ABISART 75 irbesartan 75 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

irbesartan, Quantity: 75 mg

Available from:

Sun Pharma ANZ Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: hypromellose; lactose monohydrate; croscarmellose sodium; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; macrogol 4000

Administration route:

Oral

Units in package:

30, 90

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

- Indicated for the treatment of hypertension.,- Indicated for delaying the progression of renal disease in hypertensive type II diabetics with persistent micro-albuminuria (greater than or equal to 30 mg per 24 hours) or urinary protein in excess of 900 mg per 24 hours.

Product summary:

Visual Identification: White to off-white, film-coated, oval-shaped, biconvex tablet debossed with 'I3' on one side and plain on the other.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-10-30

Patient Information leaflet

ABISART 75, ABISART 150, ABISART 300
1
ABISART 75, ABISART
150, ABISART 300
_contains the active ingredient (irbesartan) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ABISART 75,
ABISART 150 and ABISART 300
(herein referred to as ABISART).
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking ABISART against
the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT ABISART IS
USED FOR
ABISART is a trade name
(manufacturer's name) for the
medicine, irbesartan.
ABISART is used to lower high
blood pressure (i.e. hypertension).
Your doctor measured your blood
pressure and found it to be too high.
Everyone has blood pressure. This
pressure helps get your blood all
around your body. Your blood
pressure may be different at different
times of the day, depending on how
busy or worried you are. You have
hypertension (high blood pressure)
which means your blood pressure
stays high, even when you are calm
and relaxed.
There are usually no symptoms of
high blood pressure. The only way of
knowing that you have hypertension
is to have your blood pressure
checked on a regular basis. High
blood pressure, if not treated, can
damage blood vessels in several
organs such as the heart, the kidneys,
the brain and the eyes. This may lead
to heart attacks, heart or kidney
failure, strokes, or blindness. There
are usually no symptoms of high
blood pressure before damage
occurs, so your doctor needs to
measure your blood pressure to see if
it is too high.
High blood pressure can be treated
and controlled with medicines such
as ABISART. Your doctor may also
have recommended that you adjust
your lifestyle to help to lower your
high blood pressure (losing weight,
avoiding smoking, reducing alcohol
consu

Summary of Product characteristics

PRODUCT INFORMATION
ABISART 75, ABISART 150, ABISART 300
_Irbesartan _
1. NAME OF THE MEDICINE
Irbesartan
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in ABISART 75, ABISART 150 AND ABISART 300
(herein referred to as ABISART)
tablets is irbesartan. Irbesartan is a white or almost white
crystalline powder, practically insoluble in water,
sparingly soluble in methanol, slightly soluble in methylene chloride
ABISART 75 contains 75 mg of irbesartan, ABISART 150 contains 150 mg
of irbesartan and ABISART 300
contains 300 mg of irbesartan.
Excipient with known effect:
Each tablet of ABISART 75 mg, 150 mg, and 300 mg contains 24.70 mg,
49.40 mg and 98.80 mg of lactose
monohydrate respectively. Patients with rare hereditary problems of
galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption should not take this
medicine.
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
ABISART film coated tablets are white to off-white, film-coated,
oval-shaped, biconvex and debossed with
‘I3’ (75 mg), ‘I4’ (150 mg) or ‘I5’ (300 mg) on one side
and plain on the other. ABISART tablets are
formulated for oral administration.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ABISART is indicated for the treatment of hypertension.
ABISART is indicated for delaying the progression of renal disease in
hypertensive type II diabetics with
persistent micro-albuminuria (≥ 30 mg per 24 hours) or urinary
protein in excess of 900 mg per 24 hours.
4.2 DOSE AND METHOD OF ADMINISTRATION
ABISART may be used either alone or in combination with other
antihypertensive agents (e.g., thiazide
diuretic, beta-adrenergic blocking agent, long-acting calcium-channel
blocking agent).
The usual initial and maintenance dose of ABISART is 150 mg once
daily. ABISART may be administered
with or without food. Therapy should be adjusted according to blood
pressure response. Patients requiring
further reduction in blood pressure should have the dose increased to
300