APO-Valsartan HCTZ 80/12.5 valsartan 80 mg and hydrochlorothiazide 12.5 mg 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)
01-12-2017
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
hydrochlorothiazide,valsartan
Available from:
Apotex Pty Ltd
INN (International Name):
Hydrochlorothiazide,Valsartan
Authorization status:
Registered
Patient Information leaflet
APO-VALSARTAN HCTZ
TABLETS
_Contains the active ingredients valsartan and hydrochlorothiazide_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about valsartan HCTZ. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
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.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Valsartan HCTZ. It contains the
active ingredients valsartan and
hydrochlorothiazide.
It is used to treat hypertension (high
blood pressure).
High blood pressure increases the
workload of the heart and blood
vessels. If it continues for a long
time, it can damage the blood vessels
in the brain, heart and kidneys. This
can lead to stroke, heart failure or
kidney failure. High blood pressure
increases the risk of heart attacks.
Lowering your blood pressure
reduces the chance of these disorders
happening.
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.
_HOW IT WORKS_
Valsartan HCTZ reduces blood
pressure in two different ways.
1.
Vals
Read the complete document
Summary of Product characteristics
Product Information
APO-VALSARTAN HCTZ TABLETS
Page 1
APO-VALSARTAN HCTZ 80/12.5, 160/12.5, 160/25, 320/12.5, 320/25 TABLETS
NAME OF THE MEDICINE
Valsartan and hydrochlorothiazide.
VALSARTAN
Chemical Name:
(2_S_)-3-Methyl-2-[pentanoyl[[2′-(1_H_-tetrazol-5-yl)biphenyl-4-
yl]methyl]amino]butanoic acid
Structural Formula:
Molecular Formula:
C
24
H
29
N
5
O
3
Molecular Weight:
435.5
CAS Registry Number:
137862-53-4
HYDROCHLOROTHIAZIDE
Chemical Name:
6-Chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulphonamide-1,1-dioxide]
Structural Formula:
Molecular Formula:
C
7
H
8
ClN
3
O
4
S
2
Molecular Weight:
297.7
CAS Registry Number:
58-93-5
DESCRIPTION
Valsartan is a white or almost white, hygroscopic powder. It is
practically insoluble in water, freely
soluble in anhydrous ethanol, sparingly soluble in methylene chloride,
soluble in methanol, neutral and
basic aqueous solution, and very slightly soluble in solutions with pH
< 7.
Hydrochlorothiazide (HCTZ) is structurally related to the thiazide
group of diuretics. It is a white or
almost white crystalline powder. Hydrochlorothazide is very slightly
soluble in water, soluble in acetone,
sparingly soluble in ethanol (96 per cent) and freely soluble in
dimethylsulfoxide. It dissolves in dilute
solutions of alkali hydroxides.
pKa: Valsartan: Carboxylic acid group: 3.9 & Tetrazole group: 4.7;
Hydrochlorothiazide: 7.9, 9.2
Partition Coefficient: Valsartan (n-octanol/aq phosphate buffer):
0.033; LogP for Hydrochlorothiazide: -
0.07
Product Information
APO-VALSARTAN HCTZ TABLETS
Page 2
Each
tablet
contains
the
following
amount
of
valsartan
and
hydrochlorothiazide
respectively:
80/12.5mg, 160/12.5mg, 160/25mg, 320/12.5mg and 320/25mg.
In addition,
each tablet
contains the following inactive ingredients:
powdered
cellulose,
calcium
hydrogen
phosphate,
colloidal
anhydrous
silica,
croscarmellose
sodium,
magnesium
stearate,
hypromellose,
hydroxypropyl
cellulose,
titanium
dioxide,
iron
oxide
red
(80/12.5mg,
160/12.5mg,
160/25mg
&
320/12.5mg),
iron
oxide
black
(160/25mg
&
320/12.5mg
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