CLOPIDOGREL AMNEAL clopidogrel (as besilate) 75 mg film-coated tablet blister pack

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

clopidogrel besilate

Հասանելի է:

Amneal Pharma Australia Pty Ltd

INN (Միջազգային անվանումը):

clopidogrel besilate

Լիազորման կարգավիճակը:

Registered

Տեղեկատվական թերթիկ

Clopidogrel AMNEAL CMI v7.0
1
CLOPIDOGREL AMNEAL TABLETS
_clopidogrel (as besilate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CLOPIDOGREL
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 CLOPIDOGREL
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 CLOPIDOGREL
AMNEAL IS USED FOR
CLOPIDOGREL AMNEAL belongs
to a group of medicines called anti-
platelet medicines.
Platelets are very small blood cells
which clump together during blood
clotting. By preventing this clumping,
anti-platelet medicines reduce the
chances of blood clots forming (a
process called thrombosis).
CLOPIDOGREL AMNEAL 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 AMNEAL to help
prevent blood clots forming and to
reduce the risk of stroke, heart attack
and death because:
•
YOU HAVE PREVIOUSLY SUFFERED A
HEART ATTACK, STROKE OR HAVE A
CONDITION KNOWN AS PERIPHERAL
ARTERIAL DISEASE (LEG PAIN ON
WALKING OR AT REST).
•
YOU HAVE SUFFERED ACUTE
CORONARY SYNDROME (EITHER A
SEVERE TYPE OF CHEST PAIN CALLED
UNSTABLE ANGINA, OR A HEART
ATTACK). IN THIS CASE YOU MAY
ALSO BE PRESCRIBED ASPIRIN.
Your doctor may have prescribed this
medicine for another use. If you want
more information, ask your doctor.
CLOPIDOGREL AMNEAL is only
available on a doctor's prescription.
BEFORE YOU TAKE
CLOPIDOGREL AMNEAL
_WHEN YOU MUST NOT TAKE IT _
YOU SHOULD NOT TAKE
CLOPIDOGREL AMNEAL IF:
•
YOU ARE ALLERGIC TO CLOPIDOGREL
OR ANY OF THE INGREDIENTS LISTED
UNDER 'PRODUCT DESCRIPTION' AT
THE END OF THIS LEAFLET.
•
YOU

Ապրանքի հատկությունները

CLOPIDOGREL AMNEAL TABLETS
PRODUCT INFORMATION
Clopidogrel AMNEAL PI v0.1
1
NAME OF THE MEDICINE
The drug substance is clopidogrel besilate.
Clopidogrel besilate has the following chemical structure:
CAS Number:
744256-69-7
Molecular Formula:
C
16
H
16
CINO
2
S.C
6
H
6
O
3
S
Molecular Mass:
479.99
Chemical Names:
(+)-(S)-α-(2-chlorophenyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine-5-
yl-acetic acid methyl ester benzene sulfonate
DESCRIPTION
Clopidogrel besilate is a white to almost white powder. It is
practically insoluble in water. It
is very soluble in methanol, acetonitrile and dichloromethane.
CLOPIDOGREL AMNEAL is available as clopidogrel 75 mg film-coated
tablets. Each tablet
contains lactose anhydrous, microcrystalline cellulose, crospovidone,
glyceryl behenate and
talc. The coating contains purified talc, polyvinyl alcohol, titanium
dioxide, macrogol 3350,
lecithin and iron oxide red.
PHARMACOLOGY
PHARMACODYNAMICS
Clopidogrel is a specific and potent inhibitor of platelet
aggregation. Platelets have an
established role in the pathophysiology of atherosclerotic disease and
thrombotic events.
Long term use of anti-platelet drugs has shown consistent benefit in
the prevention of
ischaemic stroke, myocardial infarction and vascular death in patients
at increased risk of
such outcomes, including those with established atherosclerosis or a
history of
atherothrombosis.
Clopidogrel selectively inhibits the binding of adenosine diphosphate
(ADP) to its platelet
receptor, and the subsequent ADP-mediated activation of the GPIIb/IIIa
complex, thereby
inhibiting platelet aggregation. Biotransformation of clopidogrel is
necessary to produce
inhibition of platelet aggregation. The active metabolite, a thiol
derivative, is formed by
oxidation of clopidogrel to 2-oxoclopidogrel and subsequent
hydrolysis. The active thiol
metabolite, which has been isolated
_in vitro_
, binds rapidly and irreversibly to platelet ADP
CLOPIDOGREL AMNEAL PRODUCT INFORMATION
Clopidogrel AMNEAL PI v2
2
receptors, P2Y12, thus inhibiting platelet