IRBESARTAN NICHE

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

IRBESARTAN

可用日期:

Niche Generics Limited

ATC代码:

C09CA04

INN（国际名称）:

IRBESARTAN

剂量:

300 Milligram

药物剂型:

Film Coated Tablet

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

irbesartan

授权状态:

Not Marketed

授权日期:

2013-02-15

资料单张

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

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Irbesartan Niche 300mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 300mg tablet contains 300mg irbesartan.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Irbesartan Niche 300mg film-coated tablets are white to off-white
coloured, oval shaped, biconvex, film-coated tablets
with “U” debossed on one side and plain on the other side. The
tablet is approximately 5.6 mm thick, 15.7 mm long and
8.1 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 hypertensive ty