DIOVAN 160 MG FILM-COATED TABLETS

Active substance: VALSARTAN

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5. How to store Diovan
6. Further information

1. WHAT DIOVAN IS AND WHAT IT IS USED FOR
PACKAGE LEAFLET: INFORMATION FOR THE USER

Diovan 80 and 160 mg
film-coated tablets
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 Diovan is and what it is used for
2. Before you take Diovan
3. How to take Diovan
4. Possible side effects

Diovan belongs to a class of medicines known as angiotensin II
receptor antagonist, 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. Diovan
works by blocking the effect of angiotensin II. As a result, blood
vessels relax and blood pressure is lowered.
Diovan 80 mg and 160 mg film-coated tablets can be used for
three different conditions:
• to treat high blood pressure in adult 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, 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.
• to treat symptomatic heart failure in adult patients.
Diovan 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 beta blockers (another medication to
treat heart failure) cannot be used.

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2. BEFORE YOU TAKE DIOVAN
Do not take Diovan:
• if you are allergic (hypersensitive) to valsartan or any of the
other ingredients of Diovan 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 Diovan in early pregnancy – see pregnancy section).
If any of these apply to you, do not take Diovan

Take special care with Diovan:
• 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 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 Diovan, stop

taking Diovan 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 are below 18 years of age and you take Diovan 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 Diovan is not recommended.
• if you have lost a lot of fluid (dehydration) caused by diarrhoea,
vomiting, or high doses of water tablets (diuretics).
• you must tell your doctor if you think you are (or might become)
pregnant. Diovan 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 any of these apply to you, tell your doctor before you
take Diovan.

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

The effect of the treatment can be influenced if Diovan 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 antiinflammatory medicines (NSAIDs).
• some antibiotics (rifamycin group), a drug used to protect
against transplant rejection (ciclosporin) or an antiretroviral
drug used to treat HIV/AIDS infection (ritonavir). These drugs
may increase the effect of Diovan.
• 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 for heart failure, a triple combination
with ACE inhibitors and beta blockers (medications to treat
heart failure) is not recommended.

Taking Diovan with food and drink
You can take Diovan 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 Diovan before you become pregnant
or as soon as you know you are pregnant, and will advise you
to take another medicine instead of Diovan. Diovan 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. Diovan 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 Diovan affects you. Like many other medicines
used to treat high blood pressure, Diovan may in rare cases
cause dizziness and affect the ability to concentrate.

3. HOW TO TAKE DIOVAN
Always take Diovan 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.
Adult patients 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 Diovan
with an additional medicine (e.g. a diuretic).
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).
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.
Diovan can be given together with other treatment for heart
attack, and your doctor will decide which treatment is suitable
for you.
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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.

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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.
Diovan can be given together with other treatment for heart
failure, and your doctor will decide which treatment is suitable
for you.
You can take Diovan with or without food. Swallow Diovan with
a glass of water.
Take Diovan at about the same time each day.

If you take more Diovan 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 Diovan
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 Diovan
Stopping your treatment with Diovan 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, Diovan 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 (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 symptoms, stop taking Diovan and
contact your doctor straight away (see also section 2
“Take special care with Diovan”).

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)

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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 reactions with rash, itching and hives; 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)

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386700 GB LFT

Dimension:

(297x2) x 148 mm

Replaced no.: n.a.

Drawing no.:

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Product:

Leaflet DIOVAN FCT 80 MG & 160 MG
2X14 GB

Colours:

Black

ISO-Code:

GB

Code-no.:

n.a.

Proof date:

29.11.2012

Used fonts:

News Gothic MT Condensed,
News Gothic MT Bold Condensed,

Technical approval. To be signed by Manufacturing Site.
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Smallest font size/line spacing/scale:
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Smallest vectorized text:

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Receiving plant:

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10 pt/12,5 pt/100% Body text (News Gothic MT Condensed)
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This information was compiled with utmost care and on completion was subjected to strict internal checks. However, the
handling of data always involves a certain degree of risk and the impossibility of error cannot be guaranteed. Therefore
we would ask you to check the proof thoroughly. Pharma print design GmbH assumes no liability for errors identified
only after print approval has been given.

4. Proof

P. Amtag

Page 2 / 2

• 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)
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.

5. HOW TO STORE DIOVAN
• Do not store above 30°C. Store in the original package in order
to protect from moisture.

• Keep out of the reach and sight of children.
• Do not use Diovan after the expiry date which is stated on the
pack. The expiry date refers to the last day of that month.
• Do not use Diovan 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.

and “NVR” on the reverse side of the tablet. The tablet can be
divided into equal halves.

This medicinal product is authorised in the Member
States of the EEA under the following names:

The tablets are supplied in blister packs of 7, 14, 28, 30, 56,
90 or 98 tablets and in calendar blister packs of 14, 28, 56,
98 and 280 tablets. Perforated unit dose blister packs of 56x1,
98x1 or 280x1 tablets are also available.

6. FURTHER INFORMATION

The product licence holder is:
Novartis Pharmaceuticals UK Limited
Trading as:
Ciba Laboratories
Frimley Business Park, Frimley, Camberley, Surrey,
GU16 7SR, United Kingdom.

Member State EU / EEA
Austria, Bulgaria, Cyprus, Czech Republic,
Denmark, Estonia, Finland, Germany,
Greece, Hungary, Iceland, Ireland, Latvia,
Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal,
Romania, Slovak Republic, Slovenia,
Spain, Sweden, United Kingdom
Belgium
France, Italy
Spain

What Diovan contains
The active substance is valsartan.
One film-coated tablet contains 80 mg or 160 mg valsartan.
The other ingredients are microcrystalline cellulose, crospovidone
type A, colloidal anhydrous silica, magnesium stearate.
The tablet coating contains hypromellose, titanium dioxide
(E 171), macrogol 8000, iron oxide red (E 172), iron oxide yellow
(E 172), iron oxide black (E 172, only 160 mg).

What Diovan looks like and contents of the pack
Diovan 80 mg film-coated tablets are pale red, round tablets
that are scored on one side. They have the letters “D” on one
side of the score and “V” on the other side of the score and
“NVR” on the reverse side of the tablet. The tablet can be
divided into equal halves.
Diovan 160 mg film-coated tablets are grey-orange, ovaloid
tablets that are scored on one side. They have the letters “DX”
on one side of the score and “DX” on the other side of the score

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Diovan Tablets are released onto the market by:
Novartis Pharmaceuticals UK Limited
Wimblehurst Road
Horsham, West Sussex
RH12 5AB, United Kingdom

(Invented) Name
Diovan

Diovane
Tareg
Diovan Cardio

This leaflet was last revised in November 2012

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.

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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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