Irprestan 300 mg film-coated tablets

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Irbesartan

Disponible des:

Actavis Group PTC ehf

Codi ATC:

C09CA; C09CA04

Designació comuna internacional (DCI):

Irbesartan

Dosis:

300 milligram(s)

formulario farmacéutico:

Film-coated tablet

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Angiotensin II antagonists, plain; irbesartan

Estat d'Autorització:

Marketed

Data d'autorització:

2009-07-03

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE USER
IRPRESTAN 75 MG FILM-COATED TABLETS
IRPRESTAN 150 MG FILM-COATED TABLETS
IRPRESTAN 300 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 Irprestan is and what it is used for
2.
What you need to know before you take Irprestan
3.
How to take Irprestan
4.
Possible side effects
5.
How to store Irprestan
6.
Contents of the pack and other information
1.
WHAT IRPRESTAN IS AND WHAT IT IS USED FOR
Irprestan 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. Irprestan
prevents the binding of angiotensin-II
to these receptors, causing the blood vessels to relax and the blood
pressure to lower. Irprestan slows
the decrease of kidney function in patients with high blood pressure
and type 2 diabetes.
Irprestan is used in adult patients
-
to treat high blood pressure (_essential hypertension_)
-
to protect the kidney in hypertensive type 2 diabetic patients with
laboratory evidence of
impaired renal function.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IRPRESTAN
DO NOT TAKE IRPRESTAN
-
if you are ALLERGIC to irbesartan or any other ingredients of this
medicine, (listed in section 6)
-
if you are MORE THAN 3 MONTHS PREGNANT. (It is also better to avoid
Irprestan in early
pregnancy – see pregnancy section.)
-
IF YOU HAVE DIABETES OR IMPAIRED KIDNEY F

Fitxa tècnica

Health Products Regulatory Authority
11 June 2019
CRN008W49
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Irprestan 300 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 300 mg irbesartan.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, elliptical, biconvex,8.2 x 16.0 mm film-coated, marked 'I' on
one side and '300' on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults.
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. Irprestan 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.
In patients insufficiently controlled with 150 mg once daily, the dose
of Irprestan can be increased to 300 mg, or other
anti-hypertensive agents can be added (see sections 4.3, 4.4, 4.5 and
5.1). In particular, the addition of a diuretic such as
hydrochlorothiazide has been shown to have an additive effect with
irbesartan (see section 4.5).
In hypertensive type 2 diabetic patients, therapy should be initiated
at 150 mg irbesartan once daily and titrated up to 300 mg
once daily as the preferred maintenance dose for treatment of renal
disease. The demonstration of renal benefit of irbesartan
in hypertensive type 2 diabetic patients is based on studies where
irbesartan was used in addition to other antihypertensive
agents, as needed, to reach target blood pressure (see sections 4.3,
4.4, 4.5 and 5.1).
_Renal impairment_
No dosage adjustment is necessary in patients with impaired renal
function. A lower starti