PACKAGE LEAFLET: INFORMATION FOR THE USER

Valsol plus 80 mg/12.5 mg film-coated tablets

V alsartan/hydrochlorothiazide

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 Valsol plus is and what it is used for

2.    Before you take Valsol plus

3.    How to take Valsol plus

4.    Possible side effects

5.    How to store Valsol plus

6.    Further information

1. WHAT VALSOL PLUS IS AND WHAT IT IS USED FOR

Valsol plus film-coated tablets contain two active substances called valsartan and hydrochlorothiazide. Both of these substances help to control high blood pressure (hypertension).

•    Valsartan belongs to a class of medicines known as “angiotensin II receptor antagonists”, 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. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered.

•    Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also known as “water tablets”). Hydrochlorothiazide increases urine output, which also lowers blood pressure.

Valsol plus is used to treat high blood pressure which is not adequately controlled by a single substance alone.

High blood pressure increases the workload of 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 VALSOL PLUS

Do not take Valsol plus:

•    if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulphonamide derivatives (substances chemically related to hydrochlorothiazide) or to any of the other ingredients of Valsol plus.

•    if you are more than 3 months pregnant (it is also better to avoid Valsol plus in early pregnancy - see pregnancy section).

•    if you have severe liver disease.

•    if you have severe kidney disease.

•    if you are unable to urinate.

•    if you are treated with an artificial kidney.

•    if the level of potassium or sodium in your blood is lower than normal, or if the level of calcium in your blood is higher than normal despite treatment.

•    if you have gout.

If any of the above apply to you, do not take this medicine and speak to your doctor.

Take special care with Valsol plus

•    if you are taking potassium-sparing medicines, potassium supplements, salt substitutes containing potassium or other medicines that increase the amount of potassium in your blood such as heparin. Your doctor may need to check the amount of potassium in your blood regularly.

•    if you have    low levels of potassium in your blood.

•    if you have    diarrhoea or severe vomiting.

•    if you are taking high doses of water tablets (diuretics).

•    if you have    severe heart disease.

•    if you suffer from a narrowing of the kidney artery.

•    if you have recently received a new kidney.

•    if you suffer from hyperaldosteronism. This is a disease in which your adrenal glands make too much of the hormone aldosterone. If this applies to you, the use of Valsol plus is not recommended.

•    if you have liver or kidney disease.

•    if you have fever, rash and joint pain, which may be signs of systemic lupus erythematosus (SLE, a so-called autoimmune disease).

•    if you have diabetes, gout, high levels of cholesterol or fats in your blood.

•    if you have had allergic reactions with the use of other blood pressure-lowering agents of thisclass (angiotensin II receptor antagonists) or if you have allergy or asthma.

•    it may cause increased sensitivity of the skin to sun.

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

You must tell your doctor if you think you are (or might become) pregnant. Valsol plus 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).

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 Valsol plus 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 especially applies to the following medicines:

•    lithium, a medicine used to treat some types of psychiatric illness

•    medicines that affect or can be affected by potassium blood levels, such as digoxin, a medicine to control the heart rhythm, some antipsychotic medicines

•    medicines that may increase the amount of potassium in your blood, such as potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, heparin

•    medicines that may reduce the amount of potassium in your blood, such as corticosteroids, some laxatives

•    diuretics (water tablets), medicines for the treatment of gout, such as allopurinol, therapeutic vitamin D and calcium supplements, medicines for the treatment of diabetes (oral agents or insulins)

•    other medicines to lower your blood pressure, such as beta blockers or methyldopa, or medicines that tighten your blood vessels or stimulate your heart, such as noradrenaline or adrenaline

•    medicines to increase blood sugar levels, such as diazoxide

•    medicines to treat cancer, such as methotrexate or cyclophosphamide

•    pain killers

•    arthritis medicines

•    muscle relaxing medicines, such as tubocurarine

•    anti-cholinergic medicines, such as atropine or biperiden

•    amantadine (a medicine used to prevent influenza)

•    cholestyramine and colestipol (medicines used to treat high levels of fats in the blood)

•    ciclosporin, a medicine used for organ transplant to avoid organ rejection

•    some antibiotics (tetracyclines), anaesthetics and sedatives

•    carbamazepine, a medicine used to treat seizure conditions

Taking Valsol plus with food and drink

You can take Valsol plus with or without food.

Avoid taking alcohol until you have talked to your doctor. Alcohol may make your blood pressure fall more and/or increase the risk of you becoming dizzy or feeling faint.

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 Valsol plus before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Valsol plus. Valsol plus 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

Valsol plus 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 Valsol plus affects you. Like many other medicines used to treat high blood pressure, Valsol plus may occasionally cause dizziness and affect the ability to concentrate.

Important information about some of the ingredients of Valsol plus

Valsol plus contains lactose and sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, i.e. essentially ‘sodium-free’.

3. HOW TO TAKE VALSOL PLUS

Always take Valsol plus exactly as your doctor has told you. This will help you to get the best results and lower 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 your doctor even if you are feeling well.

Your doctor will tell you exactly how many tablets of Valsol plus to take. Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.

•    The usual dose of Valsol plus is one tablet per day.

•    Do not change the dose or stop taking the tablets without consulting your doctor.

•    The medicine should be taken at the same time each day, usually in the morning.

•    You can take Valsol plus with or without food.

•    Swallow the tablet with a glass of water.

If you take more Valsol plus 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 Valsol plus

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 Valsol plus

Stopping your treatment with Valsol plus may cause your high blood pressure to get worse. Do not stop taking your medicine unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Valsol plus 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 side effects can be serious and need immediate medical attention:

You should see your doctor immediately if you experience symptoms of angioedema, such as:

•    swollen face, tongue or pharynx

•    difficulty in swallowing

•    hives and difficulties in breathing

Other side effects include:

Uncommon

•    cough

•    low blood pressure

•    light-headedness

•    dehydration (with symptoms of thirst, dry mouth and tongue, infrequent urination, dark colored urine, dry skin)

•    muscle pain

•    tiredness

•    tingling or numbness

•    blurred vision

•    noises (e.g. hissing,    buzzing)    in ears

Very rare

•    dizziness

•    diarrhoea

•    joint pain

Not known

•    breathing difficulty

•    severely decreased urine    output

•    low level of sodium in the blood (sometimes with nausea, tiredness, confusion, malaise, convulsions)

•    low level of potassium in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm)

•    low level of white cells in the blood (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)

•    the level of bilirubin increased in blood (which can, in severe cases, trigger yellow skin and eyes)

•    the level of blood urea nitrogen and creatinine increased in blood (which can indicate abnormal kidney function)

•    the level of uric acid in blood increased (which can, in severe cases, trigger gout) • syncope (fainting)

Side effects reported with valsartan or hydrochlorothiazide alone, but not observed with Valsol plus:

Valsartan

Uncommon

•    spinning sensation

•    abdominal pain

Not known

•    skin rash with or without itching together with some of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms

•    rash, purplished-red spots, fever, itching (symptoms of inflammation of blood vessels)

•    low level of blood platelets (sometimes with unusual bleeding or bruising)

•    high level of potassium in the blood (sometimes with muscle spasms, abnormal heart rhythm)

•    allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness)

•    swelling mainly of the    face and throat; rash; itching

•    elevation of liver function values

•    the level of haemoglobin decreased and the percentage of red cells decreased in the blood (which both can, in severe cases, trigger an anaemia).

•    kidney failure

Hydrochlorothiazide

Common

•    itchy rash and other types of rash

•    reduced appetite

•    mild nausea and vomiting

•    faintness, fainting on standing up

•    impotence

Rare

•    swelling and blistering of the skin (due to increased sensitivity to sun)

•    constipation, discomfort of the stomach or bowels liver disorders (yellow skin or eyes)

•    irregular heart beat

•    headache

•    sleep disturbances

•    sad mood (depression)

•    low level of blood platelets (sometimes with bleeding or bruising underneath the skin) Very rare

•    inflammation of blood vessels with symptoms such as rash, purplish-red spots, fever

•    itching or red skin

•    blistering of the lips, eyes or mouth

•    skin peeling

•    fever

•    facial rash associated with joint pain

•    muscle disorder

•    fever (cutaneous lupus erythematosus)

•    severe upper stomach painlack or low levels of different blood cells

•    severe allergic reactions

•    difficulty breathing

•    lung infection; breathlessness

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 VALSOL PLUS

•    Keep out of the reach and sight of children.

•    Do not use Valsol plus after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

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

•    Do not use any Valsol plus pack that 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 Valsol plus contains

The active substances are valsartan and hydrochlorothiazide.

Each Valsol plus 80 mg/12.5 mg film-coated tablet contains 80 mg valsartan and 12.5 mg hydrochlorothiazide.

Other excipients are:

•    Tablet Core: cellulose, microcrystalline, silica, colloidal anhydrous, sorbitol, magnesium carbonate, pregelatinised maize starch, povidone K-30, sodium stearyl fumarate, sodium laurylsulphate, crospovidone Type A.

•    Coating: lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E 171), iron oxide red (E 172) (only the 80 mg/12.5 mg)

What Valsol plus looks like and contents of the pack Film-coated tablet.

Valsol plus 80 mg/12.5 mg film-coated tablets: cylindrical, biconvex, coated pink tablet.

The tablets are supplied in blister packs of 14, 28, 30, 56, 98 or 280 tablets.

Not all pack sizes or tablet strengths may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

LABORATORIOS LICONSA, S.A.

Gran Via Carlos III, 98, 7th

08028 Barcelona

Spain

Manufacturer:

Place of manufacture:    Laboratorios CINFA, S.A.

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

SPAIN

Laboratorios CINFA, S.A.

Avda Roncesvalles, S/N 31699 Olloqui (Navarra)

SPAIN

Laboratorios LICONSA, S.A.

Avda. Miralcampo, n° 7 - Poligono Miralcampo 19200 Azuqueca de Henares (Guadalajara) SPAIN

ZENTIVA k.s.

U. Kabelovny 130, 102 37, Praha 10 Czech Republic

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

Austria:    Valsol plus HCT 80/12,5 mg Filmtabletten

Belgium:    Valsartan Liconsa 80/12.5 mg comprime pellicule

Bulgaria:    Valsol plus 80/12.5 mg ^naMupaHH Ta6aeTKH

Estonia:    Valsartan hydrochlorothiazide Liconsa 80/12.5 mg

France:    Valsartan hydrochlorothiazide Liconsa 80/12.5 mg comprime pellicule

Germany:    Valsol Plus 80/12.5 mg Filmtabletten

Greece:    AVALSAN PLUS 80/12.5 mg SioKo sniKaXuppsvo ps Xstcto upsvio

Hungary:    Valsol plus 80/12.5 mg bevont tabletta

Ireland:    Valsol plus 80/12.5 mg film-coated tablets

Italy:    Valsol plus 80/12.5 mg compressa rivestita    con    film

Latvia:    Valsol plus 80/12.5 mg apvalkotas tabletes

The Netherlands: Valsartan/hydrochlorothiazide Liconsa 80/12.5 mg filmomhulde tablet Poland:    Valsartan Hydrochlorothiazide Liconsa

Portugal:    Valsol plus

Slovenia:    Valsartan/hidroklorotiazid Liconsa 80/12,5    mg    filmsko oblozene tablete

Slovak Republic: Valsartan/Hydrochlorotiazid Liconsa 80/12.5 mg

Spain:    Valsartan Hidroclorotiazida Cantabria 80/12.5 mg comprimidos recubiertos con

pelicula

United Kingdom: Valsol plus 80/12.5 mg film-coated tablets

This leaflet was last approved in:

02.2010