Zyllt

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

clopidogrel (as hydrogen sulfate)

Available from:

Krka, d.d., Novo mesto

ATC code:

B01AC04

INN (International Name):

clopidogrel

Therapeutic group:

Antithrombotic agents

Therapeutic area:

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

Therapeutic indications:

Prevention 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.

Product summary:

Revision: 16

Authorization status:

Authorised

Authorization date:

2009-09-28

Patient Information leaflet

33
B. PACKAGE LEAFLET
34
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZYLLT 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 get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zyllt is and what it is used for
2.
What you need to know before you take Zyllt
3.
How to take Zyllt
4.
Possible side effects
5.
How to store Zyllt
6.
Contents of the pack and other information
1.
WHAT ZYLLT IS AND WHAT IT IS USED FOR
Zyllt 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).
Zyllt 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 Zyllt 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 effec

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zyllt 75 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen
sulphate).
Excipients with known effect:
Each film-coated tablet contains 108.125 mg lactose.
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),
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:_
˗
Adult patients with moderate to high-risk TIA (ABCD2
1
score ≥4) or minor IS (NIHSS
2
≤3)
within 24 hours of either the TIA or IS event.
_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