TAREG 80MG CAPSULES

Active substance: VALSARTAN

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Ref: 0981/221013/1/F

®

Diovan 80mg Capsules
(valsartan)
Patient Information Leaflet
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.

*

Your medicine is called Diovan 80mg Capsules but will be referred to as
Diovan throughtout this leaflet. Please note that the leaflet also contains
information abouth other strengths of this medicine Diovan 40mg and Diovan
160mg

*

In this leaflet:
1 What Diovan is and what it is used for
2 Before you take Diovan
3 How to take Diovan
4 Possible side effects
5 How to store Diovan
6 Further information

1

What Diovan is and what it is used for

Diovan 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.
Diovan works by blocking the effect of angiotensin II.
As a result, blood vessels relax and blood pressure is lowered.
Diovan 80 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. Diovan 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.
In addition
Diovan 80mg 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 Diovan

Do not take Diovan:
* if you are allergic (hypersensitive) to valsartan or any of the other
ingredients of Diovan. 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 Diovan
in early pregnancy —see pregnancy section).
If any of these apply to you, speak to your doctor.
You must be especially careful and talk to your doctor before taking
Diovan if any of the following apply to you.
* 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 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 Diovan, stop taking Diovan 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 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 Diovan 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 Diovan 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.
Diovan 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).

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 Diovan 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 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).
* 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
Diovan.
* 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 (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.
Taking Diovan with food and drink
You can take Diovan 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 Diovan
before you become pregnant or as soon as you know you are pregnant,
and will advise you to take another medicine instead of Diovan. Diovan 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. Diovan 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 Diovan
affects you. Like many other medicines used to treat high blood pressure,
Diovan may in rare cases cause dizziness and affect the ability to
concentrate.

3

How to take Diovan

Always take Diovan 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.

Ref: 0981/221013/1/B

®

Diovan 80mg Capsules
(valsartan)
Patient Information Leaflet (continued)
Not known:
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.
This low dose is provided by 40 mg divisible tablets. 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.
Diovan can be given together with other treatments for heart attack, and
your doctor will decide which treatment is suitable for you.

* rash, itching, together with some of the following signs or symptoms: fever,

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.
Diovan 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 Diovan with an additional medicine (e.g. a
diuretic). You can take Diovan with or without food. Swallow Diovan with a
glass of water. Take Diovan at about the same time each day.

*

If you take more Diovan 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 Diovan
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.

*
*
*
*

*
*

*

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
If you stop taking Diovan
Stopping your treatment with Diovan 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, Diovan 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 symptoms, stop taking Diovan and contact your
doctor straight away (see also section 2 “Take special care with
Diovan”).
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

*
*

*
*
*
*

How to store this medicine

Keep out of the sight and reach of children.
Do not use Diovan after the expiry date which is stated on the
box/blisters/label. The expiry date refers to the last day of the month.
Capsules should not be thrown in your bin or put down the drain. If they
are out of date, or no longer suitable for you, return them to your
pharmacist.
Do not store above 30°C. Protect from moisture and heat.
Do not take your capsules out of the blister strip until it is time to take your
dose.
If your capsules become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
If your doctor tells you to stop taking Diovan Capsules, please take any
unused medicines 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 this medicine contains:
Each capsule contains 80mg valsartan as the active ingredient.
Your medicine contains the following inactive ingredients:
microcrystalline cellulose, polyvidone, sodium lauryl sulphate, crospovidone
and magnesium stearate.
The capsule is made up of the following: gelatin, titanium dioxide (E171),
black iron oxide (E172), red iron oxide (E172)
What this medicine looks like and contents of the pack
Diovan capsules have a light grey cap and flesh coloured body.
Each capsule is marked 'CG FZF' in black ink on the cap.
Each calendar blister pack contains 28 capsules.
Manufacturer and Licence Holder
The capsules are manufactured by Novartis Farma S.p.A., Via Provinciale
Schito 131, 80058 Torre Annunziata (NA) Italy and are procured from within
the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE.

POM

PL 15184/0981

Diovan is a registered trademark of Novartis AG.
Revision date: 22/10/13

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 0981/221013/2/F

Valsartan 80mg Capsules
Patient Information Leaflet
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.

*

Your medicine is called Valsartan 80mg Capsules but will be referred to as
Valsartan throughtout this leaflet. Please note that the leaflet also contains
information abouth other strengths of this medicine Valsartan 40mg and
Valsartan 160mg

*

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 80 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. 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.
In addition
Valsartan 80mg 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 any of these apply to you, speak to your doctor.
You must be especially careful and talk to your doctor before taking
Valsartan if any of the following apply to you.
* 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 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 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).

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. 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 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).
* 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.
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 for heart failure, a triple combination with ACE
inhibitors and beta blockers (medications to treat heart failure) is
not recommended.
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 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.

Ref: 0981/221013/2/B

Valsartan 80mg Capsules
Patient Information Leaflet (continued)
Not known:
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.
This low dose is provided by 40 mg divisible tablets. 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 treatments for heart attack, and
your doctor will decide which treatment is suitable for you.

* rash, itching, together with some of the following signs or symptoms: fever,

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 symptoms, stop taking Valsartan and contact
your doctor straight away (see also section 2 “Take special care with
valsartan”).
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

*
*
*
*

*
*

*

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.

How to store this medicine

5

*
*

*
*
*
*

Keep out of the reach and sight of children.
Do not use Valsartan after the expiry date which is stated on the
box/blisters/label. The expiry date refers to the last day of the month.
Capsules should not be thrown in your bin or put down the drain. If they
are out of date, or no longer suitable for you, return them to your
pharmacist.
Do not store above 30°C. Protect from moisture and heat.
Do not take your capsules out of the blister strip until it is time to take your
dose.
If your capsules become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
If your doctor tells you to stop taking Valsartan Capsules, please take any
unused medicines 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 this medicine contains:
Each capsule contains 80mg valsartan as the active ingredient.
Your medicine contains the following inactive ingredients:
microcrystalline cellulose, polyvidone, sodium lauryl sulphate, crospovidone
and magnesium stearate.
The capsule is made up of the following: gelatin, titanium dioxide (E171),
black iron oxide (E172), red iron oxide (E172)
What this medicine looks like and contents of the pack
Valsartan capsules have a light grey cap and flesh coloured body.
Each capsule is marked 'CG FZF' in black ink on the cap.
Each calendar blister pack contains 28 capsules.
Manufacturer and Licence Holder
The capsules are manufactured by Novartis Farma S.p.A., Via Provinciale
Schito 131, 80058 Torre Annunziata (NA) Italy and are procured from within
the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE.

POM

PL 15184/0981

Revision date: 22/10/13

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 0981/221013/3/F

®

Tareg 80mg Capsules
(valsartan)
Patient Information Leaflet
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.

*

Your medicine is called Tareg 80mg Capsules but will be referred to as Tareg
throughtout this leaflet. Please note that the leaflet also contains information
abouth other strengths of this medicine Tareg 40mg and Tareg 160mg

*

In this leaflet:
1 What Tareg is and what it is used for

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2 Before you take Tareg

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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 Tareg 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 Tareg 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.
Tareg 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).

3 How to take Tareg
4 Possible side effects
5 How to store Tareg
6 Further information

1

What Tareg is and what it is used for

Tareg 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.
Tareg works by blocking the effect of angiotensin II.
As a result, blood vessels relax and blood pressure is lowered.
Tareg 80 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. Tareg 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.
In addition
Tareg 80mg 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 Tareg

Do not take Tareg:
* if you are allergic (hypersensitive) to valsartan or any of the other
ingredients of Tareg. 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 Tareg
in early pregnancy —see pregnancy section).
If any of these apply to you, speak to your doctor.
You must be especially careful and talk to your doctor before taking
Tareg if any of the following apply to you.
* 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 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 Tareg, stop taking Tareg immediately and never take it
again. See also section 4, “Possible side effects”.

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 Tareg 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 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).
* 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
Tareg.
* 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 (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.
Taking Tareg with food and drink
You can take Tareg 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 Tareg
before you become pregnant or as soon as you know you are pregnant,
and will advise you to take another medicine instead of Tareg. Tareg 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. Tareg 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 Tareg
affects you. Like many other medicines used to treat high blood pressure,
Tareg may in rare cases cause dizziness and affect the ability to
concentrate.

3

How to take Tareg

Always take Tareg 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.

Ref: 0981/221013/3/B

®

Tareg 80mg Capsules
(valsartan)
Patient Information Leaflet (continued)
Not known:
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.
This low dose is provided by 40 mg divisible tablets. 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.
Tareg can be given together with other treatments for heart attack, and your
doctor will decide which treatment is suitable for you.

* rash, itching, together with some of the following signs or symptoms: fever,

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.
Tareg 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 Tareg with an additional medicine (e.g. a
diuretic). You can take Tareg with or without food. Swallow Tareg with a
glass of water. Take Tareg at about the same time each day.

*

If you take more Tareg 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 Tareg
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 Tareg
Stopping your treatment with Tareg 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, Tareg 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 symptoms, stop taking Tareg and contact your
doctor straight away (see also section 2 “Take special care with
Tareg”).
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

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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

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How to store this medicine
Keep out of the reach and sight of children.
Do not use Tareg after the expiry date which is stated on the
box/blisters/label. The expiry date refers to the last day of the month.
Capsules should not be thrown in your bin or put down the drain. If they
are out of date, or no longer suitable for you, return them to your
pharmacist.
Do not store above 30°C. Protect from moisture and heat.
Do not take your capsules out of the blister strip until it is time to take your
dose.
If your capsules become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
If your doctor tells you to stop taking Tareg Capsules, please take any
unused medicines 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 this medicine contains:
Each capsule contains 80mg valsartan as the active ingredient.
Your medicine contains the following inactive ingredients:
microcrystalline cellulose, polyvidone, sodium lauryl sulphate, crospovidone
and magnesium stearate.
The capsule is made up of the following: gelatin, titanium dioxide (E171),
black iron oxide (E172), red iron oxide (E172)
What this medicine looks like and contents of the pack
Tareg capsules have a light grey cap and flesh coloured body.
Each capsule is marked 'CG FZF' in black ink on the cap.
Each calendar blister pack contains 28 capsules.
Manufacturer and Licence Holder
The capsules are manufactured by Novartis Farma S.p.A., Via Provinciale
Schito 131, 80058 Torre Annunziata (NA) Italy and are procured from within
the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE.

POM

PL 15184/0981

Tareg is a registered trademark of Novartis AG.
Revision date: 22/10/13

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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