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VALSARTAN 160MG CAPSULES HARD

Active substance: VALSARTAN

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Valsartan 40 mg, 80 mg
and 160 mg Capsules, hard
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.



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.



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 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-inhibitor (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).

Your doctor may check your kidney function, blood
pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before
taking Valsartan
• 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 are taking medicines that increase the amount
of potassium in your blood. These include potassium
supplements or salt substitutes containing

See also information under the heading “Do not take
Valsartan”.

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
Valsartan is taken together with certain other
medicines. Your doctor may need to change your dose
and/or to take other precautions, or in some cases to
stop taking one of the medicines:
• other medicines that lower blood pressure,
especially water pills (diuretics).
• medicines that increase the amount of potassium
in your blood. These include potassium supplements

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or salt substitutes containing potassium,
potassium-sparing medicines and heparin.
• certain type of pain killers called non-steroidal
anti-inflammatory medicines (NSAIDs).
• lithium, a medicine used to treat some types of
psychiatric illness.
• if you are taking an ACE-inhibitor or aliskiren
(see also information under the headings “Do not
take Valsartan” and “Warnings and precautions”).

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
receptors antagonists (MRA) (for example
spironolactone, eplerenone) or betablockers (for
example metoprolol).
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

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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.
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 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
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.

headache
cough
abdominal pain
nausea
diarrhoea
tiredness
weakness

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)

4. POSSIBLE SIDE EFFECTS

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, see a doctor immediately.

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)

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 VALSARTAN

• Keep your capsules in their original pack at a

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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.

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,
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, hard 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, hard 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, hard 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
MA Holder:
Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, United Kingdom.

Manufacturer:
Novartis Pharmaceuticals UK Limited, Wimblehurst
Road, Horsham, West Sussex, RH12 5AB, United
Kingdom or Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, United Kingdom.
This leaflet was last revised in 09/2014.

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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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