Clopidogrel Krka

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

clopidogrel (as hydrochloride)

Available from:

Krka, d.d., Novo mesto

ATC code:

B01AC04

INN (International Name):

clopidogrel

Therapeutic group:

Antithrombotic agents

Therapeutic area:

Peripheral Vascular Diseases; Stroke; Myocardial Infarction

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.

Product summary:

Revision: 19

Authorization status:

Authorised

Authorization date:

2009-09-23

Patient Information leaflet

33
B. PACKAGE LEAFLET
34
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOPIDOGREL KRKA 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 Clopidogrel Krka is and what it is used for
2.
What you need to know before you take Clopidogrel Krka
3.
How to take Clopidogrel Krka
4.
Possible side effects
5.
How to store Clopidogrel Krka
6.
Contents of the pack and other information
1.
WHAT CLOPIDOGREL KRKA IS AND WHAT IT IS USED FOR
Clopidogrel Krka 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 Krka 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 Krka 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 th

Summary of Product characteristics

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Clopidogrel Krka 75 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as
hydrochloride).
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 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 events, including stroke.
For further information please refer to section 5.1.
4.