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DIOVAN 160MG CAPSULES

Active substance(s): VALSARTAN

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Package leaflet: Information for the user
Diovan 40, 80 and 160 mg Capsules
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 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

to treat people after a recent heart attack (myocardial infarction). “Recent” here means between
12 hours and 10 days.

to treat symptomatic heart failure. 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.
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

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.

What you need to know before you

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.
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 to 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
pills (diuretics).

The use of Diovan in children and adolescents below the age of 18 years is not recommended.

if you are taking any of the following medicines used to treat high blood pressure:
o an ACE inhibitors (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:


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
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 and breast-feeding

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 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.
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 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.
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 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).
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, 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, 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 “Warnings and precautions”).
Other side effects include:
Common (may affect up to 1 in 10 people):

dizziness, postural dizziness

low blood pressure with symptoms such as dizziness

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

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

Not known (frequency cannot be estimated from the available data):

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)
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.
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.
United Kingdom

5.






6.

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

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 30ºC. Store in the original package in order to protect from moisture and heat.
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 measure will help protect the environment.

Contents of the pack and other 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
and
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 April 2015.
Copyright Novartis Pharmaceuticals UK Limited
Ciba logo

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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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