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VALSARTAN 320MG FILM COATED TABLETS

Active substance(s): VALSARTAN / 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)

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

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 this medicine 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..

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 UK Ltd, Brampton Road, Hampden
Park, Eastbourne, East Sussex, BN22 9AG
England
This leaflet was last revised in 06/ 2017
PL 00289/1235, 1236, 1237 & 1238

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 and 160 mg: yellow
iron oxide (E172), 80 and 160 mg: red iron
oxide (E172), 320 mg: red iron oxide
(E172), indigotine (E132), sunset yellow
FCF (E110).

EAS1389a
88210-E
323 x 320

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

Valsartan 40 mg
Film-coated Tablets
Valsartan 80 mg
Film-coated Tablets
Valsartan 160 mg
Film-coated Tablets
Valsartan 320 mg
Film-coated Tablets

Peel Here To Open

06-Sep-2017

Pharma code 652

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 Valsartan 160 mg Film-coated Tablets are
for heart failure or after a recent heart attack. yellow, oval-shaped, film-coated tablets,
scored on one side and debossed with “V”
Side effects in children and adolescents are
on one side of the score line and “160” on
similar to those seen in adults.
the other side of the score line. Available in
If any of the side effects gets serious, or if
pack sizes of 1, 14, 15, 28, 30, 56, 60, 84, 90,
you notice any side effects not listed in this 98, 100 and 280 film-coated tablets. Hospital
leaflet, please tell your doctor or
pack: 50 film-coated tablets. Calendar pack
pharmacist.
of 28 and 98 tablets.

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If any of these apply to you, do not take
Valsartan
Warnings and precautions
Talk to your doctor or pharmacist before
taking Valsartan:
- if you have liver disease
- if you have a severe kidney disease or if
you are undergoing dialysis
- if you are suffering from a narrowing of
the kidney artery
- if you have recently had a kidney
transplantation (received a new kidney).
- if you are treated after a heart attack or for
heart failure, your doctor may check your
kidney function.
- if you have severe heart disease other
than heart failure or heart attack.
- if you are taking medicines that increase
the amount of potassium in your blood.
These include potassium supplements or
salt substitutes containing potassium,
potassium-sparing medicines and
heparin. It may be necessary to check the
amount of potassium in your blood at
regular intervals.
- if you are below 18 years of age and you
take Valsartan 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.
- if you suffer from aldosteronism. This is a
disease in which your adrenal glands
make too much of the hormone
aldosterone. If this applies to you, the use
of Valsartan is not recommended.
- if you have lost a lot of fluid (dehydration)
caused by diarrhoea, vomiting, or high
doses of water tablets (diuretics).
if you have ever experienced swelling of
the tongue and face caused by an allergic
reaction called angioedema when taking
another drug (including ACE inhibitors),
tell your doctor. If these symptoms occur
when you are taking Valsartan, stop taking
Valsartan immediately and never take it
again. (see section 4, “Possible side
effects”).
- you must tell your doctor if you think you
are (or might become) pregnant. Valsartan
is not recommended in early pregnancy,
and must not be taken if you are more
than 3 months pregnant, as it may cause
serious harm to your baby if used at that
stage (see section 2: Pregnancy,
breast-feeding and fertility).
- if you are taking any of the following
medicines used to treat high blood
pressure:
- an ACE-inhibitor (for example
enalapril, lisinopril, ramipril), in particular
if you have diabetes-related kidney
problems
- aliskiren
In addition for Valsartan 40mg, 80mg and
160mg film coated tablets
- if you are being treated with an
ACE-inhibitor together with certain other
medicines to treat your heart failure,
which are known as mineralocorticoid
receptors antagonists (MRA) (for example
spironolactone, eplerenone) or
betablockers (for example metoprolol)
- Your doctor may check your kidney
function, blood pressure, and the amount
of electrolytes (e.g. potassium) in your
blood at regular intervals.
See also information under the heading ‘Do
not take [Valsartan]'.
If any of these apply to you, tell your doctor
before you take Valsartan.

Other medicines and ValsartanTell your
doctor or pharmacist if you are taking have
recently taken or might take any other
medicines.
The effect of the treatment can be influenced
if Valsartan is taken together with certain
other medicines. It may be necessary to
change the dose, to take other precautions,
or in some cases to stop taking one of the
medicines. This applies to both prescription
and non-prescription medicines, especially:
- other medicines that lower blood pressure,
especially water tablets (diuretics).
- 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.
Your doctor may need to change your dose
and/or to take other precautions:
If you are taking an ACE-inhibitor or
aliskiren (see also information under the
headings ‘Do not take
[Valsartan]' and 'Warnings and
precautions').
In addition for Valsartan 40mg, 80 mg and
160 mg Film-Coated Tablets:
- if you are being treated after a heart
attack, a combination with ACE inhibitors
(a medication to treat heart attack) is not
recommended.
- if you are being treated with an
ACE-inhibitor together with certain other
medicines to treat your heart failure,
which are known as mineralocorticoid
receptors antagonists (MRA) (for example
spironolactone, eplerenone) or
betablockers (for example metoprolol).
Valsartan with food and drink
You can take Valsartan with or without food.
Pregnancy, breast-feeding and fertility
If 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
Ask your doctor or pharmacist for advice
before taking any medicine.
- You must tell your doctor if you think you
are (or might become) pregnant. Your
doctor will normally advise you stop
taking Valsartan before you become
pregnant or as soon as you know you are
pregnant, and will advise you to take
another medicine instead of Valsartan.
Valsartan is not recommended in early
pregnancy, and must not be taken when
more than 3 months pregnant, as it may
cause serious harm to your baby if it is
used after the third month of pregnancy.
- Tell your doctor if you are breast-feeding
or about to start breast-feeding. Valsartan
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
Before you drive a vehicle, use tools or
operate machines, or carry out other
activities that require concentration, make
sure you know how Valsartan affects you.
Like many other medicines used to treat
high blood pressure, Valsartan may in rare
cases cause dizziness and affect the ability
to concentrate.

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Valsartan 320 mg Film-Coated Tablets
If you have any further questions on the use
contains sunset yellow FCF (E110):
of this medicine, ask your doctor or
This medicinal product contains sunset yellow pharmacist.
FCF (E110) and may cause allergic reactions.

3 How to take Valsartan
Always take this medicine 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.
Valsartan 80 mg, 160 mg and 320 mg
Film-Coated Tablets:
Adults with high blood pressure: The
recommended 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).

4 Possible side effects

Like all medicines, this medicine can cause
side effects, although not everybody gets
them.

These side effects may occur with certain
frequencies, which are defined as follows:
Very common: may affect more than 1
in 10 people
Common:
may affect up to 1in 10
people
Uncommon:
may affect up to 1 in 100
people
Rare:
may affect up to 1 in 1000
people
Very rare:
may affect up to 1 in 10,000
people
Not known:
frequency cannot be
estimated from the
Valsartan 40 mg, 80 mg, 160 mg and 320 mg
available data
Film-Coated Tablets:
Some symptoms need immediate medical
Use in children and adolescents (6 to 18
attention:
years of age) with high blood pressure: In
You may experience symptoms of
patients who weigh less than 35 kg the
usual dose is 40 mg of valsartan once daily. angioedema (a specific allergic reaction),
such as
In patients who weigh 35 kg or more the
- swollen face, lips, tongue or throat
usual starting dose is 80 mg of valsartan
- difficulty in breathing or swallowing
once daily. In some cases your doctor may
- hives, itching
prescribe higher doses (the dose can be
If you get any of these, see a doctor
increased to 160 mg and to a maximum of
immediately.
320 mg).
Valsartan 40mg, 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.

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)
Adult patients with heart failure: Treatment - muscle spasms, abnormal heart rhythm
starts generally with 40 mg twice daily. Your
(signs of hyperkalaemia)
doctor will increase the dose gradually over - breathlessness, difficulty breathing when
several weeks to a maximum of 160 mg
lying down, swelling of the feet or legs
twice daily. The final dose depends on what
(signs of cardiac failure)
you as an individual patient can tolerate.
- headache
Valsartan can be given together with other
- cough
treatment for heart failure, and your doctor - abdominal pain
will decide which treatment is suitable for you. - nausea
You can take Valsartan with or without food. - diarrhea
- tiredness
Swallow Valsartan with a glass of water.
Take Valsartan at about the same time each - weakness
day.
Not known:
The tablet can be divided into equal doses. - 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
If you experience severe dizziness and/or
lymph nodes and/or flu-like symptoms
fainting, contact your doctor immediately
may occur (signs of serum sickness)
and lie down. If you have accidentally taken
- 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
- unusual bleeding or bruising (signs of
If you forget to take a dose, take it as soon
thrombocytopenia)
as you remember. However, if it is almost
- muscle pain (myalgia)
time for your next dose, skip the dose you
- fever, sore throat or mouth ulcers due to
missed. Do not take a double dose to make
infections (symptoms of low level of white
up for a forgotten dose.
blood cells also called neutropenia)
decrease
of level of haemoglobin and
If you stop taking Valsartan
decrease of the percentage of red blood
Stopping your treatment with Valsartan may
cells
in
the
blood (which can lead to
cause your disease to get worse. Do not
anaemia in severe cases)
stop taking your medicine unless your
doctor tells you to.

06-Sep-2017

Expand Transcript

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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