Clova 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Withdrawn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  
Clova 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 Clova is and what it is used for 
2. 
What you need to know before you take Clova 
3. 
How to take Clova 
4. 
Possible side effects 
5. 
How to store Clova 
6. 
  Contents of the pack and other information. 

1. 
WHAT Clova IS AND WHAT IT IS USED FOR 

Clova 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). 

Clova 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 Clova 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 athe

Summary of Product characteristics

PAGE 1 OF 18 

SUMMARY OF PRODUCT CHARACTERISTICS 
CLOPIDOGREL 75 MG FILM-COATED TABLETS 

1.       
NAME OF THE MEDICINAL PRODUCT

Clova

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. 

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 
PAGE 2 OF 18 
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