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FUROSEMIDE INJECTION 10MG IN 1ML

Active substance(s): FUROSEMIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Furosemide Injection 10mg in 1ml
Frusemide Injection 10mg in 1ml
(Furosemide/Frusemide)
Read all of this leaflet carefully before you use Furosemide
Injection.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or
pharmacist.
• 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
pharmacist.
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 having 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
Furosemide belongs to a group of medicines called loop diuretics
which remove water from the tissues by increasing the amount of
urine passed.
Furosemide Injection is used to remove excessive amounts of fluid
present in the heart, lungs, kidneys and liver.

2. Before having Furosemide Injection
You should not be given Furosemide Injection if you are:
• allergic (hypersensitive) to Furosemide or any of
ingredients listed in section 6 of this leaflet
• allergic to a type of antibiotic known as sulphonamides
• suffering from kidney failure
• unable to produce and pass urine
• suffering from any problems with your liver
• pregnant
• suffering from low blood volumes
• suffering from a loss or lack of water in your body tissues
(dehydration)
Take special care with Furosemide Injection if you are:
• suffering from a loss or likely to suffer from a lack of
fluids in the body
• suffering from an enlarged prostate gland
• diabetic
• suffering from gout
• suffering from problems in passing urine
• suffering from low blood pressure
• suffering from a decrease in the amount of proteins in your
blood
• breast-feeding
Special care should be taken if your premature baby is given
this medicine.
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

The following medicines may affect or be affected by the
action of Furosemide Injection:
• medicines used to treat bacterial infections (antibiotics) e.g.
neomycin, vancomycin or any of the cephlosporins
• medicines for pain relief (non-steroidal anti-inflammatory
agent) e.g. aspirin and ibuprofen
• medicines to reduce inflammation and pain (corticosteroids)
e.g. betamethasone, hydrocortisone and prednisolone
• carbamazepine, used to treat a number of disorders including
epilepsy and certain mental conditions
• aminoglutethimide, used to treat breast cancer
• medicines to treat diabetes
• medicines to treat tumours eg. cisplatin
• medicines used to raise low blood pressure (pressor amines)
e.g. tyramine, dopamine, serotonin and noradrenaline
The activity of the following medicines may be increased by
Furosemide Injection:





salicylates, used to treat muscle and joint disease
phenytoin, used in the treatment of epilepsy
theophylline, used to treat asthma
curare type muscle relaxants, used during major surgical
procedures

If you have any doubts about whether this medicine should be
administered to you, consult your doctor or nurse.
Pregnancy & 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.
Effects on the ability to drive and use machines
You may be less alert than usual due to the Furosemide Injection,
so you should not drive or operate machinery until the doctor sees
how the medicine affects you.

3. How Furosemide Injection is given
Your doctor or nurse will administer the injection into a vein.
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 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.
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 to 1.5mg/kg body weight daily up to
a maximum total daily dose of 20mg
Patients with severe kidney problems
It is recommended that an infusion rate of 2.5mg/min is not
exceeded.
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.

Other medicines which may interact with Furosemide Injection:
The dose of the following medicines may need to be adjusted
if taken together with Furosemide Injection:
• medicines used to treat heart conditions (cardiac glycosides)
eg. digoxin
• medicines used to lower blood pressure e.g. hydralazine,
methyldopa
• lithium, a drug used to treat mood disorders
The dose of Furosemide Injection may need to be reduced or
stopped before using:
• ACE inhibitors to lower your blood pressure e.g. ramipril.
Continued overleaf

4. Possible side effects

5. Storing Furosemide Injection

Like all medicines, Furosemide Injection can cause side effects,
although not everybody gets them:

Keep out of the reach and sight of children.

Side effects which you need to tell your doctor about
immediately:
• fever
• bruising easily
• sore throat
• repeated infections
• skin rashes,
• inflammation in your kidneys
• shock.
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.
Mild side-effects that do not normally require you to stop your
medicine.
• feeling sick (nausea)
• feeling unwell
• stomach upset
Other side effects include:
• itching
• red skin rash with itching (urticaria)
• skin raised with little water sacs (bullous lesions)
• abnormal redness of the skin(erythema multiforme)
• red scaling of the skin (exfoliative dermatitis)
• discoloration in the skin (purpura)
• decrease in the number of platelets in the blood
(thrombocytopenia)
• low blood pressure
• increase in the amount of cholesterol and triglyceride (a type of
fat) in the blood
• an altered blood sugar level. In diabetics this may lead to a
worsening of blood sugar control. Undiagnosed diabetes
may be triggered
• hearing disturbances (auditory hallucinations)
• inflammation of the pancreas
• a change in the amount of creatinine and urea (waste products)
in urine (short lived change)
• an increase of amount of uric acid in your blood
• loss of body water (dehydration)
• decrease in the amount of blood in the body
• decrease in the amount of calcium in the body
• metabolic alkalosis, metabolic disturbance where the pH of the
blood is abnormally high.
• discomfort passing urine in patients with bladder emptying
disorders such as enlarged prostate gland or narrowing of the
urethra (tube that carries urine outside the body from the
bladder)

This product has an expiry date on the syringe label and container
label. 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 and store in the original container.

6. Further Information
What Furosemide Injection contains
The active ingredient is furosemide 10mg in 1ml.
The other ingredients are water for injections, sodium chloride,
sodium hydroxide and nitrogen.
What Furosemide Injection looks like and the contents of the
pack
The injection is supplied as a sterile solution in a glass 10ml
prefilled syringe. Each prefilled syringe contains 8ml of the
solution. The prefilled syringes are supplied in single units.
Product Licence Holder:
Aurum Pharmaceuticals Ltd
Bampton Road
Harold Hill
Romford Essex RM3 8UG
Manufacturer:
Federa SC
Avenue Jean Jaures 71
B-1030 Brussels
Belgium
Product licence numbers: PL 12064/0076
Furosemide Injection 10mg in 1ml
Leaflet approved: November 2008
Date of revision: September 2007

Rare side effects include:
• sensation of burning and prickling (paraesthesiae)
• gout
• decrease in the number of circulating white blood cells in the
blood (leucopenia)
• severe reduction in number of white blood cells
(agranulocytosis)
• failure to produce sufficient new cells to replenish blood cells
by bone morrow (aplastic anaemia)
• abnormal breakdown of red blood cells (haemolytic anaemia)
• very low calcium levels in the blood (tetany)
Side effects in premature babies
• continuation of a condition known as patent ductus arterious if
Furosemide Injection is given to premature babies in the first
weeks of their life. Your paediatrician will detect this condition
and corrective measures will be taken.
• build up of calcium in the 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.

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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.

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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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