Clopidogrel Zentiva (previously Clopidogrel Winthrop)

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

clopidogrel

Διαθέσιμο από:

Zentiva k.s.

Φαρμακολογική κατηγορία (ATC):

B01AC04

INN (Διεθνής Όνομα):

clopidogrel

Θεραπευτική ομάδα:

Antithrombotic agents

Θεραπευτική περιοχή:

Stroke; Peripheral Vascular Diseases; Myocardial Infarction; Acute Coronary Syndrome

Θεραπευτικές ενδείξεις:

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 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 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.

Περίληψη προϊόντος:

Revision: 32

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2008-07-15

Φύλλο οδηγιών χρήσης

37
B. PACKAGE LEAFLET
38
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
CLOPIDOGREL ZENTIVA 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 Clopidogrel Zentiva is and what it is used for
2.
What you need to know before you take Clopidogrel Zentiva
3.
How to take Clopidogrel Zentiva
4.
Possible side effects
5
How to store Clopidogrel Zentiva
6.
Contents of the pack and other information
1.
WHAT CLOPIDOGREL ZENTIVA IS AND WHAT IT IS USED FOR
Clopidogrel Zentiva 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 Zentiva 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 Zentiva 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 th

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Clopidogrel Zentiva 75 mg film-coated tablets
Clopidogrel Zentiva 300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clopidogrel Zentiva 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.
Clopidogrel Zentiva 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 (tablet).
Clopidogrel Zentiva 75 mg film-coated tablets
Pink, round, biconvex, engraved with «75» on one side and «1171»
on the other side.
Clopidogrel Zentiva 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 medically
treated patients eligible for thrombolytic 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:
3
•
Adult patients with moderate to h