Clopidogrel / Acetylsalicylic acid Mylan

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Acetylsalicylic acid, clopidogrel hydrogen sulfate

Available from:

Mylan Pharmaceuticals Limited

ATC code:

B01AC30

INN (International Name):

clopidogrel, acetylsalicylic acid

Therapeutic group:

Antithrombotic agents

Therapeutic area:

Acute Coronary Syndrome; Myocardial Infarction

Therapeutic indications:

Clopidogrel/Acetylsalicylic acid Mylan is indicated for the secondary prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA).Clopidogrel/Acetylsalicylic acid Mylan 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 interventionST segment elevation acute myocardial infarction in medically treated patients eligible for thrombolytic therapy

Product summary:

Revision: 5

Authorization status:

Authorised

Authorization date:

2020-01-09

Patient Information leaflet

44
B. PACKAGE LEAFLET
45
Package leaflet: Information for the patient
Clopidogrel/Acetylsalicylic acid Viatris 75 mg/75 mg film-coated
tablets
Clopidogrel/Acetylsalicylic acid Viatris 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 Viatris is and what it is used
for
2.
What you need to know before you take Clopidogrel/Acetylsalicylic acid
Viatris
3.
How to take Clopidogrel/Acetylsalicylic acid Viatris
4.
Possible side effects
5.
How to store Clopidogrel/Acetylsalicylic acid Viatris
6.
Contents of the pack and other information
1. What Clopidogrel/Acetylsalicylic acid Viatris is and what it is
used for
Clopidogrel/Acetylsalicylic acid Viatris 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 Viatris 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 Viatris in
place of the two separate
medicines, clopidogrel and ASA, to help prevent blood clots because

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Clopidogrel/Acetylsalicylic acid Viatris 75 mg/75 mg film-coated
tablets
Clopidogrel/Acetylsalicylic acid Viatris 75 mg/100 mg film-coated
tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clopidogrel/Acetylsalicylic acid Viatris 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 48 mg of lactose.
Clopidogrel/Acetylsalicylic acid Viatris 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 48 mg of lactose and 0.81 mg Allura
Red AC.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film coated tablet (tablet)
Clopidogrel/Acetylsalicylic acid Viatris 75 mg/75 mg film-coated
tablets
Yellow, oval shaped, biconvex, film-coated tablets, approximately 14.5
mm x 7.4 mm debossed with
“CA2” on one side of the tablet and “M” on the other side.
Clopidogrel/Acetylsalicylic acid Viatris 75 mg/100 mg film-coated
tablets
Pink, oval shaped, biconvex, film-coated tablets, approximately 14.8
mm x 7.8 mm debossed with
“CA3” on one side of the tablet and “M” on the other side.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Clopidogrel/Acetylsalicylic acid Viatris is indicated for the
secondary prevention of atherothrombotic
events in adult patients already taking both clopidogrel and
acetylsalicylic acid (ASA).
Clopidogrel/Acetylsalicylic acid Viatris 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 (PCI)
3
•
ST segment elevation acute myocardial infarction (STEMI) in