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EPROSARTAN 600MG TABLETS

Active substance(s): EPROSARTAN / EPROSARTAN MESILATE

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By khilod ali at 12:10 pm, Mar 18, 2009

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Patient Information Leaflet
®

Teveten 600mg Tablets
Eprosartan 600mg Tablets
(eprosartan mesilate)

Your tablets are available using the above names, but will
referred to as Teveten throughout this leaflet.
This leaflet tells you about Teveten. Please read it carefully
before taking your tablets.
If there is anything you do not understand, or if you want to
know more about your tablets, ask your doctor or a pharmacist
(chemist).
Please keep this leaflet. You may want to read it again.

What is in Teveten?

Each tablet contains the active ingredient eprosartan mesilate
(equivalent to 600mg eprosartan).
Your medicine also contains inactive ingredients. These are:
lactose, microcrystalline cellulose, pregalatinised starch,
magnesium stearate, hydroxypropyl methylcellulose, titanium
dioxide (E171), polysorbate 80, polyethylene glycol and
crospovidone.
Teveten 600mg tablets are stored in a cardboard box containing
two blister strips of 14 tablets each. Each tablet is white, capsule
shaped tablets and marked with '5046' on one side and ‘SOLVAY’
on the other.
Teveten is made by Solvay Pharmaceuticals B.V., Olst, The
Netherlands.
The Product Licence holder is: BR Lewis Pharmaceuticals Ltd,
Kirk Sandall, Doncaster, DN3 1QR.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0038 POM

What is Teveten and how does it work?

Teveten is one of a group of medicines called angiotensin-II
receptor antagonists. Angiotensin II is a chemical found in the
body which makes your blood vessels contract and makes it
more difficult for blood to pass through them, causing your blood
pressure to rise. Teveten prevents this chemical from having this
effect and so lowers your blood pressure.

What is Teveten used for?

Teveten is used for the treatment of 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 the heart must do to
pump blood around the body. You may not feel unwell, but, if
high blood pressure is not treated, it can lead to heart disease
and stroke.

You may be given Teveten on its own. It may also be given with
another drug used to treat high blood pressure as both drugs
used together will lower your blood pressure (to a greater
extent) than one alone.
Your doctor may give you additional advice on how you can help
to lower your blood pressure.

Before taking your medicine
Do not take Teveten if:
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You are allergic to eprosartan or any other ingredient in
Teveten tablets (see ‘What is in Teveten’)
You are, or might become, pregnant
You are breast-feeding your baby
You have severe liver disease
you are more than 3 months pregnant. (It is also better to
avoid Teveten in early pregnancy – see pregnancy section.)

Tell your doctor if any of the following apply to you
(go back to your doctor or pharmacist and ask what you should
do. You may need to be given another medicine or the dose may
need to be changed):
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You have heart, kidney or liver problems
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You have recently suffered from vomiting or diarrhoea
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You suffer from lactose intolerance
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You are taking potassium supplements, potassium sparing
agents or potassium containing salt substitutes
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You are taking diuretics (water tablets) to help lower your
blood pressure, or for other reasons
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You are taking lithium.
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You are regularly taking non-steroidal anti-inflammatory
painkillers (e.g. ibuprofen or diclofenac), COX-2 inhibitors
(e.g. celecoxib, etoricoxib or lumiracoxib) or more than 3g
per day of aspirin.

Special Warning: This product contains lactose. If you have
been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine.

Take special care with Teveten

You must tell your doctor if 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).

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.

Assessed against UK PIL dated June 2006
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 breast-feed, especially If your
baby is newborn, or was born prematurely.

Do you drive or operate machinery?

If you feel tired or dizzy when you start to take Teveten, do not
drive or operate machinery until these effects wear off.

Taking your medicine

Follow the doctor’s instructions about how and when to take your
medicine. The doctor will decide how many tablets you need to
take each day and for how long.
The pharmacist’s label on your pack will tell you how much your
doctor would like you to take. Please read the label carefully. If
you have any questions about your medicine and how to take it
ask your doctor or pharmacist.
The usual dose of Teveten is 600 mg taken once a day. The
doctor may increase the dose to 800 mg (two 400mg tablets) if
required. If you are over 75 years of age or have kidney or liver
problems, your doctor may start you on a lower dose of 300 mg
(one tablet) once a day.
You should take the tablets with half a glass of water and with
food.
Take your tablets at about the same time each day.
It is important that you keep taking the tablets for as long as
your doctor tells you.

What if you have taken too much?

You should never take more tablets than your doctor
recommends. If you take too many tell your doctor or hospital
casualty department straight away. Show them your pack of
tablets.

What if you miss a dose?

If you forget to take a tablet, 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.

Possible side effects of Teveten

Any medicine can cause side effects. Allergic reactions have
occasionally been reported with Teveten.
Very rarely (in less than one in ten thousand patients), serious
allergic reactions involving swelling of the face, lips or tongue
and difficulty in breathing have been reported. If you develop
any of these symptoms, stop taking Teveten and contact your
doctor or hospital immediately.
Less serious side effects that have been experienced include
runny nose, dizziness and pain in the joints. These are not
necessarily due to Teveten as they have also been seen in
patients not taking it. Other side effects which may occur are
‘wind’ and an increase in fats (‘triglycerides’) in the blood.
In less than one in a thousand patients, skin rashes, itching,
headache or lethargy, have been reported.
In less than one in ten thousand patients, low blood pressure or
dizziness when standing up, and nausea have been reported.
If your doctor takes a blood sample for testing, you should
remind him that you are taking Teveten as it may affect the
result.
Tell your doctor if you notice any unwanted effects (even if not
mentioned in this leaflet) or feel unwell when you take Teveten.

Expiry Date

• Your medicine will have an expiry date on the pack. You
should not use your tablets after this date.

Storing your medicine

• Do not store above 25°C. Keep the tablets in the original
carton.

Keep all medicines where children cannot see or reach
them - preferably in a locked cupboard or medicine cabinet.
If your tablets show and signs of deterioration or appear
discoloured, take them back to your pharmacist (chemist), who
will advise you what to do.
If your doctor tells you to stop taking these tablets, take them
back to your pharmacist for safe disposal.
®

Teveten is a registered trademark of Solvay Pharmaceuticals BV
Leaflet revision and issue date (Ref): 12.03.09

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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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