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FUROSEMIDE 500MG TABLETS

Active substance(s): FUROSEMIDE

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TEVA UK Ref:

231-30-84123-F LEA FUROSEMIDE 500mg TAB TUK

Version:

1

18 December 2015

PAGE 1: FRONT FACE (INSIDE OF REEL)

Furosemide 500 mg Tablets
Furosemide

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.
What is in this leaflet

1.
2.
3.
4.
5.
6.

What Furosemide is and what it is used for
What you need to know before you take Furosemide
How to take Furosemide
Possible side effects
How to store Furosemide
Contents of the pack and other information.

1

What Furosemide is and what it is used for

Furosemide belongs to a group of medicines known as diuretics (water
tablets).
You should only use this high-dose formulation if you have severely
reduced kidney function (glomerular filtration rate (GFR) < 20 ml/min).
Furosemide is used to treat reduced urine production (oliguria) in chronic
kidney failure.
Pharma code 277
First bar is 105mm from the top edge of the leaflet.

2

What you need to know before you take Furosemide

Do not take Furosemide
• If you are allergic to furosemide, sulphonamides or any of the other
ingredients of this medicine (listed in section 6),
• If you have normal or mildly to moderately reduced kidney function with
a GFR greater than 20 ml/min, because of the risk of severe fluid and
salt (electrolyte) loss,
• If you have kidney failure and your kidneys do not produce urine at all
(anuria),
• If you have liver failure with alterations of consciousness (hepatic
coma and pre-coma),
• If you have potassium deficiency,
• If you have sodium deficiency,
• If you have too little blood (hypovolaemia) or body water (dehydration),
• If you are breast-feeding (see Pregnancy and breast-feeding below),
• If you have cardiac glycoside poisoning. Cardiac glycosides (e.g. digoxin,
digitoxin) are medicines used for heart failure and abnormal heart rhythms.
Warnings and precautions
Furosemide may be used in advanced or end-stage kidney failure (when
dialysis is or could become necessary) with fluid retention (oedema)
and/or high blood pressure, and to maintain remaining urine production
(with regular monitoring).
Talk to your doctor or pharmacist before taking Furosemide :
• If you have low blood pressure (hypotension),
• If you have or suspect you may have diabetes: regular monitoring of
your blood sugar levels is necessary,
• If you have gout: regular monitoring of your blood uric acid levels is
necessary,
• If you have an obstruction in the urine outflow tract (e.g. if you have an
enlarged prostate or narrowing of the ureter, the tube that connects the
kidney and bladder): your doctor will need to monitor your condition,
• If you have low levels of protein in your blood (hypoproteinaemia), for
instance if you have nephrotic syndrome (loss of protein, disturbance of
fat metabolism and fluid retention): your doctor will need to adjust your
dose carefully, and you must follow his/her instructions exactly,
• If you have cirrhosis of the liver (tiredness, weakness, water retention,
feeling or being sick, loss of weight or appetite, yellowing skin or eyes,
itch) as well as reduced kidney function,
• If you have circulation problems in the brain (cerebrovascular
circulatory disorders) or heart vessels (coronary heart disease): the
risks associated with a possible fall in blood pressure are higher.
• If you are elderly, if you are on other medications which can cause the
drop the blood pressure and if you have other medical conditions that
are risks for the drop of blood pressure.
Your doctor will want to monitor you, and may take blood for testing while
you are taking this medicine.
Close monitoring is necessary if you have a high risk of developing
electrolyte disturbances (e.g. if you have cirrhosis of the liver, or you take
corticosteroid medicines or use laxatives a lot, or you have a limited diet)
or if you lose a lot of fluids (e.g. if you experience significant vomiting,
diarrhoea or intensive sweating): any blood or fluid loss (hypovolaemia or
dehydration) or any electrolyte or acid-base imbalance in your body will
need to be corrected, which may require your doctor to temporarily stop
your treatment with Furosemide.
You should not lose more than 1 kg a day in body weight owing to the
increase in urine production caused by Furosemide, regardless of how
much urine you pass.
Your doctor may need to check the effect of your treatment with
Furosemide periodically by temporarily stopping it.
If you are taking another medicine called risperidone at the same time as
Furosemide, it is very important that you avoid becoming dehydrated. In
clinical studies in elderly patients with dementia, more patients died on
risperidone with furosemide than on either treatment used alone.

Tell your doctor if you are going to undergo an X-ray examination with
contrast media.
Children
Furosemide may cause calcium deposits or stones in the kidneys of
premature babies and increases the risk of a fetal blood vessel called the
ductus arteriosus remaining open after birth when it should normally
close, in premature babies with breathing difficulties. The doctor will
therefore need to monitor the baby very closely.
Athletes
Furosemide may cause positive results in drugs tests.
The use of Furosemide as a performance-enhancing substance may
endanger your health.
Other medicines and Furosemide
Tell your doctor or pharmacist if you are using, have recently used or
might use any other medicines.
The following medicines may influence the effect of Furosemide:
• Glucocorticoids ("cortisone"), carbenoxolone or laxatives may increase
potassium loss and therefore the risk of potassium deficiency.
• Anti-inflammatory medicines (NSAIDs e.g. indomethacin, acetylsalicylic
acid) may reduce the effect of Furosemide and increase the risk of
acute kidney failure in the event of blood or fluid loss (hypovolaemia or
dehydration).
• Probenecid (for gout), methotrexate (for arthritis and to suppress the
immune system) and other medicines excreted by the kidneys may
reduce the effect of Furosemide.
• Phenytoin (for epilepsy and some forms of pain) may reduce the effect
of Furosemide.
• Carbamazepine (for epilepsy and some forms of psychiatric illness) may
increase sodium loss and therefore the risk of sodium deficiency.
• Sucralfate (an antacid) reduces the uptake of Furosemide from the
intestines and may thus weaken its effect: you should take sucralfate
and Furosemide at least 2 hours apart.
Furosemide may influence the effect of the following medicines:
• Some heart medicines (glycosides) may have a stronger effect owing to
the potassium and magnesium deficiency which Furosemide may
cause. Medicines which affect the heart's rhythm (e.g. terfenadine for
allergies, some medicines used to treat abnormal heart rhythms) have a
higher risk of causing heart rhythm abnormalities if they are used at the
same time as Furosemide or in the event of electrolyte disorders.
• The side effects of high-dose salicylates (for pain) may be worsened by
Furosemide.
• The side effects of some medicines on the kidneys may be worsened
(e.g. antibiotics such as aminoglycosides, cephalosporins, polymyxins).
Furosemide together with high doses of some cephalosporins may
cause worsening of kidney function.
• Furosemide may worsen the side effects of some medicines (e.g.
aminoglycosides such as kanamycin, gentamicin, tobramycin) on
hearing. These side effects are not always reversible. Furosemide
should therefore not be used at the same time as these medicines.
• The risk of damage to hearing may be increased when cisplatin (for
cancer) and Furosemide are used together. Caution is required as the
side effects of cisplatin on the kidney may also be worsened.
• The side effects of lithium (for certain forms of depression) on the heart
and nervous system may be worse if Furosemide is used at the same
time. Your doctor should monitor your blood lithium levels if you take
these medicines together.
• Your blood pressure may fall if you take Furosemide with other
medicines with the potential to lower it, such as other diuretics.
Medicines called ACE inhibitors and angiotensin II receptor blockers
especially may lead to a massive drop in blood pressure to the point of
shock and a worsening of kidney function (in isolated cases to the point
of kidney failure) when the first dose is taken or the first time a higher
dose is used. Your doctor may tell you to stop taking Furosemide for at
least 3 days before you start taking an ACE inhibitor or an angiotensin II
receptor blocker or before the dose of these medicines is increased.
• Furosemide may reduce the removal of probenecid, methotrexate or
other medicines by the kidneys, which may lead to increased blood
levels and possible side effects.
• The effect of theophylline (for asthma) or curare-type muscle relaxants
may be increased if they are used at the same time as Furosemide.
• Antidiabetic medicines and products that increase blood pressure
(pressor amines e.g. adrenaline, noradrenaline) may not work as well
with Furosemide.
• Caution is required when using risperidone at the same time as
Furosemide (see Warnings and precautions above).
Joint inflammation and gout may occur if Furosemide is combined with
ciclosporin A.
The kidney side effects of contrast media used in some X-ray examinations
may worsen with Furosemide.
In isolated cases, the use of chloral hydrate within 24 hours after the
intravenous administration of furosemide led to hot flushes, sweating,
unrest, feeling sick and a fast heartbeat. Chloral hydrate should not be
used at the same time as Furosemide.
Furosemide with food and drink
You should not consume large amounts of liquorice while you are taking
Furosemide as it could increase your loss of potassium.
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
taking this medicine
You should not take Furosemide if you are pregnant unless your doctor
considers it to be essential: Furosemide crosses the placenta.

Top of page cut-off to middle of registration mark: 44 mm.

Package leaflet: Information for the user

TEVA UK Ref:

231-30-84123-F LEA FUROSEMIDE 500mg TAB TUK

Version:

1

18 December 2015

PAGE 2: REAR FACE (OUTSIDE OF REEL)

You must not take Furosemide if you are breast-feeding as it will pass into
your milk and inhibit your milk production. You must stop breast-feeding in
order to take Furosemide.
Ask your doctor or pharmacist for advice before using any medicine.
Driving and using machines
Furosemide may impair your ability to react to such a degree that it may
influence your capacity to drive and use machines. This is especially true
at the beginning of treatment, when the dose is increased or the medicine
switched, and if you consume alcohol during treatment.
Furosemide contains lactose.
Furosemide contains lactose. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before
taking this medicinal product.

3

How to take Furosemide

Uncommon side effects (may affect upto 1 in 100 people):
• Low numbers of blood platelets (thrombocytopenia)
• Itching, skin and mucous membrane reactions: redness, blisters, scales
(e.g. bullous exanthema, hives, purpura, erythema multiforme, bullous
pemphigoid, exfoliative dermatitis), increased sensitivity to light
(photosensitivity)
• Deafness (sometimes irreversible)
Rare side effects (may affect upto 1 in 1,000 people):
• High or low numbers of white blood cells (eosinophilia or leucopenia)
• Fever
• Inflammation of blood vessels (vasculitis)
• Inflammation of the kidneys (interstitial nephritis)
• Severe allergic reaction (anaphylactic shock): the first signs are a skin
reaction with flushing or hives, unrest, headache, sweating, feeling sick
and a bluish tinge to the skin (cyanosis)
• Pins and needles (paraesthesia)
• Usually reversible hearing disorders and/or ringing or buzzing in the
ears (tinnitus)
• Digestive problems (e.g. feeling or being sick, diarrhoea)
Very rare effects (may affect up to 1 in 10,000 people):
• Anaemia due to loss (haemolytic anaemia) or reduced production
(aplastic anaemia) of red blood cells, very low numbers of certain white
blood cells with an increased risk of infection and severe general
symptoms (agranulocytosis)
• Inflammation of the pancreas, inhibition of bile flow (intrahepatic
cholestasis), increased liver function test results (transaminases)
• Certain severe skin reactions (Stevens-Johnson syndrome, toxic
epidermal necrolysis)
Not known (frequency cannot be estimated from the available data)
• acute generalised exanthematous pustulosis (AGEP)" (acute febrile
drug eruption)
• dizziness, fainting and loss of consciousness (caused by symptomatic
hypotension)
Blood glucose levels may increase during treatment with Furosemide,
which may lead to worsened control of diabetes or the overt
manifestation of previously silent diabetes. Blood fat (cholesterol and
triglyceride), creatinine or urea levels may also increase.
Brain disease (hepatic encephalopathy) may develop in patients with
advanced liver disease.
Symptoms of obstruction in the urine outflow tract (e.g. enlarged prostate
or narrowing of the ureter, the tube that connects the kidney and bladder)
may develop or worsen, with the potential for urine retention and
associated complications.
Furosemide may cause calcium deposits or stones in the kidneys of
premature babies and increases the risk of a fetal blood vessel called the
ductus arteriosus remaining open after birth when it should normally
close, in premature babies with breathing difficulties.
If you develop any of these side effects, please contact your doctor as
soon as possible. If a side effect develops suddenly or becomes serious,
please seek medical advice immediately as some side effects may under
certain circumstances be life-threatening.
You must stop taking Furosemide at the first signs of an allergic
(hypersensitivity) reaction.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.

Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
Your doctor will decide the dose that is right for you, based mainly on how
you respond to the treatment. The dose should be as low as possible to
achieve the desired effect.
Adults
The starting dose of Furosemide is half a tablet (250 mg furosemide).
Your doctor will then adjust your dose gradually in steps of half a tablet
(250 mg) at intervals of 4 to 6 hours, up to a usual maximum dose of
2 tablets (1,000 mg). Your doctor will periodically check your urine output
and electrolyte and fluid balance.
If you have chronic kidney impairment, your doctor will adjust the dose
carefully in order to reduce your fluid retention (oedema).
Use in children and adolescents
Furosemide is not recommended for use in children and adolescents
under 18 years of age due to insufficient data on safety and effectiveness:
other pharmaceutical forms/strengths may be more appropriate for
administration to these patients.
Elderly and patients with hepatic impairment
Your doctor will carefully adjust your dose according to how you respond
to the treatment.
Method of administration
The tablets should be taken in the morning without food, without chewing,
with a sufficient amount of fluid (e.g. a glass of water).
Your doctor will decide how long you should keep taking Furosemide,
depending on the nature and severity of your illness.
If you take more Furosemide than you should
If you take too much Furosemide, or you suspect an overdose, contact a
doctor immediately. The signs of an acute overdose are related to the loss
of salt and fluid: low blood pressure (hypotension), feeling dizzy or
light-headed on standing up (orthostatic regulation problems), electrolyte
disturbances (reduced potassium, sodium and chloride levels) or an
increase in the pH value of the blood (alkalosis). Severe fluid loss may
lead to dehydration and collapse from reduced blood volume with
concentration of the blood and an increased risk of blood clots. In the
event of rapid fluid and electrolyte loss, confusion and delirium may occur.
If you forget to take Furosemide
Carry on with the usual dose at the usual time. Do not take a double dose
to make up for a forgotten dose.
If you stop taking Furosemide
Do not stop taking Furosemide unless your doctor tells you to or your
treatment may be unsuccessful.
5 How to store Furosemide
If you have any further questions on the use of this medicine, ask your
• Keep this medicine out of the sight and reach of children.
doctor or pharmacist.
• Do not use this medicine after the expiry date which is stated on the
cartons and bottle after 'EXP'. The expiry date refers to the last day of
Possible
side
effects
4
that month.
Like all medicines, this medicine can cause side effects, although not
• Store in the original package in order to protect from light.
everybody gets them.
• Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
Common side effects (may affect upto 1 in 10 people):
These measures will help protect the environment.
• Electrolyte or fluid disorders which may lead to
• sodium deficiency (hyponatraemia, most frequently characterised by
6 Contents of the pack and other information
apathy, leg cramps, loss of appetite, weakness, sleepiness, vomiting
and confusion)
What Furosemide contains
• potassium deficiency (hypokalaemia characterised most frequently by • The active substance is furosemide. Each tablet contains 500 mg
muscle weakness, pins and needles, slight paralysis, vomiting,
furosemide.
constipation, bloating, frequent urination, excessive thirst and
• The other ingredients are lactose monohydrate, maize starch, silica
abnormal heart rhythms, and, in severe cases, intestinal obstruction
colloidal anhydrous, talc, magnesium stearate and iron oxide yellow
or altered consciousness including coma)
(E172).
• calcium deficiency, sometimes leading to muscle twitching and
What Furosemide looks like and contents of the pack
cramps (tetany)
• Tablet.
• magnesium deficiency, rarely leading to muscle twitching and cramps • Light yellow, round flat tablets of 13 mm diameter, with bevelled edges,
(tetany) or heart rhythms abnormalities
debossed “FUS” on one side and quartering score lines on the other.
• increased blood pH (metabolic alkalosis)
The tablet can be divided into equal doses or quarters.
• significant fluid loss may lead to circulatory disorders chiefly
• Furosemide is available in pack sizes of 20, 28, 30, 50, 60, 90 and 100
associated with headache, dizziness, visual disturbances, mouth
tablets. Not all pack sizes may be marketed.
dryness and thirst, low blood pressure (hypotension) and feeling
Marketing
Authorisation Holder and Manufacturer
dizzy or light-headed on standing up (orthostatic regulation
problems), especially in the elderly and in children. Severe fluid loss TEVA UK Limited, Eastbourne BN22 9AG, United Kingdom
may lead to dehydration and collapse from reduced blood volume
This leaflet was last revised in 12/2015
with concentration of the blood and an increased risk of blood clots.
PL 00289/1420
• Raised blood uric acid levels which may lead to gout in some patients

84123-F
323 x 200

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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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