CLOPIDOGREL SANDOZ clopidogrel (as hydrogen sulfate) 75 mg film-coated tablet blister

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

clopidogrel hydrogen sulfate, Quantity: 97.875 mg (Equivalent: clopidogrel, Qty 75 mg)

Available from:

Sandoz Pty Ltd

INN (International Name):

clopidogrel hydrogen sulfate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: hyprolose; hydrogenated vegetable oil; mannitol; microcrystalline cellulose; titanium dioxide; hypromellose; iron oxide red; macrogol 400; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; industrial methylated spirit; iron oxide black; Shellac; sulfuric acid; ammonia; strong ammonia solution; ethanol

Administration route:

Oral

Units in package:

28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease.

Product summary:

Visual Identification: Pink colored film coated round shaped tablets with SZ/75 imprinted on one side and plain on other side; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2009-11-25

Patient Information leaflet

CLOPIDOGREL SANDOZ
®
1
CLOPIDOGREL SANDOZ
®
_clopidogrel hydrogen sulfate film-coated tablets _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Clopidogrel Sandoz.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CLOPIDOGREL
SANDOZ IS USED FOR
This medicine is used to reduce
blood clots forming and to reduce the
risk of heart attack, stroke or death in
patients who have previously
suffered a heart attack, stroke or have
a condition known as peripheral
arterial disease (leg pain when
walking or at rest).
This medicine contains the active
ingredient clopidogrel. Clopidogrel
belongs to a group of medicines
called anti-platelet medicines.
It works by preventing blood clots to
form in hardened blood vessels. This
process is called atherothrombosis
and can lead to events such as stroke,
heart attack or death.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
CLOPIDOGREL SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
clopidogrel, the active ingredient,
or to any of the other ingredients
listed at the end of this leaflet
under 'Product description'.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT TAKE THIS MEDICINE IF YOU
HAVE OR HAVE HAD:
•
severe liver disease
•
a medical condi

Summary of Product characteristics

200916-Clopidogrel Sandoz-pi
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
CLOPIDOGREL SANDOZ
® (CLOPIDOGREL HYDROGEN SULFATE)
FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Clopidogrel hydrogen sulfate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Clopidogrel Sandoz
®
75 mg film-coated tablets contains 75 mg clopidogrel hydrogen
sulfate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Clopidogrel Sandoz 75 mg film-coated tablets: Pink coloured
film-coated round shaped tablets
with
75
SZ
imprinted on one side and plain on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Prevention
of
vascular
ischaemia
associated
with
atherothrombotic
events
(myocardial
infarction, stroke and vascular death) in patients with a history of
symptomatic atherosclerotic
disease.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_ADULTS _
Generally, clopidogrel should be given as a single daily dose of 75
mg.
METHOD OF ADMINISTRATION
Clopidogrel should be taken once a day with or without food.
DOSAGE ADJUSTMENT IN:

Elderly
No dosage adjustment is necessary for either elderly patients or
patients with renal impairment.
(See Section 5.2 Pharmacokinetic properties).

Children and Adolescents
Safety and efficacy in subjects below the age of 18 have not been
established.

Pharmacogenetics
CYP2C19 poor metaboliser status is associated with diminished
antiplatelet response to
clopidogrel. Although a higher dose regimen in poor metabolisers
increases antiplatelet
response (see Section 5.2 Pharmacokinetic properties –
Pharmacogenetics), an appropriate
dose regimen for this patient population has not been established in
clinical outcome trials.
200916-Clopidogrel Sandoz-pi
Page 2 of 20
Consider alternative treatment or treatment strategies in patients
identified as CYP2C19 poor
metabolisers.
4.3
C
ONTRAINDICATIONS
•
Hypersensitivity to clopidogrel or any of the excipients.
•
Severe liver impairment.
•
Active pathological bleeding such as peptic ulcer and intracranial
haemo