iMedi.co.uk

Bumetanide 1mg Tablets

Document: leaflet MAH GENERIC_PL 00142-0445 change

^actavis


Bumetanide 1mg tablets



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, 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.


•    have an inherited disorder of the red blood pigment haemoglobin causing skin blisters, abdominal pain and nervous system disorders (porphyria).

•    have gout (high levels of uric acid in the blood) causing crystals to deposit in joints of hands or feet causing pain.

•    have or may have diabetes.

•    have impaired liver function.

•    have chronic kidney failure.

•    are elderly.

•    are on a low salt diet.


Index

T| What Bumetanide tablets are and what they are used for

^ Before you take ^ How to take "4 Possible side effects How to store "6 Further information

T| What Bumetanide tablets are and what they are used for

Bumetanide tablets belong to a group of medicines called loop diuretics (water tablets). They may be used for the treatment of fluid retention (oedema) in:

•    congestive heart failure.

•    liver disease (cirrhosis).

•    kidney disease including nephrotic syndrome.


^ Before you take

Do not take Bumetanide tablets and tell your

doctor if you:

•    are allergic (hypersensitive) to bumetanide, any of the ingredients in Bumetanide tablets (see section 6) or to sulphonamide drugs (a type of antibiotic).

•    are being treated for kidney disease and you have developed an increase in blood levels of urea or you are passing small amounts or no urine.

•    have serious liver or kidney problems.

•    have severely low levels of certain chemicals in your body (seen in a test).

•    are taking lithium (used for some mental illnesses).

Check with your doctor or pharmacist before

taking Bumetanide tablets if you:

•    have low blood pressure.

•    have an enlarged prostate.


Taking other medicines

Please tell your doctor or pharmacist if you are taking

or have recently taken any other medicines, including

medicines obtained without a prescription. Especially:

•    lithium (for some mental illnesses).

•    cardiac glycosides e.g. digoxin (used for some heart conditions).

•    blood pressure lowering drugs such as ACE inhibitors (e.g. captopril or enalapril), calcium channel blockers (e.g. amlodipine), beta blockers (e.g. atenolol), angiotensin

II antagonists (e.g. losartan) or alpha blockers (such as prazosin).

•    non-steroidal anti-inflammatory drugs (NSAIDs) e.g. naproxen.

•    medicines used for irregular heart beat such as amiodarone, disopyramide, flecainide, quinidine, lidocaine or mexiletine.

•    antibiotics such as aminoglycosides, colistimethate, colistin, vancomycin or cephalosporins (used to treat infections).

•    medicines which are poisonous to the kidney such as non-steroidal anti-inflammatory drugs (NSAIDs) or cisplatin (used in some types of cancer).

•    tricyclic antidepressants, reboxetine or monoamine-oxidase inhibitors (MAOIs) (used for depression).

•    medicines used in diabetes e.g. tolbutamide.

•    probenecid (used to treat gout).

•    medicines used in epilepsy such as carbamazepine.

•    cisapride (used for some stomach problems).

•    alprostadil (used for erection problems).

•    medicines used to treat fungal infections such as amphotericin.

•    antihistamines such as terfenadine (used for allergies).

•    pimozide, thioridazine, amisulpride or sertindole (antipsychotic medicines).

•    corticosteroids e.g. prednisolone (used to reduce inflammation caused by a number of diseases).

•    medicines used to treat cancer such as cisplatin.

•    other diuretics (water tablets) e.g. bendroflumethiazide.

•    hormone antagonists such as aminoglutethimide.

•    oestrogens or progestogens.

•    sympathomimetics e.g. salbutamol (used as decongestant, asthma or heart medicine).

•    medicines used to heal ulcers e.g. cimetidine.

•    tubocurarine, baclofen or tizanidine (muscle relaxants).

•    theophylline (used for asthma and other breathing problems).


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Pregnancy and breast-feeding

You should not take Bumetanide tablets if you are in the first three months of pregnancy. If you are pregnant, planning to become pregnant or are breast-feeding, speak to your doctor before taking Bumetanide tablets.

Sugar intolerance

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains a type of sugar called lactose.

Driving and using machines

Bumetanide tablets may make you feel dizzy or have blurred vision, make sure you are not affected before driving or operating machinery.

Tests

Your doctor may want to carry out tests to monitor the levels of certain chemicals in your body.

How to take

Always take Bumetanide tablets exactly as your doctor has told you. If you notice that you are passing too much urine, speak to your doctor or pharmacist.

Drinking alcohol with Bumetanide tablets may make you feel dizzy on standing due to low blood pressure (postural hypotension). Swallow the tablets with water.

Doses:

Adults:

1mg a day as a single dose in the morning or early evening. Depending on your response, your doctor may give you a second dose 6-8 hours later. Your doctor will decide on the best dose for you. Elderly:

0.5mg a day may be sufficient. Your doctor will decide on the best dose for you depending on your response.

Children:

Not recommended for children under 12 years.

If you take more than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately.

If you forget to take the tablets

If you forget to take a dose, take it as soon as you remember it and then take the next dose at the right time. Do not take a double dose, to make up for a forgotten dose.

"4 Possible side effects

Like all medicines, Bumetanide tablets can cause side effects, although not everybody gets them.

Contact your doctor immediately if you notice signs of an:

•    Allergic reaction: itchy skin rash, swelling of the face, lips, tongue or throat or difficulty breathing or swallowing.

•    Imbalance of chemicals within the body: faintness, weakness, dizziness, tiredness, mental confusion, muscle cramps, headache, 'pins and needles' or tingling, thirst, loss of appetite, feeling or being sick.

Tell your doctor or pharmacist if you notice any of the following side effects, they get worse or if you notice anything not listed.

•    Stomach and intestines: stomach pain or cramps, feeling or being sick, indigestion, diarrhoea, loss of appetite.

•    Nervous system: dizziness, tiredness, headache, disease of the brain (encephalopathy) in those who already have liver disease.

•    Senses: blurred vision, hearing disturbances.

•    Heart: low blood pressure, chest pain.

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•    Blood: reduction in platelets in the blood (thrombocytopenia), reduction in blood cell production by the bone marrow. If you notice increased bruising, nosebleeds, sore throats, infections, excessive tiredness, breathlessness on exertion, or abnormal paleness of the skin, you should tell your doctor who may want you to have a blood test.

•    Fluid and chemicals within the body: dehydration, decreased levels of fluid and certain chemicals within the body, gout (high levels of uric acid in the body) causing crystals to deposit in joints of hands or feet causing pain, increase in blood levels of urea, creatinine or cholesterol, high blood sugar levels.

•    Muscle and bones: joint pain (arthralgia), muscle cramps, depositing of crystals in joints due to high levels of uric acid in the blood (gout) causing pain and inflammation of joints (arthritis), severe muscle pain.

•    Skin: rashes, itching, pale or red irregular raised patches with severe itching (hives), sweating.

•    Other: enlarged breasts in men, painful breasts, premature ejaculation, inability to maintain an erection, liver enzyme abnormalities (seen in a test), inflammation of the pancreas.

•    High dose Bumetanide treatment: muscle and bone pain sometimes with muscle spasm in those who have severe, chronic kidney failure and are taking high doses of Bumetanide tablets.

Tell your doctor or pharmacist if you notice any of the

above side effects, they get worse or if you notice anything

not listed.

T| How to store

Keep out of the reach and sight of children.

Store below 25°C in a dry place.

Protect from light.

Do not use Bumetanide tablets after the expiry date stated on the label/carton/bottle. 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.

"6 Further information

What Bumetanide tablets contain

•    The active substance (the ingredient that makes the tablets work) is bumetanide PhEur. Each tablet contains 1mg of the active substance.

•    The other ingredients are IMS 740P, lactose monohydrate, magnesium stearate, polysorbate 80, povidone K25, sodium starch glycollate, microcrystalline cellulose (E460).

What Bumetanide tablets look like and contents of the pack

Bumetanide tablets are white, biconvex, uncoated tablets.

Pack size is 28.

Marketing Authorisation Holder and Manufacturer

Actavis, Barnstaple, EX32 8NS, UK.

This leaflet was last revised in April 2008.

^actavis

Actavis, Barnstaple, EX32 8NS, UK