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TEVETEN 600 MG FILM-COATED TABLETS

Active substance(s): EPROSARTAN MESILATE / EPROSARTAN MESYLATE / EPROSARTAN MESILATE / EPROSARTAN MESYLATE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Taka spacial care with Teveten

300 mg and 600 mg Film-coated Tablets
Eprosartan
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.
2.
3.
4.
5.
6.

What Teveten Is and what It Is used for
Before you taka Taveten
How to take Teveten
Possible side effects
How to store Teveten
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.
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 taka Teveten H:
• You are allergic (hypersensitive) to eprosartan or
any of the other ingredients of Teveten Oisted in
Section 6 below)
• You have severe liver problems
• You are more than 3 months pregnant Ot 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.

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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)
• 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, ramipriO , 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
• Watertablets(Diuretics}suchashydrochlorothiazide
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 uoo 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
Taveten.
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.

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Breast-feeding
• Tell your doctor if you are breast-feeding or
about to start breast-feeding. Teveten is not
recommended for mothers who are breastfeeding, 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.

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

Driving and using machines

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.

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
ingredients of Teveten

about some

of

the

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.
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.

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
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.uklyellowcard.
5. How to store Teveten
• Keep out of the reach and sight 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 your tablets above 25°C. Keep them
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.

6. Further information
What Teveten contains
• The active ingredient is eprosartan (as mesilate).
Each tablet contains 300 mg or 600 mg of
eprosartan.
• The other ingredients are: lactose, microcrystalline
cellulose (E460), pregelatinised starch, magnesium
stearate {E572), hypromellose, titanium dioxide
(E171 ), polysorbate 80 (E433) and macrogol 400
• The 300 mg tablets also contain croscarmellose
sodium
• The 600 mg tablets also contain crospovidone.
What Teveten looks like and contents of the pack
Teveten 300 mg Film-coated Tablets are white and
oval-shaped with the marking 5043.
Teveten 600 mg Film-coated Tablets are white and
capsule-shaped with the marking 5046.
Teveten is available in blister packs containing
28 tablets.

4. Possible side effects

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder is:
Abbott Healthcare Products Ltd,
Southampton, S018 3JD, UK.
~

Like all medicines, Teveten can cause side effects,
although not everybody gets them.

The Manufacturer is:
Abbott Healthcare SAS,
F-01400 Chatillon-sur-Chalaronne, France.

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 lifethreatening. 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:

This leaflet was last revised in October 2014

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® Registered trademark
For more information on blood pressure, you may
find the following organisation helpful:
The Blood Pressure Association
60 Cranmer Terrace
London SW17 OQS
Phone: 020 8772 4994
Website: www.bpassoc.org.uk

Very common (at least 1 in 10 patients or more)
• Headache

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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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