Clopacin 75mg

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

clopidogrel (clopidogrel besilate)

Available from:

Acino Pharma AG

INN (International Name):

clopidogrel (clopidogrel besilate)

Dosage:

75mg

Pharmaceutical form:

tablets film-coated

Prescription type:

Prescription

Patient Information leaflet

Patient information leaflet
_Please read this leaflet carefully before you take or _
_use the medicine._
_This medicine has been prescribed for you and you _
_should not pass it on to anyone else. The medicine _
_may harm them even if their symptoms are the same _
_as yours._
_Keep this leaflet – you may need to read it again._
Clopacin
Clopidogrel 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
platelet
aggregation
inhibitors.
Platelets
(thrombo-
cytes) are very small blood cells (smaller than red or
white blood cells) that clump together when a blood
clot (thrombus) is formed. Platelet aggregation inhibi-
tors prevent this clumping from taking place and in so
doing reduce the risk of blood clots forming (known as
thrombosis).
As you recently experienced a stroke or a heart attack
or have a condition known as peripheral arterial dis-
ease, you are at increased risk of a recurrence of
these events.
To reduce this risk you have been prescribed Clopacin.
You would have been prescribed Clopacin if you had
severe chest pain, known as "unstable angina" or "heart
attack". In this case your doctor may also prescribe
aspirin (a substance present in many medicines used
to relieve pain and lower fever).
Clopacin is also used for the prevention of thrombosis
after implantation of vascular endoprostheses (stents)
in combination with aspirin.
Clopacin may be taken only if prescribed by a doctor
and should not be given to anyone else.
What else should you consider?
Certain conditions such as high blood pressure, raised
cholesterol, smoking and diabetes are often the cause
of arterial diseases. Therefore, it is important for you to
change your lifestyle in such a way as to decrease
these risk factors.
Ask your doctor for advice.
When must Clopacin not be used?
Clopacin must not be taken:
if you are hypersensitive (allergic) to this medicine
or have previously experienced an allergic reaction to
ticlopidin

Summary of Product characteristics

_VERSION: _
_CLOPI_75_FCT_SMPC_E_01_CIS_ACINO _
_SOURCE: _
_CLOPI_75_FCT_FI_E_01_CH (SWISSMEDIC APPROVED FI CLOPIDOGREL-ACINO
PROVIDED BY F. REYMOND_BASED ON SM APPROVED _
_ORIGINATOR PLAVIX, DATE OF INFORMATION 11.2010) + APPROVED BY A.
MUTSCHLER AND S. PARISI IN JUNE 2012 _
_ _
Page 1 SUMMARY OF PRODUCT CHARACTERISTICS
__________________________________________________________________________________
1.
NAME OF THE MEDICINAL PRODUCT
Clopacin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 111.85 mg clopidogrel besilate wich is equivelent
to 75 mg Clopidogrel.
_Excipients:_ For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White to off-white, marbled, round, biconvex, film-coated tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of atherothrombotic events such as myocardial infarction,
ischaemic stroke, vascular-
induced death in patients with recent stroke (7 days up until about 6
months), recent cardiac infarction
(a few days up until 5 weeks) or manifest peripheral artery occlusive
disease.
In combination with 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 implantation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Clopacin is taken once daily, during or between meals.
_ _
_Prevention of atherothrombotic events: _
1 film-coated tablet once daily (corresponding to 75 mg clopidogrel).
_ _
_Acute coronary syndrome and stent: _
_ _
Acute coronary syndrome without ST-segment elevation:
Clopacin treatment is started with an initial dose of 300 mg (4 x 75
mg tablets) and then continued
over the long term with 1 x 75 mg tablet once daily (in combination
with 75–325 mg ASA daily).
_VERSION: _
_CLOPI_75_FCT_SMPC_E_01_CIS_ACINO _
_SOURCE: _
_CLOPI_75_FCT_FI_E_01_CH (SWISSMEDIC APPROV