Teveten 600mg film-coated tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Eprosartan

Dostępny od:

Imbat Limited

Kod ATC:

C09CA; C09CA02

INN (International Nazwa):

Eprosartan

Dawkowanie:

600 milligram(s)

Forma farmaceutyczna:

Film-coated tablet

Typ recepty:

Product subject to prescription which may be renewed (B)

Dziedzina terapeutyczna:

Angiotensin II antagonists, plain; eprosartan

Status autoryzacji:

Authorised

Data autoryzacji:

2009-08-07

Ulotka dla pacjenta

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
TEVETEN
® 600MG FILM-COATED TABLETS
(eprosartan)
The full name of your medicine is Teveten 600mg film-coated
tablets. In this leaflet the shorter name Teveten is used.
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 bette

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Teveten 600mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains Eprosartan mesylate equivalent to
600mg Eprosartan
Excipient: contains lactose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from UK and Italy_
Capsule shaped, white, film-coated tablet marked “5046” on one
side and plain on the other side.
4 CLINICAL PARTICULARS
PA2007/014/002
5 PHARMACOLOGICAL PROPERTIES
PA2007/014/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Product imported from the UK;
Tablet core:
Lactose
Microcrystalline Cellulose
Pregelatinised starch
Crospovidone
Magnesium stearate
Tablet coating:
Hypromellose (E464)
Macrogol 400
Polysorbate 80 (E433)
Titanium dioxide (E171)
Product imported from Italy;
Tablet Core:
Lactose monohydrate
Microcrystalline cellulose
Pregelatinised starch
Crospovidone
Magnesium stearate
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Purified water
Tablet Coating:
Hypromellose (E464)
Titanium dioxide (E171)
Macrogol 400
Polysorbate 80 (E433)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the blister strips and outer carton of the product as
marketed in the country of origin.
6.4 SPE