CLOPIDEXCEL 75

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CLOPIDOGREL AS BESYLATE

Available from:

DEXCEL PHARMA TECHNOLOGIES LTD

ATC code:

B01AC04

Pharmaceutical form:

FILM COATED TABLETS

Composition:

CLOPIDOGREL AS BESYLATE 75 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

DEXCEL LTD, ISRAEL

Therapeutic group:

CLOPIDOGREL

Therapeutic area:

CLOPIDOGREL

Therapeutic indications:

Secondary prevention of atherotrombotic 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 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.

Authorization date:

2015-08-31

Patient Information leaflet

PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS' REGULATIONS
(PREPARATIONS) –
1986
This medicine can be sold with a physician’s prescription only
CLOPIDEXCEL
® 75, FILM COATED TABLETS
Each tablet contains clopidogrel as besylate 75 mg
Inactive ingredients and allergens in the medicine – see section 6
"Additional
information" and in section 2 "Important information about some of the
ingredients of
the medicine".
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains
concise information about the medicine. If you have any further
questions, ask the
doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if you think that their medical condition is the same as
yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is used for the secondary prevention of atherothrombotic
events within
blood vessels (heart attacks, stroke or vascular death) in patients
with
atherosclerosis, who had a myocardial infarction, ischemic stroke or
are suffering
from peripheral arterial disease, and in patients suffering from
unstable angina
pectoris, including patients undergoing implant of a stent by
catheterization and who
are taking aspirin (acetylsalicylic acid).
The medicine is used for the prevention of atherothrombotic and
thromboembolic
events (heart attacks, stroke, emboli or vascular death) in
combination with aspirin, in
patients suffering from atrial fibrillation type arrhythmia, who are
not suitable for
treatment with anticoagulant of the vitamin K antagonist medications
such as
warfarin, antithrombin or anti-factor Xa.
THERAPEUTIC GROUP: Platelet aggregation inhibitors, from the
thienopyridines group.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:

You are hypersensitive (allergic) to the active ingredient
(clopidogrel) or to any of
the other ingredients this medicine contains (see section 6).

You suffer from a medical condition that is currently causing
bleeding, such as:
stomach or duodenal ulcer, bleeding wit