Clopidogrel HCS
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
01-08-2018
Produktets egenskaber
(SPC)
01-08-2018
Offentlige vurderingsrapport
(PAR)
04-08-2015
Aktiv bestanddel:
clopidogrel (as hydrochloride)
Tilgængelig fra:
HCS bvba
ATC-kode:
B01AC04
INN (International Name):
clopidogrel
Terapeutisk gruppe:
Antithrombotic agents
Terapeutisk område:
Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
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 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. For further information please refer to section 5.1.
Produkt oversigt:
Revision: 8
Autorisation status:
Authorised
Autorisation dato:
2010-10-28
Indlægsseddel
28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOPIDOGREL HCS 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 to your
doctor or pharmacist. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Clopidogrel HCS is and what it is used for
2.
What you need to know before you take Clopidogrel HCS
3.
How to take Clopidogrel HCS
4.
Possible side effects
5.
How to store Clopidogrel HCS
6.
Contents of the pack and other information
1.
WHAT CLOPIDOGREL HCS IS AND WHAT IT IS USED FOR
Clopidogrel HCS 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 HCS 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 HCS 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
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Clopidogrel HCS 75 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as
hydrochloride).
Excipients 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
_Secondary 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 (over 65 years)
Clopidogrel should be given as a single daily dose of 75 mg.
In patients suffering from acute coronary syndrome:
−
Non-ST segment elevation acute coronary syndrome (unstable angina or
non-Q-wave
myocardial infarction): clopidogr
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