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

איזור תרפויטי:

Angiotensin II antagonists, plain; eprosartan

תאריך אישור:

2021-03-26

עלון מידע

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 you are not
sure,

מאפייני מוצר

Health Products Regulatory Authority
26 March 2021
CRN00C7HT
Page 1 of 2
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: lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from Greece_
Capsule-shaped, white, film-coated tablet marked "5046" on one side
and no inscription on the other side.
4 CLINICAL PARTICULARS
PA2010/017/002
5 PHARMACOLOGICAL PROPERTIES
PA2010/017/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet Core:
Lactose monohydrate
Microcrystalline cellulose
Pregelatinised starch
Crospovidone
Magnesium stearate
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 and outer package of the product on the market
in the country of origin.
Health Products Regulatory Authority
26 March 2021
CRN00C7HT
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
6.5 NATURE AND CONTENTS OF CONTAINER
PVC/AL blister packs of 28 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/469/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 26
th
March 2021
10 DATE OF REVISION OF THE TEXT