Warfarin 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Warfarin sodium

Available from:

Torrent Pharma (UK) Ltd

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; GTIN: 5060623371890

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
GO/DRUGS/52
8085515-7803
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Keep this leaflet. You may need to read it again.If you have any
further questions, ask
your doctor pharmacist or nurse.
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 at 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, vitamins 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 drugs), 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 IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE WARFARIN
3.
HOW TO TAKE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT WARFARIN IS AND WHAT IT IS USED FOR
Warfarin belongs to a group of medicines called anticoagulants. It is
used to reduce the
clotting ability

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Warfarin 1 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1.10 mg Warfarin Sodium Clathrate equivalent to
1.0 mg
warfarin sodium.
Excipients with known effect:
Each Warfarin 1 mg tablet contains 54.20 mg of anhydrous lactose (see
section 4.4)
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Light brown coloured, circular flat,bevelled tablets with a breakline
on one
side. Tablet diameter 8 mm.‘W’ and ‘1’ engraved on breakline
side and plain
on the other side of the tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of systemic embolism in patients with rheumatic heart
disease and
atrial fibrillation.
Prophylaxis after insertion of prosthetic heart valves.
Prophylaxis and treatment of venous thrombosis and pulmonary embolism.
Transient attacks of cerebral ischaemia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and elderly patients: The typical induction dose is 10 mg daily
for 2
days
but
this
should
be
tailored
to
individual
requirements.
Baseline
prothrombin measurements (PT) should be taken before beginning therapy
with warfarin.
The daily maintenance dose is usually 3 to 9 mg taken at the same time
each
day. The exact maintenance dose depends on the prothrombin time or
other
appropriate coagulation tests.
The maintenance dose is omitted if the prothrombin time is excessively
prolonged. 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. 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.
Control is established with INR monitoring at regular intervals and
subsequent
warfarin
maint