VALSARTAN 80 MG TABLETS

Active substance: VALSARTAN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
VALSARTAN 40 mg, 80 mg and 160 mg 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 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 contains valsartan as an active ingredient
that 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.
Valsartan works by blocking the effect of angiotensin
II. As a result, blood vessels relax and blood pressure
is lowered.
Valsartan tablets can be used for three different
conditions:
• to treat high blood pressure in adults, 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 people after a recent heart attack
(myocardial infarction). “Recent” here means
between 12 hours and 10 days.
• to treat symptomatic heart failure. 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 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. It is caused when
the heart muscle cannot pump blood strongly enough
to supply all the blood needed throughout the body.
2. BEFORE YOU TAKE VALSARTAN
Do not take Valsartan:
• if you are allergic (hypersensitive) to valsartan or
any of the other ingredients of Valsartan 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 Valsartan in early pregnancy – see
pregnancy section).
If any of these apply to you, do not take Valsartan.
Take special care with 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 transplan­
tation (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 are taking medicines that increase the
amount of potassium in your blood. These
include potassium supplements or salt
substitutes containing potassium, potassiumsparing 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
valsartan 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 Valsartan is not recommended.
• if you have lost a lot of fluid (dehydration) caused
by diarrhoea, vomiting, or high doses of water
pills (diuretics).

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 any of these apply to you, tell your doctor before
you 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
and herbal medicine.
The effect of the treatment can be influenced if
Valsartan 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).
• 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).
• lithium, a medicine used to treat some types of
psychiatric illness.
• 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 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 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 Valsartan
affects you. Like many other medicines used to treat
high blood pressure, Valsartan may in rare cases
cause dizziness and affect the ability to concentrate.
3. HOW TO USE 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.
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 valsartan 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.
Valsartan 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.
Valsartan can be given together with other treatment
for heart failure, and your doctor will decide which
treatment is suitable for you.
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 take more than the prescribed dose, get
medical help immediately.
If you experience severe dizziness and/or fainting,
lay down and contact your doctor immediately.
If you have accidentally taken too many tablets,
contact your doctor, pharmacist, or hospital.
If you forget to take Valsartan
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 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.
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, lips, tongue or throat;
• difficulty in breathing or swallowing;
• hives, itching.
If you get any of these, see a doctor immediately.

Other 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).
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 (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;
• diarrhea;
• tiredness;
• weakness.
Not known:
• allergic reactions with rash, itching and hives,
together with some of the following signs or
symptoms: fever, swollen joints and 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 thrombo­
cytopenia);
• 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.
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 VALSARTAN
Store below 30ºC.
Store in original package to protect from moisture.
Keep out of the reach and sight of children!
Do not use Valsartan, after the expiry date which is
stated on the carton. The expiry date refers to the
last day of that month.
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.
6. FURTHER INFORMATION
What Valsartan contains:
• The active substance is valsartan.
Each film-coated tablet contains 40 mg, 80 mg
and 160 mg valsartan.
• The other ingredients are:
Tablet core: Cellulose, Microcrystalline PH 102;
Crospovidone type B; Silica, Colloidal Anhydrous;
Magnesium Stearate.
Film coating: Hypromellose (E 464); Titanium
dioxide (E 171); Macrogol 8000
Valsartan 40 mg tablet: Iron Oxide Yellow (E 172)
Valsartan 80 mg tablet: Iron Oxide Red (E 172)
Valsartan 160 mg tablet: Iron Oxide Yellow (E 172),
Iron Oxide Red (E 172).
What Valsartan looks like and contents of the pack
Valsartan 40 mg tablet: Yellow, capsule shaped, film
coated, biconvex tablets debossed with “40” on one
side and score line on the other side.
The tablet can be divided into equal halves.

Valsartan 80 mg tablet: Pink, round, film coated,
biconvex tablets debossed ”80” on one side and
score line on the other side.
The tablet can be divided into equal halves.
Valsartan 160 mg tablet: yellow, capsule shaped,
film coated, biconvex tablets debossed “160” on
one side and score line on the other side.
The tablet can be divided into equal halves.
Valsartan 40 mg, 80 mg and 160 mg tablets are
available in the following pack size: 1,7,10 14, 20, 28,
30, 50, 56, 60, 90, 98 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
ALKALOID-INT d.o.o., Šlandrova ulica 4, 1231
Ljubljana-Črnuče, Slovenia
Tel.: 386 1 300 42 90
Fax: 386 1 300 42 91
e-mail:info@alkaloid.si
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Bulgaria

Walzera 40 mg; 80 mg; 160 mg
film-coated tablets

Czech Republic

Walzera 40 mg; 80 mg; 160 mg
potahované tablety

Slovak Republic Walzera 40 mg; 80 mg; 160 mg
film-obalené tablety
Slovenia


Waleza 40 mg; 80 mg; 160 mg
filmsko obložene tablete

Romania

Warota 40 mg; 80 mg; 160 mg
comprimate filmate

UK

Valsartan 40 mg; 80 mg; 160
mg tablets

Valsartan 40 mg tablets; PL34088/0026
Valsartan 80 mg tablets; PL 34088/0027
Valsartan 160 mg tablets; PL 34088/0028
Leaflet last revised 04/2012.

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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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