INSIG indapamide hemihydrate 2.5mg sugar coated tablet blister pack

Pajjiż: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

indapamide hemihydrate, Quantity: 2.5 mg

Disponibbli minn:

Arrotex Pharmaceuticals Pty Ltd

INN (Isem Internazzjonali):

indapamide hemihydrate

Għamla farmaċewtika:

Tablet, sugar coated

Kompożizzjoni:

Excipient Ingredients: lactose monohydrate; maize starch; magnesium stearate; povidone; purified talc; calcium carbonate; titanium dioxide; sucrose; Acacia; ethyl acetate; purified water; stearic acid; industrial methylated spirit; polyvinyl acetate phthalate; Shellac; white beeswax; Carnauba Wax

Rotta amministrattiva:

Oral

Unitajiet fil-pakkett:

90 tablets, 60 tablets

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

Management of essential hypertension. It may be tried as the sole therapeutic agent in the treatment of mild to moderate hypertension. Normally indapamide is used as the initial agent in multiple drug regimens.

Sommarju tal-prodott:

Visual Identification: White, biconvex, sugar coated tablets.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

L-istatus ta 'awtorizzazzjoni:

Licence status A

Data ta 'l-awtorizzazzjoni:

2012-04-05

Fuljett ta 'informazzjoni

INSIG (INDAPAMIDE HEMIHYDRATE) TABLETS CMI
1
INSIG
_Indapamide hemihydrate tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about INSIG. 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 INSIG 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 INSIG IS USED FOR
The name of your medicine is
INSIG. INSIG contains the active
ingredient indapamide which belongs
to a group of medicines called
chlorosulfamoyl diuretics (a type of
“fluid” or “water” tablet).
YOU HAVE BEEN PRESCRIBED INSIG
FOR HIGH BLOOD PRESSURE.
INSIG is available only with a
doctor’s prescription.
There is no evidence that INSIG is
addictive.
_WHY INSIG 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.
INSIG helps to lower your blood
pressure.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY INSIG HAS
BEEN PRESCRIBED FOR YOU.
BEFORE YOU TAKE INSIG
There are some people who should
not take INSIG. Please read the list
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 _
_INSIG _
DO NOT TAKE INSIG IF:
•
YOU ARE ALLERGIC TO INDAPAM

Karatteristiċi tal-prodott

1
AUSTRALIAN PRODUCT INFORMATION – INSIG (
INDAPAMIDE
HEMIHYDRATE) TABLETS
1
NAME OF THE MEDICINE
Indapamide hemihydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipients with known effect: Lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Each tablet contains 2.5 mg Indapamide hemihydrate. INSIG are white,
biconvex, sugar coated tablets.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Management of essential hypertension. It may be tried as a sole
therapeutic agent in the
treatment
of mild to moderate hypertension. Normally I N S I G is used as the
initial agent in multiple drug
regimens.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ADULTS:
1 tablet (indapamide 2.5 mg) to be taken daily, by oral route in the
morning.
The
action of I N S I G is progressive and whilst the optimum reduction in
blood pressure is usually
seen after four weeks, a further small but useful reduction in blood
pressure may
be observed over
the following four to six weeks. A larger dose than 1 tablet (2.5 mg)
of
I N S I G daily
is
not
recommended as there is little additional antihypertensive effect,
whilst the diuretic effect becomes
more pronounced.
A single tablet of INSIG may effectively be combined with the
following antihypertensive
agents:
β-blockers,
methyldopa sesquihydrate,
clonidine,
prazosin,
and
angiotensin
converting enzyme
(ACE) inhibitors.
Combination with a diuretic agent is not recommended as significant
electrolyte disturbances may
occur.
Indapamide has a slight but significant carry-over hypotensive effect
lasting up to one to two weeks
after treatment is stopped.
4.3
C
ONTRAINDICATIONS
•
Severe renal failure, anuria, progressive and severe oliguria.
•
Hepatic coma, hepatic encephalopathy or severe impairment of liver
function.
•
Known hypersensitivity to indapamide, other sulfonamide derivatives or
any of the excipients (see
SECTION 6.1 LIST OF EXCIPIENTS).
2
•
Hypokalaemia.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
Electrolyte
changes
obse