Clopidogrel Sandoz Film Coated Tablet 75mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Clopidogrel bisulphate 97.875mg eqv Clopidogrel

Available from:

SANDOZ SINGAPORE PTE. LTD.

ATC code:

B01AC04

Dosage:

75mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Clopidogrel bisulphate 97.875mg eqv Clopidogrel 75mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Sandoz Private Limited

Authorization status:

ACTIVE

Authorization date:

2009-12-14

Summary of Product characteristics

CLOPIDOGREL SANDOZ FILM COATED TABLET 75MG
1.
NAME OF THE MEDICINAL PRODUCT
Clopidogrel Sandoz Film Coated Tablet 75 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains:
Clopidogrel (as hydrogen sulphate 97.875 mg) 75.00 mg
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink colored, round shaped, engraved with ‘SZ’ 75 on one side and
plain on other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_SECONDARY 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:
o
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).
o
ST segment elevation acute myocardial infarction, in combination with
ASA in
medically treated patients eligible for thrombolytic therapy.
_IN PATIENTS WITH MODERATE TO HIGH-RISK TRANSIENT ISCHEMIC ATTACK
(TIA) OR MINOR _
_ISCHEMIC STROKE (IS) _
Clopidogrel in combination with ASA is indicated in:

Adult patients with moderate to high-risk TIA (ABCD2
1
score
≥
4) or minor IS
(NIHSS
2
≤
3) within 24 hours of either the TIA or IS event.
1
Age, Blood pressure, Clinical features, Duration, and Diabetes
mellitus diagnosis
2
National Institutes of Health Stroke Scale
_PREVENTION OF ATHEROTHROMBOTIC AND THROMBOEMBOLIC EVENTS IN ATRIAL
FIBRILLATION _
In adult patients with atrial fibrillation (AF) 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, inclu