PACKAGE LEAFLET: INFORMATION FOR THE USER Valsartan 40 mg Film-Coated Tablets Valsartan 80 mg Film-Coated Tablets Valsartan 160 mg Film-Coated Tablets Valsartan 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 Valsartan Film-Coated Tablets are and what they are used for

2.    Before you take Valsartan Film-Coated Tablets

3.    Flow to take Valsartan Film-Coated Tablets

4.    Possible side effects

5.    Flow to store Valsartan Film-Coated Tablets

6.    Further information

1.    WHAT VALSARTAN FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR

Valsartan Film-Coated Tablets belong 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. Valsartan Film-Coated Tablets work by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered.

Valsartan 40 mg Film-Coated Tablets can be used for two 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 symptomatic heart failure in adult patients. Valsartan Film-Coated Tablets are 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.

Valsartan 80 mg and 160 mg Film-Coated Tablets can be used for two different conditions:

• to treat high blood pressure in adults and 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 symptomatic heart failure in adult patients. Valsartan Film-Coated Tablets are 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.

Valsartan 320 mg Film-Coated Tablets can be used

• to treat high blood pressure in adults and 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.

2.    BEFORE YOU TAKE VALSARTAN FILM-COATED TABLETS

Do not take Valsartan Film-Coated Tablets:

-    if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Valsartan Film-Coated Tablets.

-    if you have severe liver disease.

-    if you are more than 3 months pregnant (it is also better to avoid Valsartan Film-Coated Tablets in early pregnancy - see pregnancy section).

If any of these apply to you, do not take Valsartan Film-Coated Tablets.

Take special care with Valsartan Film-Coated Tablets:

-    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 artery to a single kidney.

-    if you have recently undergone kidney transplantation (received a new kidney).

-    if you are treated for heart failure, your doctor may check your kidney function before prescribing Valsartan Film-Coated Tablets.

-    if you have severe heart disease other than heart failure.

-    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 Valsartan Film-Coated Tablets in combination with other medicines that inhibit the renin 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.

-    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 Valsartan Film-Coated Tablets is not recommended.

-    if you have lost a lot of fluid (dehydration) caused by diarrhoea, vomiting, or high doses of water tablets (diuretics) please take care before you use valsartan.

-    you must tell your doctor if you think you are (or might become) pregnant. Valsartan Film-Coated Tablets are 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 Valsartan Film-Coated Tablets.

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 Valsartan Film-Coated Tablets are 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 psychiatric illness.

Valsartan 40/80/160 mg Film-Coated Tablets In addition:

-    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 Valsartan Film-Coated Tablets with food and drink

You can take Valsartan Film-Coated Tablets 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 Valsartan Film-Coated Tablets before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Valsartan Film-Coated Tablets. Valsartan Film-Coated Tablets are 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.

Valsartan Film-Coated Tablets are 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 Film-Coated Tablets affect you. Like many other medicines used to treat high blood pressure, Valsartan Film-Coated Tablets may in rare cases cause dizziness and affect the ability to concentrate.

Important information about some ingredients of Valsartan Film-Coated Tablets Valsartan Film-Coated Tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE VALSARTAN FILM-COATED TABLETS

Always take Valsartan Film-Coated Tablets 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.

Valsartan 40 mg Film-Coated Tablets

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 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 Film-Coated Tablets can be given together with other treatment for heart failure, and your doctor will decide which treatment is suitable for you. Valsartan 80/160 mg Film-Coated Tablets Adult patients with 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). Fie may also combine Valsartan Film-Coated Tablets with an additional medicine (e.g. a diuretic). Children and adolescents (6 to 18 years of aue) 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 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 Film-Coated Tablets can be given together with other treatment for heart failure, and your doctor will decide which treatment is suitable for you. Valsartan 320 mg Film-Coated Tablets Adult patients with 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). Fie may also combine Valsartan Film-Coated Tablets with an additional medicine (e.g. a diuretic). Children and adolescents (6 to 18 years of aue) 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).

You can take Valsartan Film-Coated Tablets with or without food. Swallow Valsartan Film-Coated Tablets with a glass of water.

Take Valsartan Film-Coated Tablets at about the same time each day.

It you take more Valsartan Film-Coated Tablets than you should

If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately. If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.

It you toruet to take Valsartan Film-Coated Tablets 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. Flowever, if it is almost time for your next dose, skip the dose you missed.

It you stop taking Valsartan Film-Coated Tablets

Stopping your treatment with Valsartan Film-Coated Tablets 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, Valsartan Film-Coated Tablets 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

-    diarrhoea

-    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)

-    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, 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.

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 VALSARTAN FILM-COATED TABLETS

-    This medicinal product does not require any special storage conditions.

-    Keep out of the reach and sight of children.

-    Do not use Valsartan Film-Coated Tablets after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

-    Do not use Valsartan Film-Coated Tablets 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 Valsartan Film-Coated Tablets contain

The active substance is: valsartan

One film-coated tablet contains 40 mg of valsartan.

One film-coated tablet contains 80 mg of valsartan.

One film-coated tablet contains 160 mg of valsartan.

One film-coated tablet contains 320 mg of valsartan.

The other ingredients are:

Core: Lactose monohydrate, croscarmellose sodium, povidone (K-30), magnesium stearate, talc.

Film-coat:

Valsartan 40 mg Film-Coated Tablets:

Hypromellose 2910 (6 cps), titanium dioxide (E171), macrogol 400.

Valsartan 80 mg Film-Coated Tablets:

Hypromellose 2910 (6 cps), titanium dioxide (E171), macrogol 400, ferric oxide red (E172).

Valsartan 160mg Film-Coated Tablets:

Hypromellose 2910 (6 cps), titanium dioxide (E171), macrogol 400, ferric oxide yellow (E172).

Valsartan 320mg Film-Coated Tablets:

Hypromellose 2910 (6 cps), titanium dioxide (E171), macrogol 400, ferric oxide yellow (E172).

What Valsartan Film-Coated Tablets look like and contents of the pack

Valsartan 40 mg Film-Coated Tablets are white to off white, oval shaped, film-coated tablets with a score line on both sides. The film-coated tablets can be divided in equal halves.

Valsartan 40 mg Film-Coated Tablets are available in AI/OPA-AI-PVC blister packs with 14 or 28 tablets.

Valsartan 80 mg Film-Coated Tablets are brick red, oval film-coated tablets with a score line on both sides. The film-coated tablets can be divided in equal halves.

Valsartan 80 mg Film-Coated Tablets are available in AI/OPA-AI-PVC blister packs with 28, 56, 98 tablets.

Valsartan 160 mg Film-Coated Tablets are yellow, oval shaped, biconvex, film-coated tablets with score line on both sides. The film-coated tablets can be divided in equal halves.

Valsartan 160 mg Film-Coated Tablets are available in AI/OPA-AI-PVC blister packs with 28, 56, 98 tablets.

Valsartan 320 mg Film-Coated Tablets are yellow, oval shaped, biconvex, film-coated tablets with a score line on one side and plain on the other side. The film-coated tablets can be divided in equal halves.

Valsartan 320 mg Film-Coated Tablets are available in AI/OPA-AI-PVC blister packs with 28, 56, 98 tablets.

Not all pack sizes may be marketed.

Marketinu Authorisation Holder

Torrent Pharma GmbH

Suedwestpark 50

90449 Nuremberg

Germany

Manufacturer

Heumann Pharma GmbH & Co. Generica KG

Suedwestpark 50 90449 Nuremberg Germany

For any information about this medicine, please _

contact the Marketing Authorisation Holder.

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

United Kingdom Valsartan 40/80/160/320 mg Film-Coated Tablets

Germany    Valsartan Fleumann 40/80/160/320 mg

Filmtabletten

Italy    Valsartan Torrent 40/80/160/320 mg

compresse revestite con film Lithuania    Valsartan Torrent 40/80/160/320 mg

plevele dengtos tabletes Romania    Valzaar

This leaflet was last approved in 04/2011.

8027985-7803