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CUENCA 80MG FILM-COATED TABLETS

Active substance(s): VALSARTAN

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PATIENT INFORMATION LEAFLET

PACKAGE LEAFLET: INFORMATION FOR THE USER
Cuenca 80 mg film-coated tablets
Cuenca 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 Cuenca is and what it is used for
2. Before you take Cuenca
3. How to take Cuenca
4. Possible side effects
5. How to store Cuenca
6. Further information

1. WHAT CUENCA IS AND WHAT IT IS USED FOR
Cuenca 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. Cuenca works by blocking the effect of angiotensin II.
As a result, blood vessels relax and blood pressure is lowered.

Cuenca 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. Cuenca 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.

Cuenca 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. Cuenca 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 CUENCA
Do not take Cuenca:

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

if you have severe liver disease.

if you are more than 3 months pregnant (it is also better to avoid Cuenca in early pregnancy see pregnancy section).
If any of these apply to you, do not take Cuenca
Take special care with Cuenca:

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

you must tell your doctor if you think you are (or might become) pregnant. Cuenca 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 Cuenca.
Taking other medicines

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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 Cuenca 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.

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 Cuenca with food and drink
You can take Cuenca 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 Cuenca before you become pregnant or as soon as
you know you are pregnant, and will advise you to take another medicine instead of Cuenca.
Cuenca 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. Cuenca 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 Cuenca affects you. Like many other medicines used to treat
high blood pressure, Cuenca may in rare cases cause dizziness and affect the ability to concentrate.
Important information about some ingredients of Cuenca
Cuenca contain lactose and sorbitol, both sugars. 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 CUENCA

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Always take Cuenca 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 Cuenca 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.
Cuenca 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.
Cuenca can be given together with other treatment for heart failure, and your doctor will decide which
treatment is suitable for you.
You can take Cuenca with or without food. Swallow Cuenca with a glass of water.
Take Cuenca at about the same time each day.
If you take more Cuenca 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 Cuenca
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 Cuenca
Stopping your treatment with Cuenca 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, Cuenca 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

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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)

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 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)

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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)

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 Cuenca
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 Cuenca after the expiry date which is stated on the pack. The expiry date refers to the
last day of that month.
Do not use Cuenca 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 to dispose of medicines no longer required. These measures will help to protect the
environment.

6. FURTHER INFORMATION
What Cuenca contains





The active substance is valsartan. Cuenca 80 mg, each film-coated tablet contains 80 mg of
valsartan, Cuenca 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). Filmcoating: lactose monohydrate, hypromellose (E 464), titanium dioxide (E 171), macrogol.
Cuenca 80 mg additionally red iron oxide (E 172).
Cuenca 160 mg additionally yellow iron oxide (E 172) and brown iron oxide (E 172).

What Cuenca looks like and contents of the pack
Cuenca 80 mg: are cylindrical, coated, scored on one side, pink film-coated tablets.
Cuenca 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
and
Laboratorios CINFA, S.A.
Olaz Chipi, 10, Polígono Areta
31620 Huarte (Pamplona), SPAIN
This medicinal product is authorised in the Member States of the EEA under the following
names:
The Netherlands:

Vodaltin 40 mg filmomhulde tablet
Vodaltin 80 mg filmomhulde tablet
Vodaltin 160 mg filmomhulde tablet
Vodaltin 320 mg filmomhulde tablet

Belgium:

Vodaltin 40 mg comprimé pelliculé
Vodaltin 80 mg comprimé pelliculé
Vodaltin 160 mg comprimé pelliculé
Vodaltin 320 mg comprimé pelliculé

Denmark:

Cuenca 40 mg
Cuenca 80 mg
Cuenca 160 mg
Cuenca 320 mg

Germany:

Cuenca 40 mg Filmtabletten
Cuenca 80 mg Filmtabletten
Cuenca 160 mg Filmtabletten
Cuenca 320 mg Filmtabletten

Spain:

Cuenca 40 mg comprimidos recubiertos con película
Cuenca 80 mg comprimidos recubiertos con película
Cuenca 160 mg comprimidos recubiertos con película
Cuenca 320 mg comprimidos recubiertos con película

Ireland:

Cuenca 40 mg film-coated tablets
Cuenca 80 mg film-coated tablets
Cuenca 160 mg film-coated tablets
Cuenca 320 mg film-coated tablets

Italy:

Cuenca 40 mg compressa rivestita con film
Cuenca 80 mg compressa rivestita con film
Cuenca 160 mg compressa rivestita con film

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Cuenca 320 mg compressa rivestita con film
Luxembourg:

Vodaltin 40 mg comprimé pelliculé
Vodaltin 80 mg comprimé pelliculé
Vodaltin 160 mg comprimé pelliculé
Vodaltin 320 mg comprimé pelliculé

Sweden:

Cuenca 40 mg filmdragerasd tablet
Cuenca 80 mg filmdragerasd tablet
Cuenca 160 mg filmdragerasd tablet
Cuenca 320 mg filmdragerasd tablet

United Kingdom:

Cuenca 40 mg film-coated tablets
Cuenca 80 mg film-coated tablets
Cuenca 160 mg film-coated tablets
Cuenca 320 mg film-coated tablets

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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