Clopidogrel/Acetylsalicylic acid Zentiva (previously DuoCover)

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

clopidogrel, Acetylsalicylic acid

Available from:

Sanofi-Aventis Groupe

ATC code:

B01AC30

INN (International Name):

clopidogrel, acetylsalicylic acid

Therapeutic group:

Antithrombotic agents

Therapeutic area:

Acute Coronary Syndrome; Myocardial Infarction

Therapeutic indications:

Acute Coronary SyndromeMyocardial Infarction

Product summary:

Revision: 22

Authorization status:

Authorised

Authorization date:

2010-03-14

Patient Information leaflet

39
B. PACKAGE LEAFLET
40
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOPIDOGREL/ACETYLSALICYLIC ACID ZENTIVA 75 MG/75 MG FILM-COATED
TABLETS
CLOPIDOGREL/ACETYLSALICYLIC ACID 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/Acetylsalicylic acid Zentiva is and what it is used
for
2.
What you need to know before you take Clopidogrel/Acetylsalicylic acid
Zentiva
3.
How to take Clopidogrel/Acetylsalicylic acid Zentiva
4.
Possible side effects
5
How to store Clopidogrel/Acetylsalicylic acid Zentiva
6.
Contents of the pack and other information
1.
WHAT CLOPIDOGREL/ACETYLSALICYLIC ACID ZENTIVA IS AND WHAT IT IS USED
FOR
Clopidogrel/Acetylsalicylic acid Zentiva 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/Acetylsalicylic acid Zentiva 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/Acetylsalicylic acid Zentiva in
place of the two separate
medicines, clopidogrel and ASA, to help prevent blood clots because
you ha

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated
tablets
Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated
tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated
tablets
Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen
sulphate) and 75 mg of
acetylsalicylic acid (ASA).
_Excipients with known effect: _
Each film-coated tablet contains 7 mg of lactose and 3.3 mg of
hydrogenated castor oil.
Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated
tablets
Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen
sulphate) and 100 mg of
acetylsalicylic acid (ASA).
_ _
_Excipients with known effect: _
Each film-coated tablet contains 8 mg of lactose and 3.3 mg of
hydrogenated castor oil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated
tablets
Yellow, oval, slightly biconvex, engraved with «C75» on one side and
«A75» on the other side.
Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated
tablets
Light pink, oval, slightly biconvex, engraved with «C75» on one side
and «A100» on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clopidogrel/Acetylsalicylic acid Zentiva is indicated for the
secondary prevention of atherothrombotic
events in adult patients already taking both clopidogrel and
acetylsalicylic acid (ASA).
Clopidogrel/Acetylsalicylic acid Zentiva 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 infor