PACKAGE LEAFLET:    A SANDOZ

INFORMATION FOR THE USER

Valsartan 40 mg, 80 mg and 160 mg Capsules, hard

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 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 blood pressure is lowered.

Valsartan 40, 80 and 160 mg Capsules can be used

•    to treat people 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.

In addition

Valsartan 80 and 160 mg Capsules can be used

•    to treat high blood pressure. 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 VALSARTAN

Do not take Valsartan:

•    if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Valsartan. These are 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 containing aliskiren.

If any of these apply to you, speak to your doctor.

Warnings and precautions

Talk to your doctor, pharmacist or nurse 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 being 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 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 pills (diuretics).

•    The use of Valsartan in children and adolescents below the age of 18 years is not recommended.

•    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”.

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. Your doctor may need to change your dose and/or to take other precautions, or in some cases to stop taking one of the medicines:

•    other medicines that lower blood pressure, especially water pills (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.

•    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 after a heart attack, a

combination with ACE inhibitors (a medication to treat heart attack) is not recommended.

•    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).

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 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

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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.

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.

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.

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.

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

Take Valsartan at about the same time each day.

If you take more Valsartan than you should If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately. If you have accidentally taken too many capsules, contact your doctor, pharmacist, or hospital.

If you forget to take Valsartan

Do not take a double dose to make up for a forgotten dose. 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.

If you stop taking Valsartan

Stopping your treatment with Valsartan 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, Valsartan 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.

Some symptoms need immediate medical attention:

You may experience symptoms of angioedema, such as

•    swollen face, tongue or throat

•    difficulty in swallowing

•    hives and difficulties in breathing

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

Other side effects include:

Common:

•    dizziness, postural dizziness

•    low blood pressure with symptoms such as dizziness

•    decreased kidney function (signs of renal impairment)

Uncommon:

•    allergic reaction with symptoms such as rash, itching, dizziness, swelling of face or lips or tongue or throat, difficulty breathing or swallowing (signs of angioedema)

•    sudden loss of consciousness

•    spinning sensation

•    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 Not known:

•    rash, itching, together with some of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms (signs of serum sickness)

•    purple-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 low level of white blood cells also called neutropenia)

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

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

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

•    increase of level of blood urea nitrogen and increase of 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 patients treated with high blood pressure than in patients treated for heart failure or after a recent heart attack.

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.

5. HOW TO STORE VALSARTAN

•    Keep your capsules in their original pack at a

temperature below 30°C. Protect from moisture and heat.

•    Keep out of the reach and sight of children.

•    Do not use Valsartan after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

•    Do not use Valsartan if you notice that the pack is damaged or shows signs of tampering.

•    If your doctor tells you to stop taking Valsartan Capsules, please take any unused capsules back to your pharmacist to be destroyed. Do not throw them away with your normal household water or waste. This will help to protect the environment.

6. FURTHER INFORMATION

What Valsartan contains

Valsartan Capsules are available in three different strengths containing either 40, 80 or 160 mg of the active ingredient valsartan. The gelatin capsules also contain the following inactive ingredients: microcrystalline cellulose, polyvidone, crospovidone, sodium lauryl sulfate and magnesium stearate. Colouring materials used in the capsule shell and ink are titanium dioxide (E171) and iron oxides (E172).

The ink also contains shellac and propylene glycol.

What Valsartan looks like and contents of the pack

Valsartan 40 mg Capsules, hard are pale grey, marked CG HBH in black ink on the cap. Pack sizes of 7 or 28 capsules are registered.

Valsartan 80 mg Capsules, hard have a pale grey cap and flesh pink body and are marked CG FZF in black ink on the cap. Pack sizes of 28 or 98 capsules are registered. Valsartan 160 mg Capsules, hard have a dark grey cap and flesh pink body and are marked CG GOG in white ink on the cap. Pack sizes of 28 or 98 capsules are registered. Some pack sizes may not be marketed. Marketing Authorisation Holder and Manufacturer MA Holder:

Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom.

Manufacturer:

Novartis Pharmaceuticals UK Limited, Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom or Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom.

This leaflet was last revised in 09/2014.

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