Warfarin 3mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Warfarin sodium

Διαθέσιμο από:

Sun Pharmaceutical Industries Europe B.V.

Φαρμακολογική κατηγορία (ATC):

B01AA03

INN (Διεθνής Όνομα):

Warfarin sodium

Δοσολογία:

3mg

Φαρμακοτεχνική μορφή:

Oral tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 02080200; GTIN: 5060011720408 5060011720408

Φύλλο οδηγιών χρήσης

1. WHAT WARFARIN TABLETS ARE AND WHAT THEY ARE USED FOR
Warfarin Tablets belong to a group of drugs called anti-coagulants.
You take Warfarin Tablets to help thin
your blood if you have had a heart problem, problems with blood clots
or your blood flow. You may also be
given Warfarin Tablets if you have been fitted with a replacement
heart valve.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE WARFARIN TABLETS
DO NOT TAKE WARFARIN TABLETS IF YOU:
- are allergic to warfarin sodium or any of the other ingredients of
this medicine (listed in section 6)
- are pregnant, breast-feeding or planning to become pregnant
- have problems with your liver or kidneys
- have had an infection of the lining of your heart
- have a condition which causes bleeding (such as a peptic ulcer) or
makes you bruise easily
- have high blood pressure
- are taking the herbal remedy, St John’s Wort (Hypericum
perforatum) for depression
Do not take Warfarin Tablets within 24 hours of surgery or giving
birth to a child.
TALK TO YOUR DOCTOR IF YOU:
- plan to have any surgery or a dental procedure. Tell all of your
healthcare professionals and dentists that you
are taking Warfarin Tablets. They should talk to the healthcare
professional who prescribed Warfarin Tablets
for you. This should be done before you have any surgery or dental
procedure. Your Warfarin Tablets may
need to be stopped for a short time or you may need your dose
adjusted. Warfarin Tablets can affect your
anaesthetic or cause bleeding
- lose weight, have an acute illness, have kidney problems or increase
your intake of Vitamin K while taking
Warfarin Tablets, as your dose may need to be changed (see section 3).
OTHER MEDICINES AND WARFARIN TABLETS
Tell your doctor if you are taking, have recently taken or might take
any other medicines. Many drugs may
increase or decrease the effects of Warfarin Tablets. It is
particularly important to tell your doctor if you are
taking, or have recently taken any of the medicines listed below:
- drugs for heart problems (amiodarone, quinidine, propafen

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Warfarin 3 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 3.30 mg Warfarin Sodium Clathrate equivalent to
3.0 mg warfarin sodium.
Excipients with known effect:
Each Warfarin 3 mg tablet contains 52.50 mg of anhydrous lactose (see
section 4.4)
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Light blue coloured circular flat bevelled tablets with a breakline on
one side.
Tablet diameter 8 mm. ‘W’ and ‘3’engraved on breakline side
and ‘Plain’ on
the other side of tablet.
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 and elderly patients: The typical induction dose 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 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.
The maintenance dose is omitted if the prothrombin time is excessively
prolonged. 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. 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 therapy with heparin affects the results of control tests,
and
should be discontinued at least six hours before the first test is
carried out.
Control is established with INR monitoring at regular intervals and
subsequent
warfarin
maint