Warfarin 5mg tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Warfarin sodium

Предлага се от:

Teva UK Ltd

АТС код:

B01AA03

INN (Международно Name):

Warfarin sodium

дозиране:

5mg

Лекарствена форма:

Oral tablet

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 02080200; GTIN: 5017007390817 5017007390329

Листовка

BEFORE YOU TAKE WARFARIN
DO NOT TAKE WARFARIN IF YOU:
•
are ALLERGIC to Warfarin or any of the other ingredients (see Section
6)
•
are PREGNANT or may become pregnant or have had a BABY IN THE LAST 48
HOURS
•
have or have ever had any BLEEDING PROBLEMS
•
have recently had a STROKE caused by bleeding in the brain
•
have had SURGERY within the last 72 hours or are going to have surgery
in the next 72 hours
•
are taking non-steroidal anti-inflammatory drugs (NSAIDS), ASPIRIN or
ANTI-CLOTTING MEDICINES as this may increase the risk of bleeding.
(See Section 2 ‘Taking other medicines’).
If any of these apply to you, do not take this medicine and go back to
your doctor to discuss your treatment.
CHECK WITH YOUR DOCTOR OR PHARMACIST BEFORE TAKING THESE TABLETS IF
YOU HAVE:
•
very HIGH BLOOD PRESSURE which is not controlled by medicines
•
a STOMACH OR DUODENAL ULCER or have ever had one
•
previously had GASTROINTESTINAL BLEEDING
•
had recent ISCHAEMIC STROKE (caused by blockage of blood vessels in
the brain)
•
an INFECTION OF THE HEART LINING (bacterial endocarditis)
•
problems with CIRCULATION OF BLOOD TO THE BRAIN (cerebrovascular
disease)
•
THYROID problems
•
severe HEART DISEASE, LIVER OR KIDNEY problems
•
have a condition making you PRONE TO BLOOD CLOTS (thrombophylia)
•
ANAEMIA (low haemoglobin causing extreme tiredness, breathlessness,
poor resistance to infection)
•
a TUMOUR OR CANCER
•
had a recent WOUND OR INJURY
•
a higher risk of bleeding, for example because you are over 65 years
of age or are unsteady on your feet and more likely to fall and injure
yourself.
If any of these apply to you, tell your doctor or pharmacist before
taking Warfarin, as you may need to be checked more often during
treatment.
REGULAR BLOOD TESTS
You will have regular blood tests to see how long it takes your blood
to clot. These blood tests are very important to make sure you are
taking the right
dose. Blood tests will be more frequent if have had your dose of
Warfarin changed, if you have st

Данни за продукта

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
Excipient with known effect:
Each tablet contains 92.80 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Pink tablet (diameter 8 mm) with WFN above and 5 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,
determina