PACKAGE LEAFLET: INFORMATION FOR THE USER

Valsartan 40, 80 and 160 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 is and what it is used for

2.    Before you take Valsartan

3.    How to take Valsartan

4.    Possible side effects

5.    How to store Valsartan

6.    Further information_

1. WHAT VALSARTAN FILM COATED TABLETS IS AND WHAT IT IS USED FOR

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

Valsartan 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 alter a recent heart attack (myocardial infarction). "Recent" here means between 12 hours and 10 days.

•    to treat symptomatic heart failure in adult patients. Valsartan 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 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.

2. BEFORE YOU TAKE VALSARTAN

Do not take Valsartan :

•    if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Valsartan 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 Valsartan in early pregnancy - see pregnancy section).

if any of these apply to you, do not take Valsartan.

Take special care with Valsartan

•    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 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 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 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. Valsartan is not recommended in early pregnancy, and must not be taken if you are more than3 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.

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 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 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, a triple combination with ACE inhibitors and beta blockers (medications to treat heart failure) is not recommended.

Taking Valsartan with food and drink You can take Valsartan 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 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.

•    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 yourdoctor 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 in rare cases cause dizziness and affect the ability to concentrate.

3. HOW TO TAKE VALSARTAN

Always take Valsartan 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 Valsartan 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).

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.

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 Valsartan with a glass of water.

Take Valsartan at about the same time each day.    |

SAME SIZE ARTWORK 130 x 420 mm Front

V3 27-10-2014 DO

SAME SIZE ARTWORK

130 x 420 mm

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