Plavix
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
07-07-2023
Charakterystyka produktu
(SPC)
07-07-2023
Sprawozdanie z oceny publicznego
(PAR)
15-02-2023
Składnik aktywny:
clopidogrel hydrogen sulfate
Dostępny od:
Sanofi Winthrop Industrie
Kod ATC:
B01AC04
INN (International Nazwa):
clopidogrel
Grupa terapeutyczna:
Antithrombotic agents
Dziedzina terapeutyczna:
Stroke; Peripheral Vascular Diseases; Atrial Fibrillation; Myocardial Infarction; Acute Coronary Syndrome
Wskazania:
Secondary 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 seven days until less than six 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 patients undergoing percutaneous coronary intervention (including patients undergoing a stent replacement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy.In patients with moderate to high-risk Transient Ischemic Attack (TIA) or minor Ischemic Stroke (IS)Clopidogrel in combination with ASA is indicated in:Adult patients with moderate to high-risk TIA (ABCD2 score ≥4) or minor IS (NIHSS ≤3) within 24 hours of either the TIA or IS event.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 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: 50
Status autoryzacji:
Authorised
Data autoryzacji:
1998-07-15
Ulotka dla pacjenta
39
B. PACKAGE LEAFLET
40
PACKAGE LEAFLET: INFORMATION FOR THE USER
PLAVIX 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 your 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 to your
doctor or pharmacist. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Plavix is and what it is used for
2.
What you need to know before you take Plavix
3.
How to take Plavix
4.
Possible side effects
5
How to store Plavix
6.
Contents of the pack and other information
1.
WHAT PLAVIX IS AND WHAT IT IS USED FOR
Plavix 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).
Plavix 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 Plavix 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
in the blocked or narrowed artery to restore effective
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Plavix 75 mg film-coated tablets
Plavix 300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Plavix 75 mg film-coated tablets
Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen
sulphate).
_Excipients with known effect: _
Each film-coated tablet contains 3 mg of lactose and 3.3 mg of
hydrogenated castor oil.
Plavix 300 mg film-coated tablets
Each film-coated tablet contains 300 mg of clopidogrel (as hydrogen
sulphate).
_Excipients with known effect: _
Each film-coated tablet contains 12 mg of lactose and 13.2 mg of
hydrogenated castor oil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Plavix 75 mg film-coated tablets
Pink, round, biconvex, engraved with «75» on one side and «1171»
on the other side.
Plavix 300 mg film-coated tablets
Pink, oblong, engraved with «300» on one side and «1332» on the
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Secondary prevention of atherothrombotic events _
Clopidogrel is indicated in:
•
Adult patients suffering from myocardial infarction (from a few days
until less than 35 days),
ischemic 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 patients
undergoing percutaneous coronary intervention (including patients
undergoing a stent
placement) or medically treated patients eligible for
thrombolytic/fibrinolytic therapy.
_ _
_In patients with moderate to high-risk_
_Transient Ischemic Attack (TIA) or minor Ischemic Stroke (IS) _
Clopidogrel in combination with ASA is indicated in:
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