Irbesan 75mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Irbesartan

Available from:

Rowex Ltd

ATC code:

C09CA; C09CA04

INN (International Name):

Irbesartan

Dosage:

75 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Angiotensin II antagonists, plain; irbesartan

Authorization status:

Not marketed

Authorization date:

2009-06-19

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
IRBESAN 75 MG FILM-COATED TABLETS
IRBESAN 150 MG FILM-COATED TABLETS
IRBESAN 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 Irbesan is and what it is used for
2. What you need to know before you take Irbesan
3. How to take Irbesan
4. Possible side effects
5. How to store Irbesan
6. Contents of the pack and other information
1.
WHAT IRBESAN IS AND WHAT IT IS USED FOR_ _
Irbesan 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. Irbesan prevents the
binding of angiotensin-II to these receptors, causing the blood
vessels to relax and the blood
pressure to lower. Irbesan slows the decrease of kidney function in
patients with high blood
pressure and type 2 diabetes.
Irbesan tablets are 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 IRBESAN
_ _
DO NOT TAKE IRBESAN:

if you are ALLERGIC to irbesartan or any of the ingredients of this
medicine (listed in section
6)

if you are MORE THAN 3 MONTHS PREGNANT. (It is also better to avoid
Irbesan in early
pregnancy – see pregnancy section.)

IF YOU HAVE DIABETES OR IMPAI

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Irbesan 75mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film- coated tablet contains 75 mg irbesartan.
Excipient with known effect:
6.463 mg of lactose monohydrate per tablet.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film- coated tablet
White, oval, biconvex, film- coated tablets, debossed with ‘75’ on
one side and scored on the other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Irbesan 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. 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.
In patients insufficiently controlled with 150 mg once daily, the dose
of irbesartan 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 (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 b