ATACAND PLUS 32/25 mg TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

AstraZeneca Pharmaceuticals (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS CANDESARTAN CILEXETIL 32,0 mg HYDROCHLOROTHIAZIDE 25,0 mg

Authorization status:

Registered

Authorization date:

2013-06-09

Patient Information leaflet

1
FINAL PATIENT INFORMATION LEAFLET
2
PATIENT INFORMATION LEAFLET: ATACAND 8, 16 & 32 MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or your
pharmacist.

This medicine 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.
SCHEDULING STATUS: S3
PROPRIETARY NAME (AND DOSAGE FORM):
ATACAND® 8 MG, ATACAND® 16 MG, ATACAND® 32 MG (TABLET)
The active substance is candesartan cilexetil.
1.
WHAT ATACAND CONTAINS:
The active substance in ATACAND 8 mg tablet is 8 mg candesartan
cilexetil.
The active substance in ATACAND 16 mg tablet is 16 mg candesartan
cilexetil.
The active substance in ATACAND 32 mg tablet is 32 mg candesartan
cilexetil.
The other ingredients are carmellose calcium, hyprolose, iron oxide,
magnesium stearate,
maize starch and macrogol. Contains sugar (lactose monohydrate).
3
2.
WHAT ATACAND IS USED FOR:
ATACAND is a type of medicine called an angiotensin II receptor
antagonist, which by
blocking the effects of the hormone angiotensin II causes the blood
vessels to relax and
widen. This results in a lowering of your blood pressure.
ATACAND is used for treating high blood pressure (hypertension). It is
also used for treating
a heart condition known as heart failure where the heart does not pump
the blood around the
body as well as it should.
3.
BEFORE YOU TAKE ATACAND:
DO NOT TAKE ATACAND:

If you are pregnant, think you might be pregnant or considering
becoming pregnant.

If you are breast-feeding.

If you have a severe kidney problem.

If you are allergic to any of the ingredients in ATACAND.

If you have a severe liver problem.

If you have a condition known as bilateral renal artery stenosis or
stenosis in the
presence of a single kidney. This is a narrowing of the kidney
arteries supplying blood to
the kidney/s, leading to a red

Summary of Product characteristics

1
FINAL PACKAGE INSERT
2
SCHEDULING STATUS: S3
PROPRIETARY NAME (AND DOSAGE FORM):
ATACAND® 8 MG, ATACAND® 16 MG, ATACAND® 32 MG (TABLET)
COMPOSITION:
Each ATACAND 8 mg tablet contains 8 mg candesartan cilexetil.
Each ATACAND 16 mg tablet contains 16 mg candesartan cilexetil.
Each ATACAND 32 mg tablet contains 32 mg candesartan cilexetil.
Contains sugar (lactose monohydrate).
PHARMACOLOGICAL CLASSIFICATION:
A 7.1.3 Other hypotensives
PHARMACOLOGICAL ACTION:
_Pharmacodynamic properties: _
Candesartan cilexetil is a prodrug. After oral administration it is
converted to the active drug,
candesartan, by ester hydrolysis during absorption from the
gastrointestinal tract. Candesartan
is an angiotensin II receptor antagonist, selective for AT
1
receptors, with tight binding to and
slow dissociation from the receptor. It has no agonist activity.
The major physiological effects of angiotensin II, such as
vasoconstriction, aldosterone
stimulation, regulation of salt and water homeostasis and stimulation
of cell growth, are
mediated via the type 1 (AT
1
) receptor.
3
The antagonism of the angiotensin II (AT
1
) receptors results in dose related increases in
plasma renin activity, angiotensin I and angiotensin II
concentrations, and a decrease in
plasma aldosterone concentration.
_Hypertension:_
In hypertension ATACAND causes a dose-related sustained reduction in
arterial blood
pressure over the dosage interval. The antihypertensive action is due
to decreased systemic
peripheral resistance, while heart rate, stroke volume and cardiac
output are not affected.
After administration of a single dose of ATACAND, onset of
antihypertensive effect generally
begins within 2 hours. With continuous treatment, the maximum
reduction in blood pressure
is generally attained within 4 weeks and is sustained during long-term
treatment. Candesartan
has a peak to trough ratio of peak versus trough effects of close to
1.
ATACAND increases renal blood flow and either has no effect on, or
increases glomerular
filtration rate while renal vascula