Bumetanide Liquid 0.2 Mg/Ml Oral Solution
Read all of this leaflet carefully before you start taking 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 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
• medicines for high blood pressure
• non-steroidal anti-inflammatory medicines (e.g. indometacin)
• medicines which may affect your kidneys.
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.
Do NOT take Bumetanide solution if you:
• are allergic to bumetanide or to any of the other ingredients (see Section 6)
• cannot pass water (urine)
• are dehydrated (thirsty with dry skin, dark urine,dry mouth, headache)
• have been told by your doctor that you have low levels of salts in your body
• are 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:
• are on a low salt diet
• have diabetes
• have long-term kidney disease
• have liver disease
• have low blood pressure
• have a condition called porphyria
• have high levels of uric acid in your blood. Your doctor may test your blood for this
• are allergic to medicines called sulfonamides or thiazides
• are 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:
• lithium, used to treat mood disorders (see Section "Do not take" above)
• aminoglycoside antibiotics (e.g. gentamicin) or other medicines which may affect your hearing
• cardiac glycosides (e.g.digoxin), used to treat heart conditions
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
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.
• methyl hydroxybenzoate and propyl hydroxybenzoate
These may cause allergic reactions (possibly delayed).
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.
• Take your medicine at the same time each day, usually in the morning or early evening; this makes it easier to remember.
• If 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.
• You are more likely to need the toilet for about 3 hours after you have taken your medicine.
• You may like to have a drink of water after taking the medicine.
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.
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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.
The following side effects usually settle without changing the dose:
• stomach ache, feeling sick or being sick, diarrhoea
• muscle cramps or pain
• itchy raised skin (hives)
• itching skin, skin rashes including dermatitis,
• swollen or painful breasts (sometimes in men)
• ringing or buzzing in the ears (tinnitus), deafness
• feeling 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).
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 at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
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:
• difficulty breathing or swallowing, swelling of the face, lips, tongue or throat
• severe itching of the skin, with a red rash or raised lumps.
Seek immediate medical attention if you have any of the following symptoms:
• feeling shaky, faint or your heart starts to beat fast or irregularly.
This may be due to a shock-like reaction
• fever, 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
• unusual or increased bleeding or bruising
• fever, sore throat, mouth ulcers, repeated infections or infections that will not go away
• feeling tired, breathless and looking pale
• yellowing 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:
• pain in your bones and muscles. This may happen if you are taking high doses and have severe kidney problems
• pain and swelling in one or more joints (gout)
• feeling thirsty with dry skin, dark urine, dry mouth, headache. This may be due to dehydration
• light-headedness or dizziness when standing up from a sitting or lying position
• reactions 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.
• a 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.
• Keep out of the reach and sight of children.
• Do 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.
• Store below 25°C.
• Do 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.
What Bumetanide Oral Solution contains
• The active ingredient is bumetanide (1 mg per 5 ml).
• The 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.
Famar Nederland BV, Industrieweg 1,5531 AD Bladel, The Netherlands.
This leaflet was last revised in