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DIOVAN 40MG CAPSULES

Active substance: VALSARTAN

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Valsartan 40 mg, 80 mg
and 160 mg Capsules

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Valsartan

Read all of this leaflet carefully before you start
taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.
• 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.
In this leaflet:
1. What Valsartan is and what it is used for
2. Before you take Valsartan
3. How to take Valsartan
4. Possible side effects
5. How to store Valsartan
6. Further information

1. WHAT VALSARTAN IS AND WHAT IT IS USED
FOR

Valsartan belongs to a class of medicines known as
angiotensin II receptor antagonists, which help to control high
blood pressure. Angiotensin II is a substance in the body that
causes vessels to tighten, thus causing your blood pressure to
increase. Valsartan works by blocking the effect of angiotensin
II. As a result, blood vessels relax and blood pressure is
lowered.

Valsartan 40, 80 and 160 mg Capsules can be used
• to treat people after a recent heart attack (myocardial
infarction). “Recent” here means between 12 hours and 10
days.
• to treat symptomatic heart failure in adult patients.
Valsartan is used when a group of medicines called
Angiotensin Converting Enzyme (ACE) inhibitors (a
medication to treat heart failure) cannot be used or it may be
used in addition to ACE inhibitors when other medications to
treat heart failure cannot be used. Heart failure symptoms
include shortness of breath, and swelling of the feet and legs
due to fluid build-up. It is caused when the heart muscle

cannot pump blood strongly enough to supply all the blood
needed throughout the body.

recommended.
• If you have lost a lot of fluid (dehydration) caused by
diarrhoea, vomiting, or high doses of water pills (diuretics).
• The use of Valsartan in children and adolescents below the
age of 18 years is not recommended.
• 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 pregnancy section).
• if you are taking any of the following medicines used to treat
high blood pressure:
- an ACE inhibitors (for example enalapril, lisinopril,
ramipril), in particular if you have diabetes-related kidney
problems.
- aliskiren
- 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).

In addition
Valsartan 80 and 160 mg Capsules can be used
• to treat high blood pressure. 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, 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.

2. BEFORE YOU TAKE VALSARTAN

Do not take Valsartan:
• if you are allergic (hypersensitive) to valsartan or any of the
other ingredients of Valsartan. These are listed in Section 6.
• 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 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, speak to your doctor.

You must be especially careful and talk to your
doctor before taking Valsartan if any of the
following apply to you.
• If you have liver disease.
• If you have severe kidney disease or if you are undergoing
dialysis.
• If you are suffering from a narrowing of the kidney artery.
• If you have recently undergone kidney transplantation
(received a new kidney).
• If you are being 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 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 also section 4, “Possible side effects”.
• 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 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

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.

Taking other medicines
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines, including medicines
obtained without a prescription.

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 pills (diuretics), ACE inhibitors (such as enalapril,
lisinopril, etc.) or aliskiren (see also information under the
headings “Do not take Valsartan” and “Take special care with
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).
• some antibiotics (rifamycin group), a drug used to protect
against transplant rejection (ciclosporin) or an antiretroviral

Artwork Proof Box
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drug used to treat HIV/AIDS infection (ritonavir). These
drugs may increase the effect of Valsartan.
• lithium, a medicine used to treat some types of psychiatric
illness.

In addition:
• 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 receptor antagonists (MRA) (for
example spironolactone, epleronone) or beta blockers (for
example metoprolol) is not recommended.
Taking Valsartan with food and drink
You can take Valsartan with or without food.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine.
• You must tell your doctor if you think that you are (or
might become) pregnant. Your doctor will normally advise
you to 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.

3. HOW TO TAKE VALSARTAN

Always take Valsartan exactly as your doctor has told you in
order to get the best results and reduce the risk of side effects.
You should 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.

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. This low dose is provided by 40 mg
divisible tablets. 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.

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 treatments for heart
failure, and your doctor will decide which treatment is suitable
for you.
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).

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, lie down and
contact your doctor immediately.
If you have accidentally taken too many capsules, contact your
doctor, pharmacist, or hospital.

If you forget to take Valsartan
Do not take a double dose to make up for a forgotten dose. 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.

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

Not known:
• blistering skin (sign of dermatitis bullous)
• rash, itching, together with some of the following signs or
symptoms: fever, joint pain, muscle pain, swollen lymph
nodes and/or flu-like symptoms (signs of serum sickness)
• purple-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, in
severe cases, lead to anaemia)
• increase of level of potassium in the blood (which can, in
severe cases, trigger muscle spasms, abnormal heart
rhythm)
• elevation of liver function values (which can indicate liver
damage) including an increase of bilirubin in the blood
(which can, in severe cases, trigger yellow skin and eyes)
• 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)

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 angioedema, such as
• swollen face, tongue or throat
• difficulty in swallowing
• hives and difficulties in breathing
If you get any of these symptoms, stop taking
Valsartan and contact your doctor straight away (see also
section 2 “You must be especially careful and talk to your
doctor before taking Valsartan if any of the following apply
to you”).

Other side effects include:
Common:
• dizziness, postural dizziness
• low blood pressure with symptoms such as dizziness
• decreased kidney function (signs of renal impairment)

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 patients treated with high blood pressure than in
patients treated for heart failure or after a recent heart attack.
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.

Uncommon:
• allergic reaction with symptoms such as rash, itching,
dizziness, swelling of face or lips or tongue or throat,
difficulty breathing or swallowing (signs of angioedema)
• sudden loss of consciousness
• spinning sensation
• 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

5. HOW TO STORE VALSARTAN

• Keep your capsules in their original pack at a temperature
below 30°C. Protect from moisture and heat.
• Keep out of the reach and sight of children.
• Do not use Valsartan after the expiry date which is stated on
the pack. The expiry date refers to the last day of that
month.
• Do not use Valsartan if you notice that the pack is damaged
or shows signs of tampering.
• If your doctor tells you to stop taking Valsartan Capsules,
please take any unused capsules back to your pharmacist to
be destroyed. Do not throw them away with your normal
household water or waste. This will help to protect the
environment.

Artwork Proof Box
Ref: N010: Article 31, Type IB WS (PF 20140707) + update
Proof no.
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Date prepared:
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Colours:
Black
Dimensions: 300 x 180 mm

Font size:
7pt
Fonts:
Helvetica

6.

FURTHER INFORMATION

What Valsartan contains
Valsartan Capsules are available in three different strengths
containing either 40, 80 or 160 mg of the
active ingredient valsartan. The gelatin capsules also contain
the following inactive ingredients:
microcrystalline cellulose, polyvidone, crospovidone type A,
sodium lauryl sulfate and magnesium stearate.
Colouring materials used in the capsule shell and ink are
titanium dioxide (E171) and iron oxides (E172). The ink also
contains shellac and propylene glycol.

What Valsartan looks like and contents of the pack
Valsartan 40 mg Capsules are pale grey, marked CG HBH in
black ink on the cap. Pack sizes of 7 or 28
capsules are registered.
Valsartan 80 mg Capsules have a pale grey cap and flesh pink
body and are marked CG FZF in black ink on the cap. Pack
sizes of 28 or 98 capsules are registered.
Valsartan 160 mg Capsules have a dark grey cap and flesh
pink body and are marked CG GOG in white ink on the cap.
Pack sizes of 28 or 98 capsules are registered.
Some pack sizes may not be marketed.

Marketing Authorisation Holder and Manufacturer
The product licence holder is:
Novartis Pharmaceuticals UK Limited.
Trading as: Ciba Laboratories, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, United Kingdom.
The distributor is: Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, United Kingdom.
Valsartan Capsules are released onto the market by:
Novartis Pharmaceuticals UK Limited, Wimblehurst Road,
Horsham, West Sussex, RH12 5AB, United Kingdom or
Novartis Pharmaceuticals UK Limited, Frimley Business Park,
Frimley, Camberley, Surrey, GU16 7SR, United Kingdom.

If you would like any more information, or would like this leaflet
in a different format, please contact Medical
Information at Novartis Pharmaceuticals UK Ltd,
telephone number 01276 698370.
This leaflet was last revised in November 2014.

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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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