Clopidogrel 75 mg film-coated tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Clopidogrel besilate

Dostępny od:

Actavis Group PTC ehf

Kod ATC:

B01AC; B01AC04

INN (International Nazwa):

Clopidogrel besilate

Dawkowanie:

75 milligram(s)

Forma farmaceutyczna:

Film-coated tablet

Typ recepty:

Product subject to prescription which may be renewed (B)

Dziedzina terapeutyczna:

Platelet aggregation inhibitors excl. heparin; clopidogrel

Status autoryzacji:

Marketed

Data autoryzacji:

2009-11-27

Ulotka dla pacjenta

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

Charakterystyka produktu

Health Products Regulatory Authority
16 October 2018
CRN008JM4
Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clopidogrel 75 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 111.86 mg clopidogrel besylate
corresponding to 75
mg of clopidogrel.
Excipients with known effect: Each film-coated tablet contains 73.61
mg of lactose
anhydrous and 0.29 mg of lecithin (contains soya oil) (E322).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pink 9 mm round, biconvex, film-coated tablet, engraved with “II”
on one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_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:
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 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
Health Products Regulatory Authority
16 October 2018
CRN008JM4
Page 2 of 22
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