PACKAGE LEAFLET: INFORMATION FOR THE USER

Grecovar 40 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 40 mg film-coated tablets can be used for three different conditions:

•    to treat high blood pressure 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 when other 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.

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.

•    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 diabetes-related 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 Grecovar”

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:

•    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.

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.

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.

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)

•    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 GRECO VAR

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

•    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.

6.    Contents of the pack and other information What Grecovar contains

•    The active substance is valsartan. Grecovar 40 mg, each film-coated tablet contains 40 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 40 mg additionally yellow iron oxide (E 172).

6

What Grecovar looks like and contents of the pack

Grecovar 40 mg: are cylindrical, coated, scored on one side, yellow 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 Via Carlos III, 98 7° floor.

08028 Barcelona Spain

Manufacturer

Laboratorios LICONSA, S.A.

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

Laboratorios CINFA, S.A.

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

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:

Vagrecor 40 mg filmomhulde tablet

Valsartan Heumann 40 mg Filmtabletten

Valsartan Pensa 40 mg compresse rivestite con film

Valsartan Vir 40 mg comprimidos recubiertos con pelicula

Vagrecor

Grecovar 40 mg film-coated tablet

7