Clopidogrel 75mg Film-coated Tablets

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

CLOPIDOGREL

Dostupné z:

Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom

ATC kód:

B01AC04

INN (Medzinárodný Name):

CLOPIDOGREL 75 mg

Forma lieku:

FILM-COATED TABLET

Zloženie:

CLOPIDOGREL 75 mg

Typ predpisu:

POM

Terapeutické oblasti:

ANTITHROMBOTIC AGENTS

Stav Autorizácia:

Withdrawn

Dátum Autorizácia:

2010-10-08

Príbalový leták

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:
-  You have a condition of hardening of the 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 sever

Súhrn charakteristických

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 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