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.

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

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)

•    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

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

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).

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).

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

^WOCKHARDT

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 25°C. 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.