Warfarin Tablets 5mg

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 5 mg

Pharmaceutical form:

TABLET

Composition:

WARFARIN SODIUM 5 mg

Prescription type:

POM

Therapeutic area:

ANTITHROMBOTIC AGENTS

Authorization status:

Authorised

Authorization date:

2019-03-26

Patient Information leaflet

Page 1 of 7
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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of
11
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Warfarin Tablets 5 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5.0 mg of warfarin sodium
Contains Lactose
Contains Sucrose
For excipients, see 6.1
3.
PHARMACEUTICAL FORM
Tablets
Flat bevelled edged, pink tablets engraved with company logo on one
side and with a
breakline, and A325 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