Teveten 600 mg film-coated tablets

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Eprosartan

זמין מ:

PCO Manufacturing Ltd.

קוד ATC:

C09CA; C09CA02

INN (שם בינלאומי):

Eprosartan

כמות:

600 milligram(s)

טופס פרצבטיות:

Film-coated tablet

סוג מרשם:

Product subject to prescription which may be renewed (B)

איזור תרפויטי:

Angiotensin II antagonists, plain; eprosartan

מצב אישור:

Authorised

תאריך אישור:

2005-08-05

עלון מידע

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PACKAGE LEAFLET: INFORMATION FOR THE USER
TEVETEN
® 600 MG FILM-COATED TABLETS
eprosartan
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
–
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 only. Do not pass it on
to others. It may harm them, even if their signs of illness are the
same as yours.
–
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1.
What Teveten is and what it is used for
2.
What you need to know before you take Teveten
3.
How to take Teveten
4.
Possible side effects
5.
How to store Teveten
6.
Contents of the pack and other information
1.
WHAT TEVETEN IS AND WHAT IT IS USED FOR
Teveten is used:

to treat high blood pressure
Teveten contains the active ingredient eprosartan.

EPROSARTAN belongs to a group of medicines called ‘angiotensin II
receptor antagonists’. It blocks the action of a substance in your
body called ‘angiotensin II’. This substance causes your blood
vessels to narrow. This makes it more difficult for the blood to flow
through the vessels and so your blood pressure increases. By
blocking this substance, the vessels relax and your blood pressure
decreases.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEVETEN
DO NOT TAKE TEVETEN IF:

you are allergic (hypersensitive) to eprosartan or any of the other
ingredients in Teveten (listed in section 6)

you have SEVERE liver disease

you have SEVERE problems with the blood flow in your kidneys

you have diabetes or impaired kidney function and you are treated
with a blood pressure lowering medicine containing aliskiren

you are more than 3 months pregnant (It is also better to avoid
Teveten in early pregnancy - see pregnancy section.)
Do not take Teveten if any of the above apply to you. If y

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Teveten 600 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains eprosartan mesylate equivalent to 600
mg eprosartan.
Excipient with known effect(s)
Lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product as imported from Czech Republic, Greece and Italy_
White capsule shaped, tablets with “SOLVAY” engraved on one side
and “5046” on the other OR white capsule
shaped, blank on one side and engraved “5046” on the other.
4 CLINICAL PARTICULARS
As per PA2010/017/002
5 PHARMACOLOGICAL PROPERTIES
As per PA2010/017/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Microcrystalline cellulose
Pregelatinised starch
Crospovidone
Magnesium stearate
_Film-coating_
Hypromellose
Titanium dioxide (E171)
Macrogol 400
Polysorbate 80
_Product imported from the the Czech Republic also contains OPADRY
OY-S-9603_
6.2 INCOMPATIBILITIES
Not applicable.
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6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 °C.
6.5 NATURE AND CONTENTS OF CONTA