Clopidogrel Bluefish 75 mg Film-coated Tablets

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Clopidogrel besilate

Disponível em:

Bluefish Pharmaceuticals AB

Código ATC:

B01AC; B01AC04

DCI (Denominação Comum Internacional):

Clopidogrel besilate

Dosagem:

75 milligram(s)

Forma farmacêutica:

Film-coated tablet

Tipo de prescrição:

Product subject to prescription which may be renewed (B)

Área terapêutica:

Platelet aggregation inhibitors excl. heparin; clopidogrel

Status de autorização:

Marketed

Data de autorização:

2010-04-09

Folheto informativo - Bula

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

Características técnicas

Health Products Regulatory Authority
13 February 2024
CRN00DG9D
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clopidogrel Bluefish 75 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as besilate).
Excipient with known effect:
Each film-coated tablet contains 2.6 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Clopidogrel Bluefish 75 mg film-coated tablets are pink, round,
biconvex.
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 Vitamin K antagonists (VKA) and who have a
low bleeding risk, clopidog