Clopidogrel BMS
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
11-11-2009
Produktets egenskaber
(SPC)
11-11-2009
Offentlige vurderingsrapport
(PAR)
11-11-2009
Aktiv bestanddel:
clopidogrel (as hydrogen sulfate)
Tilgængelig fra:
Bristol-Myers Squibb Pharma EEIG
ATC-kode:
B01AC04
INN (International Name):
clopidogrel
Terapeutisk gruppe:
Antithrombotic agents
Terapeutisk område:
Stroke; Peripheral Vascular Diseases; Myocardial Infarction; Acute Coronary Syndrome
Terapeutiske indikationer:
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.
Produkt oversigt:
Revision: 3
Autorisation status:
Withdrawn
Autorisation dato:
2008-07-16
Indlægsseddel
Medicinal product no longer authorised
40
B. PACKAGE LEAFLET
Medicinal product no longer authorised
41
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOPIDOGREL BMS 75 MG FILM-COATED TABLETS
clopidogrel
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Clopidogrel BMS is and what it is used for
2.
Before you take Clopidogrel BMS
3.
How to take Clopidogrel BMS
4.
Possible side effects
5
How to store Clopidogrel BMS
6.
Further information
1.
WHAT CLOPIDOGREL BMS IS AND WHAT IT IS USED FOR
Clopidogrel BMS belongs to a group of medicines called antiplatelet
medicinal products. Platelets are
very small structures in the blood, smaller than red or white blood
cells, 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 BMS is taken 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 BMS 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, or
-
You have experienced a severe type of chest pain known as ‘unstable
angina’ or ‘myocardial
infarction’ (heart attack). For the treatment of this condition your
doctor may have placed a stent
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Produktets egenskaber
Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Clopidogrel BMS 75 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen
sulphate).
Excipients: each tablet contains 3 mg lactose and 3.3 mg hydrogenated
castor oil.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink, round, biconvex, engraved with «75» on one side and «1171»
on the other side.
4.
CLINICAL PARTICULARS
4.1
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.
For further information please refer to section 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
•
Adults and elderly
Clopidogrel should be given as a single daily dose of 75 mg with or
without food.
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
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