Bumetanide 0.2 Mg/Ml Oral Solution

Bumetanide 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 andwhat it isused for

2.    Beforeyou take

3.    How to take

4.    Possible side effects

5.    How tostore

6.    Further information

1. What this medicine its and what it is used for

Bumetanide solution contains bumetanide which is a diuretic (water medicine).

It is usedwhere there is toomuchwater in your body. Bumetanide helps your kidneys producemoreurine over a short period of timewhichmeans that your body canget rid of more water quickly.

It is effective for peoplewho have swollen feet and ankles due to fluid which has built up as a result of heart, l iver or kidney disease.

There are other reasons why youmay need a diuretic.

Speak to your doctor if you arenot sure why this medicinehas been prescribed for you.

2. Before you take

DoNOT takeBumetanidesolution if you:

•    are allergic tobumetanide or to any of theother ingredients (see Section (6)

•    cannot pass water (urine)

•    aredehydrated (thirsty (with dry skin, dark urine, dry mouth, headache)

• have been told toy 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 theabove apply to you,speak to your doctor or pharmacist.

Take special carewithBumetanide solution

Before taking this 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 forth is

•    are allergic tomedicines called sulfonamides or thiazides

•    are an athletewhoundergoes urine doping testing.

Takingother medicines

Please tell your doctor or pharmacist if youare taking or (have recently taken any other medicines, includingmedicines obtainedwithout a prescription,andherbal preparations.

Somemedicines may beaffected toy Bumetanideor they may affect how well Bumetanide twill (work. Tell you r doctor or pharmacist if youare taking:

• lithium, used to treat mood disorders (see Section "Do not take Bumetanide solution if you" above)

•    ^rmir^<^<glycosid^^ntit3iotics (e.g. gentamicin) or other medicines which may affect your hearing

•    cardiac glycosides (e.g.digoxin),used to treat heart conditions

•    medicines for high blood pressure

•    non-steroidal anti-inflammatory medicines (e.g. indometacin)

•    medicines which may affect your kidneys.

Pregnancy and breastfeeding

DO NOT take Bumetanide if you are pregnant orwhile breast-feeding

unless advised to by your doctor

Ask yourdoctorforadvice 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

•    sorbitol

If you have been told by your doctor that you have an i ntolerance 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 sorbitot

•    methyl hydroxybenzoate and propyl hydroxybenzoate

These may cause allergic:: reactions (possibly delayed).

3. Howtotake

Always take Bumetanide solution exactly as your doctor has told you and always read the label. Your doctor willdecide on the appropriate dose tsuit your condition.Ask your doctor or pharmacist if you are not sure.

• Take your medicine at the same time each day, usually i n the morning or early evening;thismakes it easier to remember

•    If you are talking more than 5 ml a day, you may need to take two doses rattier than taking all your medicine in one go. Remember that thismay be i nconvenient if you are going on a i ong j ourney or want tgo to sleep.

• You are more i ikely to need t tie t oilet for about 3 hours after you have taken yourmedicine.

•    You may iike to have a drink of water after taking the medicine.


Adults; and children over 12 years: the usual starting dose is 5 ml


Your doctor may change your dose alter you have been taking this medicine for a while.

Elderly: you may be given a i ower starting dose as you may be more sensitive to thismedicine.

Chiidren: thismedicine is NOT suitable for children under 12 years.

Patients with severe kidney problems: if you have kidney failure! and are talking a high dose of Bumetanide solution, you willbe given this medicine in hospital under special care.

Blood tests may be carried out to check how well this medicine is working, particulariy i n patients talking a iow salt dieDiabetics may have t heir blood and urine checked.

Continued over page


If you take more than you should

1.    Tell your doctor, pharmacist or nearest hospitalcasua Itydepactment immediately.

2.    Take the bottle and any remaining solYfen w^h^m sa that y^e^^^ 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 soonau geu rememd erifet isless than 12 hours late.

If you are more than 12 hours late takiny yourmppini te,nki2 t^^mi s^^^d dose and continue as usual.

Do not take a double dose to make up fo romisned dioue.

If you stop taking

Do not stop taking this medicine, or lowo rthedosskourseiS mithoutnrst checking with your doctor.

Keep taking the solution until your doctetfelldyou to stop.

Do not let yourself run out of medicineospocielly ovettheweekend otoa holidays.

If you have any further questions on the uueaf .Is yroduct,askyour doctor or pharmacist.

The following side effects usually sTttle withoutchane mg e^^du^^: pheadache

•    stomach ache, feeling sick or being pittupiacrhaae pmusefeuramsno tno.n

•    itchy raised skin (hives)

•    itching skin, skin rashes including dprmatina,

•    swollen or painful breasts (sometime rn men ) aringing or tuinzing is file ears (tinnitpp),depfnose

•    dizziness

•    feelingtirea.

Blood tests: tell your doctor if you areoavin gbloodtesfeas^csr

day cause changes in the 16^1 of neme substances|nnour blood (including salts, sugar, waste-preducts padbpgyfats suciias chofeuterolusatriglycerides)Reporting side effects

e yoy get effects, talk to your doctot,dhatmauisf ornursa.Thiis includeu vnyne ss.ble sideeffects not listed in this leaflet. You can also report side ernects directly via the Yello!!,^K^dSi^End ue/yellowcard

Byrepoftinghide effectuuou can help provido more informatien on the safety of this medicine.

4. Possible side effects

5. How to store

Like all medicines, Bumetanide solution can cause side effects, although not everybody gets them. Do not be alormed tty ofnPssibionide effects. You may not experience any cnftiiem .

STOP taking the solution and seek medicalhelp immediate|yifdou have any of the following allergic reaefloea:

•    difficulty breathing or swallowing, swe||ingufthetaceil|pu,tonduo or throat

•    severe itching of the skin, with a red ranh on rsihepi limps.

Seek immediate medical attention ifyou haveanyof thefollawing symptoms:

•    feeling shaky, faint or your heart starts to peatfast ofirrepular.y.

This may be due to a shock-like reaction

• fever, rash, feeling sick, aches and painh,loinpain,passinc machor less urine than usual, passing red urinearpassindn usuat naM, difficulty or inability to pass urine. Thismaybepupfe changnsit your kidneys

•    unusual or increased bleeding or b ruiu|nu

•    fever, sore throat, mouth ulcers, repesten infec.ohs os.pfectionscnawill not go away

•    feeling tired, breathless and looking pa.e

•    yellowing of your skin or eyes, pale fpeneu ang ^kurtse, itphn skin. This may be due to blockage in the livor.

Tell your doctor if you get any of thTfollowingcide effects:

•    pain in your bones and muscles. Tpipmpy n spusetr youarhtPuinhigh doses and have severe kidney progfemu

•    pain and swelling in one or more jointn(gourr

•    feeling thirsty with dry skin, dark uri pe,nrpmours,heae aciye.T^s may be due to dehydration

•    light-headedness or dizziness when stahdin. hnhrpmasittizc| pt lying position

•    reactions to the sun. Your skin may pe(tomered,painfslpnd uwaNen - do not sunbathe, use a sun bed, or exporoyaurekinto am ligM

•    a collection of symptoms including tpifsarrecuon)s riypt.ou, tiredness, and increased susceptibility toinfections, sncitas tofush. This may be due to too much glucose ih thpdobn. Yonr popto r puci test for this.

p aauaosteftflefea ch euusight of children.

• Db not sake ofterthe ex^ry date which is slated on the bottle label and on the carton. The expiry date refers to the last day of that month.

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•    Do not throw it away with your household waste or in water. Return nl l paesnwanted me, icingfe or ur pharmacist. Tiiis will help to protect the environment.

6. Further information

What Bumetanide Oral Solution contains

•    Reactive rngrsrtfeY is bumetanide (1 mg pet5 ml). oThe other ingredients are:

uorbitol tE420),mprUslparahydroxybenzoate (E218), propyl pafasydroxype nsoate (E216), xanthan gum, sodium dtrate, patent B^V,. srno^pyeNow, peppermint flavour a nd purified water.

(See end of Section 2 for further Information on sorbitei, methyl hydroxybenzoate, and propyl hydroxybenzoate).

What Bumetanide Oral Solution looks like agd contents of t he pack

dnmetanide Oral Solution is a clear, green liquid witT the flavour of nanfarmi Y.

• Ss available in amber glass bottles of 5 ml, 10 ml, 2 5 ml and 150 ml. Notall pack sieesmay be marketed.

MpfketinnAutholusaTon Hoider

Eeseptial Generics, 7 Egham Business Villege, Crabtree Road, Egham, autrey,TW20 8RB.


FamarNuPeriap d sv, ladustrieweg 1, 5531 AD Bladel, The Netherlands.

This leaflet was last revised in