Warfarin 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Warfarin sodium

Available from:

DE Pharmaceuticals

ATC code:

B01AA03

INN (International Name):

Warfarin sodium

Dosage:

1mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02080200

Patient Information leaflet

Warfarin insert mock two
SAME SIZE ARTWORK
420 x 136 MM
Front
XXXXXXX
PACKAGE LEAFLET: INFORMATION FOR THE USER
WARFARIN 1 MG, 3 MG OR 5 MG TABLETS
Warfarin Sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Keep this 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. •
It is important to take the correct dose. If you have difficulty, ask
someone to help you. If you
take the wrong dose or too much, contact your doctor or pharmacist
(see section 3). •
Carry your warfarin record card with you at ALL times. Always tell any
doctors, surgeons,
nurses, dentists 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 ‘OTHER
MEDICINES AND
WARFARIN TABLETS’). 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 drugs), as these can make you more likely to bleed.
•
Some foods and illness 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 are unable to stop any bleeding, you
fall, get hurt or hit your
head.
WHAT IS IN THIS LEAFLET:
1. What Warfarin Tablets are 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
used to reduce the clotti

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Warfarin Tablets 1 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1.0 mg of warfarin sodium
For excipients, see 6.1
3.
PHARMACEUTICAL FORM
Tablets
Flat bevelled edged, brown tablets engraved with company logo on one
side and with a breakline, and A338 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
Route of administration: Oral
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.
In emergencies, anticoagulant therapy should be initiated with heparin
and warfarin
together.
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 dosage may need to be lowered as the elderly are
generally
more sensitive to the effects of warfarin and often require a smaller
dose.
Children: Dosage for children has not been established.
4.3
CONTRA-INDICATIONS
Known hypersensitivity to warfarin or to any of the excipients.
Haemorrhagic stroke (see section 4.4 for further details).
Clinically significant bleeding.
Within 72 hours of major surgery with risk of severe bleeding (for
inf