Irbesartan Rowa 75 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Irbesartan

Available from:

Rowa Pharmaceuticals Limited

ATC code:

C09CA; C09CA04

INN (International Name):

Irbesartan

Dosage:

75 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Angiotensin II antagonists, plain; irbesartan

Authorization status:

Marketed

Authorization date:

2010-11-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IRBESARTAN ROWA 75 MG TABLETS
IRBESARTAN ROWA 150 MG TABLETS
IRBESARTAN ROWA 300 MG 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. 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 Rowa is and what it is used for
2. What you need to know before you take Irbesartan Rowa
3. How to take Irbesartan Rowa
4. Possible side effects
5. How to store Irbesartan Rowa
6. Content of the pack and other information.
1.
WHAT IRBESARTAN ROWA
IS AND WHAT IS USED FOR
Irbesartan Rowa 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
Rowa
prevents
the
binding
of
angiotensin-II to these receptors, causing the blood vessels to relax
and the blood pressure to
lower. Irbesartan Rowa slows the decrease of kidney function in
patients with high blood
pressure and type 2 diabetes.
Irbesartan Rowa is used in adult patients

to treat high blood pressure, (
_essential hypertension_
)

to protect the kidney in patients with high blood pressure, type 2
diabetics and
laboratory evidence of impaired renal function.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IRBESARTAN ROWA
DO NOT TAKE IRBESARTAN ROWA

if you are
ALLERGIC
(hypersensitive) to irbesartan or any other ingredients of
this
medicine (listed in section 6)

if you are
MORE THAN 3 MONTHS PREGNANT
. (It is also better to avoid Irbesarta

Summary of Product characteristics

Health Products Regulatory Authority
23 February 2022
CRN00CJ4P
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Irbesartan Rowa 75 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 mg of Irbesartan.
Excipient: 15.4 mg of lactose monohydrate per tablet.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Irbesartan Rowa 75 mg tablets are white, cylindrical, biconvex
tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
IRBESARTAN ROWA IS INDICATED IN ADULTS FOR

Treatment of essential hypertension.

Treatment of renal disease in patients with hypertension and type 2
diabetes mellitus as part of an
antihypertensive drug 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 Rowa 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
anti-hypertensive 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 Rowa (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 Rowa 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 blood pressure (see sections 4.3,
4.4, 4.5 and 5.1).
Special Populations
_Renal impairment: _
No dosage adjus