Marevan

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

WARFARIN SODIUM

Available from:

Mercury Pharma Group Limited No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, United Kingdom

ATC code:

B01AA03

INN (International Name):

WARFARIN SODIUM 1 mg

Pharmaceutical form:

TABLET

Composition:

WARFARIN SODIUM 1 mg

Prescription type:

POM

Therapeutic area:

ANTITHROMBOTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2006-08-11

Summary of Product characteristics

Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Marevan 1mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1mg warfarin sodium BP
Excipients with known effect:
Lactose: contains 96.700 mg lactose per tablet
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Brown
coloured,
flat,
circular,
bevel-edged
uncoated
tablets
having
‘M’
breakline ‘1’ on one side and plain on other side.
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 10mg daily for 2 days but this
should be
tailored to individual requirements. The daily maintenance dose is
usually 3 to
9mg 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
Page 2 of 13
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.
_Paediatric population_:_ _ Dosage for children has not been
established.
Method of administration: Oral.
4.3
CONTRAINDICATIONS
• Hypersensitivity to the active substance or to any of the
excipients listed in
section 6.1.
• Haemorrhagic stroke (see section 4.4 for further details)
• Clinically significant bleeding
•
Within
72
hours
of
major
surgery
with
risk
of
severe