Aprovel

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

irbesartan

Available from:

Sanofi Winthrop Industrie

ATC code:

C09CA04

INN (International Name):

irbesartan

Therapeutic group:

Agents acting on the renin-angiotensin system

Therapeutic area:

Hypertension

Therapeutic indications:

Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal-product regimen.

Product summary:

Revision: 48

Authorization status:

Authorised

Authorization date:

1997-08-26

Patient Information leaflet

102
B. PACKAGE LEAFLET
103
PACKAGE LEAFLET: INFORMATION FOR THE USER
APROVEL 75 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 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 Aprovel is and what it is used for
2.
What you need to know before you take Aprovel
3.
How to take Aprovel
4.
Possible side effects
5.
How to store Aprovel
6.
Contents of the pack and other information
1.
WHAT APROVEL IS AND WHAT IT IS USED FOR
Aprovel 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. Aprovel prevents the
binding of angiotensin-II to these
receptors, causing the blood vessels to relax and the blood pressure
to lower. Aprovel slows the
decrease of kidney function in patients with high blood pressure and
type 2 diabetes.
Aprovel 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 APROVEL
DO NOT TAKE APROVEL

if you are
ALLERGIC
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 Aprovel in early pregnancy
– see pregnancy section)

IF YOU HAVE DIABETES OR IMPAIRED KIDNEY FUNCTION
and you are treated with a blood pressure
lower

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Aprovel 75 mg tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 mg of irbesartan.
Excipient with known effect: 15.37 mg of lactose monohydrate per
tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off-white, biconvex, and oval-shaped with a heart debossed on
one side and the number 2771
engraved on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aprovel 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.
Aprovel 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 haemodialyzed
patients and in the elderly over 75 years.
In patients insufficiently controlled with 150 mg once daily, the dose
of Aprovel 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 Aprovel (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 Aprovel 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_