Package Leaflet: Information for the User

Bumetanide Tablets 1mg

Bumetanide

What is in this leaflet

1.    What Bumetanide Tablets are and what they are used for

2.    What you need to know before you take Bumetanide Tablets

3.    How to take Bumetanide Tablets

4.    Possible side effects

5.    How to store Bumetanide Tablets

6.    Contents of the pack and other information

1. What Bumetanide Tablets are and what they are used for

Bumetanide Tablets 1 mg contain the active substance bumetanide. Bumetanide is one of a group of medicines called diuretics (water tablets). They make the kidneys remove water from the body.

Bumetanide Tablets are used to treat oedema, which is a build-up of fluid in the body. This may occur in many situations, for instance, with liver and kidney problems, or with heart failure (when the heart doesn't pump efficiently).

2. What you need to know before you take Bumetanide Tablets

DO NOT take Bumetanide Tablets:

■    If you are currently taking lithium.

■    If you are allergic to bumetanide, sulfonylureas or any of the other ingredients of Bumetanide Tablets (listed in section 6).

■    If you have severe progressing kidney disease, especially if you are excreting a very low amount of urine or if you cannot excrete any urine at all.

■    If you have serious problems with your liver.

■    If you have been told that you have low levels of certain chemicals (electrolytes) in your blood.

Warnings and precautions

Talk to your doctor or pharmacist before taking Bumetanide Tablets:

■    If you are on a low-salt diet or have been told you have an imbalance of body chemicals (electrolytes). Bumetanide can cause disturbances of these body chemicals and your doctor may want to monitor your blood and urine, particularly if you have muscle cramps, numbness, headache, feel faint, weak, dizzy or sick. If you are elderly, your doctor may reduce your dose.

■    If you are a diabetic or if you have ever had diabetes your doctor may ask for periodic checks on urine and blood glucose.

■    If you suffer from any kidney disease, or are taking any drugs that may affect the kidneys, your doctor may closely monitor your body fluids and kidney functions.

■    If you suffer from low blood pressure or are taking other medicines to treat high blood pressure.

■    If you are elderly and taking high doses of Bumetanide.

■    If you have problems with your liver.

Tell your doctor if any of these apply to you. He/she may want to monitor you or do some tests.

Children

Do not give this medicine to children under 12 years of

age because no information is available and it is not known if it is safe to use.

Other medicines and Bumetanide Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, for example, herbal remedies and health supplements from a pharmacy, supermarket or health food shop, as this medicine may interact with other drugs.

The effects of these medicines may change, so the dose may need adjustment when given in conjunction with these drugs, especially if you are taking:

■    medicines to treat heart failure or irregular heartbeats (cardiac glycosides, e.g. digoxin and digitalis, amiodarone, disopyramide, flecainide, sotalol)

■    other medicines used to treat high blood pressure (e.g. methyldopa and captopril, acetazolamide)

■    other medicines that may lead to a loss of potassium, e.g.:

□    medicines used to treat depression (reboxetine)

□    medicines used in asthma (theophylline)

□    medicines used to treat infection (amphotericin)

□    corticosteroids

■    Bumetanide may potentiate the effect of blood pressure lowering drugs and drugs inducing a fall in blood pressure on standing up

■    medicines used to treat anxiety and insomnia (diazepam)

■    medicines used to treat diabetes (e.g. sulfonylyureas)

■    analgesics (non-steroidal anti-inflammatory drugs (e.g. naproxen and ibuprofen)

■    any medicines that may have a harmful effect on your kidneys or your hearing such as antibiotics called aminoglycosides (e.g. gentamycin and neomycin and cephalosporins)

■    medicines used to treat psychosis (amisulpride, sertindole, atomoxetine, pimozide)

DO NOT take Bumetanide Tablets if you are taking lithium (used to treat mood disorders).

Bumetanide Tablets with food and drink

Bumetanide Tablets can be taken with or without food and drink.

Pregnancy, breast-feeding and fertility

Do not take Bumetanide Tablets if you are pregnant (or think you may be), are planning to become pregnant or are breast-feeding, unless your doctor has decided that it is absolutely necessary.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

This medicine may cause dizziness, drowsiness, tiredness or feeling faint as side effects. You must not drive or use machines if you get any of these side effects.

Bumetanide Tablets contain 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 Tablets

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

Your doctor will decide the best dose for you and may change it depending on how you respond to treatment. The tablets should be taken by mouth.

The tablets can be divided into equal doses.

Adults

The usual recommended dose is 1mg (one tablet) which can be taken as a single morning or as an early evening dose.

Depending on your response to single tablet dose, your doctor may decide to prescribe you a higher dose.

Elderly patients

The dosage will be adjusted according to response. A dose of 0.5mg (half a 1mg tablet) may be sufficient in some elderly patients.

Children

Do not give Bumetanide Tablets to children under 12 years of age.

If you take more Bumetanide Tablets than you should

If you think that you, or any other person, have taken too many tablets, contact your doctor or hospital casualty department immediately. Take any remaining tablets and this leaflet with you so that the medical staff know exactly what you have taken.

If you forget to take your Bumetanide Tablets

If you forget to take your medicine and you are less than 12 hours late, you can still take it. If you are more than 12 hours late taking your medicine then leave out this dose. Take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet. If you keep forgetting to take your tablets, speak to your doctor.

If you stop taking Bumetanide Tablets Keep taking Bumetanide Tablets, even if you feel well. Do not stop taking Bumetanide Tablets unless your doctor tells you to.

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.

Stop taking bumetanide and seek medical help immediately if you have any of the following symptoms. You may be having a severe allergic reaction.

■    Difficulty breathing, swelling of the face, lips, tongue or throat

■    Severe itching of the skin with a red rash or raised lumps Tell your doctor immediately if you notice any of the following side effects, as they may indicate a reduction in bodily fluid and electrolytes (chemicals in the blood) and can be serious:

■    muscle cramps, numbness or twitching

■    feeling faint, dizzy or sick

■    tiredness and confusion

■    thirst

■    fever or chills

■    brain disease that may be marked by headache, fits or coma

■    you feel shaky, trembly or faint and your heart starts to beat fast or irregularly

Your doctor may need to test your blood or urine before deciding whether you can continue with your medicine.

Other side effects

■    abdominal pain, indigestion, vomiting, nausea, diarrhoea and stomach cramps

■    pain and swelling in joints, muscles, bones

■    low blood pressure or fall in blood pressure on standing up which may cause light-headedness or fainting

■    tingling / pins and needles feeling (usually in the hands and feet)

■    blood disorders (which may be indicated by bruising, nose bleeds, bleeding easily, sore throat or infections)

■    skin rashes and itching

■    feeling of ‘spinning' (vertigo)

■    you may also experience hearing disturbances, such as ringing and sense of fullness of ears and deafness.

■    jaundice caused by increased bilirubin in blood (a substance produced in the liver) which can make skin and whites of eyes appear yellow

■    enlargement of breasts (in men)

■    painful breasts

■    kidney failure

■    changes in blood test results due to effects on blood cells, salts and other chemicals in the body (for example, changes in levels of creatinine, potassium, sodium, magnesium, calcium, chloride, uric acid, blood glucose levels, lipid/cholesterol). These may be found during routine blood tests. Your doctor can explain this more.

Reporting 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 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 Tablets

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. The expiry date refers to the last day of that month.

Do not store above 25°C.

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 to protect the environment.

6. Contents of the pack and other information

What Bumetanide Tablets contain:

The active substance is bumetanide.

The other ingredients are microcrystalline cellulose (E460(i)), lactose monohydrate, magnesium stearate (E572), maize starch and sodium lauryl sulfate.

What Bumetanide Tablets look like and contents of the pack:

Bumetanide Tablets 1 mg are white and plain on one side and have a breakline on the other side, with ‘1' above the breakline and ‘BMT' below the breakline.

They are packed in blister strips and supplied in cartons of 20, 28, 30, 56, 60, 84 and 120 tablets. Not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Hertfordshire,

SG4 0TW, United Kingdom

Manufacturer: Niche Generics Limited, Unit 5, 151

Baldoyle Industrial Estate, Dublin 13, Ireland.

This leaflet was last revised in: May 2016.