Warfarin Rosemont 1 mg/1 ml Oral Suspension

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

WARFARIN SODIUM

Disponible desde:

Rosemont Pharmaceuticals Ltd

Código ATC:

B01AA; B01AA03

Designación común internacional (DCI):

WARFARIN SODIUM

Dosis:

1 milligram(s)/millilitre

formulario farmacéutico:

Oral suspension

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Vitamin K antagonists; warfarin

Estado de Autorización:

Not marketed

Fecha de autorización:

2011-11-18

Información para el usuario

WARFARIN ROSEMONT 1MG/1ML ORAL SUSPENSION MODULE 1.3.1 IE - LEAFLET
VERSION: MARCH 2018
PAGE 1
PACKAGE LEAFLET: INFORMATION FOR THE USER
WARFARIN ROSEMONT 1MG/1ML ORAL SUSPENSION
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 or your pharmacist.

This medicine has been prescribed only for you. 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. See section 4.
IN THIS LEAFLET
1.
What warfarin is and what it is used for
2.
What you need to know before you take warfarin
3.
How to take warfarin
4.
Possible side effects
5.
How to store warfarin
6.
Contents of the pack and other information
1. WHAT WARFARIN IS AND WHAT IT IS USED FOR
The name of your medicine is Warfarin Rosemont 1mg/1ml Oral Suspension
(called
warfarin in this leaflet). Warfarin belongs to a group of medicines
called
anticoagulants. It is used to thin your blood and prevent your blood
from clotting.
If you are seeing another doctor or are going to the hospital, tell
them that you are
taking warfarin. They may want to contact your doctor.
2. BEFORE YOU TAKE WARFARIN
DO NOT TAKE WARFARIN IF:

you are allergic to warfarin or any of the other ingredients of this
medicine
(listed in Section 6). An allergic reaction can include swelling of
your face,
lips, tongue or throat, difficulty breathing or swallowing, severe
itching of your
skin with raised lumps

you have severe uncontrollable bleeding

you have had a stroke_ _as a result of bleeding from a blood vessel in
the brain

you are pregnant, planning to become pregnant or have just had a baby
in the
last 48 hours (please see Section 2 “Pregnancy and
breast-feeding”)

you have had surgery in the last 72 h

Ficha técnica

Health Products Regulatory Authority
12 October 2018
CRN008L33
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Warfarin Rosemont 1 mg/1 ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml of suspension contains Warfarin Sodium 1mg.
Excipients with known effect:
Liquid Maltitol
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral suspension.
A white to off-white suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicine is indicated in adults for:
· Prophylaxis of systemic embolism in patients with rheumatic heart
disease and
atrial fibrillation.
· Prophylaxis after insertion of prosthetic heart valves.
· Prophylaxis of venous thrombosis and pulmonary embolism and for use
in the
treatment of these conditions to prevent their extension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
A baseline coagulation screen and liver function tests should be
performed before
initiating warfarin therapy.
Adults: The typical induction dose is 10 mg daily for 2 days but this
should be
tailored to individual requirements.
The daily maintenance dose is usually 3 to 9 mg taken at the same time
each day.
The exact maintenance dose depends on the prothrombin time, usually
reported as
the INR (international normalised ratio), 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
Health Products Regulatory Authority
12 October 2018
CRN008L33
Page 2 of 14
established, it is rarely necessary to alter it (see Section 4.4
Commencement of
Therapy).
In emergencies, anticoagulant therapy should be initiated with heparin
and warfarin
together.
Elderly: As for adults, but dosage may need to be lowered. The elderly
are generally
more sensitive to the effects of warfarin and often require a smaller
dose.
Paediatric population:
Dosage for children has not been established. Warfarin 1mg/ml Oral
Suspension is
no