IRBESARTAN MLABS irbesartan 75 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

irbesartan, Quantity: 75 mg

Available from:

Micro Labs Pty Ltd

INN (International Name):

Irbesartan

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; sodium starch glycollate type B; magnesium stearate; colloidal anhydrous silica; macrogol 6000; polysorbate 80; hypromellose

Administration route:

Oral

Units in package:

PVC/ ACLAR-Aluminium blister pack of 30 Blister (3x10T in carton)

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 (equal to or greater than 30mg per 24 hours) or urinary protein in excess of 900mg per 24 hours.

Product summary:

Visual Identification: White to off white oval, biconvex, film coated tablets, engraved with 75 on one face and and plain on the other face.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-01-10

Patient Information leaflet

IRBESARTAN MLABS
1
IRBESARTAN MLABS
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine,
speak to your doctor or pharmacist.
1.
WHY AM I TAKING IRBESARTAN MLABS?
IRBESARTAN MLABS contains the active ingredient
irbesartan. IRBESARTAN MLABS is
used to treat high blood pressure and is also used in the treatment of
kidney disease in
patients with high blood pressure and type 2 diabetes.
For more information, see Section 1. Why am I taking IRBESARTAN MLABS?
in the full
CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE IRBESARTAN MLABS?
Do not use if you have ever had an allergic reaction to IRBESARTAN
MLABS or any of the
ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES,
OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING
.
For more information, see Section 2. What should I know before I take
IRBESARTAN
MLABS? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with IRBESARTAN MLABS and affect how it
works. A list
of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I TAKE IRBESARTAN MLABS?
•
Your doctor will tell you how many tablets to take each day. The
standard dose is one 150
mg tablet per day. This dose may be increased to a 300 mg once per
day.
•
Swallow the tablet whole with a glass of water and take IRBESARTAN
MLABS at about
the same time each day.
More instructions can be found in Section 4. How do I take IRBESARTAN
MLABS? in the
full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING IRBESARTAN MLABS?
THINGS YOU SHOULD
DO
•
Remind
any
doctor
or
dentist
you
visit
that
you
are
taking
IRBESARTAN MLABS.
•
If
you
become
pregnant
or
plan
to
breastfeed
while
taking
IRBESARTAN MLABS tell your doctor immediately
•
If you are to be started on any new medicine, tell your doctor and
pharmacist you are taking IRBESARTAN MLABS
•
If you plan to have surgery that needs a general

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
IRBESARTAN MLABS
1. NAME OF THE MEDICINE
Irbesartan
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Irbesartan MLabs 75 mg tablets which contain 75 mg of irbesartan
Irbesartan MLabs 150 mg tablets which contain 150 mg of irbesartan
Irbesartan MLabs 300 mg tablets which contain 300 mg of irbesartan
EXCIPIENTS WITH KNOWN EFFECT:
Contains lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients
3. PHARMACEUTICAL FORM
Irbesartan 75 mg film-coated Tablets are White to off-white, oval,
biconvex, film-coated tablets,
engraved with ‘75’ on one face and plain on the other face.
Irbesartan 150 mg film-coated Tablets are White to off-white, oval,
biconvex, film-coated tablets,
engraved with ‘150’ on one face and plain on the other face.
Irbesartan 300 mg film-coated Tablets are White to off-white, oval,
biconvex, film-coated tablets,
engraved with ‘300’ on one face and plain on the other face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Irbesartan MLabs is indicated for the treatment of hypertension.
Irbesartan MLabs is indicated for delaying the progression of renal
disease in hypertensive type
II diabetics with persistent micro-albuminuria (≥ 30mg per 24 hours)
or urinary protein in excess
of 900mg per 24 hours.
4.2 DOSE AND METHOD OF ADMINISTRATION
Irbesartan 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 Irbesartan MLabs is 150 mg
once daily.
I r b e s a r t a n
MLabs may
b e
a d m i n i s t e r e d
w i t h
o r
w i t h o u t
f o o d .
T h e r a p y
s h o u l d
b e
a d j u s t e d
according
to
blood
pressure
response.
Patients
requiring
further
reduction
in
blood
pressure
should have the dose increased to 300 mg once daily.
In patients with hypertension and type II diabetic renal disease,
300mg of Irbesartan MLabs once
daily
is
the
preferred
maintenance
dose.
Although
i