COAPROVEL 150/12,5 TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Sanofi Industries South Africa (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS HYDROCHLOROTHIAZIDE 12,5 mg IRBESARTAN 150,0 mg

Authorization status:

Registered

Authorization date:

2003-02-01

Patient Information leaflet

1
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
S3
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM:
APROVEL 75 MG (Tablets)
APROVEL 150 MG (Tablets)
APROVEL 300 MG (Tablets)
The active ingredient is irbesartan.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING APROVEL.

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or your
pharmacist.

APROVEL has been prescribed for you personally and you should not
share your medicine
with other people. It may harm them, even if their symptoms are the
same as yours.
WHAT APROVEL CONTAINS:
The active substance in APROVEL tablets is irbesartan. Each tablet
contains 75 mg, 150 mg or
300 mg irbesartan.
The other inactive ingredients are: croscarmellose sodium,
hypromellose, lactose monohydrate,
magnesium stearate, microcrystalline cellulose, silicon dioxide and a
film-coating.
WHAT APROVEL IS USED FOR:
APROVEL belongs to a group of medicines known as angiotensin II
receptor blockers (ARB's).
APROVEL is used in the treatment of high blood pressure (hypertension)
and for the protection
of the kidney in patients with high blood pressure, type 2 diabetes
and laboratory evidence of
impaired renal function.
BEFORE YOU TAKE APROVEL:
2
DO NOT TAKE APROVEL:

if you are hypersensitive (allergic) to irbesartan or any of the other
ingredients of APROVEL
(see “WHAT APROVEL CONTAINS”)

if you have a history of angioedema (swelling around your face, throat
or tongue) related to
previous therapy with ARBs or to angiotensin converting enzyme
inhibitors (ACEIs): You must
never again be given these medicines

if you have hereditary angioedema (swelling around your face, throat
or tongue)

if you have heart disease characterised by obstruction of blood flow
and thickening of heart
tissue (hypertrophic obstructive cardiomyopathy)

if you have kidney problems where the blood supply to your kidney is
reduced (renal artery
stenosis) or a transplanted kidney

If you have kidney problems and are taking flu

Summary of Product characteristics

1
SCHEDULING STATUS:
S3
PROPRIETARY NAME AND DOSAGE FORM:
APROVEL
®
75 MG tablets
APROVEL
®
150 MG tablets
APROVEL
®
300 MG tablets
COMPOSITION:
APROVEL tablets contain 75 mg, 150 mg or 300 mg of irbesartan.
The other ingredients are: croscarmellose sodium, hypromellose,
lactose monohydrate,
magnesium stearate, microcrystalline cellulose, silicon dioxide and a
film-coating.
Contains lactose monohydrate.
PHARMACOLOGICAL CLASSIFICATION:
A 7.1.3 Other hypotensives
PHARMACOLOGICAL ACTION:
PHARMACODYNAMIC PROPERTIES:
MECHANISM OF ACTION:
Irbesartan is a specific antagonist of angiotensin II receptors (AT
1
subtype), known as an
angiotensin receptor blocker (ARB). Angiotensin II is an important
component of the renin-
angiotensin system (RAS) and is involved in the pathophysiology of
hypertension and in sodium
homeostasis.
Irbesartan blocks the vasoconstrictor and aldosterone-secreting
effects of angiotensin II by
selective antagonism of the angiotensin II (AT
1
subtype) receptors localised on vascular smooth
muscle cells and in the adrenal cortex.
It has no agonist activity at the AT
1
receptor and a much greater affinity (more than 8500-fold) for
2
the AT
1
receptor than for the AT
2
receptor (a receptor that has not been shown to be associated
with cardiovascular homeostasis).
Irbesartan does not inhibit enzymes involved in the renin-angiotensin
system (i.e. renin,
angiotensin converting enzyme [ACE]), or affect other hormone
receptors or ion channels
involved in the cardiovascular regulation of blood pressure and sodium
homeostasis.
Irbesartan blockade of AT
1
receptors interrupts the feedback loop within the renin-angiotensin
system, resulting in increases in plasma renin levels and angiotensin
II levels.
Aldosterone plasma concentrations decline following irbesartan
administration. However, serum
potassium levels are not significantly affected (mean increase of <
0,1 mmol/l) at the
recommended doses. Irbesartan has no notable effects on serum
triglycerides, cholesterol or
glucose concentrations. There is no ef