APO-DIPYRIDAMOLE/ASPIRIN 200/25 Dipyridamole/Aspirin 200 mg/25 mg modified release capsules bottle
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)
26-11-2017
Active ingredient:
aspirin,dipyridamole
Available from:
Apotex Pty Ltd
INN (International Name):
Aspirin,Dipyridamole
Authorization status:
Registered
Patient Information leaflet
APO-DIPYRIDAMOLE/
ASPIRIN
_MODIFIED RELEASE CAPSULES_
_Contains the active ingredients Dipyridamole 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 this medicine. 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-
Dipyridamole/Aspirin Modified
Release Capsules.
It contains the active ingredients
dipyridamole and aspirin.
This medicine helps prevent
recurrence of stroke in people who
have had a previous stroke or
transient ischaemic attack (TIA).
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_
This medicine works by preventing
blood clots from forming. The ability
of this medicine to prevent blood
clots is due to its effect on blood cells
known as platelets.
There is no evidence that this
medicine is addictive.
_USE IN CHILDREN_
This medicine should not be used in
children.
There is limited information about
th
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Summary of Product characteristics
Product Information – Australia
APO-Dipyridamole/Aspirin Sustained Release Capsules
Page 1
APO-DIPYRIDAMOLE/ASPIRIN CAPSULES
NAME OF THE MEDICINE
DIPYRIDAMOLE
Chemical Name:
2,6-bis(diethanolamino)-4,8-dipiperidino-pyrimido[5,4-d]pyrimidine
Structural Formula:
Molecular Formula:
C
24
H
40
N
8
O
4
Molecular Weight:
504.6
CAS Registry Number:
58-32-2
ASPIRIN
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
Each dipyridamole/aspirin 200/25 sustained release capsule contains
dipyridamole 200 mg and
aspirin 25 mg.
The inactive ingredients in dipyridamole/aspirin 200/25 sustained
release capsules are: tartaric acid,
povidone,
methacrylic
acid
copolymer
(Eudragit
S
100),
purified
talc,
acacia,
hypromellose,
Product Information – Australia
APO-Dipyridamole/Aspirin Sustained Release Capsules
Page 2
hypromellose
phthalate,
glyceryl
triacetate,
simethicone,
cetostearyl
alcohol
ethoxylate,
sodium
benzoate,
microcrystalline
cellulose,
pregelatinised
maize
starch,
stearic
acid,
sucrose,
gelatin,
titanium dioxide, iron oxide red and iron oxide yellow.
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS
Dipyridamole has an antithrombotic action based on its ability to
modify various aspects of platelet
function. It causes inhibition of platelet adhesion and aggregation,
particularly in diseased states
where platelet stickiness is above normal, and lengthens abnormally
shortened platelet survival time.
These actions are useful in limiting the initiation of thrombus
formation. The mechanism of antiplatelet
action is believed to be related to inhibition of the uptake of
adenosine by red blood cells and platelets;
weak inhibition of cAMP phosphodiesterase which potentiates the
aggregation- inhibiting effects of
adenosine
on
platelets;
and
inhibition
of
cGMP
phosphodiesterase
which
potentiates
the
anti-
aggregating effects of EDRF (endothelium derived relaxing factor,
identified as nitric oxide (NO)).
Dipyridamole is also a coronary vasodilat
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