Irbesartan Fair-Med 300mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IRBESARTAN

Available from:

FAIR-MED HEALTHCARE GmbH Planckstr. 13, 22765 Hamburg, Germany

ATC code:

C09CA04

INN (International Name):

IRBESARTAN 300 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

IRBESARTAN 300 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Withdrawn

Authorization date:

2012-07-17

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
IRBESARTAN FAIR-MED 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, pharmacist or
nurse.
-
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, pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
_ _
WHAT IS IN THIS LEAFLET
1.
What Irbesartan Fair-Med is and what it is used for
2.
What you need to know before you take Irbesartan Fair-Med
3.
How to take Irbesartan Fair-Med
4.
Possible side effects
5.
How to store Irbesartan Fair-Med
6.
Contents of the pack and other information
1. WHAT IRBESARTAN FAIR-MED IS AND WHAT IT IS USED FOR
Irbesartan Fair-Med 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 Fair-Med prevents
the binding of angiotensin-II to these receptors, causing the blood
vessels to relax and the blood
pressure to lower. Irbesartan Fair-Med slows the decrease of kidney
function in patients with high
blood pressure and type 2 diabetes.
Irbesartan Fair-Med 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 FAIR-MED
DO NOT TAKE IRBESARTAN FAIR-MED

if you are ALLERGIC to irbesartan or any of the other ingredients of
this medicine (listed in
section 6)

if you are MORE THAN 3 MONTHS PREGNANT. (It is also better to

Summary of Product characteristics

Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Irbesartan Fair-Med 300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 300 mg of irbesartan.
Excipient with known effect: 254 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 shaped, biconvex, film coated tablet,
debossed with “L174” on one side
and “300” on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Irbesartan Fair-Med 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 Fair-Med 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 Fair-Med 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