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Valsartan 160mg Film-Coated Tablets

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Document: leaflet MAH GENERIC_PL 00289-1237 change

TEVA UK Ref: 231-30-88210-D LEA VALSARTAN A/S TABS TUK

Version: 1

16 September 2014

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•    muscle pain (myalgia)

•    fever, sore throat or mouth ulcers due to infections (symptoms of low level ofwhite blood cells also called neutropenia)

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

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

•    elevation ofliver 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 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 adult patients treated with 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

Ifyou get any side effects, talkto your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via theYellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5 HOW TO STORE VALSARTAN

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXPThe expiry date refers to the last day ofthat month.

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

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

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.

O CONTENTS OF THE PACK AND OTHER INFORMATION

What Valsartan contains

• Theactivesubstanceisvalsartan.

40 mg: Each film-coated tablet contains 40 mg ofvalsartan

80 mg: Each film-coated tablet contains 80 mg ofvalsartan

160 mg: Each film-coated tablet contains 160 mg ofvalsartan

320 mg: Each film-coated tablet contains 320 mg ofvalsartan


• The other ingredients are colloidal anhydrous silica, sodium starch glycolate (type A), crospovidone, microcrystalline cellulose, maize starch, magnesium stearate, hypromellose, macrogol, titanium dioxide (E171), talc, 40 mg and 160 mg: yellow iron oxide (E172), 80 mg and 160 mg: red iron oxide (E172),

320 mg: red iron oxide (E172), indigotine (E132), sunset yellow FCF (E110).

What Valsartan looks like and contents of the pack

Valsartan 40 mg Film-coated Tablets are yellow, oval-shaped, film-coated tablets, scored on one side and debossed with "V" on one side ofthe score line and "40" on the other side ofthe score line. Available in pack sizes of1,7,14,15, 28, 30, 56, 60, 84, 90, 98,100 and 280 film-coated tablets. Hospital pack: 50, 56 (56 x 1),98(98x 1) and 280 (280 x 1) film-coated tablets.

Valsartan 80 mg Film-coated Tablets are pink, oval-shaped, film-coated tablets, scored on one side and debossed with "V" on one side ofthe score line and "80" on


Valsartan 160 mg Film-coatedTablets are yellow, oval-shaped, film-coated tablets, scored on one side and debossed with "V" on one side ofthe score line and "160" on the other side ofthe score line. Available in packsizesofl, 14, 15, 28,30, 56, 60, 84,90, 98,100 and 280 film-coated tablets. Hospital pack: 50 film-coated tablets. Calendar pack of 28 and 98 tablets.

Valsartan 320 mg Film-coatedTablets are purple, oval-shaped, film-coated tablets, scored on one side and debossed with "V" on one side ofthe score line and "320" on the other side ofthe score line. Available in packsizesofl, 7, 10, 14, 15, 20, 28, 30, 50,

56, 84, 90, 98, 100, 280 film-coated tablets. Hospital pack: 50,56x 1,98x 1 and 280 x 1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder is:

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

Manufacturer is:

Teva Pharmaceutical Works Private Limited Company, Pallagi ut 13,4042 Debrecen.

This leaflet was last revised in 09/2014.

PL 00289/1235, 1236,1237 &1238


TfWTl


88210-D 323x 320



VALSARTAN 40 mg FILM-COATED TABLETS VALSARTAN 80 mg FILM-COATED TABLETS VALSARTAN 160 mg FILM-COATED TABLETS VALSARTAN 320 mg FILM-COATED TABLETS

PACKAGE LEAFLET: INFORMATION FORTHE 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.

•    Ifyou 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 symptoms are the same as yours.

•    Ifyou get any side effects, talkto your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.

WHAT IS INTHIS 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 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 40 mg Film-coated 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 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 ofthe 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.

Valsartan 80 mg Film-coated Tablets 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 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.

•    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 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.

Valsartan 160 mg Film-coated Tablets 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 other medication to treat heart failure cannot be used. Heart failure symptoms include shortness of breath, and swelling ofthe 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.

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 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.

©WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALSARTAN Do not take Valsartan

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

ifyouhave severe liver disease • ifyou are more than 3 months pregnant, (it is also betterto avoid Valsartan in early pregnancy - see section 2: Pregnancy, breast-feeding and fertility)

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•    ifyou 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.

Warnings and precautions

Talkto your doctor or pharmacist before taking Valsartan:

•    ifyouhaveliverdisease

•    if you have a severe kidney disease or if you are undergoing dialysis

•    ifyou are suffering from a narrowing of the kidney artery

•    ifyou have recently had a kidney transplantation (received a new kidney)

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

•    ifyou have severe heart disease other than heart failure or heart attack

•    ifyou are taking medicines that increase the amount of potassium in your blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicinesand heparin. It may be necessaryto check the amount of potassium in your blood at regular intervals.

•    ifyou are below 18 years ofage 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

•    ifyou suffer from aldosteronism.This is a disease in which your adrenal glands maketoo much ofthe hormone aldosterone. If this applies to you, the use ofValsartan is not recommended.

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

•    ifyou 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. Ifthese symptoms occur when you are taking Valsartan, stop taking Valsartan immediatelyand nevertake it again, (see section 4: Possible side effects).

•    you must tell your doctor ifyou thinkyou are (or might become) pregnant. Valsartan is 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 ofthe following medicines used to treat high blood pressure:

•    an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular ifyou have diabetes-related kidney problems

•    aliskiren

In addition forValsartan 40 mg, 80 mg and 160 mg film coated tablets

•    ifyouarebeingtreatedwithan 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 beta blockers (for example metoprolol)

•    Yourdoctormaycheckyourkidney 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]1.

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

Other medicines and Valsartan

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

The effect ofthe treatment can be influenced ifValsartan 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 ofthe 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.

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

Ifyou are taking an ACE-inhibitor or aliskiren (see also information under the headings 'Do not take [Valsartan]' and 'Warnings and precautions').

In addition for Valsartan 40 mg, 80 mg and 160 mg Film-coated Tablets:

•    ifyouarebeing treated after a heart attack, a combination with ACE inhibitors

(a medication to treat heart attack) is not recommended

•    ifyouarebeingtreatedwithan 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 beta blockers (for example metoprolol).

Valsartan with food and drink

You can take Valsartan 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.

Ask your doctor or pharmacist for advice before taking any medicine.

•    You must tell your doctor if you think 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 ofValsartan. 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 ifyour 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.

Valsartan 320 mg Film-coated Tablets

contains sunset yellow FCF (E110):

This medicinal product contains sunset yellow FCF (E110) and may cause allergic reactions.

3 HOW TOTAKE VALSARTAN

Always take this medicine exactly as your doctor has told you. Checkwith your doctor or pharmacist ifyou 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 ifyou are feeling well.

Valsartan 80 mg, 160 mg and 320 mg Film-coated Tablets:

Adults with high blood pressure:The

recommended 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).

Valsartan 40 mg, 80 mg, 160 mg and 320 mg Film-coated Tablets:

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 ofvalsartan 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).

Valsartan 40 mg, 80 mg and 160 mg Film-coated Tablets:

Adult patients after a recent heart attack: After a heart attackthe 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 ofwater.

Take Valsartan at about the same time each day.

The tablet can be divided into equal doses.

If you take more Valsartan than you should

Ifyou experience severe dizziness and/or fainting, contact your doctor immediately and lie down. Ifyou have accidentally taken too manytablets, contact your doctor, pharmacist, or hospital.

If you forget to take Valsartan

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

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.

Ifyou have any further questions on the use of this medicine, ask your doctor or pharmacist.

4 POSSIBLE SIDE EFFECTS

Like all medicines, this medicine 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

may affect uptol in10 people

may affect up to 1 in 100 people

may affect up to 1 in 1000 people

may affect up to 1 in 10,000 people

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

•    lowbloodpressurewithorwithout 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 lossofconsciousness (syncope)

•    spinningsensation(vertigo)

•    severelydecreased kidneyfunction (signs of acute renal failure)

•    muscle spasms, abnormal heart rhythm (signs of hyperkalaemia)

•    breathlessness, difficulty breathing when lying down, swelling ofthe feet or legs (signs of cardiac failure)

•    headache

•    cough

•    abdominal pain

•    nausea

•    diarrhoea

•    tiredness

•    weakness.

Not known:

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

•    purplish-red spots, fever, itching (signs of inflammation of blood vessels also called vasculitis)

•    unusual bleeding or bruising (signs of thrombocytopenia)


Common:

Uncommon:

Rare:

Very rare: Not known:



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 belongstoa class ofmedicinesknown as angiotensin II receptor antagonist, which help to control high blood pressure. Angiotensin II is a substance in the body that causes vesselsto tighten, thus causing your blood pressure to increase. Valsartanworks by blockingthe effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered.

Valsartan 40 mg Film-coated 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 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 developingthese 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 isused 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 medicationsto treat heart failure cannot be used. Heart failure symptoms include shortness of breath, and swelling ofthe 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.

Valsartan 80 mg Film-coated Tablets 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 reducesthe risk ofdeveloping 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 isused 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 medicationsto treat heart failure cannot be used. Heart failure symptoms include shortness of breath, and swelling ofthe 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.

Valsartan 160 mg Film-coated Tablets 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 reducesthe risk ofdeveloping 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. Valsartanisusedwhena groupof 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 medication to treat heart failure cannot be used. Heart failure symptoms include shortness of breath, and swelling ofthe 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.

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 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 reducesthe risk ofdeveloping these disorders.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALSARTAN Do not take Valsartan

♦ ifyou are allergic to valsartan or any ofthe other ingredients ofthis medicine (listed in section 6)

• ifyouhave severe liver disease • ifyou are more than 3 months pregnant, (it is

also betterto avoid Valsartan in early pregnancy - see section 2: Pregnancy, breast-feeding and fertility)

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


I


I


VALSARTAN 40 mg FILM-COATED TABLETS

VALSARTAN 80 mg FILM-COATED TABLETS

VALSARTAN 160 mg FILM-COATED TABLETS

VALSARTAN 320 mg FILM-COATED TABLETS

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

♦    Ifyou 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 iftheir symptoms are the same as

♦    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.

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

Warnings and precautions

Talkto your doctor or pharmacist before taking Valsartan:

♦    ifyouhaveliverdisease

♦    ifyou have a severe kidney disease or ifyou are undergoing dialysis

♦    ifyou are suffering from a narrowing ofthe kidney artery

♦    ifyouhaverecentlyhadakidney transplantation (received a new kidney)

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

♦    ifyou have severe heart disease other than heart failure or heart attack

♦    ifyou are taking medicines that increase the amount of potassium in your blood.These include potassium supplements or salt substitutescontaining potassium, potassium-sparing medicinesand heparin. It may be necessary to checkthe amount of potassium in your blood at regular intervals.

♦    ifyou are below 18years of age and you take Valsartan in combination with othermedicines 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

♦    ifyou suffer from aldosteronism.This is a disease in which your adrenal glands make too much ofthe hormone aldosterone. If this applies to you, the use of Valsartan is not recommended.

♦    ifyou have lost alotof fluid (dehydration) caused by diarrhoea, vomiting, or high doses ofwatertablets (diuretics)

♦    ifyou have ever experienced swelling ofthe tongue and face caused by an allergic reaction called angioedema when taking another drug (including ACE inhibitors), tell your doctor. If these symptoms occurwhen you are taking Valsartan, stoptaking Valsartan immediately and never take it again, (see section 4:

Possible side effects).

♦    you must tell your doctor ifyou think you are (ormight become) pregnant. Valsartan is 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 ofthe following medicines used to treat high blood pressure:

♦    an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular ifyou have diabetes-related kidney problems

•    aliskiren

In addition for Valsartan 40mg,80 mg and 160 mg film coated tablets

♦    ifyou are being treated with an ACE-inhibitor together with certain other medicinesto treat your heart failure, which are known as mineralocorticoid receptors antagonists (MRA) (for example spironolactone, eplerenone) or beta blockers (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

Tell your doctor or pharmacist ifyou are taking, have recently taken or mighttake any other medicines.

The effect ofthe 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 casesto stoptaking one ofthe medicines.This appliesto 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.

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

Ifyou are taking an ACE-inhibitor or aliskiren (see also information under the headings 'Do not take [Valsartan]' and 'Warnings and precautions').

In addition for Valsartan 40 mg, 80 mg and 160 mg Film-coated Tablets:

♦    ifyouarebeing treated after a heart attack, a

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

♦    ifyou are being treated with an ACE- inhibitor together with certain other medicinesto treat your heart failure, which are known as mineralocorticoid receptors antagonists (MRA) (for example spironolactone, eplerenone) or beta blockers (for example metoprolol).

Valsartan with food and drink

You can take Valsartan 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, ask your doctor or pharmacist for advice before taking this medicine.

Ask your doctor or pharmacist for advice before taking any medicine.

♦    You must tell your doctor if you think 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 formothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially ifyour baby is newborn, orwas 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 affectsyou.

Like many other medicines used to treat high blood pressure, Valsartan mayin rare cases cause dizziness and affect the ability to concentrate.

X


Valsartan 40 mg, 80 mg, 160 mg and 320 mg Film-coated Tablets:

Use in children and adolescents (6 to 18 years of age) with high blood pressure: In

patientswho weigh lessthan 35 kg the usual dose is 40 mg ofvalsartan once daily. In patients who weigh 35 kg or more the usual starting dose is80mg ofvalsartan once daily. In some casesyour doctor may prescribe higher doses (the dose can be increased to160mg and to a maximum of320 mg).

Valsartan 40 mg, 80 mg and 160 mg Film-coated Tablets:

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 20mg dose by dividing the 40mg tablet. Your doctor will increase this dose gradually over several weeksto a maximum of160mg 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 weeksto a maximum of160mg 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 Valsartanwith a glass ofwater.

Take Valsartan at aboutthe same time each day. The tablet can be divided into equal doses.

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

If you forget to take Valsartan If you forget to take a dose, take it as soon as you remember. However, ifitisalmosttime 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 Stopping your treatment with Valsartan may cause your disease to get worse. Do not stop taking yourmedicine unless your doctor tells

Ifyou have any further questions on the use of this medicine, ask your doctor or pharmacist.

4 POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody getsthem.


may affect more than 1 ir

may affect up to 1in10p may affect upto 1 in 100 may affect up to 1 in 100i people

may affect up to 1 ii

frequency cannot be estimated from the available data.


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)

♦    spinningsensation(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 ofthe feet or legs (signs of cardiac failure)

♦    headache

♦    cough

♦    abdominal pain


5


Valsartan 320 mg Film-coated Tablets contains sunsetyellow FCF (E110):

Thismedicinal product contains sunsetyellow FCF (E110) and may cause allergic reactions.

HOW TO TAKE VALSARTAN

Always take this medicine exactly as your doctor has told you. Checkwith your doctor or pharmacist ifyou 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 ifyou are feeling well.

Valsartan 80 mg, 160 mg and 320 mg Film-coated Tablets:

Adults with high blood pressure:The

recommended dose is 80 mg daily. In some casesyour doctor may prescribe higher doses (e g. 160 mgor 320 mg). Hemay also combine Valsartan with an additional medicine (e g. a diuretic).

Uncommoi

10,000

Some symptoms need immediate medical attention:

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

♦    swollenface,lips,tongueorthroat

♦    difficultyinbreathingorswallowing

♦    hives, itching.

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

Side effects include:

♦    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 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 effectsmay vary depending on your condition. For example, side effects such as dizziness, and decreased kidney function, were seen less frequently in adult patients treated with 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 Ifyou 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 effectsyou can help provide more information on the safety ofthismedicine.

HOW TO STORE VALSARTAN

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXPThe expiry date refers to the last day ofthat

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

Do not use Valsartan ifyou notice that the pack is damaged or shows signs oftampering.

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

©CONTENTS OF THE WCK AND OTHER INFORMATION

What Valsartan contains

♦    Theactivesubstanceisvalsartan.

40 mg: Each film-coated tablet contains 40 mg ofvalsartan

80 mg: Each film-coated tablet contains 80 mg ofvalsartan

160 mg: Each film-coated tablet contains 160 mg ofvalsartan

320 mg: Each film-coated tablet contains 320 mg ofvalsartan

♦    The other ingredients are colloidal anhydrous silica, sodium starch glycolate (type A), crospovidone, microcrystalline cellulose, maize starch, magnesium stearate, hypromellose, macrogol, titanium dioxide (E171), talc, 40mgand160 mg: yellow iron oxide (E172), 80 mg and 160 mg: red iron oxide (E172), 320 mg: red iron oxide (E172), indigotine (E132), sunset yellow FCF (E110).

What Valsartan looks like and contents of the

Valsartan 40 mg Film-coatedTablets are yellow, oval-shaped, film-coated tablets, scored on one side and debossed with "V" on one side ofthe score line and "40" on the other side ofthe score line. Available in pack sizes of1,7,14,15, 28,30, 56, 60,84, 90, 98,100 and 280 film-coated tablets. Hospital pack: 50, 56 (56x 1), 98 (98x1) and 280 (280 x1) film-coatedtablets. Valsartan 80 mg Film-coatedTablets are pink, oval-shaped, film-coated tablets, scored on one side and debossed with "V" on one side ofthe score line and "80" on the other side ofthe score line. Available in pack sizes of1,14,15, 28, 30, 56, 60,84, 90, 98,100 and 280 film-coated tablets. Hospital pack: 50 film-coated tablets. Calendar pack of 28 and 98tablets.

Valsartan 160mg Film-coated Tablets are yellow, oval-shaped, film-coated tablets, scored on one side and debossed with "V" on one side ofthe score line and "160" on the other side ofthe score line. Available in pack sizes of1,14,15, 28, 30, 56, 60,84, 90, 98,100 and 280 film-coated tablets. Hospital pack: 50 film-coated tablets. Calendar pack of 28 and 98tablets.

Valsartan 320 mg Film-coatedTablets are purple, oval-shaped, film-coated tablets, scored on one side and debossed with "V" on one side ofthe score line and "320" on the other side ofthe score line. Available in pack sizes of1,7,10,14,

15, 20, 28,30, 50, 56,84, 90, 98,100, 280 film-coated tablets. Hospital pack: 50, 56x1,

98 x 1 and 280 x 1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder is:

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

Manufacturer is:

Teva Pharmaceutical Works Private Limited Company, Pallagi ut 13, 4042 Debrecen.

This leaflet was last revised in 09/2014.

PL 00289/1235,1236,1237 & 1238

♦    diarrhoea

♦    tiredness

♦    weakness.

Not known:

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

♦    purplish-red spots, fever, itching (signs of inflammation of blood vessels also called vasculitis)

♦    unusual bleeding or bruising (signs of thrombocytopenia)

♦    musclepain(myalgia)

♦    fever, sore throat ormouth ulcers due to infections (symptoms oflow level ofwhite blood cells also called neutropenia)

♦    decrease oflevel ofhaemoglobin and decrease ofthe percentage of red blood cells in the blood (which can lead to anaemia in severe cases)

91402-C


♦    increase of level of potassium in the blood (which can trigger muscle spasmsand abnormal heart rhythm in severe cases)