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FUROSEMIDE 10MG/ML ORAL SOLUTION

Active substance(s): FUROSEMIDE

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Package leaflet: Information for the user

Furosemide 4mg/ml Oral Solution
Furosemide 8mg/ml Oral Solution
Furosemide 10mg/ml Oral Solution
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.

The name of your medicine is Furosemide 4mg/ml,
8mg/ml or 10 mg/ml Oral Solution but it will be
referred to as Furosemide throughout this leaflet.
What is in this leaflet:
1. What Furosemide is and what it is used for
2. What you need to know before you take
Furosemide
3. How to take Furosemide
4. Possible side effects
5. How to store Furosemide
6. Contents of the pack and other information

1. What Furosemide is and what it is used for
Furosemide belongs to a group of medicines called
diuretics or water tablets.
Furosemide can be used to remove the levels of
excess water in the body caused by heart, lung,
kidney, liver or blood vessel problems.
2. What you need to know before you take

Furosemide

Do not take Furosemide if:














you are allergic (hypersensitive) to Furosemide,
sulphonamides or any other ingredients in this liquid
(listed in Section 6). The signs of an allergic reaction
include a rash, itching or shortness of breath
you have symptoms of weakness, difficulty in
breathing and light-headedness. This could be a
sign of having too little water in the body
you are dehydrated
you have been told by your doctor you have low
blood volume. Sign of low blood volume can include
your skin turning pale, feeling dizzy, faint or
nauseous and feeling very thirsty
you are not passing water (urine) at all or only a
small amount each day
you have kidney failure or liver problems
you have a severe change in blood salts, such as
high potassium levels, very low potassium levels or
low sodium levels. You may notice signs of this
such as muscle cramps, weakness and tiredness.
you are allergic to antibacterials called
sulphonamides
you are breast-feeding (see section Pregnancy and
Breast-feeding).

Patient in a coma should not be given this medicine
Do not take this medicine if any of the above applies
to you. If you are not sure, talk to your doctor or
pharmacist before taking Furosemide.

Warnings and precautions
Talk to your doctor or pharmacist before taking
Furosemide if:
 you have low blood pressure. The signs of this
includes dizziness, feeling less alert than usual
fainting and general weakness
 you have difficulty in passing water (urine),
particularly if you have an enlarged prostrate gland
 you have gout
 you have hepatorenal syndrome. This is when you
develop kidney failure as a result of severe liver
failure
 you have low levels of protein in the blood. The
signs of this may include swelling, feeling sick
(nausea) or being sick (vomiting), diarrhoea and
stomach pain
 you have brain disorders affecting your nervous
system, or a condition called porphyria. This is a
disorder that can cause skin blisters, pain in and
around the stomach area (abdomen)
 you have diabetes

PIL/UK/MFG040/01-03/v1

If you are not sure if any of the above applies to you,
talk to your doctor or pharmacist before taking
Furosemide.

If you are not sure if any of the above applies to you,
talk to your doctor or pharmacist before taking
Furosemide.

Having tests whilst on Furosemide

Children and adolescents

While you are taking this medicine, your doctor may
give you regular blood tests. Your doctor will do this to
monitor levels of salts, minerals and glucose in your
blood and to check that your kidneys are working
properly.

This medicine should not be used in children and
adolescents.

Other medicines and Furosemide
Tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription, including
herbal medicines. This is because Furosemide, the main
ingredient of this medicine, can affect the way some
other medicines work. Also some medicines can affect
the way Furosemide works.
Tell your doctor if you are taking any of these
medicines:
 medicines used to treat high blood pressure known
as angiotensin converting enzyme (ACE) inhibitors
or Angiotensin-II receptor antagonists, such as
captopril, losartan
 medicines used to treat high blood pressure or
prostate problems known as alpha-blockers, such
as prazosin
 medicines used to treat high blood pressure, angina
and heart failure known as beta blockers such as,
propranolol, atenolol,sotalol
 medicines used to treat high blood pressure and
other medicines used to remove water from the
body known as diuretics, such acetazolamide and
metolazone
 digoxin used to treat heart failure and unusual
heart rhythams
 medicines used to treat unusual heart beats, such
as amiodarone, disopyramide, flecainide, lidocaine
and mexiletine
 a medicine used to prevent atrial fibrillation,
unwanted clotting and stroke called warfarin
 a medicine used to treat high cholesterol, called
clofibrate
 medicines used to treat pain and inflammation
known as nonsteroidal anti-inflammatory drugs
(NSAIDs), such as indometacin or salicylates such
as aspirin
 medicines used to treat inflammation known as
corticosteroids, such as prednisolone and
dexamethasone
 medicines used to treat infections caused by
bacteria, such as lymecycline, vancomycin,
gentamicin, ceftriaxone and colistin
 medicines used to treat infections caused by
fungus, such as amphotericin
 medicines used to treat infections caused by a
virus, such as nelfinavir, ritonavir and saquinavir
 medicine used to prevent rejection after
transplants, such as tacrolimus, ciclosporin,
 medicines used to treat depression, such as
reboxetine, amitriptyline and phenelzine
 medicines used to treat mental problems called
‘psychoses’, such as amisulpride, sertindole,
pimozide and chlorpromazine a medicine used to
treat extreme mood swings, called lithium
 a medicine used to treat Attention Deficit
Hyperactivity Disorder (ADHD), called atomoxetine
 medicines used to treat epilepsy, such as
carbamazepine, phenobarbital and phenytoin
 medicines to treat asthma, such as salmeterol,
salbutamol and theophylline. These medicines also
treat chronic obstructive pulmonary disease
 medicines used to treat blocked noses, such as
ephedrine and xylometazoline
 a medicine used to treat mouth ulcers and
problems with the digestive area of the stomach
(the upper gastrointestinal area), called
carbenoxolone
 medicines used to treat cancer, called cisplatin and
methotrexate
 medicine used to treat constipation, such
as laxatives
 a medicine used to treat gout, called probenecid
 potassium salts used to treat low potassium in the
blood
 anything that contains large amount of liquorice
 a medicine used to treat stomach ulcers, called
sucralfate. Do not take sucralfate within two hours
of taking Furosemide. This is because the sucralfate
can stop the Furosemide from working properly

Pregnancy, breast-feeding and fertility
Talk to your doctor before taking this medicine if:

You are pregnant or planning to become pregnant.

You should not take this medicine if you are
breast-feeding.
Ask your doctor or pharmacist for advice before taking
any medicine.

Driving and using machines
Do not drive or operate machinery whilst taking this
medicine as this medicine may make you feel less
alert than normal.

Furosemide contains:
This medicine contains ethanol (alcohol). Each ml of
oral solution contains 83.2mg ethanol (alcohol) i.e.
daily dose of 40mg Furosemide would include 332.8mg832mg ethanol, equivalent to 8.32ml-20.8ml of beer
or 3.47ml-8.67ml of wine depending up on the
prescribed strength. It is harmful to those who suffer
from alcoholism. You should be aware the product has
alcohol in it if:

you are pregnant or breast-feeding

you have liver disease

you have epilepsy

you have had a brain injury or brain disease

you are going to give this medicine to a child.
This medicine also contains liquid maltitol (E965). If
your doctor has told you that you cannot tolerate
some sugars, see your doctor before taking this
medicine.
3. How to take Furosemide
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

Taking this medicine






this medicine contains 4mg, 8mg or 10mg of
Furosemide in each 1ml
take this medicine by mouth
it is best to take your d ose in the morning
plan your doses so that they do not affect your
personal activities and sleep
ask your doctor or pharmacist to help you plan
the best time to take this medicine.

Adults

The usual dose for adult is

40mg each day

take the dose prescribed by your doctor.

Older people

If you are an older person, your doctor may start you
on a lower dose and gradually raise this dose.

Method of administration:
Use the measuring syringe provided in the pack to
deliver the required dose.

Instructions for the use of syringe:
1. Open the bottle: press the cap and turn it

anticlockwise (Figure 1).

2. Separate the adaptor from the syringe (Figure 2).

Insert the adaptor into the bottle neck (Figure 3).
Ensure it is properly fixed. Take the syringe and put
it in the adaptor opening (Figure 4).

TURN OVER






3. Turn the bottle upside down. Fill the syringe with a

small amount of solution by pulling the piston down
(Figure 5A) and then push the piston up in order
to remove any possible air bubbles (Figure 5B). Pull
the piston down to the graduation mark
corresponding to the quantity in millilitres (ml)
prescribed by your doctor (Figure 5C).











a



b

c

4. Turn the bottle the right way up (Figure 6A)

Remove the syringe from the adaptor (Figure 6B).



difficulty in passing water (urine)
a change in the amount of blood cells. The signs
you may feel are feeling weak, unexplained bruises
or bleeding, getting more infections and sores or
ulcers in the mouth
difficulty in controlling your blood sugar levels if
you have diabetes
developing diabetes. The signs you may feel are
thirst, needing to go to the toilet a lot more and
weight loss
loss of hearing and/or ringing in the ears. If you
have kidney problems you may be more at risk
skin problems such as rash, itching and a serious
illness with blistering of the skin, mouth, eyes and
genitals
swelling of the pancreas. This may show as severe
pain in the back and/or in the area in and around
the stomach (the abdomen) and jaundice which
shows as yellowing of the skin and the whites of
the eyes caused by liver or blood problems
tingling or numbness in the hands and feet
sudden severe joint pains linked to increased
amounts of uric acid in the blood. This is known as
gout
blood clots forming when you are severely
dehydrated
low blood pressure. The signs you may feel are
being unable to concentrate, feeling light-headed, a
feeling of pressure in the head, headache, feeling
drowsy, feeling weak, changes in vision, dry mouth
and feeling dizzy when standing up.

This medicine may raise cholesterol and lipid (fat)
levels in the blood.
If furosemide is used in babies born too soon
(prematurely), it can cause:




Persistence of a blood channel that normally closes
at or around birth. This may cause heart failure,
failure to grow, shortness of breath and rapid pulse
Kidney stones and/or calcium deposits in the body.

This medicine should not be used in babies.
5. Empty the contents of the syringe into the mouth

by pushing the piston to the bottom of the syringe
(Figure 7). Leave the syringe adaptor in place after
first use. Close the bottle with the plastic screw
cap. Wash the syringe with water and store in a
clean place (Figure 8).

Tell your doctor if you get any of these side
effects
 feeling sick (nausea) or being sick (vomiting)
 generally feeling unwell.

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.

If you take more Furosemide than you should
If you take more of the medicine than you should, talk
to a doctor or go to a hospital straight away. Take the
medicine pack with you so the doctor knows what you
have taken.

If you forget to take Furosemide




If you forget a dose, take it as soon as you
remember it. However, if it is nearly time for the
next dose, skip the missed dose
Do not take a double dose (two doses at the
same time) to make up for a forgotten dose.

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Furosemide can cause side effects,
although not everybody gets them.

If you have an allergic reaction to
Furosemide, see a doctor straight away.
An allergic reaction may include:
 any kind of skin rash
 difficulty in breathing, fever and collapse
 more long-term allergic reactions including
swelling of the kidneys and blood vessels and
particular sensitivity of the skin to sunlight and
other sources of light such as sun-beds.
If you get any of the following side effects, see
your doctor as soon as possible:
 changes in the amounts of water, salts or minerals
in your body. The signs of this you may feel are
thirst, headache, feeling dizzy particularly when
standing up, feeling confused, muscle twitching and
unusual heart beats. These may happen quickly but
also over time. If you have liver problems you may
be more at risk of these symptoms

PIL/UK/MFG040/01-03/v1

5. How to store Furosemide







Keep out of the sight and reach of children.
Do not use this medicine after the expiry date
stated on the carton box and label after ‘Exp’.
The expiry date refers to the last day of the
month.
Do not store above 25°C.
Discard 60 days after first opening.
Do not throw away any medicines via wastewater
or household waste. 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 contains
The active ingredient is Furosemide.
Each ml of solution contains 4mg, 8mg or 10mg
Furosemide.
The other ingredients are: citric acid monohydrate
(E330), ethanol, sodium hydroxide (E524), disodium
phosphate, anhydrous (E339), liquid maltitol
(E965), cherry flavour [containing propylene glycol
(E1520)] and purified water.

What Furosemide looks like and contents of
the pack
Furosemide oral solution is a clear, colourless to pale
brown coloured solution with cherry flavour supplied
in amber glass bottles with tamper evident child
resistant plastic cap. The pack also contains 10ml oral
syringe with 0.5ml graduation marks and a syringe
adaptor.
Furosemide Oral Solution is supplied in bottles
containing 100ml, 150ml and 300ml solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer:
Syri Limited t/a Thame Laboratories,
Unit 4, Bradfield Road,
Ruislip, Middlesex,
HA4 0NU, UK.
POM
This medicinal product is authorised in the
Member States of the EEA under the following
names:
UK and IE: Furosemide 4mg/ml Oral Solution
Furosemide 8mg/ml Oral Solution
Furosemide 10mg/ml Oral Solution
This leaflet was last revised in 09/2015.

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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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