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^ DIOVAN

VALSARTAN

PACKAGE LEAFLET: INFORMATION FOR THE USER

Diovan 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 Diovan is and what it is used for

2.    Before you take Diovan

3.    How to take Diovan

4.    Possible side effects

5.    How to store Diovan

6.    Further information

1.    WHAT DIOVAN IS AND WHAT IT IS USED FOR

Diovan 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. Diovan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered.

Diovan 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 DIOVAN

Do not take Diovan:

•    if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Diovan listed at the end of this leaflet.

•    if you have severe liver disease.

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

If any of these apply to you, do not take Diovan

Take special care with Diovan:

•    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 Diovan, stop taking Diovan 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 Diovan 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 Diovan 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. Diovan 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 Diovan.

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 Diovan 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).

•    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 Diovan.

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

Taking Diovan with food and drink

You can take Diovan 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 Diovan before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Diovan. Diovan is not recommended in early pregnancy, and must not betaken 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. Diovan 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 Diovan affects you. Like many other medicines used to treat high blood pressure, Diovan may in rare cases cause dizziness and affect the ability to concentrate.

HOW TO TAKE DIOVAN

Always take Diovan 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.

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). He may also combine Diovan with an additional medicine (e.g. a diuretic).

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).

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

Take Diovan at about the same time each day.

If you take more Diovan than you should

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

If you forget to take Diovan

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 Diovan

Stopping your treatment with Diovan 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, Diovan 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.

1114774 ST 13 A/B-GB

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