Warfarin 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Warfarin sodium

Available from:

Bristol Laboratories Ltd

ATC code:

B01AA03

INN (International Name):

Warfarin sodium

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02080200; GTIN: 5060013941757

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 5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Warfarin Sodium 5 mg.
Excipients with known effect: Each tablet contains 139.00 mg of
lactose
monohydrate and 8.00 mg of sucrose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
Pink coloured, circular, flat faced bevelled edged uncoated tablet
with ‘5’ debossed
on one side and ‘BL’ debossed on the other.
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:
The typical induction dose is 10 mg daily for 2 days but this should
be tailored
to individual requirements. 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.
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. The elderly are
generally
more sensitive to the effects of warfarin and often require a smaller
dose.
Paediatric population:
Warfarin Tablets are not recommended for use in children due to
insufficient
data on safety and efficacy.
Method of administration
Oral.
4.3
CONTRAINDICATIONS
• Hypersensitivity to the active substance(s) or to any of the
excipients listed