BUMETANIDE LIQUID 0.2 MG/ML ORAL SOLUTION

Active substance: BUMETANIDE

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Bumetanide Liquid
0.2 mg/ml Oral Solution
Bumetanide

118/L/h/4

Read all of this leaflet carefully before you start taking this medicine.
iKeep this leaflet. You may need to read it again.
iIf you have any further questions, ask your doctor or pharmacist.
iThis 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.
iIf 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 this medicine is and what it is used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information

1. What this medicine is and what it is used for
Bumetanide solution contains bumetanide which is a diuretic (water
medicine).
It is used where there is too much water in your body. Bumetanide helps
your kidneys produce more urine over a short period of time which means
that your body can get rid of more water quickly.
It is effective for people who have swollen feet and ankles due to fluid
which has built up as a result of heart, liver or kidney disease.
There are other reasons why you may need a diuretic.
Speak to your doctor if you are not sure why this medicine has been
prescribed for you.

2. Before you take
Do NOT take Bumetanide solution if you:
iare allergic to bumetanide or to any of the other ingredients (see
Section 6)
icannot pass water (urine)
iare dehydrated (thirsty with dry skin, dark urine,dry mouth, headache)
ihave been told by your doctor that you have low levels of salts in your
body
iare taking lithium. Check with your doctor or pharmacist if you are
not sure whether you are taking lithium.
If any of the above apply to you, speak to your doctor or pharmacist.
Take special care with Bumetanide solution
Before taking the solution, tell your doctor if you:
iare on a low salt diet
ihave diabetes
ihave long-term kidney disease
ihave liver disease
ihave low blood pressure
ihave a condition called porphyria
ihave high levels of uric acid in your blood. Your doctor may test your
blood for this
iare allergic to medicines called sulfonamides or thiazides
iare an athlete who undergoes urine doping testing.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription, and herbal preparations.
Some medicines may be affected by Bumetanide or they may affect how
well Bumetanide will work. Tell your doctor or pharmacist if you are
taking:
ilithium, used to treat mood disorders (see Section "Do not take"
above)
iaminoglycoside antibiotics (e.g. gentamicin) or other medicines
which may affect your hearing
icardiac glycosides (e.g.digoxin), used to treat heart conditions

imedicines for high blood pressure
inon-steroidal anti-inflammatory medicines (e.g. indometacin)
imedicines which may affect your kidneys.
Pregnancy and breast-feeding
DO NOT take Bumetanide if you are pregnant or while breast-feeding
unless advised to by your doctor.
Ask your doctor for advice before taking any medicine.
Driving and using machines
Bumetanide solution may cause dizziness or tiredness. If this occurs do
not drive, use machinery, or perform any tasks that may require you to be
alert.
Important information about some of the ingredients of Bumetanide
Oral Solution
isorbitol
If you have been told by your doctor that you have an intolerance to
some sugars, you should speak to your doctor before taking this
medicine.
Sorbitol may have a mild laxative effect and can cause an upset
stomach and diarrhoea.
Each 5 ml of Bumetanide solution contains 1.4 g sorbitol.
Calorific value 2.6 kcal/g sorbitol.
imethyl hydroxybenzoate and propyl hydroxybenzoate
These may cause allergic reactions (possibly delayed).

3. How to take
Always take Bumetanide solution exactly as your doctor has told you and
always read the label. Your doctor will decide on the appropriate dose to
suit your condition. Ask your doctor or pharmacist if you are not sure.
iTake your medicine at the same time each day, usually in the morning
or early evening; this makes it easier to remember.
iIf you are taking more than 5 ml a day, you may need to take two
doses rather than taking all your medicine in one go. Remember that
this may be inconvenient if you are going on a long journey or want to
go to sleep.
iYou are more likely to need the toilet for about 3 hours after you have
taken your medicine.
iYou may like to have a drink of water after taking the medicine.
Doses
Adults and children over 12 years: the usual starting dose is 5 ml
once a day.
Your doctor may change your dose after you have been taking this
medicine for a while.
Elderly: you may be given a lower starting dose as you may be
more sensitive to the medicine.
Children: this medicine is NOT suitable for children under 12 years.
Patients with severe kidney problems: if you have kidney failure
and are taking a high dose of Bumetanide solution, you will be given
this medicine in hospital under special care.
Blood tests may be carried out to check how well the medicine is
working, particularly in patients taking a low salt diet.
Diabetics may have their blood and urine checked.

Continued over page

If you take more than you should
1. Tell your doctor, pharmacist or nearest hospital casualty department
immediately.
2. Take the bottle and any remaining solution with you so that people
can see what you have taken.
3. Do this even if you feel well.
If you forget to take
If you forget to take a dose, take it as soon as you remember if it is less
than 12 hours late.
If you are more than 12 hours late taking your medicine, skip the missed
dose and continue as usual.
Do not take a double dose to make up for a missed dose.
If you stop taking
Do not stop taking this medicine, or lower the dose yourself, without first
checking with your doctor.
Keep taking the solution until your doctor tells you to stop.
Do not let yourself run out of medicine especially over the weekend or on
holidays.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

4. Possible side effects
Like all medicines, Bumetanide solution can cause side effects, although
not everybody gets them. Do not be alarmed by this list of possible side
effects. You may not experience any of them.
STOP taking the solution and seek medical help immediately if you
have any of the following allergic reactions:
idifficulty breathing or swallowing, swelling of the face, lips, tongue or
throat
isevere itching of the skin, with a red rash or raised lumps.
Seek immediate medical attention if you have any of the following
symptoms:
ifeeling shaky, faint or your heart starts to beat fast or irregularly.
This may be due to a shock-like reaction
ifever, rash, feeling sick, aches and pains, loin pain, passing more or
less urine than usual, passing red urine or passing urine at night,
difficulty or inability to pass urine. This may be due to changes in
your kidneys
iunusual or increased bleeding or bruising
ifever, sore throat, mouth ulcers, repeated infections or infections that
will not go away
ifeeling tired, breathless and looking pale
iyellowing of your skin or eyes, pale faeces and dark urine, itchy skin.
This may be due to blockage in the liver.
Tell your doctor if you get any of the following side effects:
ipain in your bones and muscles. This may happen if you are taking
high doses and have severe kidney problems
ipain and swelling in one or more joints (gout)
ifeeling thirsty with dry skin, dark urine, dry mouth, headache. This
may be due to dehydration
ilight-headedness or dizziness when standing up from a sitting or
lying position
ireactions to the sun. Your skin may become red, painful and swollen
- do not sunbathe, use a sun bed, or expose your skin to UV light.
ia collection of symptoms including thirst, frequent urination,
tiredness, and increased susceptibility to infections, such as thrush.
This may be due to too much glucose in the body. Your doctor can
test for this.
118/L/h/4

The following side effects usually settle without changing the dose:
iheadache
istomach ache, feeling sick or being sick, diarrhoea
imuscle cramps or pain
iitchy raised skin (hives)
iitching skin, skin rashes including dermatitis,
iswollen or painful breasts (sometimes in men)
iringing or buzzing in the ears (tinnitus), deafness
idizziness
ifeeling tired.
Blood tests: tell your doctor if you are having blood tests as your
medicine may cause changes in the level of some substances in your
blood (including salts, sugar, waste-products and body fats such as
cholesterol and triglycerides).
If any of the side effects get troublesome, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store
iKeep out of the reach and sight of children.
iDo not take after the expiry date which is stated on the bottle label and
on the carton. The expiry date refers to the last day of that month.
iStore below 25°C.
iDo not throw it away with your household waste or in water. Return all
the unwanted medicine to your pharmacist. This will help to protect
the environment.

6. Further information
What Bumetanide Oral Solution contains
iThe active ingredient is bumetanide (1 mg per 5 ml).
iThe other ingredients are:
sorbitol (E420), methyl hydroxybenzoate (E218), propyl
hydroxybenzoate (E216), xanthan gum, sodium citrate, patent Blue V,
quinoline yellow, peppermint flavour and purified water.
(See end of Section 2 for further information on sorbitol, methyl
hydroxybenzoate, and propyl hydroxybenzoate).
What Bumetanide Oral Solution looks like and contents of the pack
Bumetanide Oral Solution is a clear, green liquid with the flavour of
peppermint.
It is available in amber glass bottles of 5 ml, 10 ml, 25 ml and 150 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chemidex Pharma Ltd, trading as Essential Generics, 7 Egham
Business Village, Crabtree Road, Egham, Surrey, TW20 8RB.
Manufacturer
Famar Nederland BV, Industrieweg 1, 5531 AD Bladel, The Netherlands.
This leaflet was last revised in
February 2010

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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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