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EPROSARTAN 600MG FILM-COATED TABLETS

Active substance(s): EPROSARTAN MESILATE / EPROSARTAN MESYLATE

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500753/PL1i

®

Teveten 600 mg Film-Coated Tablets
(eprosartan mesilate)
Patient Information Leaflet
®
The name of your medicine is Teveten 600 mg Film-Coated
Tablets, throughout this leaflet it will be referred to as
®
Teveten . Other strength (300 mg) is also available.
Read all of this leaflet carefully before you start taking
this medicine
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
- This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet:
®
1) What 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 IT IS 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.



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 at 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 to 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

®

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
®
works by preventing the chemical,
• Teveten
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.

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 breastfeed, especially if your baby is newborn, or was born
prematurely.

®

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)
• 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)

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 ingredients 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.
®

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.
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.
Continued overleaf

®

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).
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

Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd both at St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer:
Abbott Healthcare S.A.S, Route de Belleville, Lieu dit Maillard,
F-01400 Châtillon-sur-Chalaronne, France.
Abbott Products GmbH, Justus-von-Liebig-Strasse
D-31535, Neustadt, Germany.

33,

®

Teveten 600 mg Film-Coated Tablets
PL No: 18067/0283
POM
®

Teveten is a registered trademark.
th

This leaflet was last revised on 24 August 2015.
For more information on blood pressure, you may find the
following organisation helpful:
The Blood Pressure Association
60 Cranmer Terrace
London SW17 0QS
Phone: 020 8772 4994
Website: www.bpassoc.org.uk
Both Ginova Ltd and Ginova UK Ltd are not associated with
The Blood Pressure Association.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

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.

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

5) HOW TO STORE TEVETEN
• Keep out of the sight and reach of children
• You should lock this medicine in a cupboard or
medicine cabinet
• Do not use the tablets after the expiry date which is
printed on the carton and blister pack
• Do not store above 25°C. Store in the original
container.
If your doctor stops your treatment, return any unused tablets
to a pharmacist.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
If you notice any signs of discolouration or deterioration of the
tablets, please consult your pharmacist immediately.
6) FURTHER INFORMATION
Each film-coated tablet contains eprosartan
equivalent to 600 mg eprosartan free base.

mesilate

Your medicine also contains inactive ingredients. These are
lactose
monohydrate,
microcrystalline
cellulose,
pregelatinised starch, magnesium stearate, crospovidone,
hypromellose, titanium dioxide (E171), polysorbate 80,
macrogol 400 and purified water.
®

What Teveten looks like and the contents of the pack
The tablets are capsule-shaped, bi-convex, white film-coated
tablets with ‘5046’ on one side and plain on the other.
®

Teveten is available in calendar blister packs containing 28
tablets.

500753/PL1i

500753/PL1i

Eprosartan 600 mg Film-Coated Tablets
(eprosartan mesilate)
Patient Information Leaflet
The name of your medicine is Eprosartan 600 mg FilmCoated Tablets, throughout this leaflet it will be referred to as
Eprosartan. Other strength (300 mg) is also available.
Read all of this leaflet carefully before you start taking
this medicine
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
- This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet:
1) What 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 IT IS 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.



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 at 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 to 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

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 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)
• 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
• 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)

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 ingredients 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.
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
adolescents under 18 years.

used

in

children

and

Continued overleaf

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.

Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd both at St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.

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.

Manufacturer:
Abbott Healthcare S.A.S, Route de Belleville, Lieu dit Maillard,
F-01400 Châtillon-sur-Chalaronne, France.

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:

Abbott Products GmbH, Justus-von-Liebig-Strasse
D-31535, Neustadt, Germany.

33,

Eprosartan 600 mg Film-Coated Tablets
PL No: 18067/0283
POM
th

This leaflet was last revised on 24 August 2015.
For more information on blood pressure, you may find the
following organisation helpful:
The Blood Pressure Association
60 Cranmer Terrace
London SW17 0QS
Phone: 020 8772 4994
Website: www.bpassoc.org.uk
Both Ginova Ltd and Ginova UK Ltd are not associated with
The Blood Pressure Association.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

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, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.
5) HOW TO STORE EPROSARTAN
• Keep out of the sight and reach of children
• You should lock this medicine in a cupboard or
medicine cabinet
• Do not use the tablets after the expiry date which is
printed on the carton and blister pack
• Do not store above 25°C. Store in the original
container.
If your doctor stops your treatment, return any unused tablets
to a pharmacist.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
If you notice any signs of discolouration or deterioration of the
tablets, please consult your pharmacist immediately.
6) FURTHER INFORMATION
Each film-coated tablet contains eprosartan
equivalent to 600 mg eprosartan free base.

mesilate

Your medicine also contains inactive ingredients. These are
lactose
monohydrate,
microcrystalline
cellulose,
pregelatinised starch, magnesium stearate, crospovidone,
hypromellose, titanium dioxide (E171), polysorbate 80,
macrogol 400 and purified water.
What Eprosartan looks like and the contents of the pack
The tablets are capsule-shaped, bi-convex, white film-coated
tablets with ‘5046’ on one side and plain on the other.
Eprosartan is available in calendar blister packs containing 28
tablets.

500753/PL1i

Expand view ⇕

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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