Irbesartan Clonmel 75mg Film-coated Tablets

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Irbesartan

Beschikbaar vanaf:

Clonmel Healthcare Ltd

ATC-code:

C09CA; C09CA04

INN (Algemene Internationale Benaming):

Irbesartan

Dosering:

75 milligram(s)

farmaceutische vorm:

Film-coated tablet

Prescription-type:

Product subject to prescription which may be renewed (B)

Therapeutisch gebied:

Angiotensin II antagonists, plain; irbesartan

Autorisatie-status:

Marketed

Autorisatie datum:

2010-09-10

Bijsluiter

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
IRBESARTAN CLONMEL 75MG FILM-COATED TABLETS
IRBESARTAN CLONMEL 150MG FILM-COATED TABLETS
IRBESARTAN CLONMEL 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.
_ _
WHAT IS IN THIS LEAFLET
1.
What Irbesartan Clonmel is and what it is used for
2.
What you need to know before you take Irbesartan Clonmel
3.
How to take Irbesartan Clonmel
4.
Possible side effects
5.
How to store Irbesartan Clonmel
6.
Contents of the pack and other information
1.
WHAT IRBESARTAN CLONMEL IS AND WHAT IT IS USED FOR
Irbesartan Clonmel 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 Clonmel prevents
the binding of angiotensin-II to these receptors, causing the blood
vessels to relax and the blood
pressure to lower. Irbesartan Clonmel slows the decrease of kidney
function in patients with high
blood pressure and type 2 diabetes.
Irbesartan Clonmel is used in adult patients to:
•
treat high blood pressure (essential hypertension)
•
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 CLONMEL
DO NOT TAKE IRBESARTAN CLONMEL
•
if you are allergic to irbesartan or any other ingredients of this
medicine (listed in section 6).
•
if you

Productkenmerken

Health Products Regulatory Authority
13 December 2021
CRN00CMJ6
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Irbesartan Clonmel 75mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 75 mg film-coated tablet contains 75 mg of irbesartan.
Excipient with known effect:
Each 75 mg film-coated tablet contains 17.08 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
75 mg film-coated tablets are white, biconvex, oval-shaped and
approximately 10 mm in length.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Irbesartan Clonmel 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
This medicinal product is available in 3 strengths: 75 mg, 150 mg and
300 mg. The usual recommended initial and maintenance
dose is 150 mg once daily. Irbesartan Clonmel 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 Clonmel 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