Skip to Content

The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.

TEVETEN 400 MG FILM-COATED TABLETS

PDF options:  View Fullscreen   Download PDF

PDF Transcript

300 mg, 400 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. 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 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
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.
If you are not sure if any of the above apply to you,
talk to your doctor or pharmacist before taking
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.
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 (more than 3 g per day) used for pain,
fever and to prevent blood clotting
• Lithium used for mental problems.
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 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.
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.
MKP-01878-2012

Laetus code > > >

PACKAGE LEAFLET: INFORMATION FOR THE
USER

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 starting dose is 600 mg once a day
• Your doctor may increase your daily dose to
800 mg (two 400 mg tablets).
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 lifethreatening. This side effect is uncommon (at
least 1 in 1000 and less than 1 in 100 patients).

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.
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. 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 either 300 mg, 400 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 and 400 mg tablets also contain
croscarmellose sodium
• The 400 mg tablets also contain iron oxides (E172)
• 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 400 mg Film-coated Tablets are pink and
oval-shaped with the marking 5044.
Teveten 600 mg Film-coated Tablets are white and
capsule-shaped with the marking 5046.
Teveten is available in blister packs containing 28
or 56 tablets.

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

This leaflet was last revised in November 2012
® Registered trademark

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

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

MKP-01878-2012

Laetus code > > >

A list of possible side effects reported in clinical
studies with Teveten is given below:

Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation holder is:
Abbott Healthcare Products Ltd,
Southampton, SO18 3JD, UK.
The Manufacturer is:
Abbott Healthcare SAS,
F-01400 Châtillon-sur-Chalaronne, France.

+ Expand Transcript

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.

Hide