Clopidogrel MSN 75 mg film-coated tablets

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Clopidogrel Hydrogen Sulfate

זמין מ:

MSN Labs Europe Limited

קוד ATC:

B01AC04

INN (שם בינלאומי):

Clopidogrel Hydrogen Sulfate

טופס פרצבטיות:

Film-coated tablet

איזור תרפויטי:

clopidogrel

מצב אישור:

Not marketed

תאריך אישור:

2024-01-05

עלון מידע

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

מאפייני מוצר

Health Products Regulatory Authority
26 February 2024
CRN00F41Q
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clopidogrel MSN 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 2.4 mg of lactose monohydrate and 3
mg of hydrogenated castor oil.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pink colored, round shaped, film coated tablets debossed with "MC 5"
on one side and plain on 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:
o
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).
o
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