GRECOVAR 80MG FILM-COATED TABLETS

Active substance: VALSARTAN

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PATIENT INFORMATION LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
Grecovar 80 mg film-coated tablets
Grecovar 160 mg film-coated 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 Grecovar is and what it is used for
2. Before you take Grecovar
3. How to take Grecovar
4. Possible side effects
5. How to store Grecovar
6. Further 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 80 mg film-coated tablets can be used for three different conditions:
• 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.
• to treat people after a recent heart attack (myocardial infarction). “Recent” here means
between 12 hours and 10 days.
• to treat symptomatic heart failure. 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 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.
Grecovar 160 mg film-coated tablets can be used for three different conditions:
• 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
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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. 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 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.

2. BEFORE YOU TAKE GRECOVAR
Do not take Grecovar:

if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Grecovar .

if you have severe liver disease.

if you are more than 3 months pregnant (it is also better to avoid Grecovar in early pregnancy
- see pregnancy section).
If any of these apply to you, do not take Grecovar
Take special care with 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 t reated after a h eart at tack or f or he art f ailure, your doc tor 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 s upplements or s alt s ubstitutes c ontaining pot assium, pot assium-sparing m edicines
and he parin. I t m ay be ne cessary t o check t he a mount of pot assium i n y our b lood a t r egular
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 Grecovar is not recommended.

if y ou h ave l ost a lot of f luid ( dehydration) caused by di arrhoea, v omiting, or h igh doses o f
water pills (diuretics).

the use of Grecovar in children and adolescents is not recommended (below the age of 18 years).

you must t ell y our do ctor if y ou t hink y ou a re ( or m ight become) pr egnant. Grecovar is not
recommended i n e arly pr egnancy, a nd must not b e t aken i f y ou a re m ore t han 3 m onths
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 Grecovar.
Taking other medicines

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Please tell y our doc tor o r pharmacist if y ou a re t aking or ha ve r ecently t aken any ot her m edicines,
including medicines obtained without a prescription.
The ef fect of t he t reatment can be influenced if Grecovar is t aken together w ith certain other
medicines. It may be necessary to change the dose, to take other precautions, or in some cases to stop
taking one o f the m edicines. This a pplies to both pr escription a nd non -prescription m edicines,
especially:





other medicines that lower blood pressure, especially water pills (diuretics).
medicines t hat i ncrease t he amou nt o f p otassium in y our bl ood. These i nclude pot assium
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.

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
beta blockers (medications to treat heart failure) is not recommended.
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 m ust t ell your doctor if you t hink that you ar e ( or m ight b ecome) p regnant. Y our
doctor will normally advise you to stop taking Grecovar before you become pregnant or as soon
as y ou know you a re pr egnant, a nd w ill a dvise y ou t o t ake a nother m edicine i nstead of
Grecovar. Grecovar is not recommended in early pregnancy, and must not be taken when more
than 3 m onths 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 f or m others w ho a re br east-feeding, a nd y our doc tor m ay c hoose a nother
treatment for you i f you wish t o br east-feed, e specially i f your ba by i s ne wborn, or w as bor n
prematurely.

Driving and using machines
Before y ou dr ive a v ehicle, us e t ools o r ope rate m achines, or c arry out ot her a ctivities t hat require
concentration, m ake s ure you k now how Grecovar affects y ou. Like m any ot her m edicines u sed to
treat hi gh bl ood p ressure, Grecovar may i n rare cases ca use di zziness and affect t he abi lity t o
concentrate.
Important information about some ingredients of Grecovar
Grecovar contain lactose and s orbitol, bot h s ugars. If your doc tor has told you t hat you s uffer f rom
intolerance to some sugars, consult him or her before taking this medicine.
3. HOW TO TAKE GRECOVAR

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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.
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 Grecovar with an additional medicine (e.g. a
diuretic).
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.
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.
If you take more Grecovar than you should
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 Grecovar
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 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.
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

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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 r eaction with symptoms suc h as r ash, itching, dizziness, swelling of f ace or lips o r
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, di fficulty breathing w hen lying down, swelling of t he f eet or legs (signs of
cardiac failure)

headache

cough

abdominal pain

nausea

diarrhea

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)

purplished-red s pots, f ever, i tching ( signs of i nflammation of bl ood v essels a lso c alled
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)

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increase of l evel of potassium in the blood (which can, in severe cases, trigger muscle spasms,
abnormal heart rhythm)
elevation of l iver function v alues ( which can indicate l iver d amage) i ncluding an increase o f
bilirubin in the blood (which can, in severe cases, trigger yellow skin and eyes)
increase o f l evel o f b lood urea ni trogen and increase of level of serum cr eatinine ( which can
indicate abnormal kidney function)

The frequency of some side effects may vary depending on your condition. For example, side effects
such as d izziness, and decreased kidney function, were seen less frequently i n patients treated with
high blood pressure than in patients treated for heart failure or after a recent heart attack.
If any of the side e ffects gets se rious, or if you n otice an y side effects n ot l isted in this leaflet,
please tell your doctor or pharmacist.
5. HOW TO STORE Grecovar
Do not store above 30ºC. Store in the original package in order to protect from moisture.





Keep out of the reach and sight 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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how t o di spose of m edicines no l onger r equired. These m easures w ill he lp t o pr otect t he
environment.

6. FURTHER INFORMATION
What Grecovar contains





The active substance i s valsartan. Grecovar 80 m g, each film-coated tablet c ontains 80 m g of
valsartan, 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 ), m agnesium c arbonate (E 504), maize starch, pregelatinised, povidone K-25 (E
1201), s odium stearyl f umarate, sodium l auryl s ulphate, crospovidone Type A (E 1202 ). Filmcoating: lactose monohydrate, hypromellose (E 464), titanium dioxide (E 171), macrogol.
Grecovar 80 mg additionally red iron oxide (E 172).
Grecovar 160 mg additionally yellow iron oxide (E 172) and brown iron oxide (E 172).

What Grecovar looks like and contents of the pack
Grecovar 80 mg: are cylindrical, coated, scored on one side, pink film-coated tablets.
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.

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Gran Vía Carlos III, 98, 7th 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
and
ZENTIVA k.s.
U. Kabelovny 130, 102 37, Praha 10
Czech Republic
This m edicinal pr oduct i s au thorised i n the M ember St ates o f t he E EA unde r t he following
names:
The Netherlands:

Vagrecor 40 mg filmomhulde tablet
Vagrecor 80 mg filmomhulde tablet
Vagrecor 160 mg filmomhulde tablet
Vagrecor 320 mg filmomhulde tablet

Germany:

Valsartan Heumann 40 mg Filmtabletten
Valsartan Heumann 80 mg Filmtabletten
Valsartan Heumann 160 mg Filmtabletten
Valsartan Heumann 320 mg Filmtabletten

France:

Vagrecor 40 mg comprimé pelliculé
Vagrecor 80 mg comprimé pelliculé
Vagrecor 160 mg comprimé pelliculé
Vagrecor 320 mg comprimé pelliculé

Italy:

Valsartan Pensa 40 mg compressa rivestita con film
Valsartan Pensa 80 mg compressa rivestita con film
Valsartan Pensa 160 mg compressa rivestita con film
Valsartan Pensa 320 mg compressa rivestita con film

Spain:

Valsartan Cantabria 40 mg comprimidos recubiertos con película
Valsartan Cantabria 80 mg comprimidos recubiertos con película
Valsartan Cantabria 160 mg comprimidos recubiertos con película
Valsartan Cantabria 320 mg comprimidos recubiertos con película

Portugal:

Vagrecor
Vagrecor
Vagrecor

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Vagrecor
United Kingdom:

Grecovar 40 mg film-coated tablet
Grecovar 80 mg film-coated tablet
Grecovar 160 mg film-coated tablet
Grecovar 320 mg film-coated tablet

This leaflet was last approved in
12/2009

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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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