Frumil 40mg/5mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Furosemide ; AMILORIDE HYDROCHLORIDE

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

C03EB; C03EB01

INN (International Name):

Furosemide ; AMILORIDE HYDROCHLORIDE

Dosage:

40mg /5 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

High-ceiling diuretics and potassium-sparing agents; furosemide and potassium-sparing agents

Authorization status:

Marketed

Authorization date:

1991-01-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FRUMIL® 40MG/5MG TABLETS_Furosemide _
_Amiloride Hydrochloride _
Is this leaflet hard to see or read?
Phone [phone] for help.
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 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 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.
WHAT IS IN THIS LEAFLET:
1. What Frumil Tablets are and what they are used for
2. What you need to know before you take Frumil Tablets
3. How to take Frumil Tablets
4. Possible side effects
5. How to store Frumil Tablets
6. Contents of the pack and other information
1.
WHAT FRUMIL TABLETS ARE AND WHAT THEY ARE USED FOR
WHAT FRUMIL TABLETS ARE
The name of your medicine is Frumil 40mg/5mg Tablets (called Frumil
Tablets throughout this
leaflet).
Frumil Tablets contain two different medicines called: furosemide and
amiloride hydrochloride. Both
belong to a group of medicines called diuretics (water tablets).
WHAT FRUMIL TABLETS ARE USED FOR
Frumil 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 FRUMIL TABLETS WORK
Frumil Tablets works 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 vessel, lungs, kidneys
or liver.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FRUMIL TABLETS
DO NOT TAKE FRUMIL TABLETS:
• You are allergic (hypersensitive) to furosemide, amiloride
hydrochloride or any of the other
ingredients of Frumil Tablets (listed in Section 6 below). Signs of an
allergic reaction include:

Summary of Product characteristics

Health Products Regulatory Authority
06 March 2024
CRN00F528
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Frumil 40mg/5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40 mg of furosemide and amiloride hydrochloride
equivalent to 5 mg of anhydrous amiloride
hydrochloride.
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Orange, circular, uncoated tablets, 8 mm in diameter, with a breakline
on one face and ‘FRUMIL’ on the reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Uses: In the management of fluid retention where potassium
conservation is desirable.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The route of administration is oral.
The tablets are to be swallowed whole with sufficient amounts of
liquid (approx. half a glass). They are best taken on an empty
stomach. The lowest possible dose should be used for treatment.
Recommended Dosage:
Adults: The usual adult dose is 1 tablet (40mg furosemide and 5 mg
amiloride) in the morning. This may be increased to 2
tablets if the initial response is unsatisfactory. In this case it is
best to divide the dosage into two daily doses, one to be taken in
the morning and the other at noon.
Elderly patients: The dosage should be adjusted according to diuretic
response. Extreme care should be taken with dosage in
the elderly as this patient group are more susceptible to serious side
effects associated with electrolyte disturbances.
4.3 CONTRAINDICATIONS
1.
Use in patients with Addison’s disease.
2.
Use in patients hypersensitive to the active ingredients, furosemide,
amiloride, sulfonamides or sulfonamide
derivatives, or any of the excipients of Frumil. Patients allergic to
sulfonamides may show cross-sensitivity to
furosemide.
3.
During pregnancy
4.
In breast-feeding women.
5.
Use in children.
6.
Use in patients with impaired renal function and a creatine clearance
below 30 ml/min per 1.73 m
2
body surface
area, acute renal failure or anuria.
7.
Use in patients with hyperkalemia
8.
Use in