Clopidogrel Acino
Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Листовка
(PIL)
11-08-2016
Данни за продукта
(SPC)
11-08-2016
Доклад обществена оценка
(PAR)
15-04-2016
Активна съставка:
clopidogrel
Предлага се от:
Acino AG
АТС код:
B01AC04
INN (Международно Name):
clopidogrel
Терапевтична група:
Antithrombotic agents
Терапевтична област:
Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Терапевтични показания:
Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: , , , 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, 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, Patients suffering from acute coronary syndrome., ,
Каталог на резюме:
Revision: 6
Статус Оторизация:
Withdrawn
Дата Оторизация:
2009-07-28
Листовка
26
B. PACKAGE LEAFLET
Medicinal product no longer authorised
27
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOPIDOGREL ACINO 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 Acino is and what it is used for
2.
What you need to know before you take Clopidogrel Acino
3.
How to take Clopidogrel Acino
4.
Possible side effects
5.
How to store Clopidogrel Acino
6.
Contents of the pack and other information
1.
WHAT CLOPIDOGREL ACINO IS AND WHAT IT IS USED FOR
Clopidogrel Acino contains clopidogrel and belongs to a group of
medicines called antiplatelet
medicinal products. Platelets (so-called thrombocytes) are very small
structures, 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 Acino 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 Acino 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 (disturbed blood flow in arms or legs
caused by vascular
occlusions) or
-
You have experienced a severe type of
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Данни за продукта
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Clopidogrel Acino 75 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as besilate).
Excipients with known effect
Each film-coated tablet contains 3.80 mg of hydrogenated castor oil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, marbled, round and biconvex film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clopidogrel is indicated in adults for the prevention of
atherothrombotic events in:
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.
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.
In patients suffering from acute coronary syndrome:
-
Non-ST segment elevation acute coronary syndrome (unstable angina or
non-Q-wave
m
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