INDAPAMIDE AN SR indapamide hemihydrate 1.5 mg modified release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

indapamide hemihydrate

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

indapamide hemihydrate

Authorization status:

Registered

Patient Information leaflet

Indapamide AN SR CMI v1.0
Page 1 of 4
INDAPAMIDE AN SR
_contains the active ingredient indapamide hemihydrate 1.5 mg_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about INDAPAMIDE AN SR. It
does not contain all the available
information about this medicine.
Reading this leaflet does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking INDAPAMIDE AN SR against
the expected benefits for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING
THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT INDAPAMIDE AN SR IS
The name of your medicine is
INDAPAMIDE AN SR. The medicine
releases the active ingredient
indapamide progressively over 24
hours (modified release or sustained
release tablet). Indapamide belongs to
a group of medicines called
chlorosulphamoyl diuretics (a type of
"fluid" or "water" tablet).
WHAT INDAPAMIDE AN SR IS
USED FOR
YOU HAVE BEEN PRESCRIBED INDAPAMIDE
MODIFIED (SUSTAINED) RELEASE TABLETS
FOR HIGH BLOOD PRESSURE.
INDAPAMIDE AN SR is available only
with a doctor's prescription.
There is no evidence that INDAPAMIDE
AN SR is addictive.
_WHY INDAPAMIDE IS USED FOR HIGH _
_BLOOD PRESSURE_
Everyone has blood pressure. This
pressure helps to circulate blood all
around the body. Your blood pressure
may be different at different times of
the day, depending on how busy or
stressed you are.
You have high blood pressure (also
known as hypertension) which is when
your blood pressure stays higher than
is needed, even when you are calm and
relaxed.
If high blood pressure is not treated it
can lead to serious health problems.
You may feel fine and have no
symptoms, but eventually it can cause
stroke, heart disease and kidney
failure.
Indapamide modified (sustained)
release tablets help to lower your
blood pressure.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY INDAPAMIDE AN
SR HAS BEEN PRESCRIBED FOR YOU.
BEFORE

Summary of Product characteristics

INDAPAMIDE AN SR PI v1.0
Page 1 of 12
INDAPAMIDE AN SR
_Indapamide hemihydrate 1.5 mg modified release tablets _
PRODUCT INFORMATION
NAME OF THE MEDICINE
Indapamide hemihydrate 1.5 mg
_ _
_CAS Registry Number_: 26 807-65-8
_Molecular Weight_: 374.85 (Indapamide hemihydrate)
_Melting point: _approximately 185°C
_Chemical structure_: C
16
H
16
ClN
3
O
3
S, ½ H
2
O
, ½ H
2
O
DESCRIPTION
Indapamide
hemihydrate
(4-chloro-N(2-methyl-1-indolinyl)-3-sulphamoyl
benzamide
hemihydrate) is a non-thiazide indole derivative of
chlorosulphonamide. The active ingredient
is a racemic mixture. Indapamide is a white crystalline lipophilic
powder, soluble in methanol,
ethanol, acetic acid and ethyl acetate, very slightly soluble in
ether, chloroform and benzene
and practically insoluble in water.
Indapamide AN SR modified release tablets contain 1.5 mg of indapamide
hemihydrate as the
active
ingredient.
The tablets
also
contain
the
following
inactive
ingredients
(excipients):
lactose monohydrate, povidone, hypromellose, colloidal anhydrous
silica, magnesium stearate
and Opadry II 85F18378 white (polyvinyl alcohol, macrogol, titanium
dioxide and talc).
PHARMACOLOGY
MECHANISM OF ACTION
Indapamide is an oral antihypertensive medicine. The mechanism whereby
indapamide exerts
its antihypertensive
action
has
not
been
completely
elucidated;
both
vascular
and
renal
actions have been implicated. The possible beneficial pharmacological
effects of indapamide
in the treatment of hypertension include a reduction in cardiac
hypertrophy and a reduction in
the thickening of arterial walls, a prevention of the accumulation of
the embryonic isoform of
fibronectin in coronary vessels, free radical scavenging leading to
stimulation of vasodilator
eicosanoid formation, and interaction with renal carbonic anhydrase.
The renal effects of indapamide is minimal and the antihypertensive
effect of indapamide has
been attributed to
a reduction in vascular reactivity to pressor amines. The finding that
INDAPAMIDE AN SR PI v1.0
Page 2 of 12
indapamide retains