Clopidogrel BGR (previously Zylagren)

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

clopidogrel (as hydrogen sulfate)

Available from:

Biogaran

ATC code:

B01AC03

INN (International Name):

clopidogrel

Therapeutic group:

Antithrombotic agents

Therapeutic area:

Peripheral Vascular Diseases; Stroke; Myocardial Infarction

Therapeutic indications:

Prevention of atherothrombotic events Clopidogrel is indicated in:Adult 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.

Product summary:

Revision: 17

Authorization status:

Authorised

Authorization date:

2009-09-21

Patient Information leaflet

32
B. PACKAGE LEAFLET
33
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOPIDOGREL BGR 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 your 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 BGR is and what it is used for
2.
What you need to know before you take Clopidogrel BGR
3.
How to take Clopidogrel BGR
4.
Possible side effects
5.
How to store Clopidogrel BGR
6.
Contents of the pack and other information
1.
WHAT CLOPIDOGREL BGR IS AND WHAT IT IS USED FOR
Clopidogrel BGR contains clopidogrel 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, antiplatelet medicinal products
reduce the chances of blood
clots forming (a process called thrombosis).
Clopidogrel BGR 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 Clopidogrel BGR 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
atherosclerosis), and
-
You have previously experienced a heart attack, stroke or have a
condition known as peripheral
arterial disease.
-
You have experienced a severe type of chest pain known as ‘unstable
angina’ or ‘myocardial
infarction’ (heart attack). For the treatment of this condition

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Clopidogrel BGR 75 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen
sulphate).
Excipients with known effect:
Each film-coated tablet contains 108.125 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink, round and slightly convex film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Secondary prevention of atherothrombotic events_
Clopidogrel is indicated in:

Adult 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.

Adult 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 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 events, including stroke.
For further information please refer to section 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology

Adults and elderly
Clopidogrel should be given as a single daily dose of 75 mg.
In patients suffering from acute coronary syndrome:
-
Non-ST segment elevation acute coronary syndrome (unstable angina or
non-Q-wave
myocardial infarction), clopidogrel treatment should be initiate