INDAPAMIDE SANDOZ indapamide hemihydrate 2.5mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

indapamide hemihydrate

Available from:

Sandoz Pty Ltd

INN (International Name):

indapamide hemihydrate

Authorization status:

Registered

Patient Information leaflet

Indapamide Sandoz
®
1
INDAPAMIDE SANDOZ
®
Indapamide hemihydrate tablets
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Indapamide Sandoz.
It does not contain all the available information. It does not take
the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risk of you taking
this medicine against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
WHAT INDAPAMIDE SANDOZ IS USED FOR
YOU HAVE BEEN PRESCRIBED INDAPAMIDE SANDOZ FOR HIGH BLOOD PRESSURE.
Indapamide
Sandoz
contains
the
active
ingredient
indapamide
hemihydrate
which
belongs to a group of medicines called chlorosulphamoyl diurectics (a
type of “fluid” or
“water”.
Indapamide Sandoz is available only with a doctor’s prescription.
There is no evidence that Indapamide Sandoz is addictive.
_WHY INDAPAMIDE SANDOZ 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 Sandoz helps to lower your blood pressure.
Indapamide Sandoz
®
2
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS
BEEN
PRESCRIBED FOR YOU.
BEFORE YOU TAKE INDAPAMIDE SANDOZ
There are some people who should not take Indapamide Sandoz. Please
read the lists
below. If you think any of these situations apply to you, or you have
any questions,
please consult your doctor or pharmacist.
_WHEN YOU MUST NOT TAKE I

Summary of Product characteristics

_Product Information _
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_Indapamide Sandoz 2.5mg Tablets _
_10/2017 _
_Sandoz Pty Ltd _
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PRODUCT INFORMATION
INDAPAMIDE SANDOZ
® 2.5 MG TABLETS
NAME OF THE MEDICINE
_Generic name:_
Indapamide hemihydrate
_Chemical name_
: 4-chloro-N-(2-methyl-1-indolinyl)-3-sulfamoyl benzamide hemihydrate.
_Melting point:_
approximately 185°C
_ _
_Chemical Structure: _
, ½ H
2
O
C
16
H
16
CLN
3
O
3
S, ½ H
2
O
CAS: 26 807-65-8
MW: 374.85
DESCRIPTION
Indapamide is a non-thiazide indole derivative of chlorosulfonamide.
It 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.
The excipient ingredients in Indapamide Sandoz are lactose
monohydrate, maize starch,
magnesium stearate, povidone, Opaseal P-2-0300G clear (ethyl acetate,
stearic acid, polyvinyl
acetate phthalate, purified water, industrial methylated spirit 74
OP), purified talc, calcium
carbonate, acacia, titanium dioxide, sucrose and Opaglos 6000P
off-white (shellac, industrial
methylated spirit 74 OP, beeswax white, carnuba wax).
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.
At a dose of 2.5mg the renal effects of indapamide are minimal and the
antihypertensive
effect of indapamide has been attributed to a reduction in vascular
reactivity to pressor
N
Me
N
H
O
Cl
SO
2
NH
2
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_Indapamide Sandoz 2.5mg Tablets _
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_Sandoz Pty Ltd _
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_Version 01_
amines. The finding that indapamide retains its antihypertensive
activity in functionally
anephric patients lends support to this hypothesis.
The
renal
site
of
action
of
indapamide
is
the
proximal
segment
of
the
distal
tubule.
Indapamide appears to have natriuretic properties (sodium and chlori