Bumetanide 5mg tablets

Main information

  • Trade name:
  • Bumetanide 5mg tablets
  • Dosage:
  • 5mg
  • Pharmaceutical form:
  • Tablet
  • Administration route:
  • Oral
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Bumetanide 5mg tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 02020200; GTIN: 5017007028314

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 00289/0323
  • Last update:
  • 29-01-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Top of page cut-off to middle of registration mark: 23mm. Registration Pitch: 210mm -0.45mm (Sheet depth / cut-off length: 210mm)

Pharma code 771

Bumetanide

1 mg and 5 mg Tablets

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. 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.

1. What Bumetanide is and what it is used for

2. What you need to know before you take

Bumetanide

3. How to take Bumetanide

4. Possible side effects

5. How to store Bumetanide

6. Contents of the pack and other 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.

What you need to know 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.

Warnings and precautions

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.

Other medicines and Bumetanide

Tell your doctor or pharmacist 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.

Lithium - used for mental illnesses. To help stop

side effects your doctor may need to change

the dose of your lithium and check the amount

of lithium in your blood.

Please tell your doctor or pharmacist if you are

taking or have recently taken any other medicines,

including 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

ingredients 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.

How to take 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

later.

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 children.

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 the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard or search for MHRA

Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide

more information on the safety of this medicine.

How to store Bumetanide

Keep this medicine out of the sight and reach of

children. Do not store these tablets above 25°C.

Do not use bumetanide after the expiry date that

is 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.

Contents of the pack and other 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: November 2018

PL 00289/0322-0323

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What is in this leaflet

Package leaflet: Information for the user

60904-Y

EAS1473b

160 x 210