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VALSARTAN 160 MG FILM-COATED TABLETS

Active substance(s): VALSARTAN

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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 because it contains
important information for you.

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 only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.
What Diovan is and what it is used for
2.
What you need to know before you take Diovan
3.
How to take Diovan
4.
Possible side effects
5.
How to store Diovan
6.
Contents of the pack and other information

1.

What Diovan is and what it is used for

Diovan contains the active substance: valsartan and 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 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.

2.

What you need to know before you take Diovan

Do not take Diovan:

if you are allergic (hypersensitive) to valsartan or any of the other ingredients of this medicine
(listed in section 6).

if you have severe liver disease.

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if you are more than 3 months pregnant (it is also better to avoid Diovan 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 the above apply to you, tell your doctor and do not take Diovan.
Warnings and precautions:
Talk to your doctor

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 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 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).

if you are taking any of the following medicines used to treat high blood pressure:
o an ACE inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have
diabetes-related kidney problems.
o Aliskiren
o 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 Diovan”
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).
Other medicines and Diovan
Tell 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 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:

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other medicines that lower blood pressure, especially water tablets (diuretics), ACE
inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also information under the
headings “Do not take Diovan” and “Warnings and precautions”).
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 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
other medicines to treat your heart failure which are known as mineralocorticoid
receptors antagonists (MRA) (for example spironolactone, epleronone) or beta blockers
(for example metoprolol) is not recommended.
Pregnancy, breast-feeding and fertility

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.
Patients who are concerned about their fertility while taking Diovan are advised to consult with
their doctor.

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 this medicine exactly as your doctor has told you in order to get the best results and
reduce the risk of side effects. 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 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 Diovan with
an additional medicine (e.g. a diuretic).

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Children and adolescents (6 to 18 years of age) with high blood pressure
In patients who weigh less than 35 kg the recommended dose is 40 mg of valsartan once daily.
In patients who weigh 35 kg or more the recommended 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.
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 medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious and 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 “Warning and precautions”).
Other side effects include:

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Common (may affect up to 1 in 10 people):

dizziness

low blood pressure with or without symptoms such as dizziness and fainting when standing up

decreased kidney function (signs of renal impairment)
Uncommon (may affect up to 1 in 100 people):

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 (frequency cannot be estimated from the available data):

blistering skin (sign of dermatitis bullous)

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)

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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly (see details below. By reporting side
effects you can help provide more information on the safety of this medicine.

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United Kingdom

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

5.

How to store Diovan







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. The expiry date
refers to the last day of that month.
Do not store above 30°C. Store in the original package in order to protect from moisture.
Do not use this medicine 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 Diovan contains
The active substance is valsartan. Each 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 score line is only to facilitate breaking for ease of swallowing and not
to divide into equal doses.
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 and “NVR” on
the reverse side of the tablet. The score line is only to facilitate breaking for ease of swallowing and
not to divide into equal doses.
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.
Not all pack sizes may 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.
Diovan Tablets are released onto the market by:
Novartis Pharmaceuticals UK Limited

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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 medicinal product is authorised in the Member States of the EEA under the following
names:
Member State EU / EEA

(Invented) Name

Austria, Bulgaria, Croatia, Cyprus, Czech Republic,
Denmark, Estonia, Finland, Germany, Greece, Hungary,
Iceland, Ireland, Latvia, Lithuania, Malta, Netherlands,
Norway, Poland, Portugal, Romania, Slovak Republic,
Slovenia, Spain, Sweden, United Kingdom

Diovan

Belgium, Luxembourg

Diovane

France, Italy

Tareg

Spain

Diovan Cardio

This leaflet was last revised in April 2015.

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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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