Warfarin 5mg tablets

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Warfarin sodium

متاح من:

Mawdsley-Brooks & Company Ltd

ATC رمز:

B01AA03

INN (الاسم الدولي):

Warfarin sodium

جرعة:

5mg

الشكل الصيدلاني:

Oral tablet

طريقة التعاطي:

Oral

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 02080200

خصائص المنتج

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’
embossing on one side and ‘BL’ embossing 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 liste