FUROSEMIDE 20 MG/2 ML SOLUTION FOR INJECTION

Active substance: FUROSEMIDE

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Package Leaflet: Information for the user
Furosemide Fresenius Kabi 20mg/2ml solution for injection
(Furosemide)
Read all of this leaflet carefully before you start using this medicine.
• 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. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Furosemide Fresenius Kabi is and what it is used for
2. Before you use Furosemide Fresenius Kabi
3. How to use Furosemide Fresenius Kabi
4. Possible side effects
5. How to store Furosemide Fresenius Kabi
6. Further information

1. What Furosemide Fresenius Kabi is and what it is used for
Furosemide Fresenius Kabi belongs to a group of medicines called diuretics.
Furosemide increases the amount of urine produced by your body.
Furosemide is used to rid the body of too much fluid (also called oedema). Too much
fluid can be caused by:
• heart problems
• liver problems
• kidney problems
Furosemide is also used:

in periods with extremely high blood pressure that may lead to life-threatening
conditions (hypertensive crisis).
• in situations of highly elevated levels of calcium in the blood
• in delineation of the kidneys and the urinary tract system (urography) for an
enhanced display of the used methods, e.g. contrast medium

2. Before you use Furosemide Fresenius Kabi
Do not use Furosemide Fresenius Kabi if:
You are allergic (hypersensitive) to Furosemide, or any of the other
ingredients of this medicine (see Section 6)
You are allergic to sulphonamide antibiotics
You are severely dehydrated (you have lost lots of body fluid for example by
suffering from severe diarrhoea or being sick)
You have kidney failure and are not producing urine, despite treatment with
furosemide
You have kidney failure as a consequence of poisoning with kidney or liver
toxic substances
You have very low levels of potassium or sodium in your blood
The patient is in a coma caused by liver failure
You are breastfeeding
If you are uncertain, whether you can use this medicine or not, ask your doctor or
pharmacist.

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Take special care with Furosemide Fresenius Kabi
Tell your doctor or pharmacist if:
You normally have problems passing water due to an obstruction (such as an
enlarged prostate)
You have diabetes
You have a low blood pressure or sometimes have sudden falls in blood
pressure (Your blood vessels in your heart or brain are to narrow).
You have liver disease (such as cirrhosis)
You have kidney problems (such as nephrotic syndrome
You are dehydrated (you have lost body fluids by suffering from severe
diarrhoea or being sick), this might lead to collapse or blood clothing
You have gout (painful or inflamed joints) due to high levels of uric acid (byproduct of metabolism) in your blood
You have the inflammatory disease called “ systemic lupus erythematosus
(SLE)”
You have hearing problems
You are using sorbitol (sugar substitute for people with diabetes)
You are taking medicines that cause life-threatening irregular heart beat (QT
interval prolongation)
You are taking lithium
You have porphyria (disease where the production of the oxygen binding
molecule of the red blood cells is disrupted and urine is purple-coloured)
Your skin has an increased sensitivity to sunlight (photosensitivity)
You are an athlete; this medicine might give a positive result in doping tests
If given to premature babies furosemide can cause kidney stones or calcification
If any of these apply to you, your doctor may want to change your treatment or give
you special advice.
While you are using Furosemide Fresenius Kabi, your doctors may recommend
regular blood tests of your blood sugar levels or your blood uric acid levels. They will
also check your blood levels of important body salts such as potassium and sodium
which are particularly important if you are being sick or have diarrhoea.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines you have obtained without a prescription. This
is important because some medicines should not be taken together with Furosemide
Fresenius Kabi.
In particular, tell your doctor or pharmacist if you are taking:
Lithium – for mood disorders, as its effect and side effects may be increased
by furosemide. Your doctor will prescribe this medicine to you only if
absolutely necessary and he will then check your lithium levels and may
change your dose
Heart medicines, like digoxin; your doctor may need to change your dose
Any medicines for high blood pressure, including thiazide diuretics (like
bendroflumethiazide or hydrochlorothiazide), ACE inhibitors (like lisinopril),
angiotensin II antagonists (like losartan) as furosemide may cause your blood
pressure to fall too low. Your doctor may need to change your dose of
furosemide

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Cholesterol or lipid-lowering medicines like fibrates, such as clofibrate,
fenofibrate or bezafibrate, as the effect of furosemide may be increased.
Diabetes medicines, like metformin and insulin, as your sugar levels may be
increased
Anti-inflammatory medicines, including NSAIDS (like aspirin or celecoxib) as
they can reduce the effects of furosemide; high doses of pain killers
(salicylates) may increase the side effects of furosemide
Anti-inflammatory or anti-allergic medicines like corticosteroids, medicines to
treat stomach ulcers like carbenoxolone, or laxatives, as in combination with
furosemide they will affect your sodium and potassium levels. Liquorice has
the same effect as carbenoxolone.Your doctor will check your potassium
levels
Injections given during operations, including tubocurarine, curarine derivates
and succinylcholine
Chloral hydrate - for sleeping problems (in isolated cases, the intravenous
administration (injection into a vein) of furosemide in a 24 hour period prior to
chloral hydrate administration may lead to flushing, increased sweating,
anxiety, nausea, increase in blood pressure and faster heart beat). Therefore,
the simultaneous administration of furosemide and chloral hydrate is not
recommended.
Phenytoin or phenobarbital - for epilepsy, as the effect of furosemide may be
decreased
Theophylline - for asthma, as its effect may be increased by furosemide
Antibiotics like cephalosporins, polymyxins, aminoglycosides or quinolones or
other drugs which may affect your kidneys like immunosuppressants,
iodinated contrast media, foscarnet or pentamidine as furosemide can make
this worse
Probenecid – used with some other medicines to protect the kidney, as it may
reduce the effects of furosemide
Organoplatins - used in some cancers, as furosemide may increase the side
effects of this drugs
Methotrexate - used in some cancers and for severe arthritis, as it may
reduce the effects of furosemide
Drugs to raise your blood pressure (Pressor amines), as they may not work
as well when you take them with furosemide
Aminoglutethimide – used to suppress corticosteroid production (Cushing´s
syndrome), as it may increase the side effects of furosemide
Carbamazepine – used to treat epilepsy or schizophrenia, as it may increase
the side effects of furosemide
Ciclosporin – used to prevent rejection of transplants, as you are at risk of
gouty arthritis (painful joints).
Drugs that will alter your heart beat such as amiodarone, sotalol, dofetilide,
ibutilide, as there effect may be increased by furosemide
Using Furosemide Fresenius Kabi with food and drink
You can eat and drink as usual when taking Furosemide. You do not need to change
your diet unless suggested by a doctor.
Pregnancy and breast feeding
Please tell your doctor if you are pregnant or think you might be pregnant.
• Furosemide can pass from mother to baby
• So this medicine is only given to pregnant women if absolutely necessary.
Do not use Furosemide Fresenius Kabi if you are breast-feeding

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This is because this medicine passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.



Driving and using machines
Furosemide Fresenius Kabi may make you less alert than usual. If you are affected
do not drive or use machines (see section 4 “Possible side effects”).
Important information about some of the ingredients of Furosemide Fresenius
Kabi
This medicinal product contains less than 1 mmol sodium (23 mg) per ampoule, i.e.
essentially ‘sodium- free’.

3. How to use Furosemide Fresenius Kabi
Always use Furosemide Fresenius Kabi exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
Furosemide Fresenius Kabi is normally given by a doctor or nurse. It is given:
as a slow injection into a vein (intravenous) or
exceptionally into a muscle (intramuscular).
Your doctor will decide on the dose. The dose depends on your particular condition,
how bad it is, and how long you are treated for.
The usual first dose for adults (including teenagers over 15) is 20 to 40 mg.
If your doctor thinks a higher dose is needed, you may be given further 20 mg
injections. This is usually given every 2 hours, until the desired fluid loss
occurs.
In some cases, instead of injections, your doctor may recommend this
medicine is given by continuous infusion into a vein (a drip).
For children (children below 15 will only be treated in exceptional cases), the
dose depends on the child’s weight. The first dose is 0.5 to 1 mg/kg a day.
The elderly are usually given 20 mg/day at first. This can be gradually
increased until the desired fluid loss occurs.
In case Furosemide Fresenius Kabi will be administered for the treatment of
high levels of calcium in the blood or in urography your doctor will take care of
a sufficient hydration of the body, if applicable an intravenous fluid
substitution might be necessary.
Weight loss by loss of body fluid should not be more than 1 kg of body weight
per day.
If you need to keep using Furosemide Fresenius Kabi, your doctor will probably
recommend a switch from injections to an oral (tablet) form of this medicine, as soon
as possible.
If you use more Furosemide Fresenius Kabi than you should
If you think you have been given too much of this medicine, tell your doctor straight
away.
Signs which may occur if you have been given too much of this medicine are dryness
of the mouth, increased thirst, irregular heartbeat, mood changes, muscle cramps or
pain, feeling or being sick, unusual tiredness or weakness, a weak pulse or loss of
appetite.
If you think you have missed an injection, speak to your doctor or nurse.

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If you have any further questions on the use of this product, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines Furosemide Fresenius Kabi can cause side effects, although not
everybody gets them. The following side effects may occur during treatment with
Furosemide:
Uncommon (affects less than 100 patients)
▪ Skin rashes (including itching, redness, peeling), a tendency to bruising or
your skin being sensitive to sunlight
▪ Blood cell changes can lead to failure of blood clotting (with increased risk of
bleeding)
Rare (affects less than 1 out of 1,000 patients):
Feeling or being sick, diarrhoea, constipation, loss of appetite, discomfort in
the mouth and stomach.
Hearing problems (more common in with kidney failure) and tinnitus (ringing
in the ears). patients
Anaphylaxis, a severe allergic reaction which can cause skin rashes, swelling,
breathing difficulties, and loss of consciousness. Get medical help
immediately.
Kidney damage (interstitial nephritis)
Very low white blood cell levels in the blood (which can lead to life threatening
infections). Get medical help immediately.
Muscle problems, including leg cramps or muscle weakness
Pain or discomfort where the injection is given (particularly after injection into
muscle)
The inflammatory disease lupus erythematosus may occur or get worse
Changes in blood test results (fat-like substances in your blood)
A numb feeling, tingling or feeling dizzy
High temperature
Blurred eye-sight, confusion, sleepiness
Dry mouth
Very rare (affects less than 1 out of 10,000 patients):
Severe muscle problems including twitching, spasms, cramps (also called
“tetanus”).
Blood cell changes can lead to anaemia, inability to fight infection
Pancreatitis (severe tummy pain) due to inflammation of the pancreas
The following may also occur:
Low blood pressure making you feel faint or dizzy. It may also cause the
feeling of pressure in the head, joint pain, blood clot formation, or collapse of
your circulation (shock)
Low potassium levels in the blood. This can cause muscle weakness, tingling
and numbness, slight inability to move a body part, being sick, obstipation,
increased gas in your gut, increased urine production, increased urge to
drink, or slow or irregular heart rhythm. These problems are more likely if you
have other diseases like liver or heart problems or too little potassium in your
diet or if you take other medicines (see “Taking other medicines”). Extreme
potassium losses can cause a transiently reduced movement of your intestine

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or a reduced awareness, with deep extended reduced consciousness in
extreme cases. Regular blood checks and potassium supplements may be
needed
Low sodium, calcium and magnesium levels in the blood. This may occur due
to increased loss of sodium, calcium and magnesium with your urine. Low
sodium levels typically cause a lack of interest, cramp in the calf, reduced
appetite, weakness, sleepiness, being sick and confusion. Low calcium levels
may cause badly cramps of your muscles. These badly cramps of your
muscles or an irregular heart beat can also be caused by low magnesium
levels in your body.
Gout may occur or get worse
Existing problems passing water may be made worse
Diabetes may occur or get worse
Liver problems or changes in the blood may cause jaundice (yellow skin, dark
urine, tiredness)
Reduced volume of body fluid especially in elderly patients. Sever fluid loss
may lead to increased concentration of the blood with a tendency for the
development of blood clots
Premature babies may get kidney stones or calcification
In premature babies the channel between the lung artery and the aorta which
is open in the unborn baby might stay open
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor, nurse or pharmacist.

5. How to store Furosemide Fresenius Kabi
Keep out of the reach and sight of children.
Do not use Furosemide Fresenius Kabi after the expiry date which is stated
on the pack. The expiry date refers to the last day of that month.
Keep the ampoules in the outer carton in order to protect from light.
Medicines should not be disposed via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help protect the environment.

6. Further information
What Furosemide Fresenius Kabi contains:
Each ampoule of Furosemide Fresenius Kabi contains 20 mg of furosemide as the
active substance in 2 ml of solution for injection. Other ingredients are sodium
chloride, sodium hydroxide, water for injections.
What Furosemide Fresenius Kabi looks like and contents of the pack:
Furosemide Fresenius Kabi is a clear colourless to almost colourless solution.
The pack may contain 5, 50 or 100 x 2 ml amber glass ampoules containing
Furosemide Fresenius Kabi 20 mg/2 ml solution for injection.
Marketing Authorisation holder and manufacturer:
Marketing Authorisation holder
FRESENIUS KABI PHARMA PORTUGAL, Lda.,
Avenida do Forte, n.º 3 – Edifício Suécia III, Piso 2

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2790-073 Carnaxide
Portugal
Tel: +351 21 4241280
Manufacturer:
LABESFAL – Laboratórios Almiro S.A. (Fresenius Kabi Group)
Lagedo, 3465-157 Santiago de Besteiros
Portugal
Tel: +351 232 831100
For any information about this medicinal product, please contact the local
representative of the Marketing Authorisation Holder:
België/Belgique/Belgien
Fresenius Kabi nv/sa
Molenberglei 7
B-2627 Schelle
Tél/Tel: +32 3 880 50 24
bart.van-den-daele@fresenius-kabi.com

Nederland
Fresenius Kabi Nederland B.V.
Postbus 2397
NL-5202 CJ's-Hertogenbosch
Tel: 0800 022 19 05
bart.van-den-daele@fresenius-kabi.com

Česká republika
Fresenius Kabi s.r.o.
Bozdechova 7
CZ-150 00 Prague 5
Tel: +420 2 25 27 55 55
ludmila.novakova@fresenius-kabi.com

Magyarország
Fresenius Kabi Hungary Kft.
Lajos u. 48-66.
H-1036 Budapest
Tel.: +36-1-250-8371
info@fresenius-kabi.hu

Deutschland
Fresenius Kabi Deutschland GmbH
D-61346 Bad Homburg v.d.H.
Tel: +49 6172 686 0
Kundenberatung@fresenius-kabi.de

Ελλάδα
Fresenius Kabi Hellas A.E
Λ. Μεσογείων 354
GR-15341 Αγ. Παρασκευή
Τηλ: +30 210 6542909
ioanna.petraki@fresenius-kabi.com

España
Fresenius Kabi Espana
Torre Mapfre-Villa Olimpica
Marina, 16-18, Planta 17
E-08005 Barcelona
Tel: +34 932256580

Polska
Fresenius Kabi Poland Sp. zo.o
ul Hrubieszowska 2
PL-01-209-Warszawa
Tel.: +48 22 345 67 89

France
Fresenius Kabi France
5, place du Marivel
92316 Sèvres Cedex
Tel: +0033 14 114 2683
sylvie Berthou-Talab@fresenius-kabi.de

Portugal
Fresenius Kabi Pharma Portugal, Lda
Avenida do Forte, n.º 3
Edifício Suécia III, Piso 2
2790-073 Carnaxide
Tel: +351 21 424 12 80

Ireland
Fresenius Kabi Limited

United Kingdom
Fresenius Kabi Limited

7

Cestrian Court, Eastgate Way
Manor Park Runcorn
Cheshire
WA7 1NT, UK
Tel: +44 1928 594 221

Cestrian Court, Eastgate Way
Manor Park Runcorn
Cheshire
WA7 1NT, UK
Tel: +44 1928 594 221

Suomi/Finland
Fresenius Kabi AB
Valimotie 13 b B
FIN-00380 Helsinki
Puh/Tel: +358 9 428 1550

Slovenská republika
Fresenius Kabi s.r.o. Organizacna slozka
Vajnorská 98/F
SK-831 04 Bratislava
Tel: +421/244633727

Italia
Fresenius Kabi Italia S.r.l.
Via Camagre 41
I-37063 Isola della Scala (Verona)
Tel: +39 045 6649311
ra-it@fresenius-kabi.com
This leaflet was last approved in 11/2008
----------------------------------------------------------------------------------------------------The following information is intended for medical or healthcare professionals only:
Administration
Intravenous administration of furosemide must be slow; a rate of 4 mg per minute
must not be exceeded and should never be given in association with other medicinal
products in the same syringe.
Intramuscular administration must be restricted to exceptional cases where neither
oral nor intravenous administrations are feasible. It must be noted that intramuscular
injection is not suitable for the treatment of acute conditions such as pulmonary
oedema.
The initial dose recommended for adults and adolescents over 15 years, is of 20 to
40 mg (1 or 2 ampoules) by intravenous (or in exceptional cases intramuscular)
administration; the maximum dose varying according to individual response. If larger
doses are required, they should be given increasing by 20 mg increments and not
given more often than every two hours.
In adults, the recommended maximum daily dose of furosemide is 1500 mg.
Incompatibilities
Furosemide injection may be mixed with neutral and weak alkaline solution with pH
between 7 and 10, such as 0.9% sodium chloride and Ringer’s lactate solution.
Furosemide should not be mixed with strong acid solutions (pH lower than 5,5), such
as solutions containing ascorbic acid, noradrenaline and adrenaline, due to the risk of
precipitation.
Product containing visible particles should not be used.
For single use only, discard any remaining contents after use.

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Shelf life
Shelf life of the finished medicinal product:
3 years
After first opening: Once opened the product should be used immediately
After dilution:
Chemical and physical in-use stability has been demonstrated for 24 hours at 25 ºC
protected from light.
From a microbiological point of view, the product should be used immediately. If not
used immediately, in-use storage times and conditions prior to use are the
responsibility of the user and would normally not be longer than 24 hours at 2 to 8°
C,
unless dilution has taken place in controlled and validated aseptic conditions.

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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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