Clopidogrel Vale Pharmaceuticals 75mg Film-Coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CLOPIDOGREL

Available from:

Vale Pharmaceuticals Limited 3 Anglesea Street, Clonmel, Co. Tipperary, E91 D6C5, Ireland

ATC code:

B01AC04

INN (International Name):

CLOPIDOGREL 75 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

CLOPIDOGREL 75 mg

Prescription type:

POM

Therapeutic area:

ANTITHROMBOTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2011-02-24

Patient Information leaflet

PAGE 1 OF 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CLOPIDOGREL VALE PHARMACEUTICALS75 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 Vale Pharmaceuticals is and what it is used for
2.
What you need to know before you take Clopidogrel Vale Pharmaceuticals
3.
How to take Clopidogrel Vale Pharmaceuticals
4.
Possible side effects
5.
How to store Clopidogrel Vale Pharmaceuticals
6.
Contents of the pack and other information.
1.
WHAT CLOPIDOGREL VALE PHARMACEUTICALSIS AND WHAT IT IS USED FOR
Clopidogrel Vale Pharmaceuticalscontains clopidogrel and 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 Vale Pharmaceuticalsis 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 Vale Pharmaceuticalsto 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 exper

Summary of Product characteristics

PAGE 1 OF 17
SUMMARY OF PRODUCT CHARACTERISTICS
PAGE 2 OF 17
1.
NAME OF THE MEDICINAL PRODUCT
Clopidogrel Vale Pharmaceuticals75 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
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
_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 people
Clopidogrel should be given as a single daily dose of 75 mg
PAGE 3 OF 17
In patients suffering f