Clopidogrel-Asteria tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

clopidogrel (clopidogrel bisulfate)

Available from:

ONE PHARMA INDUSTRIAL PHARMACEUTICAL COMPANY SOCIETE ANONYME

ATC code:

B01AC04

INN (International Name):

clopidogrel (clopidogrel bisulfate)

Dosage:

75mg

Pharmaceutical form:

tablets film-coated

Units in package:

(28/4x7/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-03-09

Patient Information leaflet

IN THIS LEAFLET
1. What CLOPIDOGREL-ASTERIA is and what it is used for
2. What you need to know before you take
CLOPIDOGREL-ASTERIA
3. How to take CLOPIDOGREL-ASTERIA
4. Possible side effects
5. How to store CLOPIDOGREL-ASTERIA
6. Contents of the pack and other information
1. WHAT CLOPIDOGREL-ASTERIA IS AND WHAT IT IS USED
FOR
CLOPIDOGREL-ASTERIA 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-ASTERIA
is
taken
by
adults
to
prevent
blood clots 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-ASTERIA 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 narrowed
artery to restore effective blood flow. You should also be
given acetylsalicylic acid (a substance present in many
medicines used to relieve pain and lower fever as well as
to prevent blood clotting) by your doctor.
· You have an irregular heartbeat, a condition called
‘atrial fibrillation’, and you cannot take medicines known
as ‘oral
anticoagulants’
(vitamin
K
antagonists)
which
prevent new clots from forming and prevent existing
clots from growing. You should have been told that ‘oral
anticoagulants’
are
more
effective
than
acetylsalicylic
acid
or
the
combined
use

Summary of Product characteristics

Page
1
of
20
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CLOPIDOGREL-ASTERIA 75 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CLOPIDOGREL-ASTERIA
75 mg film-coated tablets
Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen
sulphate).
Excipients with known effect:
Each film-coated tablet contains 4.16 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
CLOPIDOGREL-ASTERIA
75 mg film-coated tablets
Pink, round, biconvex tablets.
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.
Page
2
of
20
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology

ADULTS AND ELDERLY

CLOPIDOGREL-ASTERIA
75 mg film-coated tablets
Clopidogrel should be given as a single daily dose of 75 mg.
In patients suffering from acute coronary