Clopidogrel Teva Pharma B.V.
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
03-02-2015
Produktets egenskaber
(SPC)
03-02-2015
Offentlige vurderingsrapport
(PAR)
03-02-2015
Aktiv bestanddel:
clopidogrel (as hydrobromide)
Tilgængelig fra:
Teva Pharma B.V.
ATC-kode:
B01AC04
INN (International Name):
clopidogrel
Terapeutisk gruppe:
Antithrombotic agents
Terapeutisk område:
Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Terapeutiske indikationer:
Prevention of atherothrombotic eventsClopidogrel 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 fibrillationIn 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.
Produkt oversigt:
Revision: 4
Autorisation status:
Withdrawn
Autorisation dato:
2011-06-16
Indlægsseddel
B. PACKAGE LEAFLET
32
Medicinal product no longer authorised
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOPIDOGREL TEVA PHARMA B.V. 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 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 have any side effects, including any side effects not listed in
this leaflet, talk your doctor
or pharmacist. See section 4
WHAT IS IN THIS LEAFLET
1.
What Clopidogrel Teva Pharma B.V. is and what it is used for
2.
What you need to know before you take Clopidogrel Teva Pharma B.V.
3.
How to take Clopidogrel Teva Pharma B.V.
4.
Possible side effects
5.
How to store Clopidogrel Teva Pharma B.V.
6.
Contents of the pack and other information
1. WHAT CLOPIDOGREL TEVA PHARMA B.V. IS AND WHAT IT IS USED FOR
Clopidogrel Teva Pharma B.V contains clopidogrel and belongs to a
group of medicines called
“platelet aggregation inhibitors.” It works by stopping certain
particles in your blood (“platelets”)
from sticking together to form blood clots which can block blood flow
to important parts of your body
including your heart and your brain.
If you suffer from hardening of the arteries (“atherosclerosis”)
there is an increased risk of a blood clot
forming in your blood vessels. In adults Clopidogrel Teva Pharma B.V.
reduces the risk of blood clots
forming which in turn reduces the risk of serious conditions such as
heart attack and stroke from
occurring.
You have been prescribed Clopidogrel Teva Pharma B.V. because:
•
You have hardening of the arteries and have recently suffered from a
heart attack, a stroke or
have a condition known as “peripheral arterial disease” (diseases
of the blood vessels except
those in the brain and heart).
•
You have
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Produktets egenskaber
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
1.
NAME OF THE MEDICINAL PRODUCT
Clopidogrel Teva Pharma B.V. 75 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as
hydrobromide).
Excipients with known effect:
Each tablet contains 62.16 mg lactose monohydrate and 10 mg
hydrogenated castor oil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Light pink to pink, capsule-shaped film-coated tablets debossed with
“C75” on one side and plain on
the other side.
4.
CLINICAL PARTICULARS
4.1
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.
•
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 older people
Clopidogrel should be given as a single daily dose of 75 mg.
2
Medicinal product no longer authorised
In patients suff
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