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FUROSEMIDE INJECTION BP

Active substance(s): FUROSEMIDE / FUROSEMIDE / FUROSEMIDE

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Package leaflet: Information for the patient

hameln

Furosemide Injection
Furosemide

• Read all of this leaflet carefully before you start using 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 nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not
listed in this leaflet. See section 4.

What is in this leaflet
1. What Furosemide Injection is and what it is used for
2. What you need to know before Furosemide Injection is given to you
3. How Furosemide Injection is given to you
4. Possible side effects
5. How to store Furosemide Injection
6. Contents of the pack and other information

1. What Furosemide Injection is and what it
is used for
Furosemide Injection is a powerful, quick acting
diuretic which causes the body to increase the
production of urine. It is used to:
• remove large amounts of fluid that has
accumulated in the tissues and lungs (oedema)
• treat high blood pressure in emergencies
• increase the production of urine in kidney failure.

2. What you need to know before Furosemide
Injection is given to you
You should NOT be given Furosemide
Injection if:

• You are allergic to Furosemide Injection or any
of the other ingredients of this medicine (listed in
section 6). If you are allergic to a group of drugs
called sulfonamides (e.g. Co-Trimoxazole,
sulfadiazine) or sulfonamide derivatives and
amiloride you may also be allergic to this
injection.
• You are dehydrated, your blood volume is low
(you may feel dizzy, faint or have pale skin) or
you are unable to pass urine.
• You have low levels of potassium or sodium or
an imbalance of chemicals in your blood (shown
in a blood test).
• You have severe liver problems (cirrhosis) that
are affecting your consciousness.
• You previously received certain medicines that
have damaged your kidneys or liver.
• You have already taken furosemide in the past
to treat failure to pass urine or kidney failure, or
if you have kidney failure due to underlying liver
disorders.
• You have an illness called ‘Addison’s Disease’.
This can make you feel tired and weak.
• You are taking digitalis preparation/digoxin/
cardiac glycosides to treat heart problems.
• You have a disease called porphyria
characterised by abdominal pain, vomiting or
muscle weakness.
• You are breast feeding.

Warnings and precautions
Talk to your doctor or nurse before being
given the Furosemide Injection if:

• You have hypotension (low blood pressure) or
feel dizzy when you stand up.
• You feel dizzy or dehydrated. This can happen
if you have lost a lot of water due to being sick,
having diarrhoea or passing water very often.
It can also happen if you are having problems
drinking or eating.
• You are an elderly patient with dementia and are
also taking risperidone.
• You are elderly, if you are on other medications
which can cause the blood pressure to drop and
if you have other medical conditions that are
risks for the drop of blood pressure.
• You have (or potentially may have) diabetes.
• You have gout.
• You have (or have had) any problems with your
liver or kidneys.
• You have difficulty in passing water, for example
because of a large prostate gland.
• You
have
low
blood
protein
level
(hypoproteinaemia) as this may reduce the
effect of the drug and increase the risk of ear
damage.
• You have raised levels of calcium in the blood.
• Premature infants are intended to be given
furosemide as they may be more prone to
develop kidney stones and should therefore be
monitored closely during treatment.
Do not use Furosemide Injection if you are
planning to undergo a procedure that includes
the use of radiocontrast (as Furosemide Injection
may increase the risk of kidney damage).
Regular monitoring is required including a
complete blood count to check for blood
dyscrasias (imbalance of blood components)
and for blood levels of sodium, potassium,
magnesium, calcium, chloride, bicarbonate,
kidney function tests (blood urea nitrogen and
creatinine levels), glucose and uric acid.

Other medicines
Injection

and

Furosemide

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This is especially important with the
following medicines as they may interact with
your Furosemide Injection:

• Medicines to help your heart beat (e.g. cardiac
glycosides like digoxin). Your doctor may need
to change the dose of your medicine.
• Medicines to help your heart beat regularly (e.g.
amiodarone, flecainide, lidocaine, mexiletine,
disopyramide, beta blockers (sotalol)).
• Medicines to lower your blood pressure
particularly medicines known as ACE inhibitors
(ramipril, enalapril, perindopril), and angiotensin
II receptor antagonists (losartan, candesartan,
irbesartan), renin inhibitors (aliskiren).
• Other medicines used to lower your blood
pressure or for heart problems including
diuretics that help you pass more urine
(metolazone), calcium channel blockers,
hydralazine, minoxidil, thymoxamine, nitrates,
prazosin, clonidine, methyldopa, moxonidine,
sodium nitroprusside.
• Lithium e.g. used for mental illness.
• Medicines used to treat pain or inflammation
(e.g. indometacin, ketorolac, acetylsalicylic
acid).
• Antibiotics belonging to the aminoglycoside
class, or polymixin class or vancomycin (there
may be a risk of ear or kidney damage), or
cephalosporins e.g. cephalexin and ceftriaxone.
There may be a risk of low sodium levels with
trimethoprim.
• Cisplatin used to treat cancer (increased risk of
kidney damage).
• Methotrexate - increased risk of furosemide
toxicity.
• Ciclosporin and aldesleukin.
• Medicines to treat epilepsy e.g. phenytoin,
carbamazepine.
• Antihistamines (medicines to treat allergies).
• Corticosteroids to treat inflammation.
• Medicines to relax your muscles like baclofen
and tizanidine or curare like drugs.
• Anti-psychotics (medicines to treat mental
disorders) (pimozide, amisulpride, sertindol
or phenothazines), tricyclic antidepressants
and monoamine oxidase inhibitors (medicines
to treat depression) hypnotics and anxiolytics
(chloral hydrate, triclofos), risperidone to treat
dementia, drugs used to treat attention deficit
disorder (ADHD) like atomoxetine (increased
risk of hypokalaemia and cardiac arrhythmias).
• Medicines used as general anaesthetics to
induce unconsciousness.
• Medicines to treat diabetes.
• Antifungals e.g. amphotericin (risk of potassium
loss).
• Levodopa used to treat Parkinson’s disease
(increased risk of blood pressure drop).
• Birth control pills and oestrogen containing
drugs may block the effect of furosemide if taken
concurrently.
• Medicines to treat erectile dysfunction like
alprostadil.
• Theophylline used for wheezing and breathing
difficulties associated with asthma.
• Probenecid used to treat gout.
• Medicines to treat asthma when given in high
doses like salbutamol, tertbutaline, salmeterol,
formoterol or bambuterol.
• Medicines to treat blocked nose such as
ephedrine and xylomethazoline.
• Aminoglutethimide to treat breast cancer.
• Laxatives used to treat constipation e.g.
bisacodyl, senna.

Furosemide Injection with food and
alcohol

Avoid consumption of alcohol with Furosemide
Injection as it may lead to excessive lowering of
blood pressure. Liquorice may increase a risk
of potassium loss when given with Furosemide
Injection.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
being given this medicine. The doctor will then
decide if the injection is suitable for you.
Furosemide passes into the milk and may inhibit
secretion of milk. Hence it should be avoided in
breast feeding women.

Driving and using machines

You should not drive or use machinery if you are
affected by the administration of Furosemide
Injection.

Furosemide Injection contains a maximum of 4 mg
of sodium per ml. To be taken into consideration
by patients on a controlled sodium diet.

3. How Furosemide Injection is given to you
Your nurse or doctor will give you the injection.
Your doctor will decide the correct dosage for you
and how and when the injection will be given.
During treatment with Furosemide Injection,
your doctor may want you to have blood tests to
show if the chemicals and fluids in your body are
balanced.
If Furosemide Injection is given to a premature
infant then the doctor will monitor the infant’s
kidneys to ensure that the Furosemide Injection is
not causing any problems.

If you think you have been given more
Furosemide Injection than you should

Since the injection will be given to you by a doctor
or nurse, it is unlikely that you will be given too
much. If you think you have been given too much,
you must tell the person giving you the injection.
Symptoms of furosemide overdose include: low
blood volume (you might feel dizzy, faint, have
pale skin), dehydration, thickening of blood,
decreased sodium and potassium levels (shown
in a blood test).
Severe decrease in blood pressure leading to
shock, irregular heartbeat, severe kidney disorder,
blood clots, decline in mental function, paralysis
with loss of muscle tone, lack of emotions and
confusion may occur as a result of fluid loss and
chemical imbalance.
When furosemide is given at high doses temporary
loss of hearing and gout attack may also appear.

4. Possible side effects
Like all medicines, Furosemide Injection can
cause side effects, although not everybody gets
them.

Tell your doctor or nurse straight away if
you notice any of the following serious
side effects – you may need urgent
medical treatment

• Allergic reactions
Allergic reactions may be severe in nature
and may involve (severe) itching, skin rash,
nettle rash, (high) fever, difficulty in breathing,
cold clammy skin, pale skin colour and racing
heart beat, sensitivity to light, red patches on
the skin, joint pain and /or inflammation of the
eyes, conditions such as “acute generalised
exanthematous pustulosis (AGEP)”, or DRESS
(acute febrile drug eruption) characterised by
severe acute (allergic) reaction accompanied by
fever and blisters on the skin/peeling skin and
tiny spots from bleeding in the skin.
Blistering or peeling of the skin around the
lips, eyes, mouth, nose and genitals, flu-like
symptoms and fever could be a condition called
Stevens-Johnson syndrome. In a more severe
form of the condition called Toxic Epidermal
Necrolysis (also known as Lyell’s syndrome),
layers of the skin may peel off to leave large
areas of raw exposed skin all over the body.
• Severe upper abdominal pain shifting towards
the back. These could be signs of ‘pancreatitis’
(inflammation of the pancreas).
• Signs of kidney inflammation such as blood in
the urine, pain in the lower back.
• Acute kidney failure.
• Bruising more easily or bleeding, getting more
infections (e.g. sore throat, mouth ulcers,
fever), feeling weak or tired more than usual.
Furosemide can affect the number of blood
cells, causing serious blood problems.
• Increased thirst, headache, feeling dizzy or
light-headed, fainting, confusion, muscle or joint
pains or weakness, cramps or spasms, stomach
upsets or uneven heartbeats. These could be
signs of dehydration or changes in your normal
body chemicals. Severe dehydration can lead to
blood clots (especially in the elderly) or ‘gout’.
• Signs of metabolic acidosis such as: chest
pain, irregular heartbeat, nausea, vomiting,
weakness.
• You notice yellowing of your skin or eyes and
your urine becomes darker in colour. These
could be signs of a liver problem. In patients
who already have liver problems, a more serious
liver problem known as liver encephalopathy
may occur. Symptoms include forgetfulness,
fits, mood changes and coma.
• A life-threatening form of unconsciousness.

Tell your doctor as soon as possible if
you have any of the following side effects

• Problems hearing or ringing in the ears (tinnitus).
This especially affects people who already have
problems with their kidneys.
• A crawling sensation on the skin, itching or
tingling without any reason, feeling numb on the
skin.
• Small changes in your mood such as feeling
agitated or anxious.
• Dizziness, fainting and loss of consciousness
(caused by symptomatic hypotension). Also
headaches, loss of concentration, slower
reactions, feeling sleepy or weak, problems with
your sight, dry mouth. This could be due to low
blood pressure.
• Visual disturbances (blurred vision).
• An inflammation of blood vessels.

• Furosemide can cause an excessive depletion
of body fluids (e.g. passing urine more often
than normal) and minerals (sodium, potassium,
magnesium, calcium) with not known frequency
(cannot be estimated from available data):
• Symptoms
associated
with
sodium
deficiency include: dizziness, drowsiness,
confusion, feeling of weakness, listlessness,
loss of appetite, cramp in the calf muscles.
• Symptoms of potassium deficiency include:
muscle weakness and inability to contract
one or more muscles (paralysis), increased
urine excretion, heart problems, in severe
cases-intestinal functioning disorders or
confusion which can result in coma.
• Symptoms of magnesium and calcium
deficiency: increased irritability of muscles,
heart rhythm disturbances.

Tell your doctor or pharmacist if any
of the following side effects become
serious or last longer than a few days, or
if you notice any side effects not listed in
this leaflet
• Feeling sick (nausea) or a general feeling
of being unwell, diarrhoea and being sick
(vomiting) and constipation.
• People with bladder and prostate problems may
notice pain when passing water. This is due to
an increase in the amount of water passed.
• If you have diabetes you may be less able to
control the levels of glucose in your blood.
• Passing more water (urine) than you usually do.
This normally happens 1 or 2 hours after taking
this medicine.
• Pain at the site of injection. This occurs when
the medicine is injected into the muscle.
• Loss of hearing (deafness) which can sometimes
be irreversible.

Blood tests

Furosemide can change the levels of liver
enzymes or body fats known as cholesterol and
triglycerides but usually they return to normal
within 6 months.

Additional side effects in paediatric
population
Deposits of calcium salts in the kidneys and heart
defects like patent ductus arteriosus have been
reported in premature babies following treatment
with furosemide.
If you think this injection is causing you any
problems, or you are at all worried, talk to your
doctor, nurse or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor,
pharmacist or nurse: This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card

Scheme – website: www.mhra.gov.uk/
yellowcard. By reporting side effects you can
help provide more information on the safety of this
medicine.

5. How to store Furosemide Injection
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the ampoule or carton. The
expiry date refers to the last day of that month.
Your injection will be stored at less than 25°C
and protected from light. The nurse or doctor will
check that the injection is not past its expiry date
before giving you the injection.
Do not throw away any medicines via wastewater.
Ask your pharmacist how to throw away medicines
you no longer use. These measures will help
protect the environment.

6. Contents of the pack and other information
What Furosemide Injection contains

The active substance is furosemide. Each 1 ml
of solution contains 10 mg furosemide in a sterile
solution for injection.
The other excipients are: sodium chloride, sodium
hydroxide and sterile water for injections.

What Furosemide Injection looks like
and contents of the pack

Furosemide Injection is supplied in 2 ml, 5 ml
and 25 ml amber glass ampoules. The injection
is supplied in cartons of 10 ampoules. Not all
ampoule sizes may be marketed.
The marketing authorisation number of this
medicine is: PL 01502/0032.

Marketing Authorisation Holder:
hameln pharmaceuticals ltd
Gloucester
United Kingdom

Manufacturer:

hameln pharmaceuticals gmbh
Langes Feld 13, 31789 Hameln, Germany
hameln rds a.s.
Horná 36, 900 01 Modra, Slovak Republic
HBM Pharma s.r.o.
03680 Martin, Sklabinská, Slovak Republic

For
any
information
about
this
medicine, please contact the Marketing
Authorisation Holder.
This leaflet was last revised in 05.2017.
44174/18/17

Expand Transcript

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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