Co-Amilofruse 5mg/40mg Tablets

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Ingredientes activos:

AMILORIDE HYDROCHLORIDE, FUROSEMIDE

Disponible desde:

Pinewood Laboratories Limited Ballymacarbry, Clonmel, Co. Tipperary, Ireland

Código ATC:

C03EB01

Designación común internacional (DCI):

AMILORIDE HYDROCHLORIDE 5.68 mg FUROSEMIDE 40 mg

formulario farmacéutico:

TABLET

Composición:

AMILORIDE HYDROCHLORIDE 5.68 mg FUROSEMIDE 40 mg

tipo de receta:

POM

Área terapéutica:

DIURETICS

Estado de Autorización:

Withdrawn

Fecha de autorización:

2006-08-18

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
CO-AMILOFRUSE 2.5MG/20MG TABLETS
CO-AMILOFRUSE 5MG/40MG TABLETS
CO-AMILOFRUSE 10MG/80MG TABLETS
Amiloride Hydrochloride and Furosemide
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, please ask your doctor or
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.
See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Co-Amilofruse Tablets are and what they are used for
2.
What you need to know before you take Co-Amilofruse Tablets
3.
How to take Co-Amilofruse Tablets
4.
Possible side effects
5.
How to store Co-Amilofruse Tablets
6.
Contents of the pack and other information
1.
WHAT CO-AMILOFRUSE TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Co-Amilofruse Tablets. Co-Amilofruse
Tablets contain two different medicines called:
furosemide and amiloride hydrochloride. Both belong to a group of
medicines called diuretics (water tablets).
WHAT CO-AMILOFRUSE TABLETS ARE USED FOR
Co-Amilofruse Tablets can be used to stop the build up of extra water
in your body. This extra water can cause swollen
ankles, shortness of breath and feeling more tired than usual.
HOW CO-AMILOFRUSE TABLETS WORK
Co-Amilofruse Tablets work by helping you to pass more water (urine)
than you usually do. If the extra water in your
body is not removed, it can put extra strain on the heart, blood
vessels, lungs, kidneys or liver.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-AMILOFRUSE TABLETS
DO NOT TAKE CO-AMILOFRUSE TABLETS IF:

You are allergic to furosemide, amiloride hydrochloride, sulphonamides
(such as sulfadiazine or co-trimoxazole) or to
any of the other ingredients of this medi

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Co-Amilofruse 5mg/40mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Furosemide 40mg
Amiloride Hydrochloride (dihydrate) 5.68mg
Excipient with known effect:
Lactose: 84.6mg per tablet
Sunset Yellow FCF: 0.2mg per tablet
Sodium: 0.2mg per tablet
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet for oral use.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Co-Amilofruse is a potassium sparing diuretic which is indicated where
a
prompt diuresis is required. It is of particular value in conditions
where
potassium conservation is important: congestive cardiac failure,
nephrosis,
corticosteroid therapy, oestrogen therapy and for ascites associated
with
cirrhosis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The starting dose is usually 40/5mg, subsequent dosage being adjusted
to suit
the needs of the patient.
_Adults: _
One to two tablets to be taken in the morning.
_Children: _
Not indicated for children under 18 years of age.
_ Elderly: _
The dosage should be adjusted according to diuretic response. Serum
electrolytes and urea should be carefully monitored.
4.3
CONTRAINDICATIONS
Patients with hypovolaemia or dehydration (with or without
accompanying
hypotension). Patients with an impaired renal function and a
creatinine
clearance below 30ml/min per 1.73 m body surface area, anuria or renal
failure
with anuria not responding to furosemide, renal failure as a result of
poisoning
by nephrotoxic or hepatotoxic agents or renal failure associated with
hepatic
coma, hyperkalaemia, severe hypokalaemia (see section 4.8), severe
hyponatraemia, concomitant potassium supplements or potassium sparing
diuretics, precomatose states associated with cirrhosis, Addison's
disease,
and breast feeding women.
Co-amilofruse is contraindicated in children and adolescents under 18
years of
age as safety in this age group has not yet been established.
Hypersensitivity to furosemide, amiloride, sulphonamides or
sulphonamide
derivatives, or