Warfarin 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Warfarin sodium

Available from:

Teva 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: 5017007390510 5017007390121

Patient Information leaflet

•
antibiotics such as amoxicillin, levofloxacin and
tetracycline
•
allopurinol (for gout)
•
capecitabine, erlotinib, tamoxifen (for types of
cancer)
•
disulfiram (for alcohol dependence)
•
ketoconazole, fluconazole, itraconazole (for
fungal infections)
•
omeprazole (for stomach ulcers)
•
propafenone, amiodarone, quinidine (for heart
disorders)
•
methylphenidate (for attention deficit disorder)
•
zafirlukast (for asthma)
•
bezafibrate, ciprofibrate, fenofibrate, gemfibrozil
(to reduce high blood fats)
•
statins such as fluvastatin to lower cholesterol
(but this does not include pravastatin)
•
erythromycin, sulfamethoxazole, metronidazole
(for bacterial infections)
•
orlistat (for obesity).
MEDICINES WHICH DECREASE THE EFFECT OF WARFARIN:
TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING:
•
barbiturates (sedatives)
•
primidone, phenytoin, carbamazepine (to treat
epilepsy)
•
griseofulvin (for fungal infections)
•
oral contraceptives (the ’Pill’)
•
rifampicin (for tuberculosis)
•
azathioprine (for inflammatory bowel disease and
rheumatoid arthritis and to prevent organ rejection)
•
sucralfate (for stomach ulcers)
•
colestyramine (for lowering cholesterol).
MEDICINES WHICH HAVE VARYING EFFECTS ON WARFARIN:
TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING:
•
corticosteroids (for inflammation and many other
diseases)
•
nevirapine, ritonavir (for HIV infection).
PREGNANCY AND BREAST-FEEDING
Do not take this medicine if you are pregnant, may
become pregnant or have had a baby within the
last 48 hours.
See your doctor straight away if you get pregnant
whilst taking this medicine.
Warfarin is unlikely to harm your baby during
breast-feeding, if taken at the correct dose.
DRIVING AND USING MACHINES
Warfarin has no known effect on the ability to drive
or operate machines.
IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS
•
If you have been told by your doctor that you
have an intolerance to some sugars, contact your
doctor before taking this medicine.
HOW TO TAKE
Always tak

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
Excipient with known effect:
Each tablet contains 96.67 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Brown tablet (diameter 8 mm) with WFN above and 1 below a breakline on
one side
and twin triangle on reverse.
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
Posology
ADULTS
Whenever possible, base-line prothrombin time should be determined
before the
initial dose is given. An initial loading dose for warfarin is usually
10mg daily for
adults, tailored to individual requirements for the desired degree of
anticoagulant
effect. The maintenance dose is usually started after 48 hours and
depends upon the
prothrombin time - reported as international normalised ratio (INR).
Currently
recommended ranges of therapeutic anticoagulation are the following:
Prophylaxis of deep-vein thrombosis including surgery in high risk
patients: INR 2-
2.5
Prophylaxis in hip surgery and fractured femur operations, treatment
of deep vein
thrombosis, pulmonary and systemic embolism, prevention of venous
thrombo-
embolism in myocardial infarction, transient ischaemic attacks, mitral
stenosis with
embolism, tissue prosthetic heart valves: INR 2-3
Recurrent deep-vein thrombosis and pulmonary embolism, mechanical
prosthetic
heart valves, arterial disease including myocardial infarction: INR
3-4.5
The daily maintenance dose, taken at the same time each day, is
usually between 3
mg and 9 mg. In the early days of treatment, INR should be determined
daily or on
alternative days, then, depending on response, determ