ClopiVale 75mg Film-Coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CLOPIDOGREL

Available from:

Vale Pharmaceuticals Limited 3 Anglesea Street, Clonmel, Co. Tipperary, E91 D6C5, 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Withdrawn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:

2011-02-24

Patient Information leaflet

PAGE 1 OF 7 

PACKAGE LEAFLET 
CLOPIDOGREL 75 MG FILM-COATED TABLETS 

PACKAGE LEAFLET: INFORMATION FOR THE USER  
ClopiVale 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 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, tlk to your 
doctor or pharmacist. See section 4.  

In this leaflet:  
1. 
What ClopiVale is and what it is used for 
2. 
What you need to know before you take ClopiVale 
3. 
How to take ClopiVale 
4. 
Possible side effects 
5. 
How to store ClopiVale 
6. 
  Contents of the pack and other information. 

1. 
WHAT ClopiVale IS AND WHAT IT IS USED FOR 

ClopiVale  contains  clopidogrel  and  belongs  to  a  group  of  medicines  called  antiplatelet  medicines. 
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 medicines reduce the chances 
of blood clots forming (a process called thrombosis). 

ClopiVale  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  ClopiVale  to  help  prevent blood  clots  and  

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS 
CLOPIDOGREL 75 MG FILM-COATED TABLETS 

1.       
NAME OF THE MEDICINAL PRODUCT

ClopiVale

75 mg Film-coated Tablets

2.    
QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains 75 mg of clopidogrel (as
hydrobromide MONOHYDRATE). 

Excipients with known effect:  
Each tablet contains 2 mg lactose and 4.8 mg hydrogenated castor
oil 

The  full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM

Film-coated tablet. 

White, round, bioconvex film coated tablet, debossed with ‘CB’
over ‘75’ on one side and ‘G’ on 
the other side. 

4. 
CLINICAL PARTICULARS

4.1 
THERAPEUTIC INDICATIONS

_Prevention of atherothrombotic events _

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. 

PAGE 2 OF 17 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION

POSOLOGY 

Adults and older people 
Clopidogrel should be given as a single dose of 75 mg. 

In patients suffering from acute coronary syndrome: 
-  Non-ST  segment  elevation  acute  coronary  syndrome  (unstable  angina  or  non-Q-
wave myocardia