iMedi.co.uk

Bumetanide 5mg Tablets

Document: leaflet MAH GENERIC_PL 00289-0323 change

BUMETANIDE 1 mg AND 5 mg TABLETS


PACKAGE LEAFLET: INFORMATION FORTHE USER


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 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,


IN THIS LEAFLET:


1.    What Bumetanide is and what it is used for

2.    Before you take Bumetanide

3.    How to take Bumetanide

4.    Possible side effects

5.    How to store Bumetanide

6.    Further information

WHAT BUMETANIDE IS AND WHAT IT IS USED FOR

Bumetanide is a type of medicine called a diuretic which increases the amount of water (urine) passed

Bumetanide is used to treat excess fluid accumulation in the body (oedema) which can be caused by heart, liver, or kidney disease.


= o


BEFORE YOU TAKE BUMETANIDE


Do NOT take Bumetanide if you:

are allergic (hypersensitive) to bumetanide or any of the other ingredients of this medicine are in the first 3 months of pregnancy or breast-feeding

suffer from severe liver disease, or are in a coma due to severe liver problems suffer from a severe imbalance of water and salts in the body

are producing less urine than usual, or no urine at all.

Take special care with Bumetanide

Tell your doctor before you start to take this medicine if you: are on a low salt diet have kidney problems.

Your doctor may give you regular blood and urine tests whilst you are taking this medicine.

If you see another doctor or go into hospital, let him or the staff know what medicines you are taking.

Taking other medicines

Do NOT take Bumetanide if you are taking the


following medicine: lithium.

Talk to your doctor if you are taking any of the following:

cardiac glycosides e.g. digoxin

drugs for high blood pressure e.g. captopril,

atenolol

non-steroidal anti-inflammatory drugs e.g. aspirin, diclofenac

nephrotoxic drugs (which adversely affect your kidneys) e.g. bendroflumethiazide ototoxic drugs (which may affect hearing and balance) e.g. streptomycin or gentamicin.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, ncluding medicines obtained without a prescription, Pregnancy and breast-feeding Do not take bumetanide if you are in the first 3 months of pregnancy or are breast-feeding.

If you are pregnant, planning to become pregnant or breast-feeding ask your doctor or pharmacist for advice before taking any medicine,

Driving and using machines

Bumetanide is not known to affect your ability to

drive or operate machinery.

Important information about some of the ngredients of Bumetanide Patients who are intolerant to lactose should note that bumetanide tablets contain a small amount of lactose, If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicinal product,


o


HOWTOTAKE BUMETANIDE


Always take Bumetanide exactly as your doctor has told you.You should check with your doctor or pharmacist if you are not sure,

Bumetanide tablets can be taken with or without food, The tablets should be swallowed with a drink of water,

The usual dose is:

Adults

One 1 mg tablet per day taken in the morning or early evening. Your doctor may increase your dose and prescribe a second tablet 6 to 8 hours late r,

For the 5 mg tablet the usual dose is one tablet a day taken in the morning or early evening. Your doctor may increase your dose and prescribe a second tablet 12 to 24 hours later, Children

Not recommended for use in children under 12 years of age,

The Elderly

Half of one 1 mg tablet per day but your doctor will adjust the dose according to your response,


If you take more Bumetanide than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor 'immediately. An overdose is likely to cause excessive passing of urine.

Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Bumetanide You should continue to take these tablets for as long as your doctor tells you to. If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose,Take the remaining doses at the correct time,

If you stop taking Bumetanide

You should continue to take these tablets for as long as your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

) POSSIBLE SIDE EFFECTS

Like all medicines, bumetanide can have side effects, although not everybody gets them.

If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital: an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or nettle rash).

This is a very serious but rare side effect,You may need urgent medical attention or hospitalisation. The following effects have been reported: stomach ache or cramps, vomiting, nausea, indigestion or heartburn, diarrhoea, dehydration

dizziness or fainting on standing

muscle cramps, pain in your joints

tiredness, headache, dizziness

low blood pressure

high levels of blood sugar

increase in the blood levels of urea and

creatinine

itching, skin rashes e.g. nettle rash

blood disorders including unusual bleeding or

unexplained bruising

gout

painful breasts or, in men, breast enlargement. Rarely, hearing disturbances may occur but they are reversible. Bumetanide has been associated with bone marrow depression, a condition in which there is impairment in blood cell production,This can result in anaemia, reduced ability to fight infection and bruising or bleeding,


Patients with long term liver disease may develop encephalopathy, a disorder affecting the brain that may cause memory loss, changes in personality or fits and elevated levels of blood enzymes,

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 theYellow Card Scheme at: www.mhra.gov.uk/yellowcard,

By reporting side effects you can help provide more information on the safety of this medicine,

} HOWTO STORE BUMETANIDE

Keep out of the reach and sight of children. Do

not store these tablets above 25°C.

Do not use bumetanide after the expiry date that s stated on the outer packaging.The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.These measures will help to protect the environment.

} FURTHER INFORMATION

What Bumetanide tablets contain:

The active ingredient is bumetanide.

The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, povidone, sodium starch glycolate and magnesium stearate,

What Bumetanide tablets look like and contents of the pack:

The 1 mg tablets are white, circular, flat uncoated tablets engraved with 7B1 with a breakline.

The 5 mg tablets white, plain, round, flat uncoated tablets engraved with 7B2 with a breakline.

Bumetanide 1 mg and 5 mg tablets are available in pack sizes of 7, 10, 14, 20, 21, 28, 30, 50, 56, 60, 84, 90, 100, 110, 112, 120, 150, 160, 168, 250, 500, 1000 and 5000 tablets, See outer packaging or the pharmacy label for contents i.e, the number of tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder and company responsible for manufacture:TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised: May 2015

PL 00289/0322-0323

60904-V

_160 x 210