APO-INDAPAMIDE 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, Quantity: 1.5 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

indapamide hemihydrate

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: lactose monohydrate; magnesium stearate; povidone; colloidal anhydrous silica; hypromellose; macrogol 3350; titanium dioxide; purified talc; polyvinyl alcohol

Administration route:

Oral

Units in package:

10 tablets, 90 tablets, 30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of hypertension. It may be tried as a sole therapeutic agent in the treatment of hypertension. Normally, indapamide is used as the initial agent in multiple drug regimes.

Product summary:

Visual Identification: White to off-white, round, biconvex, film coated tablets.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2014-05-07

Patient Information leaflet

APO-INDAPAMIDE SR TABLETS
1
APO-INDAPAMIDE SR
TABLETS
_Indapamide hemihydrate _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about indapamide slow-
release (SR) tablets. 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 risks of you using 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.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Indapamide SR is used to treat mild
to moderate high blood pressure (also
known as hypertension). These
tablets release the active ingredient,
indapamide, progressively over 24
hours.
Indapamide belongs to a group of
medicines called diuretics (a type of
‘fluid’ or ‘water’ tablet).
Indapamide is thought to lower blood
pressure by relaxing some of the
blood vessels in the body. The blood
vessels can then carry the same
volume of blood more easily.
Everyone has blood pressure. This
pressure helps to move your 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 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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT THIS MEDICINE HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
There is not enough information to
recommend the use of this medicine
in children.
BEFORE YOU T

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – APO-
INDAPAMIDE SR MODIFIED RELEASE TABLETS
(INDAPAMIDE HEMIHYDRATE)
1
NAME OF THE MEDICINE
Indapamide hemihydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified release tablet contains 1.5 mg of indapamide hemihydrate
as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT:
Sugars as lactose.
For the full list of excipients see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
The tablets are white to off-white, round, biconvex, film coated.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hypertension. It may be tried as a sole therapeutic agent
in the treatment of
hypertension. Normally, indapamide is used as the initial agent in
multiple drug regimes.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
One modified release coated tablet (1.5 mg indapamide hemihydrate)
daily to be taken, by
oral route, in the morning. The tablet should be swallowed whole and
must not be chewed or
crushed. The action of indapamide modified release tablets 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 one tablet of indapamide modified release daily is
not recommended as
there is little additional antihypertensive effect, whilst the
diuretic effect becomes more
pronounced.
A single daily tablet of indapamide modified release may effectively
be combined with the
following antihypertensive medicines: beta-blockers, methyldopa
sesquihydrate, clonidine,
prazosin and ACE inhibitors.
Combination with a diuretic is not recommended as significant
electrolyte disturbances may
occur. Indapamide has a slight but significant carry-over hypotensive
effect lasting up to 1 or
2 weeks after treatment is stopped.
4.3
CONTRAINDICATIONS
•
Severe renal failure, anuria, progressive and severe oliguria.
•
Hepatic coma, hepatic encephalopathy or severe impairment of liver
function.
•
Known hypersensitivity to