COUMADIN warfarin sodium 1mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

warfarin sodium, Quantity: 1 mg

Available from:

Viatris Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: stearic acid; magnesium stearate; maize starch; lactose; quinoline yellow aluminium lake; amaranth aluminium lake

Administration route:

Oral

Units in package:

500 tablets (hospital only), 50 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

COUMADIN is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension and pulmonary embolism. COUMADIN is indicated for the prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation. COUMADIN is not indicated in patients with lone atrial fibrillation who are less than 60 years of age with no risk factors (eg previous thromboembolism (TIA, ischaemic stroke), diabetes mellitus, hypertension) and an otherwise normal heart. COUMADIN is indicated for use as an adjunct in the treatment of coronary occlusion.

Product summary:

Visual Identification: Light tan coloured tablet, scored, embossed COUMADIN above break bar and "1" below.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

1992-10-13

Patient Information leaflet

COUMADIN
®
C
O
U
M
A
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I
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING COUMADIN?
COUMADIN contains the active ingredient warfarin. COUMADIN is used to
prevent blood from excessive clotting or forming harmful
clots. For more information, see Section 1. Why am I using COUMADIN?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE COUMADIN?
Do not use if you have ever had an allergic reaction to COUMADIN or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2.
What should I know before I use COUMADIN? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with COUMADIN and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE COUMADIN?
•
Follow your doctor’s directions exactly about how much COUMADIN to
take. Different people require different amounts of this
medicine, and the dosage is adjusted to suit you. Your doctor will
determine how much to take through blood tests.
•
COUMADIN should be taken at about the same time each day.
More instructions can be found in Section 4. How do I use COUMADIN? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING COUMADIN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
COUMADIN.
•
If you are going to have surgery, tell the surgeon or anaesthetist
that you are taking this medicine.
•
If you become pregnant while taking this medicine, tell your doctor
immediately.
•
If you are about to have any blood tests, tell your doctor that you
are taking this medicine.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking your medicine or lower the dosage without checking
with your doctor.
•
There ar

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
COUMADIN
®
_warfarin sodium _
1
NAME OF THE MEDICINE
Warfarin sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each COUMADIN tablet contains 1 mg, 2 mg or 5 mg of warfarin sodium as
the active ingredient.
Excipients of known effect: sugars as lactose and sulfites.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
COUMADIN 1 mg tablets are light tan coloured, scored, embossed
COUMADIN above break bar and “1”
below.
COUMADIN 2 mg tablets are lavender coloured, scored, embossed COUMADIN
above break bar and “2”
below.
COUMADIN 5 mg tablets are green coloured, scored, embossed COUMADIN
above break bar and “5” below.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
COUMADIN is indicated for the prophylaxis and/or treatment of venous
thrombosis and its extension and
pulmonary embolism.
COUMADIN is indicated for the prophylaxis and/or treatment of the
thromboembolic complications
associated with atrial fibrillation.
COUMADIN is not indicated in patients with lone atrial fibrillation
who are less than 60 years of age with no
risk factors (e.g. previous thromboembolism (TIA, ischaemic stroke),
diabetes mellitus, hypertension) and an
otherwise normal heart.
COUMADIN is indicated for use as an adjunct in the treatment of
coronary occlusion.
4.2
DOSE AND METHOD OF ADMINISTRATION
It cannot be emphasised too strongly that treatment of each patient is
a highly individualised matter.
COUMADIN, a narrow therapeutic range (index) drug, may be affected by
factors such as other drugs, dietary
Vitamin K and genetic variations in CYP2CP and VKORC1 enzymes. Dosage
should be controlled by
periodic determinations of International Normalised Ratio (INR) or
other suitable coagulation tests and the
condition being treated (see Section 4.2 DOSE AND METHOD OF
ADMINISTRATION - Administration)
The following ranges of INR may be considered for the following listed
conditions or procedures; however
prescribers should consult local clinical guidelines for curren