DIOVAN 40MG CAPSULES

Active substance: VALSARTAN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

40, 80 and 160 mg Capsules
Valsartan
Read all of this leaflet carefully before you start
taking this medicine.
• 
Keep this leaflet. You may need to read it again.
•  you have any further questions, ask your
If
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.
•  any of the side effects gets serious, or if you
If
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
5. How to store Diovan
6. Further information

1.  HAT DIOVAN IS AND WHAT IT IS USED FOR
W

Diovan 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.
Diovan works by blocking the effect of angiotensin II.
As a result, blood vessels relax and blood pressure
is lowered.
Diovan 40, 80 and 160 mg Capsules can be used
•  treat people after a recent heart attack
to
(myocardial infarction). “Recent” here means
between 12 hours and 10 days.
•  o treat symptomatic heart failure. Diovan is
t
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.
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.
In addition
Diovan 80 and 160 mg Capsules can be used
•  treat high blood pressure. High blood
to
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 DIOVAN
Do not take Diovan:

•  you are allergic (hypersensitive) to valsartan or
if
any of the other ingredients of Diovan. These are
listed in Section 6.
•  you have severe liver disease.
if
•  you are more than 3 months pregnant (it is
if
also better to avoid Diovan in early pregnancy —
see pregnancy section).
If any of these apply to you, speak to your doctor.
You must be especially careful and talk to your
doctor before taking Diovan if any of the following
apply to you.
• If you have liver disease.
•  you have severe kidney disease or if you are
If
undergoing dialysis.
•  you are suffering from a narrowing of the
If
kidney artery.
•  you have recently undergone kidney
If
transplantation (received a new kidney).
•  you are being treated after a heart attack or for
If
heart failure. Your doctor may check your
kidney function.
•  you have severe heart disease other than heart
If
failure or heart attack.
•  you have ever experienced swelling of the
If
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

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substitutes containing potassium, potassiumsparing medicines and heparin. It may be
necessary to check the amount of potassium in
your blood at regular intervals.
•  you suffer from aldosteronism. This is a
If
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.
•  you have lost a lot of fluid (dehydration)
If
caused by diarrhoea, vomiting, or high doses of
water pills (diuretics).
• 
The use of Diovan 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. 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).

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 pills (diuretics).
• edicines that increase the amount of
m
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:

•  you are being treated after a heart attack, a
if

combination with ACE inhibitors (a medication
to treat heart attack) is not recommended.
•  you are being treated for heart failure, a triple
if
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.
•  must tell your doctor if you think that you
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.
•  your doctor if you are breast-feeding or about
Tell
to start breast-feeding. Diovan is not
recommended for mothers who are breastfeeding, 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.
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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.
Diovan can be given together with other treatments
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.
Diovan can be given together with other treatment
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
Diovan with an additional medicine (e.g. a diuretic).
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,
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 Diovan
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 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, such as
• swollen face, tongue or throat
• difficulty in swallowing
• hives and difficulties in breathing
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”).
Other side effects include:
Common:
• dizziness, postural dizziness
• 
low blood pressure with symptoms such
as dizziness
• 
decreased kidney function (signs of
renal impairment)
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

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Not known:
• 
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)
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.

5. HOW TO STORE DIOVAN

• 
Keep your capsules in their original pack at a
temperature below 30ºC. Protect from moisture
and heat.
• Keep out of the reach and sight of children.
•  not use Diovan after the expiry date which is
Do
stated on the pack. The expiry date refers to the
last day of that month.
•  not use Diovan if you notice that the pack is
Do
damaged or shows signs of tampering.

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•  your doctor tells you to stop taking Diovan
If
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.

6. FURTHER INFORMATION
What Diovan contains

Diovan 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 Diovan looks like and contents of the pack

Diovan 40 mg Capsules are pale grey, marked
CG HBH in black ink on the cap. Pack sizes of 7 or
28 capsules are registered.
Diovan 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.
Diovan 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.
Diovan Capsules are released onto the market by:
Novartis Pharmaceuticals UK Limited
Wimblehurst Road, Horsham, West Sussex
RH12 5AB, 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 2012
Copyright Novartis Pharmaceuticals
UK Limited
GB

387517

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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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