Clopidogrel ratiopharm GmbH

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

clopidogrel

Available from:

Archie Samiel s.r.o.

ATC code:

B01AC04

INN (International Name):

clopidogrel

Therapeutic group:

Antithrombotic agents

Therapeutic area:

Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke

Therapeutic indications:

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.

Product summary:

Revision: 12

Authorization status:

Withdrawn

Authorization date:

2009-07-28

Patient Information leaflet

B. PACKAGE LEAFLET
27
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOPIDOGREL RATIOPHARM GMBH 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 ratiopharm GmbH is and what it is used for
2.
What you need to know before you take Clopidogrel ratiopharm GmbH
3.
How to take Clopidogrel ratiopharm GmbH
4.
Possible side effects
5.
How to store Clopidogrel ratiopharm GmbH
6.
Contents of the pack and other information
1.
WHAT CLOPIDOGREL RATIOPHARM GMBH IS AND WHAT IT IS USED FOR
Clopidogrel ratiopharm GmbH contains the active ingredient Clopidogrel
which belongs to a group of
medicines called antiplatelet medicinal products. Platelets (so-called
thrombocytes) are very small
structures, 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 ratiopharm GmbH 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 ratiopharm GmbH 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 (disturbed blood flow in

Summary of Product characteristics

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
1.
NAME OF THE MEDICINAL PRODUCT
Clopidogrel ratiopharm GmbH 75 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as besilate).
Excipients with known effect:
Each film-coated tablet contains 3.80 mg of hydrogenated castor oil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, marbled, round and biconvex film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clopidogrel is indicated in adults for the secondary prevention of
atherothrombotic events 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.
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 initiated with
a single 300 mg loading
dose and then continued at 75 mg once a day (with acetylsalicylic acid
(ASA) 75 mg-325 mg
daily). Since higher doses of ASA were associated with higher bleeding
risk it is recommended
that the dose of ASA should not be higher than 100 mg. The optimal
duration of treatment has
not been formally established. Clinical trial data sup