Warfarin Tablets 3mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

WARFARIN SODIUM

Available from:

Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta

ATC code:

B01AA03

INN (International Name):

WARFARIN SODIUM 3 mg

Pharmaceutical form:

TABLET

Composition:

WARFARIN SODIUM 3 mg

Prescription type:

POM

Therapeutic area:

ANTITHROMBOTIC AGENTS

Authorization status:

Authorised

Authorization date:

2019-03-26

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
WARFARIN TABLETS 1MG, 3MG, 5 MG
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
-
Keep the leaflet. You may need to read it again.
-
If you have any questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
•
It is important to take the correct dose. If you have difficulty, ask
someone to help you. If you
take the wrong dose or take too much, contact your doctor or
pharmacist (See Section 3).
•
Carry your warfarin record card with you ALL times. Always tell any
doctors, surgeons, nurses,
dentists or pharmacists that you are taking warfarin.
•
Warfarin can be affected by many other medicines including non
prescription medicines, herbal
remedies, vitamin and food supplements (See Section 2. ‘Taking other
medicines’). Do not
start taking any new medicine without checking it is safe to take it
with warfarin; especially
aspirin, ibuprofen and other NSAIDS (non steroidal anti-inflammatory
medicines), as these
can make you more likely to bleed.
•
Some foods and illnesses can affect warfarin treatment. Follow the
advice in section 2 ‘Things
which affect warfarin’.
•
If you have any signs or symptoms of bleeding, contact a doctor
straight away (See Section 4).
•
Seek medical help at once if you unable to stop any bleeding, you
fall, get hurt or hit your head.
IN THIS LEAFLET
1.
WHAT WARFARIN TABLETS ARE IS AND WHAT THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE WARFARIN TABLETS
3.
HOW TO TAKE WARFARIN TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE WARFARIN TABLETS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT WARFARIN TABLETS ARE AND WHAT THEY ARE USED FOR
Warfarin belongs to a group of medicines called anticoagulants. It is
use

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Warfarin Tablets 3 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 3.0 mg of warfarin sodium
Contains Lactose
Contains Sucrose
For excipients, see 6.1
3.
PHARMACEUTICAL FORM
Tablets
Flat bevelled edged, blue tablets engraved with company logo on one
side and with a breakline, and
A324 on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of systemic embolism in rheumatic heart disease and atrial
fibrillation. Prophylaxis and
treatment of venous thrombosis and pulmonary embolism. Transient
cerebral ischaemic attacks.
Prophylaxis of thromboembolism after insertion of prosthetic heart
valve.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
A baseline coagulation screen and liver function tests should be
performed before initiating warfarin
therapy.
Adults:
The typical induction dose is 10mg daily for 2 days but this should be
tailored to individual
requirements. The daily maintenance dose is usually 3 to 9mg taken at
the same time each day. The
exact maintenance dose depends on the prothrombin time or other
appropriate coagulation tests.
Control tests should be made at regular intervals and the maintenance
dose should be adjusted
according to the results obtained. Once the maintenance dose is
established, it is rarely necessary to
alter it.
If prothrombin time, reported as the international normalised ratio
(INR), is excessively prolonged,
the maintenance dose should be omitted. The INR should then be
measured 1 – 2 days later to ensure
that it is falling.
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In emergencies, anticoagulant therapy should be initiated with heparin
and warfarin together. Where
there is less urgency, as in patients disposed to or at special risk
of thromboembolism, anticoagulant
therapy may be initiated with warfarin alone.
Concomitant therapy with heparin affects the results of control tests,
and should be discontinued at
least six hours before the first test is carried out.
Elderly: As for adults, but