Iscover
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
06-07-2023
Produktets egenskaber
(SPC)
06-07-2023
Offentlige vurderingsrapport
(PAR)
16-02-2023
Aktiv bestanddel:
clopidogrel
Tilgængelig fra:
Sanofi Winthrop Industrie
ATC-kode:
B01AC04
INN (International Name):
clopidogrel
Terapeutisk gruppe:
Antithrombotic agents
Terapeutisk område:
Stroke; Peripheral Vascular Diseases; Atrial Fibrillation; Myocardial Infarction; Acute Coronary Syndrome
Terapeutiske indikationer:
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 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: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 (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: 50
Autorisation status:
Authorised
Autorisation dato:
1998-07-14
Indlægsseddel
38
B. PACKAGE LEAFLET
39
PACKAGE LEAFLET: INFORMATION FOR THE USER
ISCOVER 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 Iscover is and what it is used for
2.
What you need to know before you take Iscover
3.
How to take Iscover
4.
Possible side effects
5
How to store Iscover
6.
Contents of the pack and other information
1.
WHAT ISCOVER IS AND WHAT IT IS USED FOR
Iscover 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).
Iscover 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 Iscover 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 e
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Iscover 75 mg film-coated tablets
Iscover 300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Iscover 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.
Iscover 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.
Iscover 75 mg film-coated tablets
Pink, round, biconvex, engraved with «75» on one side and «1171»
on the other side.
Iscover 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 indicat
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