Clopidogrel 75mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clopidogrel hydrogen sulphate

Available from:

Accord Healthcare Limited

ATC code:

B01AC; B01AC04

INN (International Name):

Clopidogrel hydrogen sulphate

Dosage:

75 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Platelet aggregation inhibitors excl. heparin; clopidogrel

Authorization status:

Not marketed

Authorization date:

2013-05-17

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, pharmacist or
nurse.
-
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 get any side effects, talk to your
doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. 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,
smaller than red or white blood
cells, 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
infarc

Summary of Product characteristics

Health Products Regulatory Authority
26 October 2018
CRN008HFP
Page 1 of 24
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clopidogrel 75mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 75m g 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
_Prevention of atherothrom botic 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 n
on- 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_
Health Products Regulatory Authority
26 October 2018
CRN008HFP
Page 2 of 24
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 _
Clopidogrel should be given as a single daily dose of 75 mg.
In patients suffering from