Furosemide 10 mg/ml oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Furosemide

Available from:

Syri Pharma Limited t/a Thame Laboratories

ATC code:

C03CA; C03CA01

INN (International Name):

Furosemide

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Therapeutic area:

Sulfonamides, plain; furosemide

Authorization status:

Not marketed

Authorization date:

2015-10-23

Patient Information leaflet

VAR/IA-013/RFI-I
1.3.1. Package Leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
FUROSEMIDE 4MG/ML ORAL SOLUTION
FUROSEMIDE 8MG/ML ORAL SOLUTION
FUROSEMIDE 10MG/ML ORAL SOLUTION
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 4mg/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. How to store Furosemide
6. Contents of the pack and other information
1. WHAT FUROSEMIDE IS AND WHAT IT IS USED FOR
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FUROSEMIDE
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 wat

Summary of Product characteristics

Health Products Regulatory Authority
29 January 2021
CRN009JM6
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Furosemide 10 mg/ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral solution contains 10mg furosemide.
_Excipients with known effect_:
Each ml of solution contains 276.8mg maltitol liquid and 79.87mg
ethanol (E1510).
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.
Health Products Regulatory Authority
29 Jan