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TEVETEN 600MG FILM-COATED TABLETS

Active substance(s): EPROSARTAN / EPROSARTAN MESYLATE

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Transcript
Ref: 0992/050116/1/F

®

Teveten 600mg Film-coated Tablets
(eprosartan mesilate)
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 Teveten 600mg Film-coated Tablets but will be
referred to as Teveten throughout this leaflet.
In this leaflet:
1 What Teveten is and what it is used for
2 Before you take Teveten
3 How to take Teveten
4 Possible side effects
5 How to store Teveten
6 Further information

1

What Teveten is and what is it used for

What Teveten is used for
Teveten contains a medicine called eprosartan mesilate. This belongs to a
group of medicines called ‘angiotensin II receptor antagonists’.
This medicine is used to treat high blood pressure, also called hypertension.
The main cause of high blood pressure is narrowing of the blood vessels.
This increases the amount of work your heart must do to pump blood around
your body. You may not feel unwell, but, if high blood pressure is not treated,
it can lead to heart disease and stroke.
How Teveten works
* Angiotensin II is a chemical found in the body which makes your blood
vessels contract. This makes it more difficult for blood to pass through
them
* This causes your blood pressure to rise
* Teveten works by preventing the chemical, angiotensin II, from causing
your blood vessels to contract. This has the effect of lowering your blood
pressure.
You may be given Teveten on its own or with another medicine used to treat
high blood pressure. Using both medicines together will lower your blood
pressure more than one on its own.
The active ingredient in this medicine is eprosartan mesilate. This is the new
name for eprosartan mesylate. The active ingredient itself has not changed.

2

Before you take Teveten

Do not take Teveten if:
* You are allergic (hypersensitive) to eprosartan or any of the other
ingredients of Teveten (listed in Section 6 below)
* You have severe liver problems
* You are more than 3 months pregnant (it is also better to avoid Teveten in
early pregnancy - see pregnancy section)
* If you have damaged blood flow to the kidneys or serious constrictions in
a single functioning kidney
* You have diabetes or impaired kidney function and you are treated with a
blood pressure lowering medicine containing aliskiren
Do not take Teveten if any of the above apply to you. If you are not sure, talk
to your doctor or pharmacist before taking Teveten.
Take special care with Teveten
Check with your doctor or pharmacist before taking your medicine if:
* You have heart, kidney or liver problems, especially severe heart failure,
narrowing of the heart valves, thickening of heart muscle (hypertrophic
cardiomyopathy)
* You have narrowing or a blockage of the blood vessels leading to your
kidneys or if you only have one kidney
* You have recently been sick or had diarrhoea
* You are taking water tablets (diuretics) and they make you feel dizzy when
you stand up

* You are taking water tablets or potassium supplements and you also have

a kidney problem. Your doctor might sometimes check your blood to make
sure that Teveten is not affecting the amount of potassium in your blood
* You suffer from lactose intolerance (see section ‘Important information
about some of the ingredients of Teveten’)
* You think you are (or might become) pregnant. Teveten 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 have been told you have Conn’s syndrome (primary
hyperaldosteronism) i.e. your body is making too much of the hormone
aldosterone. Teveten may not work, so check with your doctor.
* You are taking medicines to treat high blood pressure such as aliskiren or
an ACE-inhibitor (for example enalapril, lisinopril, ramipril), particularly if
you have diabetes-related kidney problems. Your doctor may check your
kidney function, blood pressure and the amount of electrolytes
(e.g. potassium) in your blood regular intervals.
If you are not sure if any of the above apply to you talk to your doctor or
pharmacist before taking Teveten. See also Section 2 of this leaflet under
the heading “Do not take Teveten”
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines. This includes medicines obtained without a
prescription, including herbal medicines. Your doctor may need to change
your dose and/or take other precautions.
In particular, tell your doctor or pharmacist if you are taking any of the
following medicines:
* Medicines for pain and inflammation such as ibuprofen, diclofenac,
celecoxib, etoricoxib or lumiracoxib (Non-steroidal anti-inflammatory
medicines)
* Potassium supplements, potassium-sparing agents or
potassium-containing salt substitutes
* Medicines that increase potassium levels such as heparin.
* Water tablets (Diuretics) such as hydrochlorothiazide and calcium channel
blocker such as nifedipine, which may be used to help lower your blood
pressure
* Aspirin used for pain, fever and to prevent blood clotting
* Lithium used for mental problems.
* ACE inhibitors or aliskiren (See also Section 2 of this leaflet under the
headings “Do not take Teveten” and “Take special care with Teveten”)
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before using Teveten.
Pregnancy and breast-feeding
Pregnancy

* You must tell your doctor if you think you are (or might become) pregnant.
Your doctor will normally advise you to stop taking Teveten before you
become pregnant or as soon as you know you are pregnant and will
advise you to take another medicine instead of Teveten. Teveten 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 used
after the third month of pregnancy.
Breast-feeding

* Tell your doctor if you are breast-feeding or about to start breast-feeding.
Teveten 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
You may feel tired or dizzy when you start taking Teveten. If this happens,
do not drive or use any tools or machines until these effects wear off.
Important information about some of the ingrediemts of Teveten
Teveten contains lactose (a type of sugar). If you have been told by your
doctor that you cannot tolerate or digest some sugars (have an intolerance
to some sugars), talk to your doctor before taking this medicine.`

Ref: 0992/050116/1/B

®

Teveten 600mg Film-coated Tablets
(eprosartan mesilate)
Patient Information Leaflet (continued)
3

How to take Teveten

Always take Teveten exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
Taking this medicine
* Your doctor will tell you how many tablets to take and for how long. It is
important that you keep taking the tablets for as long as your doctor tells
you
* The pharmacist’s label on your pack will also tell you how much your
doctor would like you to take. Please read it carefully
* Only remove a tablet from the blister strip when it is time to take your
medicine
* Take your tablet with or without food
* Take your tablets at about the same time each day.

Reporting of side effects
If you get any side effects talk to your doctor or pharmacist. 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.

5

* KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF
CHILDREN.

* Do not store above 25°C.
* Keep container in the outer carton.
* Do not use this medicine after the expiry date shown on the carton label or
*

Adults aged under 75 years

* The usual dose is 600 mg once a day
Elderly people (aged 75 or over) and people with kidney or liver
problems
* No dose adjustment is required in elderly people.
* If you have liver or kidney problems, consult your doctor. Your doctor will
decide your daily dosage.
Children and adolescents
Teveten should not be used in children and adolescents under 18 years.

*

If you take more Teveten than you should
If you take more Teveten than you should, talk to a doctor or go to a hospital
straight away. Take the medicine pack with you.
If you forget to take Teveten
* If you forget to take a dose, take it as soon as you remember
* Take your next dose at the normal time
* Do not take two doses within 12 hours of each other.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4

Possible side effects

Like all medicines, Teveten can cause side effects, although not everybody
gets them.
Stop taking Teveten and see a doctor straight away if you develop any
of the following symptoms - you may need urgent medical treatment:
* Sudden swelling of your face, lips or tongue and breathing problems.
These may be signs of a severe allergic reaction and may be
life-threatening. This side effect is uncommon (at least 1 in 1000 and less
than 1 in 100 patients).

How to store Teveten

*

blister strip.
If your tablets become discoloured or show any other signs of
deterioration, consult your pharmacist (chemist) who will tell you what to
do.
If your doctor tells you to stop taking this medicine, return any unused
tablets to your pharmacist (chemist) for safe disposal. Only keep this
medicine, if your doctor tells you to.

6

Further information

What this medicine contains:
Each film-coated tablet contains 600mg eprosartan (as mesilate) as the
active ingredient.
Your medicine also contains the following inactive ingredients: lactose
monohydrate, microcrystalline cellulose, pregelatinised starch, magnesium
stearate, crospovidone, purified water, hypromellose (E464), titanium dioxide
(E171), polysorbate 80 (E433) and macrogol 400.
What this medicine looks like and contents of the pack
The tablets are white, capsule-shaped, film-coated tablets with ‘5046’
engraved on one side and plain on the other side.
These tablets are available in calender blister strips of 28 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Abbott Healthcare SAS, Route de
Belleville, Lieu dit Maillard, F-01400 Chatillon-sur-Chalaronne,
France and is 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.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0992

Teveten 600mg Film-coated Tablets

Teveten is a registered trademark of Abbott Products Operations AG.
A list of possible side effects reported in clinical studies with Teveten is given
below:
Very common (at least 1 in 10 patients or more)

* Headache
Common (at least 1 in 100 and less than 1 in 10 patients)
* Skin rashes or itching
* Weakness or lack of strength
* Feeling dizzy
* Feeling or being sick (nausea or vomiting)
* Diarrhoea
* Runny nose
Uncommon (at least 1 in 1000 and less than 1 in 100 patients)
* Low blood pressure (hypotension)
* Sudden swelling of your face, lips or tongue and breathing problems.
These may be signs of a severe allergic reactions and may be life
threatening.
Undesirable effects have been reported since Teveten has been
marketed but the frequency is not known
* Changes in kidney function including kidney failure in patients with existing
kidney problems.

Revision date: 05/01/16

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

Ref: 0992/050116/2/F

®

Tevetenz 600mg Film-coated Tablets
(eprosartan mesilate)
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 Tevetenz 600mg Film-coated Tablets but will be
referred to as Tevetenz throughout this leaflet.
In this leaflet:
1 What Tevetenz is and what it is used for
2 Before you take Tevetenz
3 How to take Tevetenz
4 Possible side effects
5 How to store Tevetenz
6 Further information

1

What Tevetenz is and what is it used for

What Tevetenz is used for
Tevetenz contains a medicine called eprosartan mesilate. This belongs to a
group of medicines called ‘angiotensin II receptor antagonists’.
This medicine is used to treat high blood pressure, also called hypertension.
The main cause of high blood pressure is narrowing of the blood vessels.
This increases the amount of work your heart must do to pump blood around
your body. You may not feel unwell, but, if high blood pressure is not treated,
it can lead to heart disease and stroke.
How Tevetenz works
* Angiotensin II is a chemical found in the body which makes your blood
vessels contract. This makes it more difficult for blood to pass through
them
* This causes your blood pressure to rise
* Tevetenz works by preventing the chemical, angiotensin II, from causing
your blood vessels to contract. This has the effect of lowering your blood
pressure.
You may be given Tevetenz on its own or with another medicine used to
treat high blood pressure. Using both medicines together will lower your
blood pressure more than one on its own.
The active ingredient in this medicine is eprosartan mesilate. This is the new
name for eprosartan mesylate. The active ingredient itself has not changed.

2

Before you take Tevetenz

Do not take Tevetenz if:
* You are allergic (hypersensitive) to eprosartan or any of the other
ingredients of Tevetenz (listed in Section 6 below)
* You have severe liver problems
* You are more than 3 months pregnant (it is also better to avoid Tevetenz
in early pregnancy - see pregnancy section)
* If you have damaged blood flow to the kidneys or serious constrictions in
a single functioning kidney
* You have diabetes or impaired kidney function and you are treated with a
blood pressure lowering medicine containing aliskiren
Do not take Tevetenz if any of the above apply to you. If you are not sure,
talk to your doctor or pharmacist before taking Tevetenz.
Take special care with Tevetenz
Check with your doctor or pharmacist before taking your medicine if:
* You have heart, kidney or liver problems, especially severe heart failure,
narrowing of the heart valves, thickening of heart muscle (hypertrophic
cardiomyopathy)
* You have narrowing or a blockage of the blood vessels leading to your
kidneys or if you only have one kidney
* You have recently been sick or had diarrhoea
* You are taking water tablets (diuretics) and they make you feel dizzy when
you stand up

* You are taking water tablets or potassium supplements and you also have

a kidney problem. Your doctor might sometimes check your blood to make
sure that Tevetenz is not affecting the amount of potassium in your blood
* You suffer from lactose intolerance (see section ‘Important information
about some of the ingredients of Tevetenz’)
* You think you are (or might become) pregnant. Tevetenz 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 have been told you have Conn’s syndrome (primary
hyperaldosteronism) i.e. your body is making too much of the hormone
aldosterone. Tevetenz may not work, so check with your doctor.
* You are taking medicines to treat high blood pressure such as aliskiren or
an ACE-inhibitor (for example enalapril, lisinopril, ramipril), particularly if
you have diabetes-related kidney problems. Your doctor may check your
kidney function, blood pressure and the amount of electrolytes
(e.g. potassium) in your blood regular intervals.
If you are not sure if any of the above apply to you talk to your doctor or
pharmacist before taking Tevetenz. See also Section 2 of this leaflet under
the heading “Do not take Tevetenz”
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines. This includes medicines obtained without a
prescription, including herbal medicines. Your doctor may need to change
your dose and/or take other precautions.
In particular, tell your doctor or pharmacist if you are taking any of the
following medicines:
* Medicines for pain and inflammation such as ibuprofen, diclofenac,
celecoxib, etoricoxib or lumiracoxib (Non-steroidal anti-inflammatory
medicines)
* Potassium supplements, potassium-sparing agents or
potassium-containing salt substitutes
* Medicines that increase potassium levels such as heparin.
* Water tablets (Diuretics) such as hydrochlorothiazide and calcium channel
blocker such as nifedipine, which may be used to help lower your blood
pressure
* Aspirin used for pain, fever and to prevent blood clotting
* Lithium used for mental problems.
* ACE inhibitors or aliskiren (See also Section 2 of this leaflet under the
headings “Do not take Tevetenz” and “Take special care with Tevetenz”)
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before using Tevetenz.
Pregnancy and breast-feeding
Pregnancy

* You must tell your doctor if you think you are (or might become) pregnant.
Your doctor will normally advise you to stop taking Tevetenz before you
become pregnant or as soon as you know you are pregnant and will
advise you to take another medicine instead of Tevetenz. Tevetenz 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 used
after the third month of pregnancy.
Breast-feeding

* Tell your doctor if you are breast-feeding or about to start breast-feeding.
Tevetenz 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
You may feel tired or dizzy when you start taking Tevetenz. If this happens,
do not drive or use any tools or machines until these effects wear off.
Important information about some of the ingrediemts of Tevetenz
Tevetenz contains lactose (a type of sugar). If you have been told by your
doctor that you cannot tolerate or digest some sugars (have an intolerance
to some sugars), talk to your doctor before taking this medicine.`

Ref: 0992/050116/1/B

®

Tevetenz 600mg Film-coated Tablets
(eprosartan mesilate)
Patient Information Leaflet (continued)
3

How to take Tevetenz

Always take Tevetenz exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
Taking this medicine
* Your doctor will tell you how many tablets to take and for how long. It is
important that you keep taking the tablets for as long as your doctor tells
you
* The pharmacist’s label on your pack will also tell you how much your
doctor would like you to take. Please read it carefully
* Only remove a tablet from the blister strip when it is time to take your
medicine
* Take your tablet with or without food
* Take your tablets at about the same time each day.

Reporting of side effects
If you get any side effects talk to your doctor or pharmacist. 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.

5

* KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF
CHILDREN.

* Do not store above 25°C.
* Keep container in the outer carton.
* Do not use this medicine after the expiry date shown on the carton label or
*

Adults aged under 75 years

* The usual dose is 600 mg once a day
Elderly people (aged 75 or over) and people with kidney or liver
problems
* No dose adjustment is required in elderly people.
* If you have liver or kidney problems, consult your doctor. Your doctor will
decide your daily dosage.
Children and adolescents
Tevetenz should not be used in children and adolescents under 18 years.

*

If you take more Tevetenz than you should
If you take more Tevetenz than you should, talk to a doctor or go to a
hospital straight away. Take the medicine pack with you.
If you forget to take Tevetenz
* If you forget to take a dose, take it as soon as you remember
* Take your next dose at the normal time
* Do not take two doses within 12 hours of each other.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4

Possible side effects

Like all medicines, Tevetenz can cause side effects, although not everybody
gets them.
Stop taking Tevetenz and see a doctor straight away if you develop any
of the following symptoms - you may need urgent medical treatment:
* Sudden swelling of your face, lips or tongue and breathing problems.
These may be signs of a severe allergic reaction and may be
life-threatening. This side effect is uncommon (at least 1 in 1000 and less
than 1 in 100 patients).

How to store Tevetenz

*

blister strip.
If your tablets become discoloured or show any other signs of
deterioration, consult your pharmacist (chemist) who will tell you what to
do.
If your doctor tells you to stop taking this medicine, return any unused
tablets to your pharmacist (chemist) for safe disposal. Only keep this
medicine, if your doctor tells you to.

6

Further information

What this medicine contains:
Each film-coated tablet contains 600mg eprosartan (as mesilate) as the
active ingredient.
Your medicine also contains the following inactive ingredients: lactose
monohydrate, microcrystalline cellulose, pregelatinised starch, magnesium
stearate, crospovidone, purified water, hypromellose (E464), titanium dioxide
(E171), polysorbate 80 (E433) and macrogol 400.
What this medicine looks like and contents of the pack
The tablets are white, capsule-shaped, film-coated tablets with ‘5046’
engraved on one side and plain on the other side.
These tablets are available in calender blister strips of 28 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Abbott Healthcare SAS, Route de
Belleville, Lieu dit Maillard, F-01400 Chatillon-sur-Chalaronne,
France and is 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.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0992

Tevetenz 600mg Film-coated Tablets

Tevetenz is a registered trademark of Abbott Products Operations AG.
A list of possible side effects reported in clinical studies with Tevetenz is
given below:
Very common (at least 1 in 10 patients or more)

* Headache
Common (at least 1 in 100 and less than 1 in 10 patients)
* Skin rashes or itching
* Weakness or lack of strength
* Feeling dizzy
* Feeling or being sick (nausea or vomiting)
* Diarrhoea
* Runny nose
Uncommon (at least 1 in 1000 and less than 1 in 100 patients)
* Low blood pressure (hypotension)
* Sudden swelling of your face, lips or tongue and breathing problems.
These may be signs of a severe allergic reactions and may be life
threatening.
Undesirable effects have been reported since Tevetenz has been
marketed but the frequency is not known
* Changes in kidney function including kidney failure in patients with existing
kidney problems.

Revision date: 05/01/16

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

Ref: 0992/050116/3/F

Eprosartan 600mg Film-coated Tablets
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 Eprosartan 600mg Film-coated Tablets but will be
referred to as Eprosartan throughout this leaflet.
In this leaflet:
1 What Eprosartan is and what it is used for
2 Before you take Eprosartan
3 How to take Eprosartan
4 Possible side effects
5 How to store Eprosartan
6 Further information

1

What Eprosartan is and what is it used for

What Eprosartan is used for
Eprosartan contains a medicine called eprosartan mesilate. This belongs to
a group of medicines called ‘angiotensin II receptor antagonists’.
This medicine is used to treat high blood pressure, also called hypertension.
The main cause of high blood pressure is narrowing of the blood vessels.
This increases the amount of work your heart must do to pump blood around
your body. You may not feel unwell, but, if high blood pressure is not treated,
it can lead to heart disease and stroke.
How Eprosartan works
* Angiotensin II is a chemical found in the body which makes your blood
vessels contract. This makes it more difficult for blood to pass through
them
* This causes your blood pressure to rise
* Eprosartan works by preventing the chemical, angiotensin II, from causing
your blood vessels to contract. This has the effect of lowering your blood
pressure.

* You are taking water tablets or potassium supplements and you also have

a kidney problem. Your doctor might sometimes check your blood to make
sure that Eprosartan is not affecting the amount of potassium in your blood
* You suffer from lactose intolerance (see section ‘Important information
about some of the ingredients of Eprosartan’)
* You think you are (or might become) pregnant. Eprosartan 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 have been told you have Conn’s syndrome (primary
hyperaldosteronism) i.e. your body is making too much of the hormone
aldosterone. Eprosartan may not work, so check with your doctor.
* You are taking medicines to treat high blood pressure such as aliskiren or
an ACE-inhibitor (for example enalapril, lisinopril, ramipril), particularly if
you have diabetes-related kidney problems. Your doctor may check your
kidney function, blood pressure and the amount of electrolytes
(e.g. potassium) in your blood regular intervals.
If you are not sure if any of the above apply to you talk to your doctor or
pharmacist before taking Eprosartan. See also Section 2 of this leaflet under
the heading “Do not take Eprosartan”
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines. This includes medicines obtained without a
prescription, including herbal medicines. Your doctor may need to change
your dose and/or take other precautions.
In particular, tell your doctor or pharmacist if you are taking any of the
following medicines:
* Medicines for pain and inflammation such as ibuprofen, diclofenac,
celecoxib, etoricoxib or lumiracoxib (Non-steroidal anti-inflammatory
medicines)
* Potassium supplements, potassium-sparing agents or
potassium-containing salt substitutes
* Medicines that increase potassium levels such as heparin.
* Water tablets (Diuretics) such as hydrochlorothiazide and calcium channel
blocker such as nifedipine, which may be used to help lower your blood
pressure
* Aspirin used for pain, fever and to prevent blood clotting
* Lithium used for mental problems.
* ACE inhibitors or aliskiren (See also Section 2 of this leaflet under the
headings “Do not take Eprosartan” and “Take special care with
Eprosartan”)
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before using Eprosartan.
Pregnancy and breast-feeding

You may be given Eprosartan on its own or with another medicine used to
treat high blood pressure. Using both medicines together will lower your
blood pressure more than one on its own.
The active ingredient in this medicine is eprosartan mesilate. This is the new
name for eprosartan mesylate. The active ingredient itself has not changed.

2

Before you take Eprosartan

Do not take Eprosartan if:
* You are allergic (hypersensitive) to eprosartan or any of the other
ingredients of Eprosartan (listed in Section 6 below)
* You have severe liver problems
* You are more than 3 months pregnant (it is also better to avoid Eprosartan
in early pregnancy - see pregnancy section)
* If you have damaged blood flow to the kidneys or serious constrictions in
a single functioning kidney
* You have diabetes or impaired kidney function and you are treated with a
blood pressure lowering medicine containing aliskiren
Do not take Eprosartan if any of the above apply to you. If you are not sure,
talk to your doctor or pharmacist before taking Eprosartan.
Take special care with Eprosartan
Check with your doctor or pharmacist before taking your medicine if:
* You have heart, kidney or liver problems, especially severe heart failure,
narrowing of the heart valves, thickening of heart muscle (hypertrophic
cardiomyopathy)
* You have narrowing or a blockage of the blood vessels leading to your
kidneys or if you only have one kidney
* You have recently been sick or had diarrhoea
* You are taking water tablets (diuretics) and they make you feel dizzy when
you stand up

Pregnancy

* You must tell your doctor if you think you are (or might become) pregnant.
Your doctor will normally advise you to stop taking Eprosartan before you
become pregnant or as soon as you know you are pregnant and will
advise you to take another medicine instead of Eprosartan. Eprosartan 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
used after the third month of pregnancy.
Breast-feeding

* Tell your doctor if you are breast-feeding or about to start breast-feeding.
Eprosartan 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
You may feel tired or dizzy when you start taking Eprosartan. If this happens,
do not drive or use any tools or machines until these effects wear off.
Important information about some of the ingrediemts of Eprosartan
Eprosartan contains lactose (a type of sugar). If you have been told by your
doctor that you cannot tolerate or digest some sugars (have an intolerance
to some sugars), talk to your doctor before taking this medicine.`

Ref: 0992/050116/3/B

Eprosartan 600mg Film-coated Tablets
Patient Information Leaflet (continued)
3

How to take Eprosartan

Always take Eprosartan exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
Taking this medicine
* Your doctor will tell you how many tablets to take and for how long. It is
important that you keep taking the tablets for as long as your doctor tells
you
The
pharmacist’s label on your pack will also tell you how much your
*
doctor would like you to take. Please read it carefully
* Only remove a tablet from the blister strip when it is time to take your
medicine
* Take your tablet with or without food
* Take your tablets at about the same time each day.
Adults aged under 75 years
* The usual dose is 600 mg once a day
Elderly people (aged 75 or over) and people with kidney or liver
problems
* No dose adjustment is required in elderly people.
* If you have liver or kidney problems, consult your doctor. Your doctor will
decide your daily dosage.
Children and adolescents
Eprosartan should not be used in children and adolescents under 18
years.

*

If you take more Eprosartan than you should
If you take more Eprosartan than you should, talk to a doctor or go to a
hospital straight away. Take the medicine pack with you.
If you forget to take Eprosartan
If you forget to take a dose, take it as soon as you remember
Take your next dose at the normal time
Do not take two doses within 12 hours of each other.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

*
*
*

4

Possible side effects

Like all medicines, Eprosartan can cause side effects, although not everybody gets them.
Stop taking Eprosartan and see a doctor straight away if you develop
any of the following symptoms - you may need urgent medical treatment:
* Sudden swelling of your face, lips or tongue and breathing problems.
These may be signs of a severe allergic reaction and may be
life-threatening. This side effect is uncommon (at least 1 in 1000 and less
than 1 in 100 patients).
A list of possible side effects reported in clinical studies with Eprosartan is
given below:
Very common (at least 1 in 10 patients or more)

* Headache
Common (at least 1 in 100 and less than 1 in 10 patients)
* Skin rashes or itching
* Weakness or lack of strength
* Feeling dizzy
* Feeling or being sick (nausea or vomiting)
* Diarrhoea
* Runny nose
Uncommon (at least 1 in 1000 and less than 1 in 100 patients)
* Low blood pressure (hypotension)
* Sudden swelling of your face, lips or tongue and breathing problems.
These may be signs of a severe allergic reactions and may be life
threatening.
Undesirable effects have been reported since Eprosartan has been
marketed but the frequency is not known
* Changes in kidney function including kidney failure in patients with existing
kidney problems.

Reporting of side effects
If you get any side effects talk to your doctor or pharmacist. 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.

5

How to store Eprosartan

* KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF
CHILDREN.

* Do not store above 25°C.
* Keep container in the outer carton.
* Do not use this medicine after the expiry date shown on the carton label or
*
*

blister strip.
If your tablets become discoloured or show any other signs of
deterioration, consult your pharmacist (chemist) who will tell you what to
do.
If your doctor tells you to stop taking this medicine, return any unused
tablets to your pharmacist (chemist) for safe disposal. Only keep this
medicine, if your doctor tells you to.

6

Further information

What this medicine contains:
Each film-coated tablet contains 600mg eprosartan (as mesilate) as the
active ingredient.
Your medicine also contains the following inactive ingredients: lactose
monohydrate, microcrystalline cellulose, pregelatinised starch, magnesium
stearate, crospovidone, purified water, hypromellose (E464), titanium dioxide
(E171), polysorbate 80 (E433) and macrogol 400.
What this medicine looks like and contents of the pack
The tablets are white, capsule-shaped, film-coated tablets with ‘5046’
engraved on one side and plain on the other side.
These tablets are available in calender blister strips of 28 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Abbott Healthcare SAS, Route de
Belleville, Lieu dit Maillard, F-01400 Chatillon-sur-Chalaronne,
France and is 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.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0992

Eprosartan 600mg Film-coated Tablets

Revision date: 05/01/16

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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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