Clopidogrel 75mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CLOPIDOGREL

Available from:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC code:

B01AC04

INN (International Name):

CLOPIDOGREL 75 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

CLOPIDOGREL 75 mg

Prescription type:

POM

Therapeutic area:

ANTITHROMBOTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2013-03-21

Patient Information leaflet

PAGE 1 OF 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOPIDOGREL 75 MG FILM-COATED TABLETS CLOPIDOGREL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or your pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you have any side effects, including any side effects not listed in
this leaflet, talk to your
doctor or pharmacist. See section 4..
WHAT IS IN THIS LEAFLET:
1.
What Clopidogrel Tablet is and what it is used for
2.
What you need to know before you take Clopidogrel Tablet
3.
How to take Clopidogrel Tablet
4.
Possible side effects
5.
How to store Clopidogrel Tablet
6.
Contents of the pack and other information
1.
WHAT CLOPIDOGREL TABLET IS AND WHAT IT IS USED FOR
Clopidogrel Tablet contains clopidogrel and belongs to a group of
medicines called antiplatelet
medicinal products. Platelets are very small structures in the blood,
which clump together during blood
clotting. By preventing this clumping, antiplatelet medicinal products
reduce the chances of blood
clots forming (a process called thrombosis).
Clopidogrel Tablet is taken by adults to prevent blood clots (thrombi)
forming in hardened blood
vessels (arteries), a process known as atherothrombosis, which can
lead to atherothrombotic events
(such as stroke, heart attack, or death).
You have been prescribed Clopidogrel Tablet to help prevent blood
clots and reduce the risk of these
severe events because:
-
You have a condition of hardening of arteries (also known as
atherosclerosis), and
-
You have previously experienced a heart attack, stroke or have a
condition known as peripheral
arterial disease, or
-
You have experienced a severe type of chest pain known as ‘unstable
angina’ or ‘myocardial
infarction’ (heart attack). For the treatment of this condition

Summary of Product characteristics

PAGE 1 OF 18
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Clopidogrel 75 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen
sulphate)
Excipients with known effect:
Each film-coated tablet contains 67.6 mg lactose and 7.5 mg
hydrogenated castor oil
For the full list of expedients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Pink coloured, round, biconvex, film-coated tablet, plain on both
sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Secondary preventionof atherothrombotic events_
Clopidogrel is indicated in
•
Adult patients suffering from myocardial infarction (from a few days
until less than 35 days),
ischaemic stroke (from 7 days until less than 6 months) or established
peripheral arterial disease.
•
Adult patients suffering from acute coronary syndrome:
-
Non-ST segment elevation acute coronary syndrome (unstable angina or
non-Q-wave
myocardial infarction), including patients undergoing a stent
placement following
percutaneous coronary intervention, in combination with
acetylsalicylic acid (ASA).
-
ST segment elevation acute myocardial infarction, in combination with
ASA in medically
treated patients eligible for thrombolytic therapy.
_Prevention of atherothrombotic and thromboembolic events in atrial
fibrillation _
In adult patients with atrial fibrillation who have at least one risk
factor for vascular events, are not
suitable for treatment with Vitamin K antagonists (VKA) and who have a
low bleeding risk,
clopidogrel is indicated in combination with ASA for the prevention of
atherothrombotic and
thromboembolic events, including stroke.
For further information please refer to section 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
•
Adults and elderly
PAGE 2 OF 18
Clopidogrel should be given as a single daily dose of 75 mg.
In patients suffering from acute coronary syndrome:
-
Non-ST
segment
elevation
acute
coronary
syndrome
(unstable
angina
or
non-Q-wave
myocardial