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Valsartan 160 Mg Capsules

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Document: leaflet ACTAVIS_PL 00289-1124 change

•    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 a low level of white blood cells also called neutropenia)

•    decrease of the level of haemoglobin and decrease of the percentage of red blood cells in the blood (which can lead to anaemia in severe cases)

•    increase in the level of potassium in the blood (which can trigger muscle spasms and abnormal heart rhythm in severe cases)

•    elevation of liver function values (which can indicate liver damage) including an increase of bilirubin in the blood (which can, trigger yellow skin and eyes in severe cases)

•    increase of the level of blood urea nitrogen and increase of the level of serum creatinine (which can indicate abnormal kidney function)

•    low level of sodium in the blood (which can trigger tiredness, confusion, muscle twitching and/or convulsions in severe cases)

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 adult patients treated for high blood pressure than in adult patients treated for heart failure or after a recent heart attack.

Side effects in children and adolescents are similar to those seen in adults.

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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

^ HOW TO STORE VALSARTAN CAPSULES

Keep this medicine out of the sight and reach of children.

Do not use Valsartan Capsules after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.


"6| CONTENTS OF THE PACK AND OTHER INFORMATION

What Valsartan Capsules contain:

•    The active substance is valsartan.

40 mg: Each hard capsule contains 40 mg of valsartan.

80 mg: Each hard capsule contains 80 mg of valsartan.

160 mg: Each hard capsule contains 160 mg of valsartan.

•    The other ingredients are silica colloidal anhydrous, sodium starch glycolate (type A), crospovidone, cellulose microcrystalline, maize starch and magnesium stearate inside the capsule. The capsule shell is made of titanium dioxide, gelatin, black iron oxide, 80 mg and 160 mg strengths only: red iron oxide, 160 mg strength only: yellow iron oxide. The printing ink contains shellac, propylene glycol and black iron oxide.

What Valsartan Capsules look like and contents of the pack

•    Capsule, hard

•    40 mg strength: Hard-gelatin capsule with grey opaque body and cap, filled with off-white to yellowish powder with small agglomerates, imprinted V40 on body and cap.

•    80 mg strength: Hard-gelatin capsule with grey opaque body and flesh opaque cap, filled with off-white to yellowish powder with small agglomerates, imprinted V80 on body and cap.

•    160 mg strength: Hard-gelatin capsule with grey opaque body and flesh opaque cap, filled with off-white to yellowish powder with small agglomerates, imprinted V160 on body and cap.

Transparent PVC/PE/PVdC - Aluminium blister packs:

Pack sizes:

40 mg capsules: 1,7, 14, 15, 28, 30, 56, 84, 90, 98, 100 and 280 capsules.

80 & 160 mg capsules: 1, 14, 15, 28, 30, 56, 84, 90, 98, 100 and 280 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Teva UK Limited, Eastbourne, BN22 9AG, United Kingdom


This leaflet was last revised in June 2013


PL 00289/1



122-1124

If you would like a leaflet with larger text, please contact


01271 311257.


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. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

J What Valsartan is and what it is used for

What you need to know before you take Valsartan

_3| How to take Valsartan _4| Possible side effects How to store Valsartan

_6| Contents of the pack and other information

J WHAT VALSARTAN IS AND WHAT IT IS USED FOR

Valsartan belongs to a class of medicines known as "angiotensin II receptor antagonists” 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 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 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 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 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 owing to fluid build-up.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Valsartan 40mg, 80mg and 160mg Capsules

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 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 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 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 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 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.

   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.

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Actavis, Barnstaple, EX32 8NS, UK


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WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALSARTAN CAPSULES

Do NOT takeValsartan Capsules if you:

•    are allergic (hypersensitive) to valsartan or any of the other ingredients of Valsartan Capsules (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 pregnancy section).

•    if you have diabetes mellitus or impaired kidney function and taking aliskiren (a class of medicines called renin inhibitors that helps to lower high blood pressure in adult patients).

If any of these apply to you, do not take

Valsartan Capsules.

Warnings and precautions:

Talk to your doctor 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 checkyour 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 necessary to check the amount of potassium in your blood at regular intervals.

   are below 18 years of age and you takeValsartan in combination with other medicines that inhibit the renin angiotensin aldosterone system (medicines that lower blood pressure), your doctor may checkyour 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 of Valsartan Capsules is not recommended.

•    have lost a lot of fluid (dehydration) caused by diarrhoea, vomiting, or high doses of water tablets (diuretics).

•    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").

•    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 betaken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see section Pregnancy, breast-feeding and fertility).

If any of these apply to you, tell your

doctor before you takeValsartan Capsules.

Other medicines and Valsartan

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The effect of the treatment can be influenced if Valsartan Capsules 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:

•    aliskiren (a medicine that lower blood pressure), particularly if you suffer from diabetes mellitus or impaired kidney function.

•    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.

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.

•    if you are being treated for heart failure, a triple combination with ACE inhibitors and beta-blockers (medications also used to treat heart failure) is not recommended.

Valsartan Capsules with food and drink

You can takeValsartan Capsules with or without food.

Pregnancy, breast-feeding and fertility

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 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 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 Capsules are not recommended for mothers who are breastfeeding, and your doctor may choose another treatment foryou 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 Capsules affects you. Like many other medicines used to treat high blood pressure, Valsartan Capsules may cause dizziness and affect the ability to concentrate.

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|] HOWTOTAKEVALSARTAN CAPSULES

Always takeValsartan Capsules exactly as your doctor has told you. 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. For doses not realisable/ practicable with this strength, other strengths and pharmaceutical forms of this medicinal product are available.

Valsartan 80 mg and 160 mg capsules:

•    Adults with high blood pressure:

The recommended dose is 80 mg daily. In some cases your doctor may prescribe higher doses (e.g. 160mg or 320mg). He/she may also combine Valsartan Capsules with an additional medicine (e.g. a diuretic).

Valsartan 40 mg, 80 mg and 160 mg capsules:

•    Use in 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 may obtain the 20 mg dose by dividing a 40 mg valsartan 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 Capsules can be given together with other treatment for heart attack: 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 Capsules can be given together with other treatment for heart failure: your doctor will decide which treatment is suitable for you.

You can takeValsartan Capsules with or without food. Swallow Valsartan Capsules with a glass of water. Take Valsartan Capsules at about the same time each day.

If you take more Valsartan Capsules than you should

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

If you forget to takeValsartan Capsules

If you forget to take a dose then 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 Valsartan Capsules

Stopping your treatment with Valsartan Capsules 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.

Q POSSIBLE SIDE EFFECTS

Like all medicines, Valsartan Capsules can cause side effects, although not everybody gets them.

These side effects may occur with certain frequencies, which are defined as follows:

Very common: may affect more than 1 in 10 people Common:    may affect up to 1 in 10 people

Uncommon:    may affect up to 1 in 100 people

Rare:    may affect up to 1 in 1000 people

Very rare:    may affect up to 1 in 10,000 people

Not known: frequency cannot be estimated from the available data

Some symptoms need immediate medical attention:

You may experience symptoms of angioedema (a specific allergic reaction), such as

•    swollen face, lips, tongue or throat

•    difficulty in breathing or swallowing

•    hives, itching

If you get any of these, see a doctor immediately.

Side effects include:

Common

•    dizziness

•    low blood pressure with or without symptoms such as dizziness and fainting when standing up

•    decreased kidney function (signs of renal impairment)

Uncommon

•    angioedema (see section "Some symptoms need immediate medical attention")

•    sudden loss of consciousness (syncope)

•    spinning sensation (vertigo)

•    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

Frequency not known:

•    allergic reactions with rash, itching and hives; symptoms of fever, swollen joints and joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms may occur (signs of serum sickness).

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