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BUMETANIDE 1MG TABLETS BP

Active substance(s): BUMETANIDE

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Package leaflet: Information for the patient

Bumetanide 1 mg and 5 mg
Tablets

(bumetanide)
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 only. Do
not pass it on to others. It may harm them, even if
their signs of illness 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.

TBC
1211122

What is in this leaflet:

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

1. What Bumetanide is and what it is used for
Bumetanide belongs to a group of medicines called
diuretics (or ‘water’ tablets). Diuretics act on the
kidneys to increase the flow of urine. This gets rid of
excess water from your body and reduces the effect
of water build up.
Bumetanide can be used to help get rid of excess
water in your body, which may be caused by medical
problems such as heart failure, liver or kidney disease.

2. What you need to know before you take
Bumetanide
Do not take Bumetanide if you:

Warnings and precautions
Talk to your doctor or pharmacist before taking
Bumetanide if you:
• are on a low salt diet
• have liver or kidney problems
• suffer from gout
• have diabetes, or are at risk of developing diabetes
(your doctor may have told you, for example, that
you have higher than normal levels of sugar in the
blood after eating)
During treatment
Whilst taking this medicine, you may need to have
blood tests, as advised by your doctor, to check levels
of certain salts in the blood.

Description Bumetanide 1mg, 5mg all

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Do not take Bumetanide with:
• Lithium, normally used to treat manic depression
(see section ‘Do not take’ above)
If you are taking any of the following medicines, tell
your doctor or pharmacist before taking Bumetanide:
• some antibiotics used to treat infections such as
cephaloridine or gentamicin
• amphotericin, normally used to treat fungal infections
• treatment for a heart condition such as digoxin
• treatment for high blood pressure such as sotalol, or
medicines known as ACE inhibitors such as captopril
• an anti-inflammatory medicine, normally used for
arthritis or other bone and muscle problems such
as indometacin, ibuprofen, diclofenac
If you are taking any of the above medicines your
doctor may need to adjust your dose of Bumetanide
or the dose of the other medicine you are taking.

Pregnancy and breast-feeding

Bumetanide should not be given to pregnant or
breast-feeding mothers unless the benefits to
the mother outweigh the risks to the baby. If you
are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice.

Driving and using machines

This medicine should not normally have any effect on
your ability to drive or operate machines. However,
this medicine may cause dizziness, tiredness, weakness
or cause confusion as side effects. You must not drive
or use machines if you get any of these side effects.

Bumetanide contains lactose

If you have been told by your doctor that you have
an intolerance to some sugars contact your doctor
before taking this medicine.

3. How to take Bumetanide
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
At the start of treatment your doctor may monitor
your condition closely.

Adults

The usual recommended starting dose is 1 mg a
day. This dose can be taken in the morning or early
evening. In some cases an additional 1 mg may be
given 6 to 8 hours after your first dose.
If your condition is not controlled by a lower dose, or
you are being treated for a severe build-up of fluid
(oedema), you may need to take up to 5 mg a day. If
there is still no response, your doctor may increase
your dose until your fluid build up is controlled. If
you are taking more than one tablet a day it may
be recommended that you take one dose in the
morning and one dose in the early evening.

Elderly

Your doctor may give you a lower dose of 0.5mg (half
a 1mg tablet) a day.

Use in children

Bumetanide is not recommended for use in children
under 12 years old.

Date: 11 Aug 2015

Component Type Leaflet

Pharma Code TBC

No. of colours

Affiliate Item Code 691665

SAP No. N/A

Colours

Superceded Affiliate Item Code 569108
TrackWise PR No. 691665
MA No. N/A
Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 260842
Trackwise Proof No. 1
Glams Proof No. 1
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

Sign-offs

TBC
1211122

• are allergic to bumetanide, sulfonamide medicines
(which may include some medicines used to treat
infections e.g. co-trimoxazole or other diuretic
medicines such as hydrochlorothiazide) or any of the
other ingredients of this medicine (listed in section 6).
• are taking lithium to treat manic depression
• are in a coma caused by liver problems
• are passing less urine than usual, or not passing
urine at all
• know that you have severe (very low or very
high) changes in your blood “salt” levels (sodium,
potassium, chloride or bicarbonate)
• know that you have a high level of urea in the blood

Other medicines and Bumetanide

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Body Text Size 9 pt

Dimensions 170 x 240mm

Min Text Size used 9 pt

If you take more Bumetanide than you should

Contact your doctor or nearest hospital emergency
department immediately. Take the container and
any remaining tablets with you.

If you forget to take Bumetanide

Take the next dose as soon as you remember unless
it is almost time for your next dose. Do not take a
double dose to make up for a forgotten dose. If you
keep forgetting to take your medicine, tell your doctor.

If you stop taking Bumetanide

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Do not suddenly stop taking your medicine unless
your doctor told you. If you stop taking this medicine,
the fluid build-up in the body may return. Therefore,
before you stop taking, talk to your doctor or
pharmacist for advice.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If any of the following happen, stop taking
Bumetanide and tell your doctor immediately or go
to your nearest hospital emergency department:
• difficulty breathing (which may feel like an asthma
attack), raised, red very itchy skin rash (hives) or
an itchy, runny nose. These may be signs of
allergic reaction.
• in people with liver problems, due to a
build-up of potentially harmful substances in
the body, confusion, drowsiness and difficulty
performing normal tasks such as writing may occur.
In some instances, this may lead to a loss
of consciousness (coma).
• passing little or no urine

Other side effects are:

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.

5. How to store Bumetanide
Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date which
is stated on the carton after EXP. The expiry date
refers to the last day of that month.
This medicine does not require any special storage
conditions.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

6. Contents of the pack and other information
What Bumetanide contains

The active substance is bumetanide. Each tablet
contains either 1 mg or 5 mg of bumetanide.
The other ingredients are lactose monohydrate,
maize starch, pregelatinised maize starch,
microcrystalline cellulose and magnesium stearate.

What Bumetanide looks like and contents
of the pack

Your medicine is available in two strengths 1 mg and
5 mg, both are a white tablet. The 1 mg tablets are
marked ‘BU/1’ on one side and ‘G’ on the other and
the 5 mg tablets are marked ‘BU/5’ on one side and ‘G’
on the other.
Bumetanide is available in blisters and containers
of 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 168 and 180 tablets. Not all pack sizes
and pack types may be marketed.

TBC
1211122

Common (may affect up to 1 in 10 people):
• dehydration (reduced fluid in the body), which may
make you feel thirsty
• headache
• low blood pressure, which can make you feel dizzy
especially when standing up
• feeling sick
• in people with liver problems, itching of the skin
• feeling unusually tired
Uncommon (may affect up to 1 in 100 people):
• severe loss of fluid and salts from the body – you
may feel very weak or confused
• vertigo (a spinning sensation)
• earache
• diarrhoea
• painful breasts or chest discomfort
Rare (may affect up to up to 1 in 1,000 people):
• hearing disturbances
• reduction in the activity of the bone marrow (where
blood cells are produced), which may be seen in
blood tests
Not known (cannot be estimated from the available
data):
• unusual bleeding or bruising of the skin
• stomach ache or cramps
• being sick

• indigestion or heartburn
• skin rash
• muscle cramps. In people taking very high doses of
this medicine, these may be severe and long-lasting
(up to 12 hours) and you may also notice muscle
and bone pain across the whole body.
• joint pain
• swelling or growth of the breasts
• raised blood levels of uric acid, urea and creatinine
or changes in liver enzymes (which show how the
liver is working) in the blood, which may be seen in
blood tests
• raised levels of sugar in the blood

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United
Kingdom

Manufacturer

Gerard Laboratories, 35/36, Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.
Generics [UK] ltd, Station Close, Potters Bar,
Hertfordshire, EN6 1TL, United Kingdom.
This leaflet was last revised in
July 2015
691665

Description Bumetanide 1mg, 5mg all

Date: 11 Aug 2015

Component Type Leaflet

Pharma Code TBC

No. of colours

Affiliate Item Code 691665

SAP No. N/A

Colours

Superceded Affiliate Item Code 569108
TrackWise PR No. 691665
MA No. N/A
Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 260842
Trackwise Proof No. 1
Glams Proof No. 1
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

Sign-offs

1

Time: 08:41
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro

Body Text Size 9 pt

Dimensions 170 x 240mm

Min Text Size used 9 pt

Expand view ⇕

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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