VALSARTAN 80MG FILM COATED TABLETS

Active substance: VALSARTAN

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• 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).

Do not use Valsartan if you notice that the
pack is damaged or shows signs of
tampering.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines
no longer required. These measures will
help to protect the environment.

Marketing Authorisation Holder and
Manufacturer
Teva UK Limited, Eastbourne, BN22 9AG,
United Kingdom.
This leaflet was last revised in
October 2011
PL 00289/1235, 1236, 1237 & 1238

6 FURTHER 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).
88210-B
320 x 323

VALSARTAN 40 mg FILM-COATED Valsartan 80 mg film-coated tablets can
be used for three different conditions:
TABLETS
VALSARTAN 80 mg FILM-COATED • to treat high blood pressure in adults
and in children and adolescents 6 to 18
TABLETS
years of age. High blood pressure
VALSARTAN 160 mg FILM-COATED
increases the workload on the heart and
TABLETS
arteries. If not treated it can damage the
VALSARTAN 320 mg FILM-COATED
blood vessels of the brain, heart, and
TABLETS

kidneys, and may result in a stroke,
heart failure, or kidney failure. High
blood pressure increases the risk of
heart attacks. Lowering your blood
Read all of this leaflet carefully before you
pressure to normal reduces the risk of
start taking this medicine.
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
you. Do not pass it on to others. It may • to treat symptomatic heart failure in
adult patients. Valsartan is used when a
harm them, even if their symptoms are
group of medicines called Angiotensin
the same as yours.
Converting Enzyme (ACE) inhibitors (a
• If any of the side effects gets serious, or
medication to treat heart failure) cannot
if you notice any side effects not listed
be used or it may be used in addition to
in this leaflet, please tell your doctor or
ACE inhibitors when beta blockers
pharmacist.
(another medication to treat heart failure)
IN THIS LEAFLET:
cannot be used. Heart failure symptoms
include shortness of breath, and swelling
1. What Valsartan is and what it is used
of the feet and legs due to fluid build-up.
for
It is caused when the heart muscle cannot
2. Before you take Valsartan
pump blood strongly enough to supply all
3. How to take Valsartan
the blood needed throughout the body.
4. Possible side effects
PACKAGE LEAFLET: INFORMATION
FOR THE USER

5. How to store Valsartan
6. Further information

Valsartan 160 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
1 WHAT VALSARTAN IS AND WHAT
IT IS USED FOR
years of age. High blood pressure
increases the workload on the heart and
Valsartan belongs to a class of medicines
arteries. If not treated it can damage the
known as angiotensin II receptor
blood vessels of the brain, heart, and
antagonist, which help to control high
kidneys, and may result in a stroke,
blood pressure. Angiotensin II is a
heart failure, or kidney failure. High
substance in the body that causes vessels
blood pressure increases the risk of
to tighten, thus causing your blood
heart attacks. Lowering your blood
pressure to increase.
pressure to normal reduces the risk of
Valsartan works by blocking the effect of
developing these disorders.
angiotensin II. As a result, blood vessels
• to treat adult patients after a recent
relax and blood pressure is lowered.
heart attack (myocardial infarction).
Valsartan 40 mg film-coated tablets can
“Recent” here means between 12 hours
be used for three different conditions:
and 10 days.
• to treat high blood pressure in children • to treat symptomatic heart failure in
and adolescents 6 to 18 years of age.
adult patients. Valsartan is used when a
High blood pressure increases the
group of medicines called Angiotensin
workload on the heart and arteries. If
Converting Enzyme (ACE) inhibitors (a
not treated it can damage the blood
medication to treat heart failure) cannot
vessels of the brain, heart, and kidneys,
be used or it may be used in addition to
and may result in a stroke, heart failure,
ACE inhibitors when beta blockers
or kidney failure. High blood pressure
(another medication to treat heart
increases the risk of heart attacks.
failure) cannot be used. Heart failure
Lowering your blood pressure to
symptoms include shortness of breath,
normal reduces the risk of developing
and swelling of the feet and legs due to
these disorders.
fluid build-up. It is caused when the
• to treat adults patients after a recent
heart muscle cannot pump blood
heart attack (myocardial infarction).
strongly enough to supply all the blood
“Recent” here means between 12 hours
needed throughout the body.
and 10 days.
Valsartan 320 mg film-coated tablets can
• to treat symptomatic heart failure in
adult patients. Valsartan is used when a be used
• to treat high blood pressure in adults
group of medicines called Angiotensin
and in children and adolescents 6 to 18
Converting Enzyme (ACE) inhibitors (a
years of age. High blood pressure
medication to treat heart failure) cannot
increases the workload on the heart and
be used or it may be used in addition to
arteries. If not treated it can damage the
ACE inhibitors when beta blockers
blood vessels of the brain, heart, and
(another medication to treat heart failure)
kidneys, and may result in a stroke, heart
cannot be used. Heart failure symptoms
failure, or kidney failure. High blood
include shortness of breath, and swelling
pressure increases the risk of heart attacks.
of the feet and legs due to fluid build-up.
Lowering your blood pressure to normal
It is caused when the heart muscle cannot
reduces the risk of developing these
pump blood strongly enough to supply all
disorders.
the blood needed throughout the body.
Peel Here To Open

Pharma code 123

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 filmcoated 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”
The frequency of some side effects may
on the other side of the score line.
vary depending on your condition. For
Available in pack sizes of 1, 14, 15, 28, 30,
example, side effects such as dizziness,
56, 60, 84, 90, 98, 100 and 280 film- coated
and decreased kidney function, were seen tablets. Hospital pack: 50 film-coated
less frequently in adult patients treated
tablets. Calendar pack of 28 and 98
with high blood pressure than in adult
tablets.
patients treated for heart failure or after a Valsartan 160 mg Film-coated Tablets are
recent heart attack.
yellow, oval-shaped, film-coated tablets,
scored on one side and debossed with
Side effects in children and adolescents
“V” on one side of the score line and
are similar to those seen in adults.
“160” on the other side of the score line.
If any of the side effects gets serious, or if Available in pack sizes of 1, 14, 15, 28, 30,
you notice any side effects not listed in
56, 60, 84, 90, 98, 100 and 280 film- coated
this leaflet, please tell your doctor or
tablets. Hospital pack: 50 film-coated
pharmacist.
tablets. Calendar pack of 28 and 98
tablets.
HOW TO STORE VALSARTAN
5
Valsartan 320 mg Film-coated Tablets are
Keep out of the reach and sight of
purple, oval-shaped, film-coated tablets,
children.
scored on one side and debossed with
Do not use Valsartan after the expiry date “V” on one side of the score line and
“320” on the other side of the score line.
which is stated on the carton and blister
after EXP The expiry date refers to the last Available in pack sizes of 1, 7, 10, 14, 15,
.
20, 28, 30, 50, 56, 84, 90, 98, 100, 280
day of that month.
film-coated tablets. Hospital pack: 50, 56 x
Do not store above 25°C. Store in the
1, 98 x 1 and 280 x 1 film-coated tablets.
original package in order to protect from
Not all pack sizes may be marketed.
moisture.

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2 BEFORE YOU TAKE VALSARTAN
Do not take Valsartan
• if you are allergic (hypersensitive) to
valsartan (active ingredient) or any of
the other ingredients of this medicinal
product listed at the end of this leaflet
• if you have severe liver disease
• if you are more than 3 months
pregnant, (it is also better to avoid
Valsartan in early pregnancy - see
pregnancy section).
If any of these apply to you, do not take
Valsartan.

• medicines that increase the amount of
potassium in your blood. These include
potassium supplements or salt
substitutes containing potassium,
potassium-sparing medicines and
heparin
• certain type of pain killers called
non-steroidal anti-inflammatory
medicines (NSAIDs)
• lithium, a medicine used to treat some
types of psychiatric illness.

In addition for Valsartan 40 mg, 80 mg
and 160 mg Film-Coated Tablets:
• if you are being treated after a heart
attack, a combination with ACE
Take special care with Valsartan
inhibitors (a medication to treat heart
Talk to your doctor before you start to
attack) is not recommended
take this medicine:
• if you are being treated for heart failure,
• if you have liver disease
a triple combination with ACE inhibitors
• if you have a severe kidney disease or if
and beta blockers (medications to treat
you are undergoing dialysis
heart failure) is not recommended.
• if you are suffering from a narrowing of
the kidney artery
Taking Valsartan with food and drink
• if you have recently had a kidney
You can take Valsartan with or without
transplantation (received a new kidney) food.
• if you are treated after a heart attack or
for heart failure, your doctor may check Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice
your kidney function
before taking any medicine.
• if you have severe heart disease other
• You must tell your doctor if you think
than heart failure or heart attack
you are (or might become) pregnant.
• if you are taking medicines that increase
Your doctor will normally advise you to
the amount of potassium in your blood.
stop taking Valsartan before you become
These include potassium supplements
pregnant or as soon as you know you
or salt substitutes containing potassium,
are pregnant, and will advise you to
potassium-sparing medicines and
take another medicine instead of
heparin. It may be necessary to check
Valsartan. Valsartan is not
the amount of potassium in your blood
recommended in early pregnancy, and
at regular intervals
must not be taken when more than 3
• if you are below 18 years of age and
months pregnant, as it may cause
you take Valsartan in combination with
serious harm to your baby if it is used
other medicines that inhibit the renin
after the third month of pregnancy.
angiotensin aldosterone system
(medicines that lower blood pressure), • Tell your doctor if you are
breast-feeding or about to start
your doctor may check your kidney
breast-feeding. Valsartan is not
function and the amount of potassium
recommended for mothers who are
in your blood at regular intervals
breast-feeding, and your doctor may
• if you suffer from aldosteronism. This is
choose another treatment for you if you
a disease in which your adrenal glands
wish to breast-feed, especially if your
make too much of the hormone
baby is newborn, or was born
aldosterone. If this applies to you, the
prematurely.
use of Valsartan is not recommended
• if you have lost a lot of fluid (dehydration) Driving and using machines
caused by diarrhoea, vomiting, or high Before you drive a vehicle, use tools or
doses of water tablets (diuretics)
operate machines, or carry out other
• you must tell your doctor if you think
activities that require concentration, make
you are (or might become) pregnant.
sure you know how Valsartan affects you.
Valsartan is not recommended in early
pregnancy, and must not be taken if you Like many other medicines used to treat
are more than 3 months pregnant, as it high blood pressure, Valsartan may in rare
may cause serious harm to your baby if cases cause dizziness and affect the ability
to concentrate.
used at that stage (see pregnancy
section).
Important information about some
If any of these apply to you, tell your
ingredients of Valsartan 320 mg
doctor before you take Valsartan.
Film-Coated Tablets:
This medicinal product contains sunset
Taking other medicines
yellow FCF (E110) and may cause allergic
Please tell your doctor or pharmacist if
you are taking or have recently taken any reactions.
other medicines, including medicines
3 HOW TO TAKE VALSARTAN
obtained without a prescription.
The effect of the treatment can be
Always take Valsartan exactly as your
influenced if Valsartan is taken together
doctor has told you in order to get the
with certain other medicines. It may be
best results and reduce the risk of side
necessary to change the dose, to take
effects. You should check with your doctor
other precautions, or in some cases to
or pharmacist if you are not sure. People
stop taking one of the medicines. This
with high blood pressure often do not
applies to both prescription and
notice any signs of this problem. Many
non-prescription medicines, especially:
may feel quite normal. This makes it all
• other medicines that lower blood
the more important for you to keep your
pressure, especially water tablets
appointments with the doctor even if you
(diuretics)
are feeling well.

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

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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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