Irbesartan Torrent 150 mg filmomhulde tabletten

Država: Nizozemska

Jezik: nizozemščina

Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktivna sestavina:

IRBESARTAN

Dostopno od:

Torrent Pharma GmbH

Koda artikla:

C09CA04

INN (mednarodno ime):

IRBESARTAN

Farmacevtska oblika:

Filmomhulde tablet

Sestava:

CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; POLYETHYLEENGLYCOL (E 1521) ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171),

Pot uporabe:

Oraal gebruik

Terapevtsko območje:

Irbesartan

Povzetek izdelek:

Hulpstoffen: CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE (E 464); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); POLYETHYLEENGLYCOL (E 1521); POVIDON K 30 (E 1201); TITAANDIOXIDE (E 171);

Datum dovoljenje:

2011-11-03

Navodilo za uporabo

Irbesartan Torrent, 75-150-300 mg, film-coated tablets –
NL/H/2066/001-003/DC
Page 1
NL pl
NL/p/008/16/2
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
IRBESARTAN TORRENT 75 MG FILMOMHULDE TABLETTEN
IRBESARTAN TORRENT 150 MG FILMOMHULDE TABLETTEN
IRBESARTAN TORRENT 300 MG FILMOMHULDE TABLETTEN
Irbesartan
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 Irbesartan Torrent is and what it is used for
2.
What you need to know before you take Irbesartan Torrent
3.
How to take Irbesartan Torrent
4.
Possible side effects
5
How to store Irbesartan Torrent
6.
Contents of the pack and other information
1. WHAT IRBESARTAN TORRENT IS AND WHAT IT IS USED FOR
Irbesartan Torrent belongs to a group of medicines known as
angiotensin-II receptor antagonists.
Angiotensin-II is a substance produced in the body which binds to
receptors in blood vessels causing
them to tighten. This results in an increase in blood pressure.
Irbesartan Torrent prevents the binding of
angiotensin-II to these receptors, causing the blood vessels to relax
and the blood pressure to lower.
Irbesartan Torrent slows the decrease of kidney function in patients
with high blood pressure and type 2
diabetes.
Irbesartan Torrent is used in adult patients
-
to treat high blood pressure (_essential hypertension_)
-
to protect the kidney in patients with high blood pressure, type 2
diabetes and laboratory evidence
of impaired kidney function.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IRBESARTAN TORRENT
DO NOT TAKE IRBESARTAN TORRENT
-
if you are ALLERGI

Lastnosti izdelka

Irbesartan Torrent, 75-150-300 mg, film-coated tablets –
NL/H/2066/001-003/DC
Page 1
NL spc
NL/s/005/16/2
1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Irbesartan Torrent 75 mg filmomhulde tabletten.
Irbesartan Torrent 150 mg filmomhulde tabletten.
Irbesartan Torrent 300 mg filmomhulde tabletten.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75/150/300 mg of irbesartan.
Excipients with known effect:
Irbesartan Torrent 75 mg:
This medicine contains 63.50 mg of lactose monohydrate and less than 1
mmol sodium (23 mg) per
film-coated tablet
Irbesartan Torrent 150 mg:
This medicine contains 127.00 mg of lactose monohydrate and less than
1 mmol sodium (23 mg) per
film-coated tablet
Irbesartan Torrent 300 mg:
This medicine contains 254.00 mg of lactose monohydrate and less than
1 mmol sodium (23 mg) per
film-coated tablet
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Irbesartan Torrent 75 mg film-coated tablets:
White to off-white, oval-shaped, biconvex film-coated tablets debossed
with “L172” on one side and
“75” on the other side.
Irbesartan Torrent 150 mg film-coated tablets:
White to off-white, oval-shaped, biconvex film-coated tablets debossed
with “L173” on one side and
“150” on the other side.
Irbesartan Torrent 300 mg film-coated tablets:
White to off-white, oval-shaped, biconvex film-coated tablets debossed
with “L174” on one side and
“300” on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Irbesartan Heumann is indicated in adults for the treatment of
essential hypertension.
It is also indicated for the treatment of renal disease in adult
patients with hypertension and type 2
diabetes mellitus as part of an antihypertensive medicinal product
regimen (see sections 4.3, 4.4, 4.5
and 5.1).
Irbesartan Torrent, 75-150-300 mg, film-coated tablets –
NL/H/2066/001-003/DC
Page 2
NL spc
NL/s/005/16/2
2
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The usual recommende