IRBESARTAN ACCORD

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

IRBESARTAN

Tersedia dari:

Accord Healthcare Limited

Kode ATC:

C09CA04

INN (Nama Internasional):

IRBESARTAN

Dosis:

150 Milligram

Bentuk farmasi:

Film Coated Tablet

Jenis Resep:

Product subject to prescription which may be renewed (B)

Area terapi:

irbesartan

Status otorisasi:

Marketed

Tanggal Otorisasi:

2012-08-03

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE USER
Irbesartan Accord
75 mg Film-coated
Tablets
Irbesartan Accord
150 mg Film-coated
Tablets
Irbesartan Accord
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 further questions, please 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, call 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 Accord is and what it is used
for
2. What you need to know before you take
Irbesartan Accord
3. How to take Irbesartan Accord
4. Possible side effects
5. How to store Irbesartan Accord
6. Contents of the pack and other information
1.
WHAT IRBESARTAN ACCORD IS AND
WHAT IT IS USED FOR
Irbesartan Accord 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 Accord
prevents the binding of angiotensin -II to these
receptors, causing the blood vessels to relax and
the blood pressure to lower. Irbesartan Accord
slows the decrease of kidney function in patients
with high blood pressure and type 2 diabetes.
Irbesartan Accord 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 ACCORD
DO NOT TAKE IRBESARTAN ACCORD:
•
If you are allergic to Irbesartan or any of the
other ingredients of this medicine (listed in
section 6).
•
If you are more tha

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Irbesartan Accord 150 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film - coated tablet contains 150 mg Irbesartan.
Excipient with known effect: 50.72 mg of lactose monohydrate per
tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White to off white, oval, biconvex, film coated tablet debossed ‘I
150’ on one side and plain on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Irbesartan 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 section 5.1)
Irbesartan can be used alone or in combination with other
antihypertensive agents (see sections 4.3, 4.4, 4.5 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Irbesartan can be used alone or in combination with other
antihypertensive agents (see sections 4.3, 4.4, 4.5 and 5.1).
The usual recommended initial and maintenance dose is 150 mg once
daily, with or without food. Irbesartan Tablets 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 Irbesartan Tablets can be increased to 300 mg,
or other anti-hypertensive agents can be added. In particular, the
addition of a diuretic such as hydrochlorothiazide has
been shown to have an additive effect with Irbesartan Tablets. (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 Tablets in hy