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PATIENT INFORMATION LEAFLET

PACKAGE LEAFLET: INFORMATION FOR THE USER Cuenca 320 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 320 mg film-coated tablets can be used

• 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.

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

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.

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

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).

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

•    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)

•    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 30°C. 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 320 mg, each film-coated tablet contains 320 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 320 mg additionally yellow iron oxide (E 172) and brown iron oxide (E 172), indigo carmine aluminium lake (E 132).

What Cuenca looks like and contents of the pack

Cuenca 320 mg: are oblong, coated, scored on one side, greyish-violet 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

Laboratories Liconsa, S.A.

Gran Via Carlos III, 98, 7th floor 08028 Barcelona, SPAIN

Manufacturer

Laboratorios LICONSA, S.A.

Avda. Miralcampo, N° 7, Poligono Industrial Miralcampo 19200 Azuqueca de Henares (Guadalajara), SPAIN

and

Laboratorios CINFA, S.A.

Olaz Chipi, 10, Poligono Areta 31620 Huarte (Pamplona), SPAIN

This medicinal product is authorised in the Member States of the EEA under the following names:

Italy:	Cuenca 40 mg compressa rivestita con film Cuenca 80 mg compressa rivestita con film Cuenca 160 mg compressa rivestita con film Cuenca 320 mg compressa rivestita con film
Luxembourg:	Vodaltin 40 mg comprime pellicule Vodaltin 80 mg comprime pellicule Vodaltin 160 mg comprime pellicule Vodaltin 320 mg comprime pellicule
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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