Warfarin 1mg tablets

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Warfarin sodium

Доступна з:

Sun Pharmaceutical Industries Europe B.V.

Код атс:

B01AA03

ІПН (Міжнародна Ім'я):

Warfarin sodium

Дозування:

1mg

Фармацевтична форма:

Oral tablet

Адміністрація маршрут:

Oral

Клас:

No Controlled Drug Status

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 02080200; GTIN: 5060011720330 5060011720330

інформаційний буклет

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

Характеристики продукта

1.
NAME OF THE MEDICINAL PRODUCT
Warfarin Tablets 1 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1.0 mg of warfarin sodium
For excipients, see 6.1
3.
PHARMACEUTICAL FORM
Tablets
Flat bevelled edged, brown tablets engraved with company logo on one
side and with a breakline, and A338 on
the other side.
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
Route of administration: Oral
A baseline coagulation screen and liver function tests should be
performed before
initiating warfarin therapy.
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 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 as the elderly are
generally
more sensitive to the effects of warfarin and often require a smaller
dose.
Children: Dosage for children has not been established.
4.3
CONTRA-INDICATIONS
Known hypersensitivity to warfarin or to any of the excipients.
Haemorrhagic stroke (see section 4.4 for further details).
Clinically significant bleeding.
Within 72 hours of major surgery with risk of severe bleeding (for
inf