Skip to Content

EPROSARTAN 600MG TABLETS

Active substance(s): EPROSARTAN / EPROSARTAN MESILATE

View full screen / Print PDF » Download PDF ⇩
Transcript
THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

This product is available as any of the above names, but will usually be referred to as Teveten throughout
this leaflet. Other strengths (300mg and 400mg) are also available.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

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.

PROOF HISTORY:
v.1 - waymade - 18/12/13

Leaflet Flat Size = 148 x 400

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.

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.

WARNING!

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.

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

DATE:

CUSTOMER
APPROVED:

The active ingredient in this medicine is eprosartan mesilate. This is the new name for eprosartan mesylate.
The active ingredient itself has not changed.

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.
UK PIL DATED FEBRUARY 2013
REPORTING OF SIDE EFFECTS

TVT CHECKED
6464/1636D
CODE:

18/12/13
DATE OF PROOF:

DATE:

DT
ARTWORKER:
PRODUCT: Teveten 600mg tabs

05-0269
CUSTOMER:

Waymade

PRE-PRESS NO.:

Q.A.
APPROVED:

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.

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 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.
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.

Colour
Swatch

Black

WARNING!

27mm

TEVETEN 600mg TABLETS/
EPROSARTAN 600mg TABLETS
(eprosartan mesilate)
Patient Information Leaflet

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

000-0000D

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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.

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.

WARNING!

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).

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.

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.

TVT CHECKED

By reporting side effects you can help provide more information on the safety of this medicine.




UK PIL DATED FEBRUARY 2013
REPORTING OF SIDE EFFECTS

6464/1636D

18/12/13
DATE OF PROOF:

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.

CODE:

DATE:

DT
ARTWORKER:
PRODUCT: Teveten 600mg tabs

Q.A.
APPROVED:
05-0269
CUSTOMER:

Waymade

PRE-PRESS NO.:

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.




5. How to store Teveten
Teveten 600mg Tablets/Eprosartan 600mg Tablets should not be stored above 25°C. Do not
remove the tablets from the blister strip until you are ready to take your medicine. Keep the tablets
in their original pack.
Do not use after the expiry date printed on the carton, carton label or blister strip.
Keep all medicines out of the sight and reach of children.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe
disposal. Only keep the tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of deterioration, consult your
pharmacist 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
Your medicine is called Teveten 600mg Tablets/Eprosartan 600mg Tablets.
Each white capsule-shaped tablet contains 600mg of the active ingredient, eprosartan, as the mesilate and
is marked ‘5046’ on one side and plain on the other side.
Teveten 600mg Tablets/Eprosartan 600mg Tablets also contain the following inactive ingredients:
microcrystalline cellulose, magnesium stearate, lactose monohydrate, hypromellose, polysorbate 80,
polyethylene glycol, crospovidone, titanium dioxide (E171) and pregelatinised maize starch.
Teveten 600mg Tablets/Eprosartan 600mg Tablets are available as blister packs of 28 and 56 tablets.
POM

PL No: 6464/1636

This product is manufactured by SmithKline Beecham Pharmaceuticals, Manor Royal, Crawley, Sussex,
England, and/or, Abbott Biologicals B.V., Veerweg 12-8121 AA Olst, Holland, and/or, Abbott Healthcare
SAS, Route De Bellville, 01400 Chatillon-sur-Chalaronne, France, and/or, Abbott Products GmbH,
Justus-von-Leibig-Strasse 33, D-31535 Neustadt, Germany and procured from within the EU and
repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 18.12.2013

Black

Teveten is a registered trademark of Abbott Products Operations AG.
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

Colour
Swatch

000-0000D

WARNING!

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

DATE:

CUSTOMER
APPROVED:

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

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

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.

PROOF HISTORY:
v.1 - waymade - 18/12/13

Leaflet Flat Size = 148 x 400

Adults aged under 75 years
• The usual dose is 600 mg once a day

Expand view ⇕

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