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VALSARTAN 40 mg, 80 mg and 160 mg CAPSULES

Package leaflet: Information for the user

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.

•    Ifyou 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

OWhat Valsartan is and what it is used for

Valsartan belongs to a class of medicines known as "angiotensin II receptor antagonists','which helpto 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 40 mg Capsules 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 increasesthe 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 after a recent heart attack (myocardial infarction). "Recent" here means between 12 hours and 10 days ago.

* to treat symptomatic heart failure in adult patients. Valsartan is used when a group of medicines called AngiotensinConverting Enzyme (ACE) inhibitors (a medication to treat heart failure) cannot be used or it may be used in addition to ACE-inhibitors when other medications to treat heart failure cannot be used. Heart failure symptoms include shortness of breath, and swelling of the feet and legs owing 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 Capsules 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    <2

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    f

a stroke, heart failure or kidney    &

failure. High blood pressure increases    |

the risk of heart attacks. Lowering your blood pressure reduces the risk of developing these disorders.

*    to treat adult patients after a recent heart attack (myocardial infarction).

"Recent" here means between 12 hours and 10 days ago.

*    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 other medications to treat heart failure cannot be used. Heart failure symptoms include shortness of breath and swelling ofthe feet and legs owing 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 160 mg Capsules 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 increases the workload on the heart and arteries. If not treated it can damage the blood vessels ofthe 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 after 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 other medications 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.

©What you need to know before you take Valsartan Capsules Do not take Valsartan Capsules if you:

• are allergic to valsartan or any ofthe other ingredients of this medicine (listed in section 6)

* have severe liver disease * are more than 3 months pregnant (it is better to avoid Valsartan Capsules in early pregnancy - see section 2:

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Pregnancy, breast-feeding and fertility)

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

If any of these apply to you, do not take

Valsartan Capsules.

Warnings and precautions:

Talk to your doctor or pharmacist before

taking Valsartan if you:

•    have liver disease

•    have severe kidney disease or if you are undergoing dialysis

•    are suffering from a narrowing of the kidney artery

•    have recently undergone kidney transplantation (received a new kidney)

•    are treated after a heart attack or for heart failure, your doctor may check your kidney function

•    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, salt substitutes containing potassium, potassium-sparing medicines and heparin. It may be necessaryto check the amount of potassium in your blood at regular intervals.

•    ifyou 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

•    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 ofValsartan Capsules is not recommended.

•    have lost a lot of fluid (dehydration)

caused by diarrhoea, vomiting, or high doses of water tablets (diuretics)

•    ifyou have everexperienced 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 section 4, "Possible side effects").

•    you must tell your doctor if you think you are (or might become) pregnant. Valsartan Capsules are not recommended in early pregnancy, and must not be taken ifyou are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see section 2: Pregnancy, breast-feeding and fertility).

•    ifyou 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

•    ifyou are being treated with an ACE-inhibitortogetherwith certain other medicines to treat your heart failure, which are known as mineralocorticoid receptors antagonists (MRA) (forexample spironolactone, eplerenone) or beta blockers (forexample 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 Capsules. Other medicines and Valsartan Tell your doctor or pharmacist ifyou are taking, have recently taken or might take any other medicines.

The effect of the treatment can be influenced ifValsartan Capsules are taken togetherwith 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, 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.

Your doctor may need to change your dose and/ortake 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')

•    if you are being treated with an ACE-inhibitortogetherwith certain other medicines to treat your heart failure, which are known as mineralocorticoid receptor antagonists (MRA) (forexample spironolactone, eplerenone) or beta blockers (for example metoprolol).

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.

Valsartan Capsules with food and drink You can take Valsartan Capsules with or without food.

Pregnancy, breast-feeding and fertility

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

•    You must tell your doctor ifyou think that you are (or might become) pregnant.Yourdoctorwill normally advise you to stop taking Valsartan Capsules before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Valsartan Capsules. Valsartan Capsules are not recommended in early pregnancy, and