Clopidogrel Teva Generics B.V.
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
12-05-2014
Valmisteyhteenveto
(SPC)
12-05-2014
Julkisesta arviointikertomuksesta
(PAR)
12-05-2014
Aktiivinen ainesosa:
clopidogrel (as hydrochloride)
Saatavilla:
Teva Pharma B.V.
ATC-koodi:
B01AC04
INN (Kansainvälinen yleisnimi):
clopidogrel
Terapeuttinen ryhmä:
Antithrombotic agents
Terapeuttinen alue:
Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Käyttöaiheet:
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.
Tuoteyhteenveto:
Revision: 3
Valtuutuksen tilan:
Withdrawn
Valtuutus päivämäärä:
2010-10-28
Pakkausseloste
23
B. PACKAGE LEAFLET
Medicinal product no longer authorised
24
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOPIDOGREL TEVA GENERICS B.V. 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 Teva Generics B.V. is and what it is used for
2.
Before you take Clopidogrel Teva Generics B.V.
3.
How to take Clopidogrel Teva Generics B.V.
4.
Possible side effects
5.
How to store Clopidogrel Teva Generics B.V.
6.
Further information
1.
WHAT CLOPIDOGREL TEVA GENERICS B.V. IS AND WHAT IT IS USED FOR
Clopidogrel Teva Generics B.V. 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 Teva Generics B.V. 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 Teva Generics B.V. 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
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Clopidogrel Teva Generics B.V. 75 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as
hydrochloride).
Excipient:
Each film-coated tablet contains 13 mg hydrogenated castor oil.
For a 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
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 of treatment has not been formally established.
Clinical trial data supp
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