CLOPIDOGREL CLONMEL 75 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
10-05-2016
Summary of Product characteristics
(SPC)
10-05-2016
Active ingredient:
CLOPIDOGREL BESILATE
Available from:
Clonmel Healthcare Ltd
ATC code:
B01AC04
INN (International Name):
CLOPIDOGREL BESILATE
Dosage:
75 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Platelet aggregation inhibitors excl. Heparin
Authorization status:
Authorised
Authorization date:
2011-02-04
Patient Information leaflet
Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOPIDOGREL CLONMEL 75MG 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, 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 Clonmel is and what it is used for
2.
What you need to know before you take Clopidogrel Clonmel
3.
How to take Clopidogrel Clonmel
4.
Possible side effects
5.
How to store Clopidogrel Clonmel
6.
Contents of the pack and other information
1.
WHAT CLOPIDOGREL CLONMEL IS AND WHAT IT IS USED FOR
Clopidogrel Clonmel 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 Clonmel 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 Clonmel 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 atheroscleros
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clopidogrel Clonmel 75mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as clopidogrel besilate).
Excipient with known effect: each tablet contains 2.80 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pink, round, biconvex, film-coated tablets with ‘75’ embossed on one side and a diameter of approximately 8.3 mm.
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:
-
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
Posology
•
Adults and elderly
C
Read the complete document
