Warfarin 1mg tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Warfarin sodium

Disponível em:

Sandoz Ltd

Código ATC:

B01AA03

DCI (Denominação Comum Internacional):

Warfarin sodium

Dosagem:

1mg

Forma farmacêutica:

Oral tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 02080200

Folheto informativo - Bula

Warfarin insert mock two
SAME SIZE ARTWORK
420 x 136 MM
Front
XXXXXXX
PACKAGE LEAFLET: INFORMATION FOR THE USER
WARFARIN 1 MG, 3 MG OR 5 MG TABLETS
Warfarin Sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Keep this leaflet. You may need to read it again. If you have any
questions, ask your doctor or
pharmacist. This medicine has been prescribed for you. Do not pass it
on to others. It may harm
them, even if their symptoms are the same as yours. •
It is important to take the correct dose. If you have difficulty, ask
someone to help you. If you
take the wrong dose or too much, contact your doctor or pharmacist
(see section 3). •
Carry your warfarin record card with you at ALL times. Always tell any
doctors, surgeons,
nurses, dentists pharmacists that you are taking warfarin. •
Warfarin can be affected by many other medicines including non
prescription medicines,
herbal remedies, vitamin and food supplements (see section 2 ‘OTHER
MEDICINES AND
WARFARIN TABLETS’). Do not start taking any new medicine without
checking it is safe to take
it with warfarin; especially aspirin, ibuprofen and other NSAIDS (non
steroidal anti-
inflammatory drugs), as these can make you more likely to bleed.
•
Some foods and illness can affect warfarin treatment. Follow the
advice in section 2 ‘Things
which affect warfarin’.
•
If you have any signs or symptoms of bleeding, contact a doctor
straight away (See
Section 4).
•
Seek medical help at once if you are unable to stop any bleeding, you
fall, get hurt or hit your
head.
WHAT IS IN THIS LEAFLET:
1. What Warfarin Tablets are and what they are used for
2. What you need to know before you take Warfarin Tablets
3. How to take Warfarin Tablets
4. Possible Side Effects
5. How to store Warfarin tablets
6. Contents of the pack and other information
1. WHAT WARFARIN TABLETS ARE AND WHAT THEY ARE USED FOR
Warfarin belongs to a group of medicines called anticoagulants. It is
used to reduce the clotti

Características técnicas

PRODUCT SUMMARY
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Warfarin 1mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Warfarin Sodium Clathrate 1.09 mg (equivalent to warfarin sodium 1mg)
3.
PHARMACEUTICAL FORM
Tablets
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Prophylaxis of systemic embolisation 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 cerebral ischaemic attacks.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults and elderly _
The usual starting dose of Warfarin is 10mg daily for 2 days. This
should,
however, be tailored to individual requirements.
The usual maintenance dose is between 3 to 9mg of warfarin a day,
taken at
the same time each day. The exact dose for an individual is dependent
on the
prothrombin time or other coagulation tests. Control tests must be
made at
regular intervals and Warfarin maintenance dosage further adjusted
according
to the results obtained.
Once the maintenance dose is stabilised in the therapeutic range, it
is rarely
necessary to alter it. If prothrombin time, reported as the
international
normalised ratio (INR), is excessively prolonged, the maintenance dose
should
be omitted. The INR should then be measured 1 – 2 days later to
ensure that it
is falling.
In emergency cases, 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 heparin therapy affects the results of control tests and
should be
discontinued at least six hours before the first test is carried out.
_Children _
The dose of Warfarin to be used in children has not yet been
established.
_ _
4.3
CONTRAINDICATIONS
•
Known hypersensitivity to warfarin or to any of the excipients.
•
Haemorrhagic stroke (see section 4.4 for further details).
•
Clinically sign