CLOPIDOGREL 75 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CLOPIDOGREL HYDROCHLORIDE

Available from:

Wockhardt UK Limited

INN (International Name):

CLOPIDOGREL HYDROCHLORIDE

Dosage:

75 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

CHANGE CONTROL :  
Version changes due to change in:

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 Non-Regulatory
Changes in detail:  • Regulatory text amends
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOPIDOGREL 75MG FILM-COATED TABLETS
Clopidogrel (as hydrochloride) 
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE THIS 
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.  
-  Keep this leaflet. You may need to read it again while you are 
receiving your treatment. 
-  If you have any further questions, ask your doctor or 
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 Tablets are and what they are used for
2. What you need to know before you take Clopidogrel Tablets
3. How to take Clopidogrel Tablets
4. Possible side effects 
5. How to store Clopidogrel Tablets 
6. Contents of the pack and other information 
1.  WHAT CLOPIDOGREL TABLETS ARE AND WHAT THEY ARE USED FOR
Clopidogrel Tablets contain clopidogrel and belong 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 Tablets are 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 Tablets to help prevent 
blood clots and reduce the risk of these severe events because:

Summary of Product characteristics

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 75 mg of clopidogrel (as clopidogrel hydrochloride).
Excipients with known effect:
Each tablet contains 5.25 mg hydrogenated castor oil.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pink, round, biconvex tablets with a bevelled edge, plain on both sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:
• 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.
• 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.
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 acute coronary syndrome:
− Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction),
clopidogrel treatment should be initiated with a single 300 mg loading dose and then continued at 75 mg once a day
(with acetylsalicylic acid (ASA) 75 mg-325 mg daily). Since higher doses of ASA were associated with