Co-Amilofruse

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AMILORIDE HYDROCHLORIDE; FUROSEMIDE

Available from:

Wockhardt UK Limited

ATC code:

C03EB01

INN (International Name):

AMILORIDE HYDROCHLORIDE; FUROSEMIDE

Pharmaceutical form:

TABLET

Composition:

AMILORIDE HYDROCHLORIDE; FUROSEMIDE

Prescription type:

POM

Therapeutic area:

DIURETICS

Authorization status:

Authorised

Authorization date:

2006-08-18

Patient Information leaflet

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 TO TAKE THIS MEDICINE.  
− Keep this leaflet. You may need to read it 
again while you are receiving your 
treatment. 
− If you have any further questions, please 
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.
− If any of the side effects get serious, or if 
you notice any side effects not listed in 
this leaflet, please tell your doctor or 
pharmacist. 
IN THIS LEAFLET: 
1.  What Co-Amilofruse Tablets are and 
what they are used for
2.  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.  Further information 
1.  What Co-Amilofruse Tablets are and 
what they are used for
The name of your medicine is 
Co-Amilofruse Tablets. This is a medicine 
containing two active ingredients, amiloride 
hydrochloride and furosemide. Amiloride 
hydrochloride belongs to a group of 
medicines called potassium sparing 
diuretics which also remove excess water 
and prevent a reduction in potassium 
levels. Furosemide belongs to a group of 
medicines called loop diuretics which 
remove excess water from the body but can 
cause a reduction of potassium levels. 
Co-Amilofruse Tablets comes in three 
strengths and is used in the treatment of:
•  heart failure 
•  fluid retention in kidney disease
•  fluid retention due to liver disease
•  fluid retention due to treatment with 
steroids or hormones (oestrogens).
2.  Before you take Co-Amilofruse Tablets
YOU SHOULD NOT TAKE CO-AMILOFRUSE 
TABLETS IF YOU: 
•  are allergic (hypersensitive) to 
furosemide, amiloride hydrochloride or to 
any of the other ingredients in�

Summary of Product characteristics

Page 1 of 12 
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 

For excipients, see 6.1. 

3 
PHARMACEUTICAL FORM 

 Tablet for oral use. 

4      CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

Co-Amilofruse is indicated where a prompt diuresis is required especially in conditions 
where potassium conservation is important: congestive cardiac failure, nephrosis, fluid 
retention due to corticosteroid or oestrogen therapy and 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 

Co-amilofruse is contraindicated in the following circumstances 
•

Hypersensitivity to furosemide and/or amiloride, any of the product’s excipients, 
sulphonamides, sulphonamide derivatives 
•

Anuria and impaired renal function (creatinine clearance below 30mL/min per 1.73 m
2

body surface area) severe progressive renal disease, and renal failure resulting from 
poisoning by nephrotoxic and/or hepatotoxic agents 
•

Electrolyte disturbances (see also section 4.4) 
•

severe hyponatraemia 
Page 2 of 12 
•

severe hypokalaemia or hyperkalaemia (plasma potassium over 5.5 mmol/L) 
•

dehydration 
•

hypotension 
•

Concomitant potassium supplements or