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GRECOVAR 160MG FILM-COATED TABLETS

Active substance(s): VALSARTAN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Grecovar 160 mg film-coated 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 symptoms are the same as yours.

If any of the side effects gets serious, 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 Grecovar is and what it is used for
2.
What you need to know before you take Grecovar
3.
GrecovarHow to take Grecovar
4.
Possible side effects
5.
How to store Grecovar
6.
Contents of the pack and other information

1.

WHAT GRECOVAR IS AND WHAT IT IS USED FOR

Grecovar 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. Grecovar works by blocking the effect of angiotensin II. As a result, blood
vessels relax and blood pressure is lowered.
Grecovar 160 mg film-coated tablets can be used for three different conditions:

to treat high blood pressure in adult and in 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 adult patients after a recent heart attack (myocardial infarction). “Recent” here means
between 12 hours and 10 days.

to treat symptomatic heart failure in adult patients. Grecovar 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 whenother 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.
2.

What you need to know before you take GRECOVAR

Do not take Grecovar:

if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Grecovar listed at
the end of this leaflet (listed in section 6).

if you have severe liver disease.
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if you are more than 3 months pregnant (it is also better to avoid Grecovar 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 Grecovar
Warnings and precautions:
Talk to your doctor or pharmacist before taking Grecovar
















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 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 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 Grecovar, stop taking Grecovar 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 are below 18 years of age and you take Grecovar in combination with other medicines that
inhibit the renin angiotensin aldosterone system (medicines that lower blood pressure), your doctor
may need to do periodically blood tests to control the renal function and the potassium..
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 Grecovar is not recommended.
if you have lost a lot of fluid (dehydration) caused by diarrhoea, vomiting, or high doses of water
tablets (diuretics).
you must tell your doctor if you think you are (or might become) pregnant. Grecovar 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:
o
an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetesrelated kidney problems.
o
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.
See also information under the heading “Do not take Valsartan”
If any of these apply to you, tell your doctor before you take Grecovar.
Other medicines and Grecovar
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including medicines obtained without a prescription.
The effect of the treatment can be influenced if Grecovar 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:
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other medicines that lower blood pressure, especially water tablets (diuretics), ACE
inhibitors (such as enalapril, lisinopril, etc.,) or aliskiren (see also information under the
headings “Do not take X” 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
Grecovar.
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, with an 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).
Your doctor may need to change your dose and/or to take other precautions.
Taking Grecovar with food and drink
You can take Grecovar 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 Grecovar before you become pregnant or as soon as you know
you are pregnant, and will advise you to take another medicine instead of Grecovar. Grecovar 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. Grecovar 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 Grecovar affects you. Like many other medicines used to treat high
blood pressure, Grecovar may in rare cases cause dizziness and affect the ability to concentrate.
Grecovar contain lactose and sorbitol
If your doctor has told you that you suffer from intolerance to some sugars, consult him or her before taking
this medicine.

3.

HOW TO TAKE GRECOVAR

Always take Grecovar 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
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prescribe higher doses (e.g. 160 mg or 320 mg). He may also combine Grecovar 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.
Grecovar 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.
Grecovar can be given together with other treatment for heart failure, and your doctor will decide which
treatment is suitable for you.
You can take Grecovar with or without food. Swallow Grecovar with a glass of water.
Take Grecovar at about the same time each day.

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If you take more Grecovar than you should
If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down. If
you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.
If you forget to take Grecovar
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 Grecovar
Stopping your treatment with Grecovar 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, Grecovar can cause side effects, although not everybody gets them.
Some symptoms need immediate medical attention:
You may experience symptoms of angioedema (a specific allergic reaction), 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

angioedema (see section “Some symptoms need immediate medical attention”)

sudden loss of consciousness (syncope)

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; symptoms of fever, swollen joints and joint
pain, muscle pain, swollen lymph nodes and/or flu-like symptoms may occur (signs of serum
sickness)
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purplish-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 lead to anaemia in severe cases)
increase of level of potassium in the blood (which can trigger muscle spasms and abnormal
heart rhythm in severe cases)
elevation of liver function values (which can indicate liver damage) including an increase of
bilirubin in the blood (which can trigger yellow skin and eyes in severe cases)
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 adult patients treated with
high blood pressure than in adult 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 national reporting system listed in
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 GRECOVAR

Do not store above 30ºC. Store in the original package in order to protect from moisture.





6.

Keep out of the sight and reach of children.
Do not use Grecovar after the expiry date which is stated on the pack. The expiry date refers to
the last day of that month.
Do not use Grecovar if you notice that the pack is damaged or shows signs of tampering.
Do not throw away any medicines via wastewater . Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Grecovar contains


Grecovar 160 mg, each film-coated tablet contains 160 mg of valsartan The other ingredients are:
cellulose, microcrystalline (E 460), silica, colloidal anhydrous (E 551), sorbitol (E 420), magnesium
carbonate (E 504), maize starch, pregelatinised, povidone K-25 (E 1201), sodium stearyl fumarate,
sodium lauryl sulphate, crospovidone Type A (E 1202). Film-coating: lactose monohydrate,
hypromellose (E 464), titanium dioxide (E 171), macrogol 4000.
Grecovar 160 mg additionally yellow iron oxide (E 172) and brown iron oxide (E 172).
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What Grecovar looks like and contents of the pack
Grecovar 160 mg: are cylindrical, coated, scored on one side, ochre film-coated tablets.
Pack size of 7, 14, 28, 56, 98 or 280 film-coated tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder
Laboratorios liconsa, S.A
Gran Vía Carlos III, 98 7º floor.
08028 Barcelona
Spain
Manufacturer
Laboratorios LICONSA, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), Spain
Laboratorios CINFA, S.A.
Olaz Chipi, 10, Polígono Areta
31620 Huarte (Pamplona), Spain
ZENTIVA k.s.
U. Kabelovny 130, 102 37, Praha 10
Czech Republic

For any information about this medicine, please contact the Marketing Authorisation Holder.
This leaflet was last approved in 09/12/2015
This medicinal product is authorised in the Member States of the EEA under the following names:
The Netherlands:
Germany:
Italy:
Spain:
Portugal:
United Kingdom:

Vagrecor 160 mg filmomhulde tablet
Valsartan Heumann 160 mg Filmtabletten
Valsartan Pensa 160 mg compresse rivestite con film
Valsartan Vir 160 mg comprimidos recubiertos con película
Vagrecor
Grecovar 160 mg film-coated tablet

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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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