30 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

Valsartan 320 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. See section 4.

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

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 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. 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 Valsartan (listed in section 6).

•    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 you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine called aliskiren.

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

Warnings and precautions

Talk to your doctor or pharmacist or before taking 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 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 Valsartan, stop taking Valsartan 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 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 than 3 months pregnant, as it may cause serious harm to your baby if used at that stage. (see pregnancy section).

•    if you are taking any of the following medicines used to treat high blood pressure:

-    an ACE inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes related kidney problems.

-    aliskiren.

•    if you are being treated with an ACE-inhibitor together with certain other medicines to treat your heart failure, which are known as mineralocorticoid receptors antagonists (MRA) (for example spironolactone, eplerenone) or betablockers (for example metoprolol).

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading "Do not take Valsartan"

If any of these apply to you, tell your doctor before you take Valsartan.

Other medicines and Valsartan

Please tell your doctor or pharmacist if you are taking or 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).

•    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 Valsartan.

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

Your doctor may need to change your dose and/or to take other precautions:

•    if you are taking an ACE-inhibitor or aliskiren (see also information under the headings "Do not take Valsartan" and "Warnings and precautions")

In addition:

•    if you are being treated with an ACE-inhibitor together with certain other medicines to treat your heart failure, which are known as mineralocorticoid receptors antagonists (MRA) (for example spironolactone, eplerenone) or betablockers (for example metoprolol).

•    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.

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 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 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. 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).

SAME SIZE ARTWORK

130 x 450 mm

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V9 24-09-2015 D0

SAME SIZE ARTWORK

130 x 450 mm

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