Warfarin Teva 1 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Warfarin sodium clathrate

Available from:

Sun Pharmaceutical Industries Europe B.V.

ATC code:

B01AA; B01AA03

INN (International Name):

Warfarin sodium clathrate

Dosage:

1 milligram(s)

Pharmaceutical form:

Tablet

Administration route:

Oral use

Units in package:

blisters containing 10, 20, 28, 30, 50, 56 or 100 tablets; bottles containing 100 tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic group:

Antithrombotic agent (Vitamin K Antagonist)

Therapeutic area:

Vitamin K antagonists; warfarin

Therapeutic indications:

It is indicated for the prophylaxis of venous thrombosis and pulmonary embolism, and for use in the treatment of these conditions to prevent their extension and for the prophylaxis of systemic embolisation in patients with rheumatic heart disease and atrial fibrillation.

Authorization status:

Marketed

Authorization date:

2007-10-26

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
WARFARIN TEVA
0.5 MG, 1 MG, 2 MG, 2.5 MG, 3 MG, 5 MG, 6 MG, 7.5 MG AND 10 MG 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 further questions, please ask your doctor or your
pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What
WARFARIN TEVA TABLETS
are and what they are used for
2.
What you need to know before you take
WARFARIN TEVA TABLETS
3.
How to take
WARFARIN TEVA TABLETS
4.
Possible side effects
5.
How to store
WARFARIN TEVA TABLETS
6.
Contents of the pack and other Information
1.
WHAT WARFARIN TEVA TABLETS ARE AND WHAT THEY ARE USED FOR
Warfarin Teva Tablets contain an active substance called warfarin
which belongs to a group of
drugs called anticoagulants. They thin the blood and help prevent
blood clots from forming in the
heart and blood vessels.
You may be given Warfarin Teva Tablets to prevent or treat problems
with blood clots in the veins.
You may also be given Warfarin Teva Tablets to prevent problems with
blood clots in the heart, if
your heartbeat is irregular and your heart valves are damaged.
Warfarin Teva Tablets are not suitable for treating children.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE WARFARIN TEVA TABLETS
DO NOT TAKE WARFARIN TEVA TABLETS
-
if you are allergic to warfarin or to any of the other ingredients in
the tablets (listed in section
6)
-
if you are pregnant or you think that you may be pregnant
-
if you have just had a baby (within the last two days)
-
if you have had any bleeding problems including a stroke
-
if you have had major surgery less than three days ago or if you are
due to have an op

Summary of Product characteristics

Health Products Regulatory Authority
15 January 2022
CRN00CQWJ
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Warfarin Teva 1 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains warfarin sodium clathrate equivalent to 1 mg
warfarin sodium.
Excipients with known effect: 197.6mg of lactose anhydrous and 0.20 mg
of E129 (allura red AC).
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Brown, flat, capsule shaped, scored tablet with ‘WARFARIN’ on top
of ‘TARO’ engraved on one side and ‘1’ on the other side.
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
Warfarin is indicated in adults.
Warfarin is indicated for the prophylaxis of venous thrombosis and
pulmonary embolism, and for use in the treatment of these
conditions to prevent their extension.
Warfarin is indicated for the prophylaxis of systemic embolisation in
patients with rheumatic heart disease and atrial fibrillation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The usual induction dose of warfarin is 10mg daily for 2 days, but
this should be tailored to individual requirements. A baseline
coagulation screen and liver function tests should be performed before
initiating warfarin therapy. Subsequent daily doses
should be adjusted according to the results of the prothrombin time,
usually reported as the INR (international normalised
ratio).
The daily maintenance dose of warfarin is usually in the range 3 to
9mg, taken at the same time each day. The maintenance
dose is omitted if the INR is excessively high.
_Paediatric population_
The safety and efficacy of warfarin in children have not been
established.
_Elderly patients_
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.
In emergencies, anticoagulant therapy should be initiated with heparin