Furosemide 4mg/ml Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Furosemide

Available from:

SYRI Limited, t/a Thame Laboratories

ATC code:

C03CA; C03CA01

INN (International Name):

Furosemide

Dosage:

4 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Administration route:

oral use

Units in package:

Pack size: 100ml, 150ml and 300ml

Prescription type:

Product subject to prescription which may be renewed (B)

Manufactured by:

SYRI Limited t/a Thame Laboratories

Therapeutic group:

High-Ceiling Diuretic Sulfonamide

Therapeutic area:

Sulfonamides, plain; furosemide

Therapeutic indications:

Furosemide is indicated in all conditions requiring prompt diuresis in patients who are unable to take solid dose forms. Indications include cardiac, pulmonary, hepatic and renal oedema, peripheral oedema due to mechanical obstruction or venous insufficiency and hypertension

Authorization status:

Not marketed

Authorization date:

2015-10-23

Patient Information leaflet

2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
FUROSEMIDE
1. WHAT FUROSEMIDE IS AND WHAT IT IS USED FOR
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 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.
The name of your medicine is Furosemide 4
mg/ml,
8mg/ml or 10mg/ml Oral Solution but it will be
referred to as Furosemide throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1.
WHAT FUROSEMIDE IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
FUROSEMIDE
3.
HOW TO TAKE FUROSEMIDE
4.
POSSIBLE SIDE EFFECTS
5.
H
OW TO STORE FUROSEMIDE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
Furosemide belongs to a group of medicines called
diuretics or water tablets.
Furosemide can be used to remove the levels of
excess water in the body caused by heart, lung,
kidney, liver or blood vessel problems.
DO NOT TAKE FUROSEMIDE IF:

you are allergic (hypersensitive) to Furosemide,
sulphonamides or any other ingredients in this liquid
(listed in Section 6). The signs of an allergic reaction
include a rash, itching or shortness of breath

you have symptoms of weakness, difficulty in
breathing and light-headedness. This could be a
sign of having too little water in the body

you are dehydrated

you have been told by your doctor you have low
blood volume. Sign of low blood volume can include
your skin turning pale, feeling dizzy, faint or
nauseous and feeling very thirsty

you are not passing water (urine) at all or only a
small amount each day

you have kidney failure or liver problems

you have a severe change in blood salts, such as
very low potassium levels or

Summary of Product characteristics

Health Products Regulatory Authority
28 March 2019
CRN008JQJ
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Furosemide 4mg/ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is furosemide.
Each ml of oral solution contains 4mg furosemide.
_Excipients with known effect_:
Each ml of solution contains 0.2ml liquid maltitol (E965) and 83.2mg
ethanol (alcohol).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution
Clear, colourless to pale brown coloured solution with cherry flavour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Furosemide is indicated in all conditions requiring prompt diuresis in
patients who are unable to take solid dose forms.
Indications include cardiac, pulmonary, hepatic and renal oedema,
peripheral oedema due to mechanical obstruction or venous
insufficiency and hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The medication should be administered in the morning to avoid
nocturnal diuresis.
_Adults(more than 18 years of age):_
The usual initial daily dose is 40mg. This may be adjusted until an
effective dose is achieved.
_Elderly_
In the elderly, furosemide is generally eliminated more slowly. Dosage
should be titrated until the required response is
achieved.
_Paediatric population_
This product should not be used in children below 18 years of age (see
section 4.4).
This product should not be mixed with food or beverages before use.
METHOD OF ADMINISTRATION
For oral administration only
The syringe adaptor should be placed in the neck of the bottle and the
required dose should be drawn from the container into
the graduated oral syringe provided. The open end of the syringe
should be placed in the mouth of the patient, and the piston
slowly depressed to release the contents.
4.3 CONTRAINDICATIONS
Hypovolaemia or dehydration. Anuria. Renal failure with anuria not
responding to furosemide, or as a result of poisoning by
nephrotoxic or hepatotoxic agents, or associated with hepatic coma.
Severe