Chemmart Clopidogrel/Aspirin 75/100, Clopidogrel (as hydrogen sulfate)/Aspirin 75mg/100mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

aspirin,clopidogrel hydrogen sulfate

Available from:

Apotex Pty Ltd

INN (International Name):

Aspirin,clopidogrel hydrogen sulfate

Class:

Medicine Registered

Authorization status:

Registered

Patient Information leaflet

CHEMMART CLOPIDOGREL/
ASPIRIN 75/75
CHEMMART CLOPIDOGREL/
ASPIRIN 75/100 TABLETS
_Contains the active ingredients clopidogrel (as clopidogrel hydrogen
sulfate) and aspirin_
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 Clopidogrel/Aspirin.
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
Chemmart Clopidogrel/Aspirin 75/75
or Chemmart Clopidogrel/Aspirin
75/100. It contains the active
ingredients clopidogrel (as
clopidogrel hydrogen sulfate) and
aspirin.
•
It is used to prevent blood clots
forming in hardened blood
vessels (a process known as
atherothrombosis) which can lead
to events such as stroke, heart
attack or death.
You may have been prescribed
Clopidogrel/Aspirin to help prevent
blood clots forming and to reduce the
risk of heart attack, stroke or death,
because you have suffered a severe
type of chest pain called unstable
angina, or had a heart attack.
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 anoth

Summary of Product characteristics

Product Information – Australia
Chemmart Clopidogrel/Aspirin 75/75 Tablets
Chemmart Clopidogrel/Aspirin 75/100 Tablets
Page 1
CHEMMART CLOPIDOGREL/ASPIRIN 75/75 TABLETS
CHEMMART CLOPIDOGREL/ASPIRIN 75/100 TABLETS
NAME OF THE MEDICINE
Clopidogrel (as clopidogrel hydrogen sulfate) and Aspirin
(acetylsalicylic acid).
CLOPIDOGREL HYDROGEN SULFATE
Chemical Name:
Methyl (2_S_)-
(2-chlorophenyl)-[6,7-dihydrothieno[3,2-_c_]pyridin-5(4_H-_yl)-acetate
sulfate
(1:1)
Structural Formula:
Molecular Formula:
C
16
H
16
ClNO
2
S.H
2
SO
4
Molecular Weight:
419.9
CAS Registry Number:
120202-66-6 (Clopidogrel hydrogen sulfate), 113 665-84-2 (Clopidogrel
base)
ASPIRIN (ACETYLSALICYLIC ACID)
Chemical Name:
2-acetoxybenzoic acid.
Structural Formula:
Molecular Formula:
C
9
H
8
O
4
Molecular Weight:
180.2
CAS Registry Number:
50-78-2
DESCRIPTION
CLOPIDOGREL
Clopidogrel hydrogen sulfate is a white to off-white powder. It is
practically insoluble in water at neutral pH but
freely soluble at pH 1. It is freely soluble in methanol, sparingly
soluble in methylene chloride and is practically
insoluble in ethyl ether. It has a specific optical rotation of about
+ 56
°
.
,H
2
SO
4
Product Information – Australia
Chemmart Clopidogrel/Aspirin 75/75 Tablets
Chemmart Clopidogrel/Aspirin 75/100 Tablets
Page 2
ASPIRIN
Aspirin is a white crystalline powder or colourless crystals,
odourless or almost odourless, slightly soluble in water,
freely soluble in alcohol, soluble in chloroform and in ether. It
melts at about 135°C.
Each tablet of Chemmart Clopidogrel/Aspirin 75/75 contains 75 mg
clopidogrel (as clopidogrel hydrogen sulfate)
and 75 mg aspirin. Each tablet of Chemmart Clopidogrel/Aspirin 75/100
contains 75 mg clopidogrel (as clopidogrel
hydrogen sulfate) and 100 mg aspirin.
In
addition,
each
tablet
contains
the
following
inactive
ingredients:
lactose
anhydrous,
methylcellulose,
crospovidone, colloidal anhydrous silica, zinc stearate,
microcrystalline cellulose, maize starch, iron oxide yellow,
hypromellose, hydroxypropylcellulose, macrogol