Clopidogrel ASA Billev 75mg per 75mg

Negara: Malta

Bahasa: Inggris

Sumber: Medicines Authority

Bahan aktif:

CLOPIDOGREL, ACETYLSALICYLIC ACID

Tersedia dari:

Billev Pharma ApS Fuglebækgaard, Elmegårdsvej 1A, Tørslev, 3630 Jægerspris, Denmark

Kode ATC:

B01AC30

INN (Nama Internasional):

CLOPIDOGREL 75 mg ACETYLSALICYLIC ACID 75 mg

Bentuk farmasi:

FILM-COATED TABLET

Komposisi:

CLOPIDOGREL 75 mg ACETYLSALICYLIC ACID 75 mg

Jenis Resep:

POM

Area terapi:

ANTITHROMBOTIC AGENTS

Status otorisasi:

Withdrawn

Tanggal Otorisasi:

2014-07-17

Selebaran informasi

1 

PACKAGE LEAFLET 
2 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

Clopidogrel/ASA Billev 75 mg/75 mg film-coated tablets 
Clopidogrel/ASA Billev 75 mg/100 mg film-coated tablets 
clopidogrel/acetylsalicylic acid 

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 get any side effects  talk to your doctor or pharmacist.
This includes any possible side effects 
not listed in this leaflet. See section 4. 

WHAT IS IN THIS LEAFLET 

1. 
What Clopidogrel/ASA Billev is and what it is used for  
2. 
What you need to know before you take Clopidogrel/ASA Billev  
3. 
How to take Clopidogrel/ASA Billev 
4. 
Possible side effects  
5. 
How to store Clopidogrel/ASA Billev 
6. 
Contents of the pack and other information 

1. 
WHAT CLOPIDOGREL/ASA BILLEV IS AND WHAT IT IS USED FOR 

Clopidogrel/ASA Billev contains clopidogrel and acetylsalicylic acid
(ASA) and belongs 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 in some
types of blood vessels (called arteries), 
antiplatelet medicinal products reduce the chances of blood clots
forming (a process called 
atherothrombosis). 

Clopidogrel/ASA Billev is taken by adults to prevent blood clots
forming in hardened arteries which can lead 
to atherothrombotic events (such as stroke, heart attack, or
death). 

You have been prescribed Clopidogrel/ASA Billev in place of the two
separate medicines, clopidogrel and 
ASA, to hel

Karakteristik produk

1 

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Clopidogrel/ASA Billev 75 mg/75 mg film-coated tablets 
Clopidogrel/ASA Billev 75 mg/100 mg film-coated tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen
sulphate) and 75 mg of acetylsalicylic 
acid (ASA). 
Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen
sulphate) and 100 mg of acetylsalicylic 
acid (ASA). 

Excipient with known effect:  
Each film-coated tablet contains 108 mg of lactose monohydrate. 
Each film-coated tablet contains 124 mg of lactose monohydrate. 

For the full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Film-coated tablet 

Yellow, film-coated capsule shaped tablets. Plain on both sides
of the tablet. The film-coated tablets have a 
length of 14.0 mm and a width of 6.8 mm. 
Light pink to pink, film-coated capsule shaped tablets. Plain
on both sides of the tablet. The film-coated 
tablets have a length of 14.0 mm and a width of 6.8 mm. 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Clopidogrel/ASA Billev is indicated for the prevention of
atherothrombotic events in adult patients already 
taking both clopidogrel and acetylsalicylic acid
(ASA). Clopidogrel/ASA Billev is a fixed-dose combination 
medicinal product for continuation of therapy in: 

 
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 
 
ST segment elevation acute myocardial infarction
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 older people _
Clopidogrel/ASA Billev should be given as a single daily 75 mg/75
mg�