CLOPIDOGREL 75 Milligram Film Coated Tablet

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

CLOPIDOGREL HYDROBROMIDE MONOHYDRATE

Disponibbli minn:

McDermott Laboratories Ltd t/a Gerard Laboratories

Kodiċi ATC:

B01AC04

INN (Isem Internazzjonali):

CLOPIDOGREL HYDROBROMIDE MONOHYDRATE

Dożaġġ:

75 Milligram

Għamla farmaċewtika:

Film Coated Tablet

Tip ta 'preskrizzjoni:

Product subject to prescription which may be renewed (B)

Żona terapewtika:

Platelet aggregation inhibitors excl. Heparin

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2011-09-23

Fuljett ta 'informazzjoni

PAGE 1 OF 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 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 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 belongs to a group of medicines called antiplatelet
medicines. Platelets are very small structures
in the blood, smaller than red or white blood cells, which clump
together during blood clotting. By
preventing this clumping, antiplatelet medicines 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 in the blocked or
narrowe

Karatteristiċi tal-prodott

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 75 mg of clopidogrel (as hydrobromide
monohydrate).
Excipients with known effect:
Each tablet contains 2 mg lactose monohydrate and 4.8 mg hydrogenated
castor oil
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, round, biconvex film coated tablet approximately 8.6 mm in
diameter, debossed with ‘CB’ over ‘75’ on one side
and ‘G’ on the 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), 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.
For further information, please refer to section 5.1.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and Elderly people
Clopidogrel should be given as a single daily dose of 75 mg.
In patients suffering from acute coronary syndrome:
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