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VALSARTAN 80 MG TABLETS

Active substance: VALSARTAN

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Package leaflet: Information for the user
Valsartan 40 mg tablets
Valsartan 80 mg tablets
Valsartan 160 mg 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 thisleaflet. See section 4.
What is in this leaflet:
1. What Valsartan is and what it is used for
2. What you need to know before you take Valsartan
3. How to take Valsartan
4. Possible side effects
5. How to store Valsartan
6. Contents of the pack and other 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 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. 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
Valsartan
Do not take Valsartan:
- if you are allergic 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 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, do not take Valsartan.
Warnings and precautions:
Talk to your doctor or pharmacist 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 transplanta­
tion (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, potassium-sparing 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).

- 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 diabetesrelated 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).
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).
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
Valsartan”
If any of these apply to you, tell your doctor
before you take Valsartan.
Other medicines and Valsartan
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 Valsartan is taken together with certain other
medicines. Your doctor may need to change your
dose and/or to take other precautions. This applies
to both prescription and non-prescription medicines,
especially:
- If you are taking an ACE-inhibitor or aliskiren (see
also information under the headings “Do not take
Valsartan” and “Warnings and precautions”)
- 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).
- If you are taking other medicines that lower
blood pressure, especially water pills (diuretics).
- 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.
- If you are taking certain type of pain killers
called non-steroidal anti-inflammatory medicines
(NSAIDs).

- If you are taking 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.
Valsartan with food, drink and alcohol
You can take Valsartan with or without food.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby ask your doctor
or pharmacist for advice before taking this 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
high blood pressure, Valsartan may in rare cases
cause dizziness and affect the ability to concentrate.
3. How to take VALSARTAN
Always take this medicine exactly as your doctor or
pharmacist has told you. 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.
The tablet can be divided into equal halves.
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
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 any 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 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 (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):
- 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;
- diarrhoea;
- tiredness;
- weakness.
Not known (frequency cannot be estimated from the
available data):
- 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.
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 via the Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine
5. How to store Valsartan
Store below 30ºC.
Store in original package to protect from moisture.
Keep this medicine out of the sight and reach of
children.
Do not usethis medicine, after the expiry date which
is stated on the carton after EXP .
The expiry date refers to the last day of that month.
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 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.
Valsartan 80 mg tablet: Pink, round, film coated,
biconvex tablets debossed ”80” on one side and
score line on the other side.
Valsartan 160 mg tablet: yellow, capsule shaped, film
coated, biconvex tablets debossed “160” on one side
and score line on the other side.
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 filmcoated tablets

Czech
Republic

Walzera 40 mg; 80 mg; 160 mg
potahované tablety

Slovak
Republic

Walzera 40 mg; 80 mg; 160 mg filmobalené 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
This leaflet was last revised in 01/2015.

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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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