Clopidogrel Teva Pharma (previously Clopidogrel HCS)
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
26-02-2016
Charakterystyka produktu
(SPC)
26-02-2016
Sprawozdanie z oceny publicznego
(PAR)
19-04-2016
Składnik aktywny:
clopidogrel (as hydrochloride)
Dostępny od:
Teva B.V.
Kod ATC:
B01AC04
INN (International Nazwa):
clopidogrel
Grupa terapeutyczna:
Antithrombotic agents
Dziedzina terapeutyczna:
Myocardial Infarction; Peripheral Vascular Diseases; Stroke
Wskazania:
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.
Podsumowanie produktu:
Revision: 9
Status autoryzacji:
Withdrawn
Data autoryzacji:
2009-09-21
Ulotka dla pacjenta
B. PACKAGE LEAFLET
28
Medicinal product no longer authorised
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOPIDOGREL TEVA PHARMA 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 of the side effects, including any side effects not
listed in this leaflet, talk to
your doctor or pharmacist. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Clopidogrel Teva Pharma is and what it is used for
2.
What you need to know before you take Clopidogrel Teva Pharma
3.
How to take Clopidogrel Teva Pharma
4.
Possible side effects
5.
How to store Clopidogrel Teva Pharma
6.
Contents of the pack and other information
1.
WHAT CLOPIDOGREL TEVA PHARMA IS AND WHAT IT IS USED FOR
Clopidogrel Teva Pharma contains clopidogrel and 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 Pharma 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 Teva Pharma 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
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Charakterystyka produktu
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
1.
NAME OF THE MEDICINAL PRODUCT
Clopidogrel Teva Pharma 75 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as
hydrochloride).
Excipient with known effect
:
Each film-coated tablet contains 13 mg of hydrogenated castor oil.
For the 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
_ _
_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 elderly
Clopidogrel should be given as a single daily dose of 75 mg.
In patients suffering from acute coronary syndrome:
2
Medicinal product no longer authorised
Non-ST segment elevation
_ _
acute coronary syndrom
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