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BUMETANIDE 1 MG TABLETS

Active substance(s): BUMETANIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Bumetanide 1mg Tablets
Bumetanide 5mg Tablets
Bumetanide (Referred to as Bumetanide Tablets in the remainder of the leaflet)
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, please 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 Bumetanide Tablets are and what they are used for
2. Before you take Bumetanide Tablets
3. How to take Bumetanide Tablets
4. Possible side effects
5. How to store Bumetanide Tablets
6. Further information
1. What Bumetanide Tablets are and what they are used for
The name of your medicine is Bumetanide Tablets. The active
ingredient in your medicine is bumetanide. Bumetanide Tablets belong
to a group of medicines called diuretics (water tablets) which increase
the amount of urine you produce.
Bumetanide Tablets are used to treat fluid retention (oedema)
associated with kidney, liver, or heart problems.
2. Before you take Bumetanide Tablets
Do not take Bumetanide Tablets if you
• are allergic (hypersensitive) to bumetanide or to any of the other
ingredients in this medicine (see section 6 “Further information”)
• are in a coma or coma like state that has been caused by liver
problems
• are unable to pass water (urine) because you have serious kidney
problems.
Take special care with Bumetanide Tablets if you
• are elderly
• are on a low salt diet
• have low levels of salts (electrolytes) in your blood
• have kidney problems
• have a decreased blood volume
• are diabetic, or suffer from gout
• have severe asthma and are taking medicines called beta-agonists;
these include bambuterol, fenoterol, formoterol, reproterol,
salbutamol, salmeterol, terbutaline and tulobuterol
• have low blood pressure
• have an enlarged prostate
• have a condition known as porphyria (an inherited condition causing
skin blisters, abdominal pain, and brain or nervous system disorders)
• have liver problems.
If you are currently taking lithium to treat manic depression or bipolar
disorder, you should not take Bumetanide Tablets.

• medicines used to treat diabetes
• medicines taken for depression and mental illness
including tricyclic antidepressants, monoamine oxidase inhibitors
(MAOIs), reboxetine, pimozide, sertindole, and lithium
• medicines used to treat epilepsy (fits) (e.g. carbamazepine)
• medicines used to treat fungal infections, such as amphotericin
• medicines, called antihistamines, used to treat allergies, such as
terfenadine
• medicines used to treat high blood pressure including calcium
channel blockers, beta blockers, ACE inhibitors, angiotensin-II
antagonists, and alpha-blockers such as prazosin
• medicines used to treat inflammation, known as corticosteroids
• medicines used in the treatment of various types of cancer, such as
cisplatin
• other diuretics including thiazides, acetazolamide, and loop diuretics
• medicines called muscle relaxants, such as baclofen and tizanidine
• female sex hormones including oestrogen and progestogen used in
oral contraceptives (“the pill”, mini-pill)
• medicines, called peripheral vasodilators that cause widening of
blood vessels and increased blood flow to parts of the body, such as
thymoxamine or moxisylyte
• medicines, called prostaglandins, such as alprostadil
• medicines known as beta-agonists, which are used to treat asthma
(e.g. bambuterol, fenoterol, formoterol, reproterol, salbutamol,
salmeterol, terbutaline, and tulobuterol)
• ritodrine, used to stop premature labour
• theophylline, used in the treatment of asthma
• medicines used to treat stomach ulcers, such as carbenoxolone.
Taking Bumetanide Tablets with food and drink
During treatment with Bumetanide Tablets, talk to your doctor before
consuming alcoholic drinks. Consuming alcohol whilst being treated
with Bumetanide Tablets may cause your blood pressure to drop,
making you feel dizzy or light-headed, especially when standing up
(orthostatic or postural hypotension).
Pregnancy
If you are pregnant or thinking of becoming pregnant, check with your
doctor before you use Bumetanide Tablets. Your doctor will decide if
you should take them. Bumetanide Tablets should not be used during
the first 12 weeks of pregnancy.
Breast-feeding
Do not breast-feed if you are taking Bumetanide Tablets.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machinery
Do not drive or operate machinery when taking Bumetanide Tablets
because they may reduce your level of mental alertness.
Important information about some of the ingredients of
Bumetanide Tablets
This medicine contains lactose (a type of sugar). If you have been
told by your doctor that you cannot tolerate some sugars, contact your
doctor before taking this medicine.
3. How to take Bumetanide Tablets

Patients with long-term kidney failure, who are receiving high doses of
bumetanide should remain under constant hospital supervision.

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

Taking other medicines
Please tell your doctor if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
The following medicines can affect or be affected by treatment with
Bumetanide Tablets:
• alcohol (see also section below “Taking Bumetanide Tablets with
food and drink”)
• medicines, called non-steroidal anti-inflammatory drugs (NSAIDs),
used to treat pain or inflammation, such as indometacin or ketorolac
• medicines used for heart problems including amiodarone,
disopyramide, flecainide, quinidine, lidocaine, mexiletine, and cardiac
glycosides
• medicines used to treat bacterial infections (e.g. antibiotics such as
cephalosporins, aminoglycosides, colistin, and vancomycin)

Adults
The usual starting dose for Bumetanide 1mg Tablets is one tablet
taken once a day. Your doctor may decide to increase this to one (or
more) tablets, taken twice a day, depending on your condition. If you
are taking the medicine twice a day, take the first dose in the morning,
then take the second dose 6-8 hours later.
The usual starting dose for Bumetanide 5mg Tablets is one tablet
taken once a day. Your doctor may decide to increase this gradually,
by 5mg at a time, every 12-24 hours depending on your symptoms.
Elderly patients
The usual dose is one half of a 1mg tablet once a day. Your doctor will
decide on your dose.

Children
Bumetanide Tablets are not recommended for use in children.
If you take more Bumetanide Tablets than you should
If you accidentally take too many Bumetanide Tablets, you should
contact your doctor or go to your nearest hospital casualty department
immediately. Take this leaflet and any unused tablets with you to show
the doctor.
The symptoms of overdose include excessive production or passage
of water (urine).
If you forget to take Bumetanide Tablets
If you forget to take your medicine take it as soon as you remember. If
it is almost time for your next dose do not take the missed dose at all.
NEVER take a double dose to make up for the one missed.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
4. Possible side effects
Like all medicines, Bumetanide Tablets can cause side effects,
although not everybody gets them.
If you notice any of these problems talk to your doctor straight away:
• muscle cramp
• feeling dizzy or light-headed, especially when standing up (low
blood pressure)
• headache
• dry mouth
• feeling thirsty
• excessive loss of water/fluid (dehydration)
• feeling weak, tired, drowsy or sleepy
• feeling restless
• lower than normal production of water (urine)
• irregular heartbeat.
Other side effects that may be experienced while taking this
medicine are:
• changes in the salts and electrolytes in your blood (shown in
blood tests)
• in rare cases, ringing in the ears or deafness, which is usually
temporary, but can be permanent
• blurred vision
• allergic reaction: symptoms include skin rash, itching, hives and skin
inflammation or increased sensitivity to the sun (photosensitivity)
• kidney problems
• high temperature (fever)
• increased sugar levels in the blood or urine
• abdominal pain
• feeling or being sick
• heartburn (dyspepsia)
• diarrhoea
• stomach cramps
• severe stomach pain which may reach through to your back
(pancreatitis)
• changes to various types of blood cells (shown in blood tests)
• changes to the levels of proteins in your blood
• swollen or painful breasts (in both men and women)
• an increase in uric acid in your blood (gout).
Patients taking high doses of Bumetanide Tablets may experience
severe pains in bones and muscles.
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.
5. How to store Bumetanide Tablets
Keep out of the reach and sight of children.
Do not use Bumetanide Tablets after the expiry date stated on the
blister or carton. The expiry date refers to the last day of that month.
Do not store above 25ºC. Store in the original container.
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 protect the environment.

6. Further information
What Bumetanide Tablets contain
The active ingredient is bumetanide.
Each Bumetanide 1mg Tablet contains 1mg of
bumetanide.
Each Bumetanide 5mg Tablet contains 5mg of bumetanide.
The other ingredients of Bumetanide 1mg Tablets are maize starch,
lactose, polyvidone K25, polysorbate 80, colloidal anhydrous silica,
agar, talc and magnesium stearate.
The other ingredients of Bumetanide 5mg Tablets are maize starch,
lactose, polyvidone K25, polysorbate 80, colloidal anhydrous silica,
talc and magnesium stearate.
What Bumetanide Tablets look like and the contents of the pack
Bumetanide 1mg Tablets are white, flat, circular tablets marked “1mg”
with a break line on one side.
Bumetanide 5mg Tablets are white, flat, circular, bevel-edged tablets
marked “5mg” with a break line on one side.
Both strengths of tablets are available in the following packs:
• glass tablet containers containing 100 tablets
• PVC/aluminium strips in packs containing 14, 28 and 56 tablets.
Bumetanide 1mg Tablets are also available in glass tablet containers
containing 10 and 1000 tablets.
Marketing Authorisation Holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK
Manufacturer
CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or
audio please call, free of charge: 0800 198 5000 (UK only).
Please be ready to give the following information:
Product name

Reference number

Bumetanide 1mg Tablets

PL 29831/0326

Bumetanide 5mg Tablets

PL 29831/0324

This is a service provided by the Royal National Institute of Blind
People.
For the Republic of Ireland please call + 353 52 36253.
Leaflet Prepared: December 2010

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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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