THESE DISORDERS
s to treat adult patients after a recent heart
0!#+!'% ,%!&,%4 ).&/2-!4)/.
attack (myocardial infarction). h2ECENTv
&/2 4(% 53%2
HERE MEANS BETWEEN  HOURS AND 
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. 6ALSARTAN IS USED WHEN A GROUP
s +EEP THIS LEAFLET9OU MAY NEED TO READ IT
OF MEDICINES CALLED !NGIOTENSIN
AGAIN
#ONVERTING %NZYME !#% INHIBITORS A
s )F YOU HAVE ANY FURTHER QUESTIONS ASK YOUR
MEDICATION TO TREAT HEART FAILURE CANNOT
DOCTOR OR PHARMACIST
BE USED OR IT MAY BE USED IN ADDITION TO
s 4HIS MEDICINE HAS BEEN PRESCRIBED FOR YOU
!#% INHIBITORS WHEN OTHER MEDICATIONS TO
ONLY $O NOT PASS IT ON TO OTHERS )T MAY
TREAT HEART FAILURE CANNOT BE USED (EART
HARM THEM EVEN IF THEIR SYMPTOMS ARE
FAILURE SYMPTOMS INCLUDE SHORTNESS OF
THE SAME AS YOURS
BREATH AND SWELLING OF THE FEET AND LEGS
s )F YOU GET ANY SIDE EFFECTS TALK TO YOUR
DUE TO FLUID BUILD UP )T IS CAUSED WHEN THE
DOCTOR OR PHARMACIST4HIS INCLUDES ANY
HEART MUSCLE CANNOT PUMP BLOOD STRONGLY
POSSIBLE SIDE EFFECTS NOT LISTED IN THIS
ENOUGH TO SUPPLY ALL THE BLOOD NEEDED
LEAFLET 3EE SECTION 
THROUGHOUT THE BODY

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. (IGH BLOOD PRESSURE INCREASES THE
WORKLOAD ON THE HEART AND ARTERIES )F NOT
TREATED IT CAN DAMAGE THE BLOOD VESSELS OF
THE BRAIN HEART AND KIDNEYS AND MAY
RESULT IN A STROKE HEART FAILURE OR KIDNEY
FAILURE (IGH BLOOD PRESSURE INCREASES THE
1 WHAT VALSARTAN IS AND WHAT IT
RISK OF HEART ATTACKS ,OWERING YOUR BLOOD
IS USED FOR
PRESSURE TO NORMAL REDUCES THE RISK OF
6ALSARTAN BELONGS TO A CLASS OF MEDICINES
DEVELOPING THESE DISORDERS
KNOWN AS ANGIOTENSIN II RECEPTOR ANTAGONIST s to treat adult patients after a recent heart
WHICH HELP TO CONTROL HIGH BLOOD PRESSURE
attack (myocardial infarction). h2ECENTv
!NGIOTENSIN II IS A SUBSTANCE IN THE BODY
HERE MEANS BETWEEN  HOURS AND 
THAT CAUSES VESSELS TO TIGHTEN THUS CAUSING
DAYS
YOUR BLOOD PRESSURE TO INCREASE
s to treat symptomatic heart failure in adult
6ALSARTAN WORKS BY BLOCKING THE EFFECT OF
patients. 6ALSARTAN IS USED WHEN A GROUP
ANGIOTENSIN II !S A RESULT BLOOD VESSELS
OF MEDICINES CALLED !NGIOTENSIN
RELAX AND BLOOD PRESSURE IS LOWERED
#ONVERTING %NZYME !#% INHIBITORS A
MEDICATION TO TREAT HEART FAILURE CANNOT
Valsartan 40 mg Film-coated Tablets can be
BE USED OR IT MAY BE USED IN ADDITION TO
used for three different conditions:
!#% INHIBITORS WHEN OTHER MEDICATION TO
s to treat high blood pressure in children
TREAT HEART FAILURE CANNOT BE USED (EART
and adolescents 6 to 18 years of age (IGH
FAILURE SYMPTOMS INCLUDE SHORTNESS OF
BLOOD PRESSURE INCREASES THE WORKLOAD ON
BREATH AND SWELLING OF THE FEET AND LEGS
THE HEART AND ARTERIES )F NOT TREATED IT CAN
DUE TO FLUID BUILD UP )T IS CAUSED WHEN THE
DAMAGE THE BLOOD VESSELS OF THE BRAIN
HEART MUSCLE CANNOT PUMP BLOOD STRONGLY
HEART AND KIDNEYS AND MAY RESULT IN A
ENOUGH TO SUPPLY ALL THE BLOOD NEEDED
STROKE HEART FAILURE OR KIDNEY FAILURE
THROUGHOUT THE BODY.
(IGH BLOOD PRESSURE INCREASES THE RISK OF
HEART ATTACKS ,OWERING YOUR BLOOD
Valsartan 320 mg Film-coated Tablets can be
PRESSURE TO NORMAL REDUCES THE RISK OF
used
DEVELOPING THESE DISORDERS
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. (IGH BLOOD PRESSURE INCREASES THE
HERE MEANS BETWEEN  HOURS AND 
WORKLOAD ON THE HEART AND ARTERIES )F NOT
DAYS
TREATED IT CAN DAMAGE THE BLOOD VESSELS OF
s to treat symptomatic heart failure in adult
THE BRAIN HEART AND KIDNEYS AND MAY
patients. 6ALSARTAN IS USED WHEN A GROUP
RESULT IN A STROKE HEART FAILURE OR KIDNEY
OF MEDICINES CALLED !NGIOTENSIN
FAILURE (IGH BLOOD PRESSURE INCREASES THE
#ONVERTING %NZYME !#% INHIBITORS A
RISK OF HEART ATTACKS ,OWERING YOUR BLOOD
MEDICATION TO TREAT HEART FAILURE CANNOT
PRESSURE TO NORMAL REDUCES THE RISK OF
BE USED OR IT MAY BE USED IN ADDITION TO
DEVELOPING THESE DISORDERS
!#% INHIBITORS WHEN OTHER MEDICATIONS TO
TREAT HEART FAILURE CANNOT BE USED (EART
2 WHAT YOU NEED TO KNOW
BEFORE YOU TAKE VALSARTAN
FAILURE SYMPTOMS INCLUDE SHORTNESS OF
BREATH AND SWELLING OF THE FEET AND LEGS
Do not take Valsartan
DUE TO FLUID BUILD UP )T IS CAUSED WHEN THE s IF YOU ARE allergic TO VALSARTAN OR ANY OF
HEART MUSCLE CANNOT PUMP BLOOD STRONGLY
THE OTHER INGREDIENTS OF THIS MEDICINE
ENOUGH TO SUPPLY ALL THE BLOOD NEEDED
LISTED IN SECTION 
THROUGHOUT THE BODY
s IF YOU HAVE severe 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 IF YOU ARE more than 3 months pregnant
IT IS ALSO BETTER TO AVOID 6ALSARTAN IN EARLY
PREGNANCY SEE SECTION  0REGNANCY
BREAST FEEDING AND FERTILITY
0EEL (ERE4O /PEN

0HARMA CODE 

4HE FREQUENCY OF SOME SIDE EFFECTS MAY
VARY DEPENDING ON YOUR CONDITION &OR
EXAMPLE SIDE EFFECTS SUCH AS DIZZINESS AND
DECREASED KIDNEY FUNCTION WERE SEEN LESS
FREQUENTLY IN ADULT PATIENTS TREATED WITH HIGH
BLOOD PRESSURE THAN IN ADULT PATIENTS TREATED
FOR HEART FAILURE OR AFTER A RECENT HEART ATTACK

s 4HE OTHER INGREDIENTS ARE COLLOIDAL
ANHYDROUS SILICA SODIUM STARCH GLYCOLATE
TYPE ! CROSPOVIDONE MICROCRYSTALLINE
CELLULOSE MAIZE STARCH MAGNESIUM
STEARATE HYPROMELLOSE MACROGOL
TITANIUM DIOXIDE % TALC  MG AND
 MG YELLOW IRON OXIDE %  MG
AND  MG RED IRON OXIDE %
 MG RED IRON OXIDE % INDIGOTINE
% SUNSET YELLOW &#& % 

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 IF YOU HAVE DIABETES OR IMPAIRED KIDNEY
FUNCTION AND YOU ARE TREATED WITH A BLOOD
PRESSURE LOWERING MEDICINE CONTAINING
aliskiren
If any of these apply to you, do not take
Valsartan.
Warnings and precautions
4ALK TO YOUR DOCTOR OR PHARMACIST BEFORE
TAKING 6ALSARTAN
s IF YOU HAVE LIVER DISEASE
s IF YOU HAVE A SEVERE KIDNEY DISEASE OR IF
YOU ARE UNDERGOING DIALYSIS
s IF YOU ARE SUFFERING FROM A NARROWING OF
THE KIDNEY ARTERY
s IF YOU HAVE RECENTLY HAD A KIDNEY
TRANSPLANTATION RECEIVED A NEW KIDNEY
s IF YOU ARE TREATED AFTER A HEART ATTACK OR FOR
HEART FAILURE YOUR DOCTOR MAY CHECK YOUR
KIDNEY FUNCTION
s IF YOU HAVE SEVERE HEART DISEASE OTHER
THAN HEART FAILURE OR HEART ATTACK
s IF YOU ARE TAKING MEDICINES THAT INCREASE
THE AMOUNT OF POTASSIUM IN YOUR BLOOD
4HESE INCLUDE POTASSIUM SUPPLEMENTS OR
SALT SUBSTITUTES CONTAINING POTASSIUM
POTASSIUM SPARING MEDICINES AND
HEPARIN )T MAY BE NECESSARY TO CHECK THE
AMOUNT OF POTASSIUM IN YOUR BLOOD AT
REGULAR INTERVALS
s IF YOU ARE BELOW  YEARS OF AGE AND YOU
TAKE 6ALSARTAN IN COMBINATION WITH OTHER
MEDICINES THAT INHIBIT THE RENIN
ANGIOTENSIN ALDOSTERONE SYSTEM
MEDICINES THAT LOWER BLOOD PRESSURE
YOUR DOCTOR MAY CHECK YOUR KIDNEY
FUNCTION AND THE AMOUNT OF POTASSIUM IN
YOUR BLOOD AT REGULAR INTERVALS
s IF YOU SUFFER FROM ALDOSTERONISM4HIS IS A
DISEASE IN WHICH YOUR ADRENAL GLANDS
MAKE TOO MUCH OF THE HORMONE
ALDOSTERONE )F THIS APPLIES TO YOU THE USE
OF 6ALSARTAN IS NOT RECOMMENDED
s IF YOU HAVE LOST A LOT OF FLUID DEHYDRATION
CAUSED BY DIARRHOEA VOMITING OR HIGH
DOSES OF WATER TABLETS DIURETICS
s IF YOU HAVE EVER EXPERIENCED SWELLING OF
THE TONGUE AND FACE CAUSED BY AN ALLERGIC
REACTION CALLED ANGIOEDEMA WHEN TAKING
ANOTHER DRUG INCLUDING !#% INHIBITORS
TELL YOUR DOCTOR )F THESE SYMPTOMS OCCUR
WHEN YOU ARE TAKING 6ALSARTAN STOP TAKING
6ALSARTAN IMMEDIATELY AND NEVER TAKE IT
AGAIN SEE SECTION  0OSSIBLE SIDE
EFFECTS 
s YOU MUST TELL YOUR DOCTOR IF YOU THINK YOU
ARE OR MIGHT BECOME PREGNANT 6ALSARTAN
IS NOT RECOMMENDED IN EARLY PREGNANCY
AND MUST NOT BE TAKEN IF YOU ARE MORE
THAN  MONTHS PREGNANT AS IT MAY CAUSE
SERIOUS HARM TO YOUR BABY IF USED AT THAT
STAGE SEE SECTION  0REGNANCY
BREAST FEEDING AND FERTILITY 
s IF YOU ARE TAKING ANY OF THE FOLLOWING
MEDICINES USED TO TREAT HIGH BLOOD
PRESSURE
s AN !#% INHIBITOR FOR EXAMPLE ENALAPRIL
LISINOPRIL RAMIPRIL IN PARTICULAR IF YOU
HAVE DIABETES RELATED KIDNEY PROBLEMS
s ALISKIREN
)N ADDITION FOR 6ALSARTAN  MG  MG AND
 MG FILM COATED TABLETS
s IF YOU ARE BEING TREATED WITH AN
!#% INHIBITOR TOGETHER WITH CERTAIN OTHER
MEDICINES TO TREAT YOUR HEART FAILURE
WHICH ARE KNOWN AS MINERALOCORTICOID
RECEPTORS ANTAGONISTS -2! FOR EXAMPLE
SPIRONOLACTONE EPLERENONE OR BETA
BLOCKERS FOR EXAMPLE METOPROLOL
s 9OUR DOCTOR MAY CHECK YOUR KIDNEY
FUNCTION BLOOD PRESSURE AND THE AMOUNT
OF ELECTROLYTES EG POTASSIUM IN YOUR
BLOOD AT REGULAR INTERVALS
3EE ALSO INFORMATION UNDER THE HEADING @$O
NOT TAKE ;6ALSARTAN=g

If any of these apply to you, tell your doctor
before you take Valsartan.
Other medicines and Valsartan
4ELL YOUR DOCTOR OR PHARMACIST IF YOU ARE
TAKING HAVE RECENTLY TAKEN OR MIGHT TAKE
ANY OTHER MEDICINES
4HE EFFECT OF THE TREATMENT CAN BE
INFLUENCED IF 6ALSARTAN IS TAKEN TOGETHER WITH
CERTAIN OTHER MEDICINES )T MAY BE NECESSARY
TO CHANGE THE DOSE TO TAKE OTHER
PRECAUTIONS OR IN SOME CASES TO STOP TAKING
ONE OF THE MEDICINES4HIS APPLIES TO BOTH
PRESCRIPTION AND NON PRESCRIPTION
MEDICINES ESPECIALLY
s other medicines that lower blood
pressure, ESPECIALLY water tablets
DIURETICS
s medicines that increase the amount of
potassium IN YOUR BLOOD4HESE INCLUDE
POTASSIUM SUPPLEMENTS OR SALT SUBSTITUTES
CONTAINING POTASSIUM POTASSIUM SPARING
MEDICINES AND HEPARIN
s certain type of pain killers CALLED
NON STEROIDAL ANTI INFLAMMATORY
MEDICINES (NSAIDs)
s lithium A MEDICINE USED TO TREAT SOME
TYPES OF PSYCHIATRIC ILLNESS
9OUR DOCTOR MAY NEED TO CHANGE YOUR DOSE
ANDOR TO TAKE OTHER PRECAUTIONS
)F YOU ARE TAKING AN !#% INHIBITOR OR
ALISKIREN SEE ALSO INFORMATION UNDER THE
HEADINGS @$O NOT TAKE ;6ALSARTAN= AND
@7ARNINGS AND PRECAUTIONS 
In addition for Valsartan 40 mg, 80 mg and
160 mg Film-coated Tablets:
s IF YOU ARE BEING treated after a heart
attack, A COMBINATION WITH ACE inhibitors
A MEDICATION TO TREAT HEART ATTACK IS NOT
RECOMMENDED
s IF YOU ARE BEING TREATED WITH AN !#%
INHIBITOR TOGETHER WITH CERTAIN OTHER
MEDICINES TO TREAT YOUR HEART FAILURE
WHICH ARE KNOWN AS MINERALOCORTICOID
RECEPTORS ANTAGONISTS -2! FOR EXAMPLE
SPIRONOLACTONE EPLERENONE OR BETA
BLOCKERS FOR EXAMPLE METOPROLOL 
Valsartan with food and drink
9OU CAN TAKE 6ALSARTAN WITH OR WITHOUT FOOD
Pregnancy, breast-feeding and fertility
)F YOU ARE PREGNANT OR BREAST FEEDING THINK
YOU MAY BE PREGNANT OR ARE PLANNING TO
HAVE A BABY ASK YOUR DOCTOR OR PHARMACIST
FOR ADVICE BEFORE TAKING THIS MEDICINE
!SK YOUR DOCTOR OR PHARMACIST FOR ADVICE
BEFORE TAKING ANY MEDICINE
s You must tell your doctor if you think you
are (or might become) pregnant9OUR
DOCTOR WILL NORMALLY ADVISE YOU TO STOP
TAKING 6ALSARTAN BEFORE YOU BECOME
PREGNANT OR AS SOON AS YOU KNOW YOU ARE
PREGNANT AND WILL ADVISE YOU TO TAKE
ANOTHER MEDICINE INSTEAD OF 6ALSARTAN
6ALSARTAN IS NOT RECOMMENDED IN EARLY
PREGNANCY AND MUST NOT BE TAKEN WHEN
MORE THAN  MONTHS PREGNANT AS IT MAY
CAUSE SERIOUS HARM TO YOUR BABY IF IT IS
USED AFTER THE THIRD MONTH OF PREGNANCY
s Tell your doctor if you are breast-feeding
or about to start breast-feeding. 6ALSARTAN
IS NOT RECOMMENDED FOR MOTHERS WHO ARE
BREAST FEEDING AND YOUR DOCTOR MAY
CHOOSE ANOTHER TREATMENT FOR YOU IF YOU
WISH TO BREAST FEED ESPECIALLY IF YOUR
BABY IS NEWBORN OR WAS BORN
PREMATURELY
Driving and using machines
"EFORE YOU DRIVE A VEHICLE USE TOOLS OR
OPERATE MACHINES OR CARRY OUT OTHER
ACTIVITIES THAT REQUIRE CONCENTRATION MAKE
SURE YOU KNOW HOW 6ALSARTAN AFFECTS YOU

FOLD
LINE.

1

16 September 2014

PAGE 3: RIGHT HAND INSIDE FACE AFTER FOLDING AND TACKING

,IKE MANY OTHER MEDICINES USED TO TREAT
HIGH BLOOD PRESSURE 6ALSARTAN MAY IN RARE
CASES CAUSE DIZZINESS AND AFFECT THE ABILITY
TO CONCENTRATE

AS YOU REMEMBER (OWEVER IF IT IS ALMOST
TIME FOR YOUR NEXT DOSE SKIP THE DOSE YOU
MISSED $O NOT TAKE A DOUBLE DOSE TO MAKE
UP FOR A FORGOTTEN DOSE

Valsartan 320 mg Film-coated Tablets
CONTAINS SUNSET YELLOW &#& % 
4HIS MEDICINAL PRODUCT CONTAINS SUNSET
YELLOW &#& % AND MAY CAUSE ALLERGIC
REACTIONS

If you stop taking Valsartan
3TOPPING YOUR TREATMENT WITH 6ALSARTAN MAY
CAUSE YOUR DISEASE TO GET WORSE $O NOT
STOP TAKING YOUR MEDICINE UNLESS YOUR
DOCTOR TELLS YOU TO

3

HOW TO TAKE VALSARTAN

!LWAYS TAKE THIS MEDICINE EXACTLY AS YOUR
DOCTOR HAS TOLD YOU #HECK WITH YOUR DOCTOR
OR PHARMACIST IF YOU ARE NOT SURE 0EOPLE
WITH HIGH BLOOD PRESSURE OFTEN DO NOT NOTICE
ANY SIGNS OF THIS PROBLEM -ANY MAY FEEL
QUITE NORMAL4HIS MAKES IT ALL THE MORE
IMPORTANT FOR YOU TO KEEP YOUR
APPOINTMENTS WITH THE DOCTOR EVEN IF YOU
ARE FEELING WELL
Valsartan 80 mg, 160 mg and 320 mg
Film-coated Tablets:
Adults with high blood pressure:4HE
RECOMMENDED DOSE IS  MG DAILY )N SOME
CASES YOUR DOCTOR MAY PRESCRIBE HIGHER
DOSES EG  MG OR  MG  (E MAY ALSO
COMBINE 6ALSARTAN WITH AN ADDITIONAL
MEDICINE EG A DIURETIC 
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 PATIENTS WHO WEIGH LESS THAN
 KG THE USUAL DOSE IS  MG OF VALSARTAN
ONCE DAILY )N PATIENTS WHO WEIGH  KG OR
MORE THE USUAL STARTING DOSE IS  MG OF
VALSARTAN ONCE DAILY )N SOME CASES YOUR
DOCTOR MAY PRESCRIBE HIGHER DOSES THE
DOSE CAN BE INCREASED TO  MG AND TO A
MAXIMUM OF  MG 
Valsartan 40 mg, 80 mg and 160 mg
Film-coated Tablets:
Adult patients after a recent heart
attack: !FTER A HEART ATTACK THE TREATMENT IS
GENERALLY STARTED AS EARLY AS AFTER  HOURS
USUALLY AT A LOW DOSE OF  MG TWICE DAILY
9OU OBTAIN THE  MG DOSE BY DIVIDING THE
 MG TABLET9OUR DOCTOR WILL INCREASE THIS
DOSE GRADUALLY OVER SEVERAL WEEKS TO A
MAXIMUM OF  MG TWICE DAILY4HE FINAL
DOSE DEPENDS ON WHAT YOU AS AN INDIVIDUAL
PATIENT CAN TOLERATE
6ALSARTAN CAN BE GIVEN TOGETHER WITH OTHER
TREATMENT FOR HEART ATTACK AND YOUR DOCTOR
WILL DECIDE WHICH TREATMENT IS SUITABLE FOR
YOU

)F YOU HAVE ANY FURTHER QUESTIONS ON THE USE
OF THIS MEDICINE ASK YOUR DOCTOR OR
PHARMACIST

4

POSSIBLE SIDE EFFECTS

,IKE ALL MEDICINES THIS MEDICINE CAN CAUSE
SIDE EFFECTS ALTHOUGH NOT EVERYBODY GETS
THEM
4HESE SIDE EFFECTS MAY OCCUR WITH CERTAIN
FREQUENCIES WHICH ARE DEFINED AS FOLLOWS
6ERY COMMON MAY AFFECT MORE THAN  IN 
PEOPLE
#OMMON
MAY AFFECT UP TO  IN 
PEOPLE
5NCOMMON MAY AFFECT UP TO  IN 
PEOPLE
2ARE
MAY AFFECT UP TO  IN 
PEOPLE
6ERY RARE
MAY AFFECT UP TO  IN  
PEOPLE
.OT KNOWN
FREQUENCY CANNOT BE
ESTIMATED FROM THE AVAILABLE
DATA
Some symptoms need immediate medical
attention:
9OU MAY EXPERIENCE SYMPTOMS OF
ANGIOEDEMA A SPECIFIC ALLERGIC REACTION
SUCH AS
s SWOLLEN FACE LIPS TONGUE OR THROAT
s DIFFICULTY IN BREATHING OR SWALLOWING
s HIVES ITCHING
If you get any of these, see a doctor
immediately.
Side effects include:
Common:
s DIZZINESS
s LOW BLOOD PRESSURE WITH OR WITHOUT
SYMPTOMS SUCH AS DIZZINESS AND FAINTING
WHEN STANDING UP
s DECREASED KIDNEY FUNCTION SIGNS OF RENAL
IMPAIRMENT 

Uncommon:
s ANGIOEDEMA SEE SECTION @3OME SYMPTOMS
NEED IMMEDIATE MEDICAL ATTENTION
s SUDDEN LOSS OF CONSCIOUSNESS SYNCOPE
s SPINNING SENSATION VERTIGO
Adult patients with heart failure:
s SEVERELY DECREASED KIDNEY FUNCTION SIGNS
4REATMENT STARTS GENERALLY WITH  MG TWICE
OF ACUTE RENAL FAILURE
DAILY9OUR DOCTOR WILL INCREASE THE DOSE
s MUSCLE SPASMS ABNORMAL HEART RHYTHM
GRADUALLY OVER SEVERAL WEEKS TO A MAXIMUM
SIGNS OF HYPERKALAEMIA
OF  MG TWICE DAILY4HE FINAL DOSE
s BREATHLESSNESS DIFFICULTY BREATHING WHEN
DEPENDS ON WHAT YOU AS AN INDIVIDUAL
LYING DOWN SWELLING OF THE FEET OR LEGS
PATIENT CAN TOLERATE
SIGNS OF CARDIAC FAILURE
6ALSARTAN CAN BE GIVEN TOGETHER WITH OTHER
s HEADACHE
TREATMENT FOR HEART FAILURE AND YOUR DOCTOR s COUGH
WILL DECIDE WHICH TREATMENT IS SUITABLE FOR
s ABDOMINAL PAIN
YOU
s NAUSEA
9OU CAN TAKE 6ALSARTAN WITH OR WITHOUT FOOD s DIARRHOEA
s TIREDNESS
3WALLOW 6ALSARTAN WITH A GLASS OF WATER
s WEAKNESS
4AKE 6ALSARTAN AT ABOUT THE SAME TIME EACH
DAY
Not known:
4HE TABLET CAN BE DIVIDED INTO EQUAL DOSES
s ALLERGIC REACTIONS WITH RASH ITCHING AND
HIVES OR SYMPTOMS OF FEVER SWOLLEN
If you take more Valsartan than you should
JOINTS AND JOINT PAIN MUSCLE PAIN SWOLLEN
)F YOU EXPERIENCE SEVERE DIZZINESS ANDOR
LYMPH NODES ANDOR FLU LIKE SYMPTOMS
FAINTING CONTACT YOUR DOCTOR IMMEDIATELY
MAY OCCUR SIGNS OF SERUM SICKNESS
AND LIE DOWN )F YOU HAVE ACCIDENTALLY TAKEN
s PURPLISH RED SPOTS FEVER ITCHING SIGNS OF
TOO MANY TABLETS CONTACT YOUR DOCTOR
INFLAMMATION OF BLOOD VESSELS ALSO CALLED
PHARMACIST OR HOSPITAL
VASCULITIS
If you forget to take Valsartan
s UNUSUAL BLEEDING OR BRUISING SIGNS OF
)F YOU FORGET TO TAKE A DOSE TAKE IT AS SOON
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)/. &/2 4(% 53%2

Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
s +EEP THIS LEAFLET9OU MAY NEED TO READ IT
AGAIN
s )F YOU HAVE ANY FURTHER QUESTIONS ASK YOUR
DOCTOR OR PHARMACIST
s 4HIS MEDICINE HAS BEEN PRESCRIBED FOR YOU
ONLY $O NOT PASS IT ON TO OTHERS )T MAY HARM
THEM EVEN IF THEIR SYMPTOMS ARE THE SAME AS
YOURS
s )F YOU GET ANY SIDE EFFECTS TALK TO YOUR DOCTOR
OR PHARMACIST4HIS INCLUDES ANY POSSIBLE SIDE
EFFECTS NOT LISTED IN THIS LEAFLET 3EE SECTION 
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

6ALSARTAN BELONGS TO A CLASS OF MEDICINES KNOWN
AS ANGIOTENSIN II RECEPTOR ANTAGONIST WHICH HELP
TO CONTROL HIGH BLOOD PRESSURE !NGIOTENSIN II IS
A SUBSTANCE IN THE BODY THAT CAUSES VESSELS TO
TIGHTEN THUS CAUSING YOUR BLOOD PRESSURE TO
INCREASE 6ALSARTAN WORKS BY BLOCKING THE EFFECT
OF ANGIOTENSIN II !S A RESULT BLOOD VESSELS RELAX
AND BLOOD PRESSURE IS LOWERED
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 (IGH BLOOD
PRESSURE INCREASES THE WORKLOAD ON THE HEART
AND ARTERIES )F NOT TREATED IT CAN DAMAGE THE
BLOOD VESSELS OF THE BRAIN HEART AND KIDNEYS
AND MAY RESULT IN A STROKE HEART FAILURE OR
KIDNEY FAILURE (IGH BLOOD PRESSURE INCREASES
THE RISK OF HEART ATTACKS ,OWERING YOUR BLOOD
PRESSURE TO NORMAL REDUCES THE RISK OF
DEVELOPING THESE DISORDERS
s to treat adult patients after a recent heart
attack (myocardial infarction) h2ECENTv HERE
MEANS BETWEEN  HOURS AND  DAYS
s to treat symptomatic heart failure in adult
patients. 6ALSARTAN IS USED WHEN A GROUP OF
MEDICINES CALLED !NGIOTENSIN #ONVERTING
%NZYME !#% INHIBITORS A MEDICATION TO TREAT
HEART FAILURE CANNOT BE USED OR IT MAY BE
USED IN ADDITION TO !#% INHIBITORS WHEN OTHER
MEDICATIONS TO TREAT HEART FAILURE CANNOT BE
USED (EART FAILURE SYMPTOMS INCLUDE
SHORTNESS OF BREATH AND SWELLING OF THE FEET
AND LEGS DUE TO FLUID BUILD UP )T IS CAUSED
WHEN THE HEART MUSCLE CANNOT PUMP BLOOD
STRONGLY ENOUGH TO SUPPLY ALL THE BLOOD
NEEDED THROUGHOUT THE BODY
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.
(IGH BLOOD PRESSURE INCREASES THE WORKLOAD
ON THE HEART AND ARTERIES )F NOT TREATED IT CAN
DAMAGE THE BLOOD VESSELS OF THE BRAIN HEART
AND KIDNEYS AND MAY RESULT IN A STROKE HEART
FAILURE OR KIDNEY FAILURE (IGH BLOOD PRESSURE
INCREASES THE RISK OF HEART ATTACKS ,OWERING
YOUR BLOOD PRESSURE TO NORMAL REDUCES THE
RISK OF DEVELOPING THESE DISORDERS
s to treat adult patients after a recent heart
attack (myocardial infarction). h2ECENTv HERE
MEANS BETWEEN  HOURS AND  DAYS
s to treat symptomatic heart failure in adult
patients. 6ALSARTAN IS USED WHEN A GROUP OF
MEDICINES CALLED !NGIOTENSIN #ONVERTING
%NZYME !#% INHIBITORS A MEDICATION TO TREAT
HEART FAILURE CANNOT BE USED OR IT MAY BE
USED IN ADDITION TO !#% INHIBITORS WHEN OTHER
MEDICATIONS TO TREAT HEART FAILURE CANNOT BE
USED (EART FAILURE SYMPTOMS INCLUDE
SHORTNESS OF BREATH AND SWELLING OF THE FEET
AND LEGS DUE TO FLUID BUILD UP )T IS CAUSED
WHEN THE HEART MUSCLE CANNOT PUMP BLOOD
STRONGLY ENOUGH TO SUPPLY ALL THE BLOOD
NEEDED THROUGHOUT THE BODY
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.
(IGH BLOOD PRESSURE INCREASES THE WORKLOAD
ON THE HEART AND ARTERIES )F NOT TREATED IT CAN
DAMAGE THE BLOOD VESSELS OF THE BRAIN HEART
AND KIDNEYS AND MAY RESULT IN A STROKE HEART
FAILURE OR KIDNEY FAILURE (IGH BLOOD PRESSURE
INCREASES THE RISK OF HEART ATTACKS ,OWERING
YOUR BLOOD PRESSURE TO NORMAL REDUCES THE
RISK OF DEVELOPING THESE DISORDERS
s to treat adult patients after a recent heart
attack (myocardial infarction). h2ECENTv HERE
MEANS BETWEEN  HOURS AND  DAYS
s to treat symptomatic heart failure in adult
patients. 6ALSARTAN IS USED WHEN A GROUP OF
MEDICINES CALLED !NGIOTENSIN #ONVERTING
%NZYME !#% INHIBITORS A MEDICATION TO TREAT
HEART FAILURE CANNOT BE USED OR IT MAY BE
USED IN ADDITION TO !#% INHIBITORS WHEN OTHER
MEDICATION TO TREAT HEART FAILURE CANNOT BE
USED (EART FAILURE SYMPTOMS INCLUDE
SHORTNESS OF BREATH AND SWELLING OF THE FEET
AND LEGS DUE TO FLUID BUILD UP )T IS CAUSED
WHEN THE HEART MUSCLE CANNOT PUMP BLOOD
STRONGLY ENOUGH TO SUPPLY ALL THE BLOOD
NEEDED THROUGHOUT THE BODY

Version:

1

16 September 2014

If any of these apply to you, do not take
Valsartan.
Warnings and precautions
4ALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING
6ALSARTAN
s IF YOU HAVE LIVER DISEASE
s IF YOU HAVE A SEVERE KIDNEY DISEASE OR IF YOU
ARE UNDERGOING DIALYSIS
s IF YOU ARE SUFFERING FROM A NARROWING OF THE
KIDNEY ARTERY
s IF YOU HAVE RECENTLY HAD A KIDNEY
TRANSPLANTATION RECEIVED A NEW KIDNEY
s IF YOU ARE TREATED AFTER A HEART ATTACK OR FOR
HEART FAILURE YOUR DOCTOR MAY CHECK YOUR
KIDNEY FUNCTION
s IF YOU HAVE SEVERE HEART DISEASE OTHER THAN
HEART FAILURE OR HEART ATTACK
s IF YOU ARE TAKING MEDICINES THAT INCREASE THE
AMOUNT OF POTASSIUM IN YOUR BLOOD4HESE
INCLUDE POTASSIUM SUPPLEMENTS OR SALT
SUBSTITUTES CONTAINING POTASSIUM
POTASSIUM SPARING MEDICINES AND HEPARIN )T
MAY BE NECESSARY TO CHECK THE AMOUNT OF
POTASSIUM IN YOUR BLOOD AT REGULAR INTERVALS
s IF YOU ARE BELOW  YEARS OF AGE AND YOU TAKE
6ALSARTAN IN COMBINATION WITH OTHER MEDICINES
THAT INHIBIT THE RENIN ANGIOTENSIN ALDOSTERONE
SYSTEM MEDICINES THAT LOWER BLOOD PRESSURE
YOUR DOCTOR MAY CHECK YOUR KIDNEY FUNCTION
AND THE AMOUNT OF POTASSIUM IN YOUR BLOOD AT
REGULAR INTERVALS
s IF YOU SUFFER FROM ALDOSTERONISM4HIS IS A
DISEASE IN WHICH YOUR ADRENAL GLANDS MAKE
TOO MUCH OF THE HORMONE ALDOSTERONE )F THIS
APPLIES TO YOU THE USE OF 6ALSARTAN IS NOT
RECOMMENDED
s IF YOU HAVE LOST A LOT OF FLUID DEHYDRATION
CAUSED BY DIARRHOEA VOMITING OR HIGH DOSES
OF WATER TABLETS DIURETICS
s IF YOU HAVE EVER EXPERIENCED SWELLING OF THE
TONGUE AND FACE CAUSED BY AN ALLERGIC REACTION
CALLED ANGIOEDEMA WHEN TAKING ANOTHER DRUG
INCLUDING !#% INHIBITORS TELL YOUR DOCTOR )F
THESE SYMPTOMS OCCUR WHEN YOU ARE TAKING
6ALSARTAN STOP TAKING 6ALSARTAN IMMEDIATELY
AND NEVER TAKE IT AGAIN SEE SECTION 
0OSSIBLE SIDE EFFECTS 
s YOU MUST TELL YOUR DOCTOR IF YOU THINK YOU ARE
OR MIGHT BECOME PREGNANT 6ALSARTAN IS NOT
RECOMMENDED IN EARLY PREGNANCY AND MUST
NOT BE TAKEN IF YOU ARE MORE THAN  MONTHS
PREGNANT AS IT MAY CAUSE SERIOUS HARM TO
YOUR BABY IF USED AT THAT STAGE SEE SECTION 
0REGNANCY BREAST FEEDING AND FERTILITY 
s IF YOU ARE TAKING ANY OF THE FOLLOWING
MEDICINES USED TO TREAT HIGH BLOOD PRESSURE
s AN !#% INHIBITOR FOR EXAMPLE ENALAPRIL
LISINOPRIL RAMIPRIL IN PARTICULAR IF YOU HAVE
DIABETES RELATED KIDNEY PROBLEMS
s ALISKIREN
)N ADDITION FOR 6ALSARTAN  MG  MG AND 
MG FILM COATED TABLETS
s IF YOU ARE BEING TREATED WITH AN !#% INHIBITOR
TOGETHER WITH CERTAIN OTHER MEDICINES TO TREAT
YOUR HEART FAILURE WHICH ARE KNOWN AS
MINERALOCORTICOID RECEPTORS ANTAGONISTS
-2! FOR EXAMPLE SPIRONOLACTONE
EPLERENONE OR BETA BLOCKERS FOR EXAMPLE
METOPROLOL
s 9OUR DOCTOR MAY CHECK YOUR KIDNEY FUNCTION
BLOOD PRESSURE AND THE AMOUNT OF
ELECTROLYTES EG POTASSIUM IN YOUR BLOOD AT
REGULAR INTERVALS
3EE ALSO INFORMATION UNDER THE HEADING @$O NOT
TAKE ;6ALSARTAN=
If any of these apply to you, tell your doctor
before you take Valsartan.
Other medicines and Valsartan
4ELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING
HAVE RECENTLY TAKEN OR MIGHT TAKE ANY OTHER
MEDICINES
4HE EFFECT OF THE TREATMENT CAN BE INFLUENCED IF
6ALSARTAN IS TAKEN TOGETHER WITH CERTAIN OTHER
MEDICINES )T MAY BE NECESSARY TO CHANGE THE
DOSE TO TAKE OTHER PRECAUTIONS OR IN SOME
CASES TO STOP TAKING ONE OF THE MEDICINES4HIS
APPLIES TO BOTH PRESCRIPTION AND
NON PRESCRIPTION MEDICINES ESPECIALLY
s other medicines that lower blood pressure,
ESPECIALLY water tablets DIURETICS
s medicines that increase the amount of
potassium IN YOUR BLOOD4HESE INCLUDE
POTASSIUM SUPPLEMENTS OR SALT SUBSTITUTES
CONTAINING POTASSIUM POTASSIUM SPARING
MEDICINES AND HEPARIN
s certain type of pain killers CALLED NON STEROIDAL
ANTI INFLAMMATORY MEDICINES (NSAIDs)
s lithium A MEDICINE USED TO TREAT SOME TYPES
OF PSYCHIATRIC ILLNESS
9OUR DOCTOR MAY NEED TO CHANGE YOUR DOSE
ANDOR TO TAKE OTHER PRECAUTIONS
)F YOU ARE TAKING AN !#% INHIBITOR OR ALISKIREN
SEE ALSO INFORMATION UNDER THE HEADINGS @$O
NOT TAKE ;6ALSARTAN= AND @7ARNINGS AND
PRECAUTIONS 
In addition for Valsartan 40 mg, 80 mg and 160 mg
Film-coated Tablets:
s IF YOU ARE BEING treated after a heart attack, A
COMBINATION WITH ACE inhibitors A
MEDICATION TO TREAT HEART ATTACK IS NOT
RECOMMENDED
s IF YOU ARE BEING TREATED WITH AN !#% INHIBITOR
TOGETHER WITH CERTAIN OTHER MEDICINES TO TREAT
YOUR HEART FAILURE WHICH ARE KNOWN AS
MINERALOCORTICOID RECEPTORS ANTAGONISTS
-2! FOR EXAMPLE SPIRONOLACTONE
EPLERENONE OR BETA BLOCKERS FOR EXAMPLE
METOPROLOL 
Valsartan with food and drink
9OU CAN TAKE 6ALSARTAN WITH OR WITHOUT FOOD
Pregnancy, breast-feeding and fertility
)F YOU ARE PREGNANT OR BREAST FEEDING THINK YOU
MAY BE PREGNANT OR ARE PLANNING TO HAVE A BABY
ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE BEFORE
TAKING THIS MEDICINE

!SK YOUR DOCTOR OR PHARMACIST FOR ADVICE BEFORE
TAKING ANY MEDICINE
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) pregnant9OUR DOCTOR WILL
children and adolescents 6 to 18 years of age.
NORMALLY ADVISE YOU TO STOP TAKING 6ALSARTAN
(IGH BLOOD PRESSURE INCREASES THE WORKLOAD
BEFORE YOU BECOME PREGNANT OR AS SOON AS
ON THE HEART AND ARTERIES )F NOT TREATED IT CAN
YOU KNOW YOU ARE PREGNANT AND WILL ADVISE
DAMAGE THE BLOOD VESSELS OF THE BRAIN HEART
YOU TO TAKE ANOTHER MEDICINE INSTEAD OF
AND KIDNEYS AND MAY RESULT IN A STROKE HEART
6ALSARTAN 6ALSARTAN IS NOT RECOMMENDED IN
FAILURE OR KIDNEY FAILURE (IGH BLOOD PRESSURE
EARLY PREGNANCY AND MUST NOT BE TAKEN WHEN
INCREASES THE RISK OF HEART ATTACKS ,OWERING
MORE THAN  MONTHS PREGNANT AS IT MAY CAUSE
YOUR BLOOD PRESSURE TO NORMAL REDUCES THE
SERIOUS HARM TO YOUR BABY IF IT IS USED AFTER
RISK OF DEVELOPING THESE DISORDERS
THE THIRD MONTH OF PREGNANCY
s
Tell your doctor if you are breast-feeding or
YOU NEED TO KNOW
2 WHAT
about to start breast-feeding. 6ALSARTAN IS NOT
BEFORE YOU TAKE VALSARTAN
RECOMMENDED FOR MOTHERS WHO ARE
Do not take Valsartan
BREAST FEEDING AND YOUR DOCTOR MAY CHOOSE
s IF YOU ARE allergic TO VALSARTAN OR ANY OF THE
ANOTHER TREATMENT FOR YOU IF YOU WISH TO
OTHER INGREDIENTS OF THIS MEDICINE LISTED IN
BREAST FEED ESPECIALLY IF YOUR BABY IS
SECTION 
NEWBORN OR WAS BORN PREMATURELY
s IF YOU HAVE severe liver disease
s IF YOU ARE more than 3 months pregnant IT IS Driving and using machines
"EFORE YOU DRIVE A VEHICLE USE TOOLS OR OPERATE
ALSO BETTER TO AVOID 6ALSARTAN IN EARLY
MACHINES OR CARRY OUT OTHER ACTIVITIES THAT
PREGNANCY SEE SECTION  0REGNANCY
REQUIRE CONCENTRATION MAKE SURE YOU KNOW HOW
BREAST FEEDING AND FERTILITY
6ALSARTAN AFFECTS YOU
s IF YOU HAVE DIABETES OR IMPAIRED KIDNEY
FUNCTION AND YOU ARE TREATED WITH A BLOOD
,IKE MANY OTHER MEDICINES USED TO TREAT HIGH
PRESSURE LOWERING MEDICINE CONTAINING
BLOOD PRESSURE 6ALSARTAN MAY IN RARE CASES
aliskiren
CAUSE DIZZINESS AND AFFECT THE ABILITY TO
CONCENTRATE

TEVA UK Ref:

Version:

231-30-91402-C LEA VALSARTAN A/S TAB TUK
Valsartan 320 mg Film-coated Tablets CONTAINS
SUNSET YELLOW &#& % 
4HIS MEDICINAL PRODUCT CONTAINS SUNSET YELLOW
&#& % AND MAY CAUSE ALLERGIC REACTIONS

3

HOW TO TAKE VALSARTAN

!LWAYS TAKE THIS MEDICINE EXACTLY AS YOUR
DOCTOR HAS TOLD YOU #HECK WITH YOUR DOCTOR OR
PHARMACIST IF YOU ARE NOT SURE 0EOPLE WITH HIGH
BLOOD PRESSURE OFTEN DO NOT NOTICE ANY SIGNS OF
THIS PROBLEM -ANY MAY FEEL QUITE NORMAL4HIS
MAKES IT ALL THE MORE IMPORTANT FOR YOU TO KEEP
YOUR APPOINTMENTS WITH THE DOCTOR EVEN IF YOU
ARE FEELING WELL
Valsartan 80 mg, 160 mg and 320 mg
Film-coated Tablets:
Adults with high blood pressure:4HE
RECOMMENDED DOSE IS  MG DAILY )N SOME
CASES YOUR DOCTOR MAY PRESCRIBE HIGHER DOSES
EG  MG OR  MG  (E MAY ALSO COMBINE
6ALSARTAN WITH AN ADDITIONAL MEDICINE EG A
DIURETIC 

1

16 September 2014

s ELEVATION OF LIVER FUNCTION VALUES WHICH CAN
INDICATE LIVER DAMAGE INCLUDING AN INCREASE
OF BILIRUBIN IN THE BLOOD WHICH CAN TRIGGER
YELLOW SKIN AND EYES IN SEVERE CASES
s INCREASE OF LEVEL OF BLOOD UREA NITROGEN AND
INCREASE OF LEVEL OF SERUM CREATININE WHICH
CAN INDICATE ABNORMAL KIDNEY FUNCTION
s LOW LEVEL OF SODIUM IN THE BLOOD WHICH CAN
TRIGGER TIREDNESS CONFUSION MUSCLE TWITCHING
ANDOR CONVULSIONS IN SEVERE CASES 
4HE FREQUENCY OF SOME SIDE EFFECTS MAY VARY
DEPENDING ON YOUR CONDITION &OR EXAMPLE SIDE
EFFECTS SUCH AS DIZZINESS AND DECREASED KIDNEY
FUNCTION WERE SEEN LESS FREQUENTLY IN ADULT
PATIENTS TREATED WITH HIGH BLOOD PRESSURE THAN
IN ADULT PATIENTS TREATED FOR HEART FAILURE OR AFTER
A RECENT HEART ATTACK
3IDE EFFECTS IN CHILDREN AND ADOLESCENTS ARE
SIMILAR TO THOSE SEEN IN ADULTS
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.

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
PATIENTS WHO WEIGH LESS THAN  KG THE USUAL
DOSE IS  MG OF VALSARTAN ONCE DAILY )N PATIENTS
WHO WEIGH  KG OR MORE THE USUAL STARTING
DOSE IS  MG OF VALSARTAN ONCE DAILY )N SOME
CASES YOUR DOCTOR MAY PRESCRIBE HIGHER DOSES
THE DOSE CAN BE INCREASED TO  MG AND TO A
MAXIMUM OF  MG 

Reporting of side effects
)F YOU GET ANY SIDE EFFECTS TALK TO YOUR DOCTOR
PHARMACIST OR NURSE4HIS INCLUDES ANY POSSIBLE
SIDE EFFECTS NOT LISTED IN THIS LEAFLET9OU CAN ALSO
REPORT SIDE EFFECTS DIRECTLY VIA THE9ELLOW #ARD
3CHEME AT WWWMHRAGOVUKYELLOWCARD

Valsartan 40 mg, 80 mg and 160 mg Film-coated
Tablets:
Adult patients after a recent heart attack:
!FTER A HEART ATTACK THE TREATMENT IS GENERALLY
STARTED AS EARLY AS AFTER  HOURS USUALLY AT A
LOW DOSE OF  MG TWICE DAILY9OU OBTAIN THE
 MG DOSE BY DIVIDING THE  MG TABLET9OUR
DOCTOR WILL INCREASE THIS DOSE GRADUALLY OVER
SEVERAL WEEKS TO A MAXIMUM OF  MG TWICE
DAILY4HE FINAL DOSE DEPENDS ON WHAT YOU AS AN
INDIVIDUAL PATIENT CAN TOLERATE
6ALSARTAN CAN BE GIVEN TOGETHER WITH OTHER
TREATMENT FOR HEART ATTACK AND YOUR DOCTOR WILL
DECIDE WHICH TREATMENT IS SUITABLE FOR YOU

Keep this medicine out of the sight and reach of
children.
$O NOT USE THIS MEDICINE AFTER THE EXPIRY DATE
WHICH IS STATED ON THE CARTON AND BLISTER AFTER
%804HE EXPIRY DATE REFERS TO THE LAST DAY OF THAT
MONTH
$O NOT STORE ABOVE ยช# 3TORE IN THE ORIGINAL
PACKAGE IN ORDER TO PROTECT FROM MOISTURE
$O NOT USE 6ALSARTAN IF YOU NOTICE THAT THE PACK
IS DAMAGED OR SHOWS SIGNS OF TAMPERING
$O NOT THROW AWAY ANY MEDICINES VIA
WASTEWATER OR HOUSEHOLD WASTE !SK YOUR
PHARMACIST HOW TO THROW AWAY MEDICINES YOU
NO LONGER USE4HESE MEASURES WILL HELP PROTECT
THE ENVIRONMENT

Adult patients with heart failure:4REATMENT
STARTS GENERALLY WITH  MG TWICE DAILY9OUR
DOCTOR WILL INCREASE THE DOSE GRADUALLY OVER
SEVERAL WEEKS TO A MAXIMUM OF  MG TWICE
DAILY4HE FINAL DOSE DEPENDS ON WHAT YOU AS AN
INDIVIDUAL PATIENT CAN TOLERATE
6ALSARTAN CAN BE GIVEN TOGETHER WITH OTHER
TREATMENT FOR HEART FAILURE AND YOUR DOCTOR WILL
DECIDE WHICH TREATMENT IS SUITABLE FOR YOU

"Y REPORTING SIDE EFFECTS YOU CAN HELP PROVIDE
MORE INFORMATION ON THE SAFETY OF THIS MEDICINE

5

6

HOW TO STORE VALSARTAN

CONTENTS OF THE PACK AND
OTHER INFORMATION

What Valsartan contains
s 4HE ACTIVE SUBSTANCE IS VALSARTAN
 MG %ACH FILM COATED TABLET CONTAINS
 MG OF VALSARTAN
 MG %ACH FILM COATED TABLET CONTAINS
 MG OF VALSARTAN
9OU CAN TAKE 6ALSARTAN WITH OR WITHOUT FOOD
 MG %ACH FILM COATED TABLET CONTAINS
3WALLOW 6ALSARTAN WITH A GLASS OF WATER
 MG OF VALSARTAN
4AKE 6ALSARTAN AT ABOUT THE SAME TIME EACH DAY
 MG %ACH FILM COATED TABLET CONTAINS
4HE TABLET CAN BE DIVIDED INTO EQUAL DOSES
 MG OF VALSARTAN
If you take more Valsartan than you should
s 4HE OTHER INGREDIENTS ARE COLLOIDAL ANHYDROUS
)F YOU EXPERIENCE SEVERE DIZZINESS ANDOR FAINTING
SILICA SODIUM STARCH GLYCOLATE TYPE !
CONTACT YOUR DOCTOR IMMEDIATELY AND LIE DOWN )F
CROSPOVIDONE MICROCRYSTALLINE CELLULOSE
YOU HAVE ACCIDENTALLY TAKEN TOO MANY TABLETS
MAIZE STARCH MAGNESIUM STEARATE
CONTACT YOUR DOCTOR PHARMACIST OR HOSPITAL
HYPROMELLOSE MACROGOL TITANIUM DIOXIDE
% TALC  MG AND  MG YELLOW IRON
If you forget to take Valsartan
OXIDE %  MG AND  MG RED IRON
)F YOU FORGET TO TAKE A DOSE TAKE IT AS SOON AS
OXIDE %  MG RED IRON OXIDE %
YOU REMEMBER (OWEVER IF IT IS ALMOST TIME FOR
INDIGOTINE % SUNSET YELLOW &#& % 
YOUR NEXT DOSE SKIP THE DOSE YOU MISSED $O
NOT TAKE A DOUBLE DOSE TO MAKE UP FOR A
What Valsartan looks like and contents of the
FORGOTTEN DOSE
pack
If you stop taking Valsartan
6ALSARTAN  MG &ILM COATED4ABLETS ARE YELLOW
3TOPPING YOUR TREATMENT WITH 6ALSARTAN MAY
OVAL SHAPED FILM COATED TABLETS SCORED ON ONE
CAUSE YOUR DISEASE TO GET WORSE $O NOT STOP
SIDE AND DEBOSSED WITH h6v ON ONE SIDE OF THE
TAKING YOUR MEDICINE UNLESS YOUR DOCTOR TELLS
SCORE LINE AND hv ON THE OTHER SIDE OF THE
YOU TO
SCORE LINE !VAILABLE IN PACK SIZES OF    
        AND 
)F YOU HAVE ANY FURTHER QUESTIONS ON THE USE OF
FILM COATED TABLETS (OSPITAL PACK    X 
THIS MEDICINE ASK YOUR DOCTOR OR PHARMACIST
  X  AND   X  FILM COATED TABLETS

4

POSSIBLE SIDE EFFECTS

,IKE ALL MEDICINES THIS MEDICINE CAN CAUSE SIDE
EFFECTS ALTHOUGH NOT EVERYBODY GETS THEM
4HESE SIDE EFFECTS MAY OCCUR WITH CERTAIN
FREQUENCIES WHICH ARE DEFINED AS FOLLOWS
6ERY COMMON MAY AFFECT MORE THAN  IN 
PEOPLE
#OMMON
MAY AFFECT UP TO  IN  PEOPLE
5NCOMMON
MAY AFFECT UP TO  IN  PEOPLE
2ARE
MAY AFFECT UP TO  IN 
PEOPLE
6ERY RARE
MAY AFFECT UP TO  IN  
PEOPLE
.OT KNOWN
FREQUENCY CANNOT BE ESTIMATED
FROM THE AVAILABLE DATA

6ALSARTAN  MG &ILM COATED4ABLETS ARE PINK
OVAL SHAPED FILM COATED TABLETS SCORED ON ONE
SIDE AND DEBOSSED WITH h6v ON ONE SIDE OF THE
SCORE LINE AND hv ON THE OTHER SIDE OF THE
SCORE LINE !VAILABLE IN PACK SIZES OF    
       AND  FILM COATED
TABLETS (OSPITAL PACK  FILM COATED TABLETS
#ALENDAR PACK OF  AND  TABLETS
6ALSARTAN  MG &ILM COATED4ABLETS ARE YELLOW
OVAL SHAPED FILM COATED TABLETS SCORED ON ONE
SIDE AND DEBOSSED WITH h6v ON ONE SIDE OF THE
SCORE LINE AND hv ON THE OTHER SIDE OF THE
SCORE LINE !VAILABLE IN PACK SIZES OF    
       AND  FILM COATED
TABLETS (OSPITAL PACK  FILM COATED TABLETS
#ALENDAR PACK OF  AND  TABLETS

Some symptoms need immediate medical
attention:
9OU MAY EXPERIENCE SYMPTOMS OF ANGIOEDEMA
A SPECIFIC ALLERGIC REACTION SUCH AS
s SWOLLEN FACE LIPS TONGUE OR THROAT
s DIFFICULTY IN BREATHING OR SWALLOWING
s HIVES ITCHING
If you get any of these, see a doctor
immediately.

6ALSARTAN  MG &ILM COATED4ABLETS ARE PURPLE
OVAL SHAPED FILM COATED TABLETS SCORED ON ONE
SIDE AND DEBOSSED WITH h6v ON ONE SIDE OF THE
SCORE LINE AND hv ON THE OTHER SIDE OF THE
SCORE LINE !VAILABLE IN PACK SIZES OF    
          
FILM COATED TABLETS (OSPITAL PACK   X 
 X  AND  X  FILM COATED TABLETS

Side effects include:

.OT ALL PACK SIZES MAY BE MARKETED

Common:
s DIZZINESS
s LOW BLOOD PRESSURE WITH OR WITHOUT SYMPTOMS
SUCH AS DIZZINESS AND FAINTING WHEN STANDING
UP
s DECREASED KIDNEY FUNCTION SIGNS OF RENAL
IMPAIRMENT 

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

Manufacturer is:
4EVA 0HARMACEUTICAL 7ORKS 0RIVATE ,IMITED
#OMPANY 0ALLAGI UT   $EBRECEN
Uncommon:
s ANGIOEDEMA SEE SECTION @3OME SYMPTOMS
This leaflet was last revised in 09/2014.
NEED IMMEDIATE MEDICAL ATTENTION
0,     
s SUDDEN LOSS OF CONSCIOUSNESS SYNCOPE
s SPINNING SENSATION VERTIGO
s SEVERELY DECREASED KIDNEY FUNCTION SIGNS OF
ACUTE RENAL FAILURE
s MUSCLE SPASMS ABNORMAL HEART RHYTHM SIGNS
OF HYPERKALAEMIA
s BREATHLESSNESS DIFFICULTY BREATHING WHEN
LYING DOWN SWELLING OF THE FEET OR LEGS SIGNS
OF CARDIAC FAILURE
s HEADACHE
s COUGH
s ABDOMINAL PAIN
s NAUSEA
s DIARRHOEA
s TIREDNESS
s WEAKNESS
Not known:
s ALLERGIC REACTIONS WITH RASH ITCHING AND HIVES
OR SYMPTOMS OF FEVER SWOLLEN JOINTS AND JOINT
PAIN MUSCLE PAIN SWOLLEN LYMPH NODES
ANDOR FLU LIKE SYMPTOMS MAY OCCUR SIGNS OF
SERUM SICKNESS
s PURPLISH RED SPOTS FEVER ITCHING SIGNS OF
INFLAMMATION OF BLOOD VESSELS ALSO CALLED
VASCULITIS
s UNUSUAL BLEEDING OR BRUISING SIGNS OF
THROMBOCYTOPENIA
s MUSCLE PAIN MYALGIA
s FEVER SORE THROAT OR MOUTH ULCERS DUE TO
INFECTIONS SYMPTOMS OF LOW LEVEL OF WHITE
BLOOD CELLS ALSO CALLED NEUTROPENIA
s DECREASE OF LEVEL OF HAEMOGLOBIN AND
DECREASE OF THE PERCENTAGE OF RED BLOOD CELLS
IN THE BLOOD WHICH CAN LEAD TO ANAEMIA IN
SEVERE CASES
s INCREASE OF LEVEL OF POTASSIUM IN THE BLOOD
WHICH CAN TRIGGER MUSCLE SPASMS AND
ABNORMAL HEART RHYTHM IN SEVERE CASES

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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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