PACKAGE LEAFLET: INFORMATION FOR THE USER

Valsartan 80 mg film-coated tablets Valsartan 160 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 signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1.    What valsartan is and what it is used for

2.    What you need to know before you take valsartan

3.    How to take valsartan

4.    Possible side effects

5.    How to store valsartan

6.    Contents of the pack and other information

1. WHAT VALSARTAN IS AND WHAT IT IS USED FOR

The active ingredient of Valsartan 80 mg film-coated tablets and Valsartan 160 mg film-coated tablets is valsartan.

Valsartan belongs to a class of medicines known as “angiotensin II receptor antagonists”. Valsartan helps blood vessels relax and so reduces strain on the heart.

Valsartan 80 mg film-coated tablets Valsartan 160 mg film-coated tablets can be used for three different conditions:

•    to treat high blood pressure in adults and in children and adolescents 6 to 18 years of age.

High blood pressure may damage the body’s blood vessels and may result in a stroke, heart failure or kidney failure. Lowering your blood pressure reduces the risk of developing these disorders.

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.

•    to treat adult patients after a recent heart attack.

“Recent” here means between 12 hours and 10 days.

•    to treat symptomatic heart failure in adult patients.

Heart failure occurs when the heart muscle cannot pump blood strongly enough to supply all the blood needed throughout the body. Heart failure symptoms include shortness of breath and swelling of the feet and legs owing to fluid build-up.

Valsartan is used for heart failure when a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors (a medication to treat heart failure) cannot be used or valsartan may be used in addition to ACE inhibitors when beta blockers (another medication to treat heart failure) cannot be used.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALSARTAN

Do not take valsartan if you:

•    are allergic to valsartan or any of the other ingredients of this medicine listed in section 6.

•    have severe liver disease.

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

If any of the above apply to you, do not take valsartan

Warnings and precautions

Talk to your your doctor or pharmacist before taking

valsartan, if you:

•    have liver disease.

•    have severe kidney disease or if you are undergoing dialysis.

•    are known to have narrowing of the kidney arteries.

•    have recently had a kidney transplant.

•    are receiving treatment after a heart attack or for heart failure then your doctor may check how your kidneys are working.

•    have severe heart disease other than heart failure or heart attack.

•    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 valsartan in combination with other medicines that inhibit the rennin angiotensin aldosterone system (medicines that lower blood pressure), your doctor may check your kidney function and the amount of potassium in your blood at regular intervals.

•    are known to have “primary aldosteronism”, a hormone imbalance If this applies to you then the use of valsartan is not recommended.

•    have lost a lot of fluid by diarrhoea, vomiting, or high doses of water pills (diuretics).

In addition:

•    You must tell your doctor if you think you are (or might become) pregnant. Valsartan 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 the above apply to you, tell your doctor before you take valsartan.

Other medicines and valsartan

Tell your doctor or pharmacist if you are taking have recently taken or might take any other medicines.

The effect of the treatment can be influenced if valsartan 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).

•    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 mental illness.

In addition:

•    if you are being treated after a heart attack, a combination with ACE inhibitors (medicines used to treat heart attack) is not recommended.

•    if you are being treated for heart failure, a triple combination with ACE inhibitors and beta blockers (medicines also used to treat heart failure) is not recommended.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

•    You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will normally advise you to stop taking valsartan before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of valsartan. Valsartan 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.

Breast-feeding

•    Tell your doctor if you are breast-feeding or about to start breast-feeding. Valsartan 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 valsartan affects you. Like many other medicines used to treat high blood pressure, valsartan may cause dizziness and affect the ability to concentrate.

Valsartan contains lactose and sorbitol

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

3. HOW TO TAKE VALSARTAN

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adult patients with high blood pressure: The usual dose is 80 mg daily. In some cases your doctor may prescribe higher doses (e.g. 160mg or 320mg). He may also combine valsartan with an additional medicine e.g. a diuretic (“water tablet”).

Children and adolescents (6 to 18 years of age) with high blood pressure: For patients who weigh less than 35 kg the usual dose is 40 mg valsartan once daily. For patients who weigh 35 kg or more the usual starting dose is 80 mg 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. 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.

Valsartan 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.

Valsartan can be given together with other treatment for heart failure, and your doctor will decide which treatment is suitable for you.

You can take valsartan with or without food. Swallow with a glass of water.

Take valsartan at about the same time each day.

The tablet can be divided into equal doses.

If you take more valsartan 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 then contact your doctor, pharmacist or hospital.

If you forget to take valsartan

If you forget to take a dose then 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 valsartan

Stopping your treatment with valsartan may cause your disease 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 medicine, ask your doctor or pharmacist.

*    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)

*    decreased levels of sodium in the blood

*    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)

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.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. HOW TO STORE VALSARTAN

Keep out of the sight and reach of children.

Do not use valsartan after the expiry date which is stated on the carton/blister after EXP. The expiry date refers to the last day of that month.

Store below 30°C

Do not use valsartan if you notice that the pack is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. FURTHER INFORMATION

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects,

although not everybody gets them

Some symptoms need immediate medical attention:

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.

Side effects include:

Common, affecting up to 1 in 10 people:

*    dizziness

*    low blood pressure with or without symptoms such as dizziness and fainting when standing up

*    kidney problems, as shown by changes in certain blood tests.

Uncommon, affecting fewer than 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 heart 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)

What valsartan contains

The active substance is valsartan.

Valsartan 80 mg: each film-coated tablet contains 80 mg of valsartan, Valsartan 160 mg: each film-coated tablet contains 160 mg of valsartan.

The other ingredients are: microcrystalline cellulose, colloidal anhydrous silica, sorbitol (E450), magnesium carbonate (heavy), maize starch, pregelatinised, povidone K-25, sodium stearyl fumarate, sodium lauryl sulphate, crospovidone Type A.

Film-coating: lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000.

Valsartan 80 mg: additionally red iron oxide (E 172). Valsartan 160 mg: additionally yellow iron oxide (E 172) and brown iron oxide (E 172).

What valsartan looks like and contents of the pack Valsartan 80 mg: are cylindrical, bioconvex, coated, pink tablets, scored on one side, ‘snap-tab’ tablets. The tablet can be divided into equal doses.

Valsartan 160 mg: are oblong, biconvex, coated, ochre tablets, scored on one side, ‘snap-tab’ tablets. The tablet can be divided into equal doses.

The tablets are supplied in blister packs of 14, 28, 30, 56,

90, 98 or 280 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK Manufacturer

Sanofi-Aventis Sp. z o.o.

Drug Production and Distribution Plant, ul. Lubelska 52, 35-233 Rzeszow,

Poland

This leaflet was last revised in June 2012