IRBESARTAN HCTZ AMNEAL 300/12.5 irbesartan hydrochlorothiazide 300/12.5 mg tablets blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
01-12-2017
Summary of Product characteristics
(SPC)
01-12-2017
Public Assessment Report
(PAR)
28-11-2017
Active ingredient:
hydrochlorothiazide,irbesartan
Available from:
Amneal Pharma Australia Pty Ltd
INN (International Name):
Hydrochlorothiazide,Irbesartan
Authorization status:
Registered
Patient Information leaflet
IRBESARTAN HCTZ AMNEAL CMI V4.0
1
Irbesartan HCTZ AMNEAL
_contains the active ingredients irbesartan and hydrochlorothiazide _
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common
questions about IRBESARTAN HCTZ
AMNEAL.
It does not contain all of 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 IRBESARTAN
HCTZ AMNEAL against the benefits
they expect it will have 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 is IRBESARTAN HCTZ
AMNEAL
IRBESARTAN HCTZ AMNEAL tablets
contain two medicines, irbesartan
and hydrochlorothiazide.
Both these medicines are in the
tablets your doctor has prescribed
for you.
_WHAT IRBESARTAN HCTZ AMNEAL _
_IS USED FOR _
IRBESARTAN HCTZ AMNEAL lowers
high blood pressure, which doctors
call 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 IRBESARTAN HCTZ AMNEAL. You
Read the complete document
Summary of Product characteristics
_Irbesartan HCTZ AMNEAL tablets Product Information _
_Amneal Pharma Australia Pty Ltd _
Irbesartan HCTZ AMNEAL PI v3.0
Page 1 of 16
Irbesartan HCTZ AMNEAL
150/12.5, 300/12.5, 300/25
(Irbesartan/Hydrochlorothiazide)
Tablets
PRODUCT INFORMATION
NAMES OF THE MEDICINES
IRBESARTAN
The chemical name for irbesartan is
2-butyl-3-[(2’-(1_H_-tetrazol-5-yl)biphenyl-4-yl)methyl]-1,3-
diazaspiro[4,4]non-1-en-4-one. Its structural formula is:
C
25
H
28
N
6
O
Molecular weight: 428.5
CAS No.: 138402-11-6
HYDROCHLOROTHIAZIDE
The chemical name is
6-chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulfonamide
1,1-dioxide.
Its structural formula is:
C
7
H
8
ClN
3
O
4
S
2
Molecular weight: 297.7
CAS No.: 58-93-5
DESCRIPTION
Irbesartan is a white or almost white crystalline powder. It is
practically insoluble in water,
sparingly soluble in methanol and slightly soluble in methylene
chloride.
Hydrochlorothiazide is a white or almost white crystalline powder. It
is very slightly soluble in
water, soluble in acetone, sparingly soluble in ethanol (96 per cent).
It dissolves in dilute
solutions of alkali hydroxides.
Irbesartan HCTZ AMNEAL tablets come in three strengths and contain 150
mg of irbesartan and
12.5 mg of hydrochlorothiazide, 300 mg of irbesartan and 12.5 mg of
hydrochlorothiazide or
_Irbesartan HCTZ AMNEAL tablets Product Information _
_Amneal Pharma Australia Pty Ltd _
Irbesartan HCTZ AMNEAL PI v3.0
Page 2 of 16
300 mg of irbesartan and 25 mg of hydrochlorothiazide. The tablets
also contain mannitol,
povidone,
microcrystalline
cellulose,
croscarmellose
sodium,
silica
colloidal
anhydrous,
magnesium stearate, Opadry II complete film coating system 85F34353
Pink (ARTG 107713;
150 mg/12.5 mg strength) Opadry II complete film coating system
85F34229 Pink (ARTG 107715;
300 mg/12.5 mg strength) and Opadry II complete film coating system
85F34230 Dark Pink
(ARTG 107714; 300 mg/25 mg strength). The tablets are gluten free.
PHARMACOLOGY
Irbesartan HCTZ AMNEAL (irbesartan/hydrochlorothiazide) is an oral
antihypertensive agent
combini
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