PLAVIX 75 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CLOPIDOGREL AS HYDROGEN SULFATE

Available from:

SANOFI ISRAEL LTD

ATC code:

B01AC04

Pharmaceutical form:

FILM COATED TABLETS

Composition:

CLOPIDOGREL AS HYDROGEN SULFATE 75 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

SANOFI WINTHROP INDUSTRIE, FRANCE

Therapeutic group:

CLOPIDOGREL

Therapeutic area:

CLOPIDOGREL

Therapeutic indications:

Secondary Prevention of atherotrobmotic eventsClopidogrel 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/non-Q-wave myocardial infarction (MI)), 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 therapyPrevention of atherotrobmotic 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 the treatment with Vitamin K antagonists (VKA) Anti-Thrombin or Anti Factor Xa, and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.

Authorization date:

2023-04-30

Patient Information leaflet

PATIENT PACKAGE LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
PLAVIX 75 MG film-coated tablets
ACTIVE INGREDIENT
Each Plavix 75 mg tablet contains: clopidogrel (as hydrogen
sulfate) 75 mg
For information about inactive ingredients and allergens in the
medicine, see section 2 under “Important information about some of
the medicine’s ingredients” and section 6 “Additional
information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THIS
MEDICINE. This leaflet contains concise information about this
medicine. If you have any further questions, consult your doctor
or pharmacist.
This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if it seems to you that their
medical condition is similar.
1. WHAT IS THIS MEDICINE INTENDED FOR?
The
medicine
is
intended
for
secondary
prevention
of
atherothrombotic vascular events (heart attacks, cerebral stroke
or vascular death) in patients with atherosclerosis who had a
myocardial infarction, ischemic cerebrovascular event, or who
suffer from peripheral arterial disease, and in patients suffering
from
unstable angina pectoris, including patients undergoing implant of
a stent by catheterization and who are being treated with aspirin.
The medicine is intended for prevention of atherothrombotic and
thromboembolic events (heart attacks, cerebral stroke, emboli or
vascular death) in combination with aspirin, in patients suffering
from heart rhythm disorder such as atrial fibrillation, who are
not suitable for treatment with anti-coagulants of the vitamin K
antagonist type such as warfarin (Coumadin), anti-thrombin or
anti-factor Xa.
THERAPEUTIC GROUP: Platelet aggregation inhibitors, from the
thienopyridine group.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
- you are sensitive (allergic) to clopidogrel or to any of the other
ingredients of this medicine (see section 6).
- you suffer from a medical condition that is c

Summary of Product characteristics

1
_Plavix-SPC-22.0 _
1.
NAME OF THE MEDICINAL PRODUCT
Plavix 75 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Plavix 75mg
Each film-coated tablet contains 75mg of Clopidogrel (as hydrogen
sulphate).
_Excipients with known effect:_
Each film-coated tablet contains 3 mg lactose and 3.3 mg hydrogenated
castor oil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Plavix 75 mg film-coated tablets are pink, round, biconvex, engraved
with «75» on one side and «1171»
on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Secondary prevention of atherotrombotic 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/non-Q-wave myocardial
infarction (MI)), 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 atherothrobmotic 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 the treatment with Vitamin K antagonists (VKA)
Anti-Thrombin or Anti Factor Xa
,
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.
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
•
Adults and elderly
Plavix 75 mg
film-coated tablets
Clopidogrel
should be given as a single daily dose of 75 mg.
In patients suffering from acute coronary syn