CHEMMART IRBESARTAN irbesartan 150mg film-coated tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
irbesartan
Available from:
Apotex Pty Ltd
INN (International Name):
Irbesartan
Authorization status:
Registered
Patient Information leaflet
CHEMMART IRBESARTAN
_Irbesartan_
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 irbesartan. 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
Irbesartan is used to treat high blood
pressure and kidney disease in type 2
diabetic patients with high blood
pressure. It belongs to a group of
medicines known as angiotensin-II
receptor antagonists.
_HOW IT WORKS_
Irbesartan relaxes your blood vessels,
helping to lower your blood pressure.
It also slows the decrease of kidney
function in type 2 diabetic patients
with high blood pressure.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY 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 TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
irbesartan
•
any other angiotensin-II receptor
antagonists or 'sartans'
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue,
throat or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE THIS MEDICINE IF YOU
HAVE OR HAVE HAD THE FOLLOWING
MEDICAL CONDITIONS:
•
diabetes or moderate to severe
kidney impairment, and you are
taking aliskiren
•
di
Read the complete document
Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION
CHEMMART IRBESARTAN (IRBESARTAN) TABLETS
1
NAME OF THE MEDICINE
Irbesartan
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 mg, 150 mg or 300 mg irbesartan, as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
75 MG TABLETS:
White to off-white, oval shaped, biconvex, film-coated tablet debossed
with “L172” on one side
and “75” on the other side.
150 MG TABLETS:
White to off-white, oval shaped, biconvex, film-coated tablet debossed
with “L173” on one side
and “150” on the other side.
300 MG TABLETS:
White to off-white, oval shaped, biconvex, film-coated tablet debossed
with “L174” on one side
and “300” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Irbesartan is indicated for:
•
Treatment of hypertension.
•
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.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
Chemmart Irbesartan tablets are intended for oral administration.
DOSAGE
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 is 150 mg once
daily. Irbesartan 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 mg once daily.
In patients with hypertension and type II diabetic renal disease, 300
mg of irbesartan once
daily is the preferred maintenance dose. Although irbesartan slowed
the progression of renal
disease in hypertensive patients separately to its effect on blood
pressure, this does not
remove the clinical requirement for a patient’s
Read the complete document
