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TEVETEN 300MG TABLETS

Active substance(s): EPROSARTAN MESILATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

®

TEVETEN 300mg Tablets
(eprosartan mesilate)
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.
The name of your medicine is Teveten 300mg
Tablets but will be referred to as Teveten
throughout this leaflet. Please note that this leaflet
also contains information about other strength
Teveten 600mg Film-coated tablets.

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.

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 have diabetes or impaired kidney function
and you are treated with a blood pressure
lowering medicine containing aliskiren
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 overleaf)
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
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)
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, rampril),
particularly if you have diabetes-related kidney
problems
Your doctor may check you 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 of 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 breastfeed, 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
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 600mg 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 orgo 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 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:

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 lifethreatening.

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.
Do not store above 25°C.
Do not take your tablets after the expiry date which
is stated on the pack after ‘Exp’. The expiry date
refers to the last day of that month.

6. Further information
What Teveten contains
Your medicine contains 300mg of the active
ingredient eprosartan mesilate.
Your medicine also contains inactive ingredients.
These are lactose, microcrystalline cellulose
(E460), pregelatinised starch, magnesium stearate
(E572), hypromellose (E464), titanium dioxide
(E171), polysorbate 80 (E433) and macrogol 400
and croscarmellose sodium.

What Teveten looks like and contents of the
pack
The tablets are white, oval-shaped film-coated
tablets
Teveten is available in blister packs containing 28
or 56 tablets.
Manufactured by: Solvay Pharma, avenue du
Marechal foch – bp 25, F 01400 Châtillon – SurChalaronne, France.
Procured from within the EU and repackaged by
the Product Licence holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
TEVETEN 300mg Tablets – PL No 18799/0353
Leaflet date: 18.11.2015

POM

Teveten is a registered trademark of Solvay
Pharmaceuticals.

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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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