Burinex 1 mg Tablets

BURINEX 1 mg is a type of medicine called a diuretic which increases the amount of water (urine) passed. BURINEX 1 mg is used to treat excess fluid accumulation in the body (oedema) which can be caused by heart, liver, lungs or kidney disease.

Do not take BURINEX 1 mg:

• if you are hypersensitive (allergic) to bumetanide or any of the other ingredients of BURINEX 1 mg (listed in section 6).
• if you are producing less urine than usual, or no urine at all.
• if you suffer from severe liver disease.
• if you suffer from a severe imbalance of water and salts in the body.

Warnings and precautions

Take special care with BURINEX 1 mg:

• if you are on a low salt diet.
• if you know that you have severe (very low or very high) changes in your blood “salt” levels (sodium, magnesium, potassium, chloride or bicarbonate).
• if you are taking BURINEX 1 mg long-term, it may cause low potassium levels in your body. You may need to have a high potassium diet or take potassium supplements or your doctor will prescribe another medicine such as spironolactone.
• If you have a urinary tract obstruction.
• if you are treated long-term with corticosteroids, you have ulcerative colitis, prolonged vomiting or diarrhoea.
• if you have pre-existing liver impairment.
• if you have low blood pressure.
• if you suffer from gout.
• if you have kidney problems.
• if you 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).
• If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking BURINEX 1 mg or other sulphonamides, e.g., loop diuretics.
• Serious skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with BURINEX 1 mg treatment. Stop using BURINEX 1 mg and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Your doctor may give you regular blood and urine tests whilst you are taking BURINEX 1 mg.

Children and adolescents

Not recommended for children.

Other medicines and BURINEX 1 mg

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Take special care with the following medicines:

• medicines for diabetes.
• cardiac glycosides e.g., digoxin.
• non-depolarising neuromuscular blocking medicines that with cause hypokalaemia.
• medicines for high blood pressure e.g., captopril, atenolol.
• non-steroidal anti-inflammatory drugs e.g., aspirin, diclofenac.
• lithium – used for mental illnesses. To help stop side effects your doctor may need to change the dose of your lithium and check the amount of lithium in your blood.
• ototoxic medicines (which may affect hearing and balance) e.g. streptomycin or gentamicin.
• medicines used to treat irregular heartbeat e.g. amiodarone, sotalol.
• medicines that deplete blood potassium levels e.g. diuretics, laxatives.
• probenecid – used to treat gout.
• proton-pump inhibitors – used to treat acid reflux and peptic ulcers. When used together with BURINEX 1 mg, may cause very low levels of magnesium in the blood.

Do not share medicines prescribed for you with any other person. Always take BURINEX 1 mg exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is one 1 mg tablet per day taken in the morning or early evening. Your doctor may increase your dose and prescribe a second tablet 6 to 8 hours later.

Your doctor will tell you how long your treatment with BURINEX 1 mg will last. If you have the impression that the effect of BURINEX 1 mg is too strong or too weak, tell your doctor or pharmacist.

If you take more BURINEX 1 mg than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take BURINEX 1 mg

Do not take a double dose to make up for forgotten individual doses.

If you stop taking BURINEX 1 mg

You should continue to take these tablets for as long as your doctor tells you to.

BURINEX 1 mg can have side effects. Not all side effects reported for BURINEX 1 mg are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking BURINEX 1 mg, please consult your health care provider for advice.

If any of the following happens, stop taking BURINEX 1 mg and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching.
• reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

These are all very serious side effects. If you have them, you may have had a serious reaction to BURINEX 1 mg. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• electrolyte depletion such as low potassium, low sodium, low chloride levels in blood, a high level of the electrolyte potassium in the blood
• dizziness
• fatigue
• headache
• stomach pain and discomfort
• nausea
• muscle cramps or spasms
• problems with voiding the bladder

Less frequent side effects:

• bone marrow depression, a condition in which there is impairment in blood cell production. This can result in anaemia, reduced ability to fight infection and bruising or bleeding.
• dehydration
• Glucose metabolism disorder
• an excess of uric acid in the blood
• gout
• fainting
• hearing disturbances (reversible)
• chest pain and discomfort
• low blood pressure
• difficulty in breathing
• cough
• vomiting
• diarrhoea
• constipation
• dry mouth
• thirst
• rash
• swelling of the skin
• hives
• itchy skin
• sensitivity of the skin to light
• kidney problems
• swelling in the feet and ankles

Side effects with unknown frequency:

• high levels of blood sugar
• inflamed pancreas with high doses (symptoms include upper abdominal pain, nausea and vomiting)
• patients with long term liver disease may develop encephalopathy, a disorder affecting the brain that may cause memory loss, changes in personality or fits and elevated levels of blood enzymes
• Stevens-Johnson syndrome (SJS)
• Toxic epidermal necrolysis (TEN)
• joint pain
• painful breasts or, in men, breast enlargement
• increase in the blood levels of urea and creatinine

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety App (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting these side effects, you can help provide more information on the safety of BURINEX 1 mg.

For reporting of side effects directly to the HCR, contact +27 11 635 0134 or email [email protected].

Store all medicines out of reach of children. Store at or below 30 °C. Protect from light. Keep blisters in the carton until required for use. Do not use after the expiry date stated on the label / carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).