Irbesartan Teva

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

irbesartan

MAH:

Teva B.V.

ATC_code:

C09CA04

INN:

irbesartan

therapeutic_group:

Agents acting on the renin-angiotensin system

therapeutic_area:

Hypertension

therapeutic_indication:

Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen.

leaflet_short:

Revision: 16

authorization_status:

Authorised

authorization_date:

2009-10-30

PIL

35
B. PACKAGE LEAFLET
36 PACKAGE LEAFLET: INFORMATION FOR THE USER
IRBESARTAN TEVA 75 MG FILM-COATED TABLETS
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 Teva is and what it is used for
2.
What you need to know before you take Irbesartan Teva
3.
How to take Irbesartan Teva
4.
Possible side effects
5.
How to store Irbesartan Teva
6.
Contents of the pack and other information
1.
WHAT IRBESARTAN TEVA IS AND WHAT IT IS USED FOR
Irbesartan Teva 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 Teva prevents the binding of
angiotensin-II to these receptors, causing the blood vessels to relax
and the blood pressure to lower.
Irbesartan Teva slows the decrease of kidney function in patients with
high blood pressure and type 2
diabetes.
Irbesartan Teva 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 TEVA
DO NOT TAKE IRBESARTAN TEVA

If you are
ALLERGIC
to irbesartan or to any of the other ingredients of this medicine
(listed in
section 6).

If you are
MORE THAN 3 MONTHS PREGNANT
(it is also better to avoid Irbesartan Teva in early
pregnancy - see pregnanc

SPC

1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Irbesartan Teva 75 mg film-coated tablets
Irbesartan Teva 150 mg film-coated tablets
Irbesartan Teva 300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Irbesartan Teva 75 mg film-coated tablets
Each film-coated tablet contains 75 mg of irbesartan
Irbesartan Teva 150 mg film-coated tablets
Each film-coated tablet contains 150 mg of irbesartan
Irbesartan Teva 300 mg film-coated tablets
Each film-coated tablet contains 300 mg of irbesartan
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Irbesartan Teva 75 mg film-coated tablets
White to off white capsule shaped, film coated tablet. One side of the
tablet debossed with the number
“93”. The other side of the tablet debossed with number
“7464”.
Irbesartan Teva 150 mg film-coated tablets
White to off white capsule shaped, film coated tablet. One side of the
tablet debossed with the number
“93”. The other side of the tablet debossed with number
“7465”.
Irbesartan Teva 300 mg film-coated tablets
White to off white capsule shaped, film coated tablet. One side of the
tablet debossed with the number
“93”. The other side of the tablet debossed with number
“7466”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Irbesartan Teva 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).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual recommended initial and maintenance dose is 150 mg once
daily, with or without food.
Irbesartan at a dose of 150 mg once daily generally provides a better
24 hour blood pressure control
than 75 mg. However, initiation of therapy with 75 mg could be
considered, particularly in
haemodialysed patients and in the elderly over 75 years.
3
In patie