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FUROSEMIDE 10 MG/ML SOLUTION FOR INJECTION/INFUSION

Active substance(s): FUROSEMIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

D01720

Furosemide 10mg/ml
Solution for Injection / Infusion
Furosemide/Frusemide
Read all of this leaflet carefully before you are given
Furosemide Injection.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor
or nurse.
• If any of the side effects become serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or nurse.

If any of the above applies to you or your child, please
consult your doctor.
Taking other medicines
Please tell your doctor or nurse if you are taking or have recently
taken any other medicines, including those obtained without
prescription.

Furosemide Injection is used to remove excessive amounts of
fluid present in the arms and legs, heart, lungs, kidney and liver. It
can also be used to treat heart failure, high blood pressure
(hypertension) or a reduction in the volume of urine due to
kidney problems (oliguria). It is used when oral products are not
suitable or for emergency treatment.

The action of Furosemide Injection may affect or be affected by a
number of medicines such as the following;
• medicines used to treat heart conditions (antiarrhythmics)
e.g. mexiletine, quinidine and cardiac glycosides
• medicines used to treat chest pain e.g. nitrates
• medicines used to treat high blood pressure e.g. adrenergic
neurone blockers, alpha blockers, beta blockers, ACE
inhibitors and calcium channel blockers.
• medicines that help you to sleep (hypnotics) such as chloral
and triclofos.
• medicines used to treat serious mental disorders e.g. lithium
and phenothiazines
• medicines used to treat schizophrenia (a serious mental
disorder) e.g. amisulpride and sertindole
• medicines used to treat epilepsy (fits) such as
acetazolamide and carbamazepine
• medicines used to treat depression e.g. tricyclic
antidepressants, monoamine oxidase inhbitors (MAOI’s) and
reboxetine
• medicines used to increase the volume of urine e.g.
bumetanide and thiazides
• medicines used to treat infection e.g. aminoglycosides,
polymyxins and vancomycin
• medicines used in the treatment of multiple sclerosis (MS)
such as tizanidine and baclofen
• medicines used to treat cancer e.g. aminoglutethimide,
aldesleukin and platinum compounds such as oxaliplatin
• medicines used to treat parkinsons e.g. levodopa
• medicines used to treat inflammation such as indometacin,
ketorolac, corticosteroids and NSAIDs (non-steroidal antiinflammatory drugs)
• moxisylyte (a medicine used to improve circulation)
• theophylline (a medicine used to treat asthma)
• terfenadine (a medicine used to treat erectile dysfunction)
• medicines used to treat diabetes
• oral contraceptives (birth control) or other medicines
containing oestrogen
• general anaesthetics.

2. Before you are given Furosemide Injection

If you have any doubts about whether this medicine should
be given to you, consult your doctor or nurse.

The active ingredient in this medicine is Furosemide. This is the
new name for Frusemide. The ingredient itself has not changed.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Furosemide Injection is and what it is used for
Before you are given Furosemide Injection
How Furosemide Injection is given
Possible side effects
Storing Furosemide Injection
Further information

1. What Furosemide Injection is and what it is
used for
Your medicine is called 'Furosemide 10mg/ml Solution for
Injection/Infusion'. It will be referred to throughout this leaflet as
'Furosemide Injection'.
Furosemide belongs to a group of medicines called loop diuretics
which remove water from the tissues by increasing the amount
of urine passed.

You should not be given Furosemide Injection if:
• you are allergic (hypersensitive) to furosemide or any of the
ingredients in the product listed in section 6 of this leaflet.
• you are allergic to a type of antibiotic known as sulphonamides
• you are suffering from kidney failure
• you are unable to produce and pass urine
• you have any problems with your liver
• you are pregnant
• you have lack of salts in your body
• you suffer from porphyria (a blood disease)

Using Furosemide Injection with food and drink
You are advised not to drink alcohol whilst you are being treated
with Furosemide

Take special care with Furosemide Injection:
Tell your doctor if:
• you are suffering from a loss or likely to suffer from lack of
fluids in the body
• you are diabetic
• you have gout
• you have an enlarged prostate gland
• you are breast-feeding
• you have liver or kidney problems
• you have problems with your adrenal glands

Effects on the ability to drive and use machines
You may be less alert than usual, have blurred vision or dizziness
due to the Furosemide Injection, so you should not drive or
operate machinery until the doctor sees how the medicine affects
you.

Pregnancy and breast-feeding
Furosemide Injection should not be used if you are pregnant. It
should be used with special care if you are breast-feeding. If you
are pregnant, think you may be pregnant or you are breastfeeding, you should consult your doctor if you are to be given or
have been given this medicine.

3. How Furosemide Injection is given
Your doctor or nurse will inject Furosemide Injection into a
muscle (intramuscularly) or into a vein (intravenously).
Furosemide will always be injected slowly.
Adults
Your doctor or nurse will decide on the correct dose for you but
usual initial doses are 20 - 50mg by intramuscular or slow
intravenous injection. If larger doses are required the injection
will be given to you as a slow infusion (drip). An infusion rate of
4mg per minute should not be exceeded. Your doctor or nurse
will adjust the dose according to its effects
For the treatment of difficulty in passing urine:
250mg may be given over the first hour. If the desired response
is not achieved within the next hour a further 500mg may be
given over the next 2 hours. If the desired response is still not
achieved within the next hour a further 1g may be given over the
next four hours. If a satisfactory response is still not achieved
your doctor may treat you using kidney dialysis. An effective dose
up to 1g may be repeated every 24 hours.
The elderly
The recommended dose is the same as for adults. Your doctor or
nurse may adjust your dose until the required effect is achieved
as this drug leaves the body more slowly in the elderly.
Children
Usual dosage ranges from 0.5 - 1.5mg/kg body weight daily up to
a maximum total daily dose of 20mg.
If you are given too much Furosemide Injection
If you are at all concerned that you have been given too much of
this medicine please tell your doctor immediately.

4. Possible side effects
Like all medicines, Furosemide Injection can cause side effects,
although not everybody gets them.
Side effects which you need to tell your doctor about
immediately:
• fever
• bruising easily
• sore throat
• repeated infections
• skin rashes
The above are signs of an allergic (hypersensitive) reaction and a
condition called bone marrow depression. If you experience any
of the above tell your doctor immediately as your treatment with
Furosemide should be discontinued.
Most common side effects:
• headache
• low blood pressure
• dry mouth
• thirst
• weakness
• drowsiness
• muscle cramps
• tiredness
• decrease in passing urine
• disorders of heart rhythm may occur

Less common side effects:
• feeling sick
• stomach upset
• an increase of amount of uric acid in your blood
• gout (often felt as a severe pain in a joint)
• high level of sugar in blood
• increase in the amount of cholesterol and triglyceride (a
type of fat) in the blood
Rare side effects:
• skin rashes
• sensitivity to light
• blurred vision
• dizziness
• headache
• inflammation of blood vessels, kidney or pancreas
• very low calcium levels in the blood
• ringing in the ears
• loss of hearing
Side effects in premature babies:
• build up of calcium in kidney has been reported.
Other side effects:
You may not know if you have some of the side effects. Your
doctor may need to do tests.
If any of the side effects become serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or nurse.

5. Storing Furosemide Injection
Keep out of the reach and sight of children.
This product has an expiry date on the ampoule and carton
labels. The doctor or nurse will check that the product has not
passed this date. Any product that has passed this date must be
returned to a pharmacist for safe disposal.
Do not store above 25°C. Keep in the outer carton.

6. Further Information
What Furosemide Injection contains
The active ingredient is furosemide 10mg/ml
The other ingredients are sodium chloride, water for Injections
and sodium hydroxide.
What Furosemide Injection looks like and contents of
the pack
Furosemide Injection is a clear almost colourless solution
presented in 2ml or 5ml clear glass ampoules in packs of 10
ampoules.
Marketing Authorisation Holder and Manufacturer
Martindale Pharmaceuticals Ltd
Bampton Road
Romford Essex RM3 8UG
Product licence number: PL 01883/0045
Date of revision: November 2011

D01720

Continued overleaf

100mm Measurement Verification Bar

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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