Warfarin 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Warfarin sodium

Available from:

A A H Pharmaceuticals 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: 5025903004523

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

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Warfarin 1 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Warfarin Sodium 1 mg.
Excipients with known effect: 196.50 mg lactose anhydrous, 1.10 mg
quinoline yellow
(E104), 0.45 mg allura red (E129) and 0.20 mg indigotin (E132) per
tablet.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Warfarin 1 mg Tablets are brown, flat round tablets, with an 8.8 mm
diameter, plain on one
side and scored on the other, engraved with “W” above the score
and “1” underneath.
The tablet can be divided into equal halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Warfarin is indicated for the prophylaxis of systemic embolisation in
patients with
rheumatic heart disease and atrial fibrillation.
Warfarin is indicated for the prophylaxis after insertion of
prosthetic heart valves.
Warfarin is indicated for the prophylaxis and treatment of venous
thrombosis and
pulmonary embolism.
Warfarin is indicated for transient cerebral ischaemic attacks.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults and elderly patients: _The typical induction dose of warfarin
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 of warfarin is usually 3 to 9 mg taken at
the same time each day.
The exact maintenance dose for an individual is dependent 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 stabilised in the therapeutic range, 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 heparin t