Clopidogrel Hexal
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
26-07-2012
Charakterystyka produktu
(SPC)
26-07-2012
Sprawozdanie z oceny publicznego
(PAR)
26-07-2012
Składnik aktywny:
clopidogrel
Dostępny od:
Acino Pharma GmbH
Kod ATC:
B01AC04
INN (International Nazwa):
clopidogrel
Grupa terapeutyczna:
Antithrombotic agents
Dziedzina terapeutyczna:
Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Wskazania:
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.
Podsumowanie produktu:
Revision: 2
Status autoryzacji:
Withdrawn
Data autoryzacji:
2009-07-28
Ulotka dla pacjenta
23
B. PACKAGE LEAFLET
Medicinal product no longer authorised
24
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOPIDOGREL HEXAL 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 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 HEXAL is and what it is used for
2.
Before you take Clopidogrel HEXAL
3.
How to take Clopidogrel HEXAL
4.
Possible side effects
5.
How to store Clopidogrel HEXAL
6.
Further information
1.
WHAT CLOPIDOGREL HEXAL IS AND WHAT IT IS USED FOR
Clopidogrel HEXAL 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 HEXAL 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 HEXAL 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 arms or legs
caused by vascular
occlusions) or
-
You have experienced a severe type of chest pain known as ‘unstable
angina’ or ‘myocardial
infarction’ (heart attack). For t
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Charakterystyka produktu
1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Clopidogrel HEXAL 75 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as besilate).
Excipients: each film-coated tablet contains 3.80 mg of hydrogenated
castor oil.
For a 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 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
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 support us
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