VALSARTAN 160MG FILM-COATED TABLETS

Active substance: VALSARTAN

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FOLD
LINE.

The frequency of some side effects may
vary depending on your condition. For
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.
Side 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
If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By 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.
Do not use Valsartan after the expiry date
which is stated on the carton and blister
after EXP The expiry date refers to the last
.
day of that month.
Do not store above 25°C. Store in the
original package in order to protect from
moisture.
Do not use Valsartan if you notice that the
pack is damaged or shows signs of
tampering.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help protect the environment.

6

CONTENTS OF THE PACK AND
OTHER INFORMATION

What Valsartan contains
• The active substance is valsartan.
40 mg: Each film-coated tablet contains
40 mg of valsartan

80 mg: Each film-coated tablet contains
80 mg of valsartan
160 mg: Each film-coated tablet
contains 160 mg of valsartan
320 mg: Each film-coated tablet
contains 320 mg of valsartan
• The other ingredients are colloidal
anhydrous silica, sodium starch
glycolate (type A), crospovidone,
microcrystalline cellulose, maize starch,
magnesium stearate, hypromellose,
macrogol, titanium dioxide (E171), talc,
40 mg and 160 mg: yellow iron oxide
(E172), 80 mg and 160 mg: red iron
oxide (E172), 320 mg: red iron oxide
(E172), indigotine (E132), sunset yellow
FCF (E110).
What Valsartan looks like and contents of
the pack
Valsartan 40 mg Film-coated Tablets are
yellow, oval-shaped, film-coated tablets,
scored on one side and debossed with
“V” on one side of the score line and “40”
on the other side of the score line.
Available in pack sizes of 1, 7, 14, 15, 28,
30, 56, 60, 84, 90, 98, 100 and 280
film-coated tablets. Hospital pack: 50, 56
(56 x 1), 98 (98 x 1) and 280 (280 x 1)
film-coated tablets.
Valsartan 80 mg Film-coated Tablets are
pink, oval-shaped, film-coated tablets,
scored on one side and debossed with
“V” on one side of the score line and “80”
on the other side of the score line.
Available in pack sizes of 1, 14, 15, 28, 30,
56, 60, 84, 90, 98, 100 and 280 film-coated
tablets. Hospital pack: 50 film-coated
tablets. Calendar pack of 28 and 98
tablets.
Valsartan 160 mg Film-coated Tablets are
yellow, oval-shaped, film-coated tablets,
scored on one side and debossed with
“V” on one side of the score line and
“160” on the other side of the score line.
Available in pack sizes of 1, 14, 15, 28, 30,
56, 60, 84, 90, 98, 100 and 280 film-coated
tablets. Hospital pack: 50 film-coated
tablets. Calendar pack of 28 and 98
tablets.
Valsartan 320 mg Film-coated Tablets are
purple, oval-shaped, film-coated tablets,
scored on one side and debossed with
“V” on one side of the score line and
“320” on the other side of the score line.
Available in pack sizes of 1, 7, 10, 14, 15,
20, 28, 30, 50, 56, 84, 90, 98, 100, 280
film-coated tablets. Hospital pack: 50, 56 x 1,
98 x 1 and 280 x 1 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder is:
Teva UK Limited, Eastbourne, BN22 9AG,
United Kingdom.
Manufacturer is:
Teva Pharmaceutical Works Private
Limited Company, Pallagi ut 13, 4042
Debrecen.
This leaflet was last revised in 02/2014.
PL 00289/1235, 1236, 1237 & 1238

88210-C
320 x 323

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

Valsartan 80 mg Film-coated Tablets can
be used for three different conditions:
• to treat high blood pressure in adults
and in children and adolescents 6 to 18
years of age. High blood pressure
increases the workload on the heart and
arteries. If not treated it can damage the
blood vessels of the brain, heart, and
kidneys, and may result in a stroke,
PACKAGE LEAFLET: INFORMATION
heart failure, or kidney failure. High
FOR THE USER
blood pressure increases the risk of
Read all of this leaflet carefully before you
heart attacks. Lowering your blood
start taking this medicine because it
pressure to normal reduces the risk of
contains important information to you.
developing these disorders.
• Keep this leaflet. You may need to read it • to treat adult patients after a recent
again.
heart attack (myocardial infarction).
• If you have any further questions, ask
“Recent” here means between 12 hours
your doctor or pharmacist.
and 10 days.
• This medicine has been prescribed for
• to treat symptomatic heart failure in
you only. Do not pass it on to others. It
adult patients. Valsartan is used when a
may harm them, even if their symptoms
group of medicines called Angiotensin
are the same as yours.
Converting Enzyme (ACE) inhibitors (a
• If you get any side effects, talk to your
medication to treat heart failure) cannot
doctor. This includes any possible side
be used or it may be used in addition to
effects not listed in this leaflet. “See
ACE inhibitors when beta blockers
section 4“
.
(another medication to treat heart failure)
cannot be used. Heart failure symptoms
WHAT IS IN THIS LEAFLET:
include shortness of breath, and swelling
1. What Valsartan is and what it is used for
of the feet and legs due to fluid build-up.
2. What you need to know before you take
It is caused when the heart muscle cannot
Valsartan
pump blood strongly enough to supply all
3. How to take Valsartan
the blood needed throughout the body.
4. Possible side effects
5. How to store Valsartan
Valsartan 160 mg Film-coated Tablets can
6. Contents of the pack and other
be used for three different conditions:
information
• to treat high blood pressure in adults
and in children and adolescents 6 to 18
1 WHAT VALSARTAN IS AND WHAT
years of age. High blood pressure
IT IS USED FOR
increases the workload on the heart and
arteries. If not treated it can damage the
Valsartan belongs to a class of medicines
blood vessels of the brain, heart, and
known as angiotensin II receptor
kidneys, and may result in a stroke,
antagonist, which help to control high
heart failure, or kidney failure. High
blood pressure. Angiotensin II is a
blood pressure increases the risk of
substance in the body that causes vessels
heart attacks. Lowering your blood
to tighten, thus causing your blood
pressure to normal reduces the risk of
pressure to increase.
developing these disorders.
Valsartan works by blocking the effect of
• to treat adult patients after a recent
angiotensin II. As a result, blood vessels
heart attack (myocardial infarction).
relax and blood pressure is lowered.
“Recent” here means between 12 hours
Valsartan 40 mg Film-coated Tablets can
and 10 days.
be used for three different conditions:
• to treat symptomatic heart failure in
• to treat high blood pressure in children
adult patients. Valsartan is used when a
and adolescents 6 to 18 years of age.
group of medicines called Angiotensin
High blood pressure increases the
Converting Enzyme (ACE) inhibitors (a
workload on the heart and arteries. If
medication to treat heart failure) cannot
not treated it can damage the blood
be used or it may be used in addition to
vessels of the brain, heart, and kidneys,
ACE inhibitors when beta blockers
and may result in a stroke, heart failure,
(another medication to treat heart
or kidney failure. High blood pressure
failure) cannot be used. Heart failure
increases the risk of heart attacks.
symptoms include shortness of breath,
Lowering your blood pressure to
and swelling of the feet and legs due to
normal reduces the risk of developing
fluid build-up. It is caused when the
these disorders.
heart muscle cannot pump blood
• to treat adult patients after a recent
strongly enough to supply all the blood
heart attack (myocardial infarction).
needed throughout the body.
“Recent” here means between 12 hours
Valsartan 320 mg Film-coated Tablets can
and 10 days.
be used
• to treat symptomatic heart failure in
adult patients. Valsartan is used when a • to treat high blood pressure in adults
and in children and adolescents 6 to 18
group of medicines called Angiotensin
years of age. High blood pressure
Converting Enzyme (ACE) inhibitors (a
increases the workload on the heart and
medication to treat heart failure) cannot
arteries. If not treated it can damage the
be used or it may be used in addition to
blood vessels of the brain, heart, and
ACE inhibitors when beta blockers
kidneys, and may result in a stroke, heart
(another medication to treat heart failure)
failure, or kidney failure. High blood
cannot be used. Heart failure symptoms
pressure increases the risk of heart attacks.
include shortness of breath, and swelling
Lowering your blood pressure to normal
of the feet and legs due to fluid build-up.
reduces the risk of developing these
It is caused when the heart muscle cannot
disorders.
pump blood strongly enough to supply all
the blood needed throughout the body.
Peel Here To Open

Pharma code 123

• muscle pain (myalgia)
• fever, sore throat or mouth ulcers due
to infections (symptoms of low level of
white blood cells also called
neutropenia)
• 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)
• increase of level of potassium in the blood
(which can trigger muscle spasms and
abnormal heart rhythm in severe cases)
• 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)
• increase of level of blood urea nitrogen
and increase of level of serum creatinine
(which can indicate abnormal kidney
function)
• low level of sodium in the blood (which
can trigger tiredness, confusion, muscle
twitching and/or convulsions in severe
cases).

Other medicines and Valsartan
Tell your doctor or pharmacist if you are
BEFORE YOU TAKE VALSARTAN
taking, have recently taken or might take
Do not take Valsartan
any other medicines.
• if you are allergic to valsartan (active
The effect of the treatment can be
ingredient) or any of the other
influenced if Valsartan is taken together
ingredients of this medicine (listed in
with certain other medicines. It may be
section 6)
necessary to change the dose, to take
• if you have severe liver disease
other precautions, or in some cases to
• if you are more than 3 months
stop taking one of the medicines. This
pregnant, (it is also better to avoid
applies to both prescription and
Valsartan in early pregnancy - see
non-prescription medicines, especially:
pregnancy section)
• if you have diabetes mellitus or impaired • aliskiren (a medicine that lowers blood
pressure), particularly if you suffer from
kidney function and are taking aliskiren
diabetes mellitus or impaired kidney
(a class of medicines called renin
function
inhibitors that helps to lower blood
• other medicines that lower blood
pressure in adult patients).
pressure, especially water tablets
If any of these apply to you, do not take
(diuretics)
Valsartan.
• medicines that increase the amount of
Warnings and precautions
potassium in your blood. These include
Talk to your doctor before taking this
potassium supplements or salt substitutes
medicine:
containing potassium, potassium-sparing
• if you have liver disease
medicines and heparin.
• if you have a severe kidney disease or if • certain type of pain killers called
you are undergoing dialysis
non-steroidal anti-inflammatory
• if you are suffering from a narrowing of
medicines (NSAIDs)
the kidney artery
• lithium, a medicine used to treat some
• if you have recently had a kidney
types of psychiatric illness.
transplantation (received a new kidney)
• if you are treated after a heart attack or In addition for Valsartan 40 mg, 80 mg
for heart failure, your doctor may check and 160 mg Film-coated Tablets:
• if you are being treated after a heart
your kidney function
attack, a combination with ACE
• if you have severe heart disease other
inhibitors (a medication to treat heart
than heart failure or heart attack
attack) is not recommended
• if you are taking medicines that increase
the amount of potassium in your blood. • if you are being treated for heart failure,
a triple combination with ACE inhibitors
These include potassium supplements
and beta blockers (medications to treat
or salt substitutes containing potassium,
heart failure) is not recommended.
potassium-sparing medicines and
Valsartan with food and drink
heparin. It may be necessary to check
the amount of potassium in your blood You can take Valsartan with or without food.
at regular intervals.
Pregnancy, breast-feeding and fertility
• if you are below 18 years of age and
Ask your doctor or pharmacist for advice
you take Valsartan in combination with before taking any medicine.
other medicines that inhibit the renin
• You must tell your doctor if you think
angiotensin aldosterone system
you are (or might become) pregnant.
(medicines that lower blood pressure),
Your doctor will normally advise you to
your doctor may check your kidney
stop taking Valsartan before you become
function and the amount of potassium
pregnant or as soon as you know you
in your blood at regular intervals
are pregnant, and will advise you to
• if you suffer from aldosteronism. This is
take another medicine instead of
a disease in which your adrenal glands
Valsartan. Valsartan is not
make too much of the hormone
recommended in early pregnancy, and
aldosterone. If this applies to you, the
must not be taken when more than 3
use of Valsartan is not recommended.
months pregnant, as it may cause
• if you have lost a lot of fluid (dehydration)
serious harm to your baby if it is used
caused by diarrhoea, vomiting, or high
after the third month of pregnancy.
doses of water tablets (diuretics)
• Tell your doctor if you are
• If you have ever experienced swelling of
breast-feeding or about to start
the tongue and face caused by an
breast-feeding. Valsartan is not
allergic reaction called angioedema
recommended for mothers who are
when taking another drug (including
breast-feeding, and your doctor may
ACE inhibitors), tell your doctor. If these
choose another treatment for you if you
symptoms occur when you are taking
wish to breast-feed, especially if your
Valsartan, stop taking Valsartan
baby is newborn, or was born
immediately and never take it again
prematurely.
(See also section 4, “Possible side
Driving and using machines
effects”).
Before you drive a vehicle, use tools or
• you must tell your doctor if you think
operate machines, or carry out other
you are (or might become) pregnant.
activities that require concentration, make
Valsartan is not recommended in early
pregnancy, and must not be taken if you sure you know how Valsartan affects you.
are more than 3 months pregnant, as it Like many other medicines used to treat
may cause serious harm to your baby if high blood pressure, Valsartan may in rare
used at that stage (see section
cases cause dizziness and affect the ability
“Pregnancy, breast-feeding and
to concentrate.
fertility“).
Valsartan 320 mg Film-coated Tablets
If any of these apply to you, tell your
contains sunset yellow FCF (E110):
doctor before you take Valsartan.
This medicinal product contains sunset

2 WHAT YOU NEED TO KNOW

yellow FCF (E110) and may cause allergic
reactions.

3 HOW TO TAKE VALSARTAN
Always take Valsartan exactly as your
doctor has told you. Check with your
doctor or pharmacist if you are not sure.
People with high blood pressure often do
not notice any signs of this problem.
Many may feel quite normal. This makes it
all the more important for you to keep
your appointments with the doctor even if
you are feeling well.

If you stop taking Valsartan
Stopping your treatment with Valsartan
may cause your disease to get worse. Do
not stop taking your medicine unless your
doctor tells you to.
If you have further questions on the use
of this product, ask your doctor or
pharmacist.

4 POSSIBLE SIDE EFFECTS

Like all medicines, Valsartan can cause
side effects, although not everybody gets
them.
Valsartan 80 mg, 160 mg and 320 mg
These side effects may occur with certain
Film-coated Tablets:
frequencies, which are defined as follows:
Adults with high blood pressure: The Very common: may affect more than 1 in
recommended dose is 80 mg daily. In
10 people
some cases your doctor may prescribe
Common:
may affect up to 1 in 10
higher doses (e.g. 160 mg or 320 mg). He
people
may also combine Valsartan with an
Uncommon: may affect up to 1 in 100
additional medicine (e.g. a diuretic).
people
Rare:
may affect up to 1 in 1000
Valsartan 40 mg, 80 mg, 160 mg and
people
320 mg Film-coated Tablets:
may affect up to 1 in 10,000
Use in children and adolescents (6 to Very rare:
people
18 years of age) with high blood
Not known: frequency cannot be
pressure: In patients who weigh less
estimated from the
than 35 kg the usual dose is 40 mg of
available data.
valsartan once daily. In patients who
weigh 35 kg or more the usual starting
Some symptoms need immediate
dose is 80 mg of valsartan once daily. In
medical attention:
some cases your doctor may prescribe
You may experience symptoms of
higher doses (the dose can be increased
angioedema (a specific allergic reaction),
to 160 mg and to a maximum of 320 mg). such as
• swollen face, lips, tongue or throat
Valsartan 40 mg, 80 mg and 160 mg
• difficulty in breathing or swallowing
Film-coated Tablets:
• hives, itching.
Adult patients after a recent heart
attack: After a heart attack the treatment If you get any of these, see a doctor
immediately.
is generally started as early as after 12
hours, usually at a low dose of 20 mg
Side effects include:
twice daily. You obtain the 20 mg dose by Common:
dividing the 40 mg tablet. Your doctor will • dizziness
increase this dose gradually over several • low blood pressure with or without
weeks to a maximum of 160 mg twice
symptoms such as dizziness and
daily. The final dose depends on what you
fainting when standing up
as an individual patient can tolerate.
• decreased kidney function (signs of
Valsartan can be given together with
renal impairment).
other treatment for heart attack, and your
Uncommon:
doctor will decide which treatment is
• angioedema (see section “Some
suitable for you.
symptoms need immediate medical
Adult patients with heart failure:
attention”)
Treatment starts generally with 40 mg
• sudden loss of consciousness (syncope)
twice daily. Your doctor will increase the
• spinning sensation (vertigo)
dose gradually over several weeks to a
maximum of 160 mg twice daily. The final • severely decreased kidney function
(signs of acute renal failure)
dose depends on what you as an
• muscle spasms, abnormal heart rhythm
individual patient can tolerate.
(signs of hyperkalaemia)
Valsartan can be given together with
• breathlessness, difficulty breathing
other treatment for heart failure, and your
when lying down, swelling of the feet or
doctor will decide which treatment is
legs (signs of cardiac failure)
suitable for you.
• headache
You can take Valsartan with or without food. • cough
Swallow Valsartan with a glass of water.
• abdominal pain
Take Valsartan at about the same time
• nausea
each day.
• diarrhoea
The tablet can be divided into equal halves. • tiredness
If you take more Valsartan than you should • weakness.
If you experience severe dizziness and/or Not known:
fainting, contact your doctor immediately • allergic reaction with rash, itching and
and lie down. If you have accidentally
hives, or symptoms of fever, swollen
taken too many tablets, contact your
joints and joint pain, muscle pain,
doctor, pharmacist, or hospital.
swollen lymph nodes and/or flu-like
symptoms may occur (signs of serum
If you forget to take Valsartan
If you forget to take a dose, take it as soon sickness)
as you remember. However, if it is almost • purplish-red spots, fever, itching (signs
of inflammation of blood vessels also
time for your next dose, skip the dose you
called vasculitis)
missed. Do not take a double dose to
• unusual bleeding or bruising (signs of
make up for a forgotten dose.
thrombocytopenia)

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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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