Zyllt tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

clopidogrel (clopidogrel hydrogen sulphate)

Available from:

KRKA-FARMA d. o.o.

ATC code:

B01AC04

INN (International Name):

clopidogrel (clopidogrel hydrogen sulphate)

Dosage:

75mg

Pharmaceutical form:

tablets film-coated

Units in package:

(14/2x7/) in blister, (28/4x7/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-12-07

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Zyllt 75 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen
sulphate).
Excipients with known effect:
Each film-coated tablet contains 108.125 mg lactose and 4 mg
hydrogenated castor oil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink, round and slightly convex film-coated tablets.
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
Clopidogrel should be given as a single daily dose of 75 mg.
In patien