Warfant 5 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

WARFARIN SODIUM

Available from:

Mercury Pharmaceuticals (Ireland) Ltd

ATC code:

B01AA; B01AA03

INN (International Name):

WARFARIN SODIUM

Dosage:

5 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Vitamin K antagonists; warfarin

Authorization status:

Marketed

Authorization date:

1995-10-17

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
WARFANT® 1MG, 3MG, 5MG TABLETS
warfarin sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or
nurse.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
This product will be referred to as Warfant Tablets from here on.
WHAT IS IN THIS LEAFLET
1. What Warfant Tablets are and what they are used for
2. What you need to know before you take Warfant Tablets
3. How to take Warfant Tablets
4. Possible side effects
5. How to store Warfant Tablets
6. Contents of the pack and other information
1. WHAT WARFANT TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Warfant 1mg, 3mg or 5mg Tablets and the
active ingredient is warfarin
sodium.
Warfarin belongs to a group of medicines called anticoagulants.
These medicines increase the time it takes for your blood to clot.
Warfarin is used to prevent and treat blood clots in the veins and
arteries, for example clots in the lungs or
heart.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE WARFANT TABLETS
DO NOT TAKE WARFANT TABLETS:
• if you are allergic to warfarin sodium or any of the other
ingredients of this medicine (listed in section
6).
• if you have had a stroke as a result of bleeding from a blood
vessel in the brain
• if you are pregnant or planning to become pregnant or have just
had a baby in the last 48 hours (please
see the Section on “Pregnancy, breast-feeding and fertility”)
• if you have had surgery in the last 72 hours
• if you are taking medicines that may increase your risk of
bleeding or other medicines that stop the
blood from clotting
• if you suffer

Summary of Product characteristics

Health Products Regulatory Authority
07 June 2022
CRN00CR56
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Warfant 5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains warfarin sodium clathrate equivalent to 5 mg
warfarin sodium.
Excipients with known effect:
Each tablet contains 122.69 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Round pink uncoated tablet, scored and marked ‘W5’ on one side
with company logo on reverse.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For prophylaxis against venous thrombosis and pulmonary embolism, and
for use in the treatment of these conditions to
prevent their extension. For the prophylaxis of systemic embolisation
in patients with rheumatic heart disease and atrial
fibrillation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
An initial daily dose of 10mg on the first two days. Subsequent daily
doses should be adjusted according to the results of the
prothrombin time or other appropriate coagulation tests. The single
daily maintenance requirement is usually between 5mg
and 12mg but can vary between 2mg and 30mg.
The maintenance dose is omitted if the prothrombin time is excessively
prolonged. Once the maintenance dose is stabilized in
the therapeutic range it is rarely necessary to alter it.
Doses of warfarin should be given at the same time each day.
_Elderly _
The elderly are generally more sensitive to the effects of warfarin
and often require a smaller dose on a weight for weight basis
than younger patients.
_Paediatric population_
Safety and efficacy of warfarin in children have not been established.
Method of administration
Warfant tablets are for oral administration.
4.3 CONTRAINDICATIONS
Health Products Regulatory Authority
07 June 2022
CRN00CR56
Page 2 of 10
• Hypersensitivity to the active substance or to any of the
excipients