Frumil

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Amiloride hydrochloride dihydrate 5mg;  ;  ; Furosemide 40mg

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Amiloride hydrochloride dihydrate 5 mg

Dosage:

40mg/5mg

Pharmaceutical form:

Tablet

Composition:

Active: Amiloride hydrochloride dihydrate 5mg     Furosemide 40mg Excipient: Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose Purified talc Sodium starch glycolate Sunset yellow FCF

Units in package:

Blister pack, 2 x 14 tablets, 28 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Olon SpA

Therapeutic indications:

Frumil is indicated for the treatment of cardiac failure, in patients who require diuretics plus potassium supplements, or potassium sparing diuretics.

Product summary:

Package - Contents - Shelf Life: Blister pack, - 28 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1988-07-14

Patient Information leaflet

FRUMIL®
1
FRUMIL
®
Furosemide (frusemide)
40mg/amiloride hydrochloride 5mg
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Frumil.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT FRUMIL IS USED
FOR
Frumil contains a combination of two
diuretics, furosemide (frusemide) and
amiloride as the active ingredients. A
diuretic helps reduce the amount of
excess fluid in the body by increasing
the amount of urine produced.
Frumil is used for the treatment of
heart failure. Heart failure means that
the heart muscle cannot pump blood
strongly enough to supply all the
blood needed throughout the body.
Heart failure is not the same as heart
attack and does not mean that the
heart stops. Heart failure may start
off with no symptoms, but as the
condition progresses, patients may
feel short of breath or may get tired
easily after light physical activity
such as walking. Some patients may
wake up short of breath at night.
Fluid may collect in different parts of
the body, often first noticed as
swollen ankles and feet.
The combination of active
ingredients in Frumil work by
making your kidneys pass more
water and salt whilst minimising
potassium loss.
Frumil may be taken alone or in
combination with other medicines to
treat your condition.
Your doctor may have prescribed
Frumil for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available with
a doctor's prescription.
This medicine is not addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE FRUMIL IF YOU HAVE:
•
CERTAIN KIDNEY PROBLEMS
•
LOW SODIUM

Summary of Product characteristics

New Zealand Data Sheet
Frumil – furosemide (frusemide) and amiloride hydrochloride
(anhydrous)
frumil-ccdsv12-dsv13-20jun22
Page 1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Frumil

40mg/5mg Tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Furosemide (frusemide) 40 mg and Amiloride hydrochloride 5 mg
(anhydrous).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Orange tablets with break-line; FRUMIL on reverse side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Frumil is indicated for the treatment of cardiac failure, in patients
who require diuretics plus
potassium supplements, or potassium sparing diuretics.
4.2
DOSE AND METHOD OF ADMINISTRATION
The
initial
adult
dose
is
one
tablet
(40
mg
furosemide
(frusemide)
and
5
mg
amiloride
hydrochloride) to be taken each morning. This may be increased to two
tablets daily 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. The total daily dose of
amiloride should not exceed
20 mg. The tablets are to be swallowed whole with sufficient amounts
of liquid (approximately
half a glass). They are best taken on an empty stomach.
New Zealand Data Sheet
Frumil – furosemide (frusemide) and amiloride hydrochloride
(anhydrous)
frumil-ccdsv12-dsv13-20jun22
Page 2
4.3
CONTRAINDICATION
_ _
Patients with hyperkalemia (serum potassium above 5.5 mmol per litre).
Patients with severe hypokalaemia. However, if hypokalaemia develops
during treatment it can
usually be corrected without interrupting administration of Frumil
(see Section 4.8).
Patients with hypovolaemia or dehydration.
Patients with impaired renal function and a creatinine clearance below
30 mL/min per 1.73 m
2
body surface area, acute renal failure or anuria.
Patients with severe hyponatraemia.
Patients with pre-comatose and comatose states associated with hepatic
encephalopathy.
Patients on concomitant potassium supplements.
Patients who are pregnant or breastfeeding.
Patients
with
a
h