Clopacin 75mg tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

clopidogrel (clopidogrel besilate)

Available from:

Acino Pharma AG

ATC code:

B01AC04

INN (International Name):

clopidogrel (clopidogrel besilate)

Dosage:

75mg

Pharmaceutical form:

tablets film-coated

Units in package:

(28/2x14/) in blister, (84/6x14/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-04-12

Patient Information leaflet

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Kontur
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1 2
Acino Pharma AG
–
40915-4018
Clopacin 75 mg fi tab Acino CIS
160 x 420 mm
18.10.2018 EM
–
23.10.2018 EM
–
–
–
–
29U
Patient Information
Read all of this leaflet carefully before you start
taking/using this medicine.
This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
Keep this leaflet. You may need to read it again.
Clopacin 75 mg,
film-coated tablets
What is Clopacin and when is it used?
Clopidogrel, the active substance in Clopacin
film-coated
tablets,
belongs
to
a
group
of
medicines
called
antiplatelet
drugs.
Platelets
(thrombocytes)
are
very
small
blood
cells
(smaller than red or white blood cells) which
clump together during the formation of a blood
clot (thrombus). Antiplatelet drugs prevent this
clumping and thus reduce the risk of blood clots
forming (known as thrombosis).
As you have recently suffered a stroke or heart
attack or suffer from narrowed peripheral arteries,
you are at greater risk of experiencing these
events again.
To reduce this risk, you have been prescribed
Clopacin.
Clopacin has also been prescribed to you
– for peripheral arterial occlusive disease, or
– if
you
have
suffered
severe
chest
pain,
known
as
“unstable
angina
pectoris”,
or
have suffered a “heart attack”. If so, your
doctor
may
prescribe
you
acetylsalicylic
acid (a substance present in many medicines
for pain and fever) at the same time or
– if you have an irregular heart rate known
as
atrial
fibrillation
and
you
cannot
be
treated with oral anticoagulants. In this case,
the
doctor
will
also
prescribe
you
acetylsalicylic acid.
Clopacin is likewise used in combination with
acetylsalicylic acid to prevent thrombosis after a
vascular prosthesis (stent) has been implanted.
Clopacin may be taken only when prescribed by
a doctor and must not be passed on to other
people.
What should be taken into consideration?
Certain factors such as

Summary of Product characteristics

CLOPACIN 75, FILM-COATED TABLETS
MANUSCRIPT OF THE PRESCRIBING INFORMATION
ACINO PHARMA AG_ _
_ _
1/13
CLOPACIN 75, FILM-COATED TABLETS
COMPOSITION
Active substance: Clopidogrel as clopidogrel besilate.
Excipients: Macrogol 6000, carbon dioxide, microcrystalline cellulose
(E 460), crospovidone,
hydrogenated castor oil, ethyl cellulose, titanium dioxide.
PHARMACEUTICAL FORM AND AMOUNT OF ACTIVE SUBSTANCE PER UNIT
One film-coated tablet contains 111.85 mg clopidogrel besilate
(equivalent to 75 mg
clopidogrel).
INDICATIONS/POSSIBILITIES FOR USE
Clopidogrel is indicated in the following cases for the secondary
prevention of
atherothrombotic events in adults:
−
Prevention of atherothrombotic events such as myocardial infarction,
stroke, vascular
death in patients with recent stroke (from 7 days to approximately 6
months
previously), recent myocardial infarction (from a few days to 5 weeks
previously) or
manifest peripheral arterial occlusive disease.
−
In combination with acetylsalicylic acid (ASA) in patients with acute
coronary
syndrome without ST segment elevation (unstable angina pectoris or
non-Q-wave
infarction).
−
In combination with ASA after fibrinolysis in acute myocardial
infarction with ST
segment elevation.
−
Clopidogrel is used in combination with ASA for the prevention of
thrombotic events
after coronary stent placement.
Clopidogrel is also indicated in combination with ASA in adult
patients with atrial fibrillation
who have a stroke risk factor with a CHAD2DS2-VASc score ≥1 and who
decline oral
anticoagulants or do not tolerate anticoagulants for a reason other
than haemorrhaging.
POSOLOGY/ADMINISTRATION
Clopacin is taken once daily, with food or between meals.
_Prevention of atherothrombotic events _
Once daily 1 film-coated tablet (equivalent to 75 mg Clopacin).
_Acute coronary syndrome and stent _
_Acute coronary syndrome without ST segment elevation_: Clopacin
treatment is started with
an initial dose of 300 mg (four 75 mg tablets) and then continued with
one 75 mg tablet once
a day for l