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EPROSARTAN 600MG TABLETS

Active substance(s): EPROSARTAN MESILATE

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Teveten ® 600mg Tablets / Eprosartan 600mg Tablets

Ref: 0676/161117/1/F

(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 Tablets / Eprosartan 600mg Tablets,
but will be referred to as Teveten throughout this Leaflet.
In this leaflet:

*

*
*

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, 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.

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
* 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’)

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
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.
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.

Ref: 0676/161117/1/B

Teveten® 600mg Tablets / Eprosartan 600mg Tablets
(eprosartan mesilate)
Patient Information Leaflet (continued)
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).
A list of possible side effects reported in clinical studies with Teveten is given
below:

Do not use this medicine after the expiry date shown on the carton label or
blister strip.
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.
If your tablets become discoloured or show any other signs of deterioration,
consult your pharmacist (chemist) who will tell you what to do.
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 this medicine contains:
Each tablet contains 600mg of the active ingredient eprosartan (as mesilate).
These tablets also contain the following inactive ingredients; lactose
monohydrate, microcrystalline cellulose, pregelatinised starch, magnesuim
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 engraved 5046’ on
one side and plain on the reverse.
These tablets are available in calender blister strips of 28 tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Mylan Laboratories SAS, Route de
Belleville, Lieu dit Maillard, F-01400 Chatillon-sur-Chalaronne, France and
are 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 15184/0676

Teveten is a registered trademark of BGP Products Operations GmbH.

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

Revision date: 16/11/17

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

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

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 on this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google
Play or Apple App Store. By reporting side effects, you can help provide
more information on the safety of this medicine.

5

How to store Teveten

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not take your tablets out of the blister strip until it is time to take your
dose.

+ 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.

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