IRBESARTAN NICHE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

IRBESARTAN

Available from:

Niche Generics Limited

ATC code:

C09CA04

INN (International Name):

IRBESARTAN

Dosage:

150 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

irbesartan

Authorization status:

Not Marketed

Authorization date:

2013-02-15

Patient Information leaflet

PA 1063/056/001-002
1
28/09/2017
PACKAGE LEAFLET: INFORMATION FOR THE USER
IRBESARTAN NICHE 150MG FILM-COATED TABLETS
IRBESARTAN NICHE 300MG 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.
The name of your medicine is Irbesartan Niche 150 mg or 300 mg
Film-Coated Tablets. It will be
called Irbesartan Niche for ease from here on.
WHAT IS IN THIS LEAFLET:
1.
What Irbesartan Niche is and what it is used for
2.
What you need to know before you take Irbesartan Niche
3.
How to take Irbesartan Niche
4.
Possible side effects
5.
How to store Irbesartan Niche
6.
Contents of the pack and other information
1.
WHAT IRBESARTAN NICHE IS AND WHAT IT IS USED FOR
Irbesartan Niche 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 Niche prevents the binding of
angiotensin-II to these receptors, causing the blood vessels to relax
and the blood pressure to lower.
Irbesartan Niche slows the decrease of kidney function in patients
with high blood pressure and type 2
diabetes.
Irbesartan Niche 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 NICHE
DO NOT TAKE IRBESARTAN NICHE:

if you are

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Irbesartan Niche 150mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 150mg tablet contains 150mg of irbesartan.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Irbesartan Niche 150mg film-coated tablets are white to off-white
coloured, oval shaped, biconvex, film-coated tablets
with “U” debossed on one side and “I” debossed on the other
side.
The tablet is approximately 4.8 mm thick, 12.5 mm
long and 6.5 mm wide.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Irbesartan Niche 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 Niche 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.
A dose of 75 mg cannot be given with Irbesartan Niche. Another
appropriate formulation should be used for this dose.
In patients insufficiently controlled with 150 mg once daily, the dose
of Irbesartan Niche can be increased to 300 mg,
or other antihypertensive 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 Niche (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 Niche in h