Patient Medication Information: uses, side effects, how to take - Burinex
Serious warnings and precautions box
What BURINEX is used for:
BURINEX is used to treat the swelling in your body that is caused by excess fluid in your tissues (edema) that happens as a result of:
- congestive heart failure, or
- liver disease (cirrhosis), or
- kidney disease, including nephrotic syndrome.
How BURINEX works:
Edema means your body is retaining water. It can lead to swollen feet or ankles or trouble breathing. BURINEX works to remove the excess water by making your kidneys produce more urine.
The ingredients in BURINEX are:
Severe skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with BURINEX treatment. Symptoms include:
- reddish circular patches;
- blistering or peeling of the skin;
- severe skin rash;
- fever;
- flu-like symptoms;
- ulcers of mouth, throat, nose, genitals and eyes.
See the “Serious side effects and what to do about them” table, below, for more information. If you notice any signs or symptoms of serious skin reactions, stop taking BURINEX and seek medical attention right away. If SJS or TEN is confirmed, you must not take BURINEX again.
- BURINEX is a strong diuretic. Diuretics are also known as “water pills.” Taking too much BURINEX can cause you to lose too much water and too many electrolytes. You must be supervised by a healthcare professional while taking this drug. Your healthcare professional will adjust your dose and your dosing schedule to treat your particular condition.
Medicinal ingredient(s): bumetanide.
Non-medicinal ingredients: agar, colloidal anhydrous silica, lactose, magnesium stearate, maize starch, microcrystalline cellulose, polysorbate 80, povidone, and talc.
BURINEX comes in the following dosage form(s):
Tablets; 1 mg and 5 mg of bumetanide.
Do not use BURINEX if:
- you are allergic to bumetanide or any of the other ingredients in this medicine or products containing sulfonamide.
- you cannot pass urine or the amount of urine you pass is very low.
- you are dehydrated or told you have very low blood levels of potassium, sodium or chloride.
- you have severe liver disease or have a decline in brain function, including coma as a result of liver failure.
- you have problems digesting or absorbing galactose, lactose (milk sugar), or glucose-galactose. Lactose is an ingredient in BURINEX.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take BURINEX. Talk about any health conditions or problems you may have, including if you:
- have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking BURINEX or other sulphonamides, e.g., loop diuretics
- have liver disease.
- have kidney disease.
- have low blood pressure.
- have abnormal levels of potassium in your blood.
- have gout.
- are taking a medicine (proton pump inhibitor) to treat acid reflux or peptic ulcers.
- have diabetes. BURINEX may affect your glucose (blood sugar) levels.
- are allergic to milk protein.
are pregnant or planning on becoming pregnant.
- are breast-feeding or planning to breast-feed.
Other warnings you should know about:
- Ear Toxicity: Taking BURINEX, especially at high doses, may have a toxic effect on the ears. This may result in damage to the inner ears that are responsible for hearing and balance.
- Liver Damage: Taking BURINEX may lead to abnormal changes in your blood cells or cause liver damage.
- Effect on Blood Calcium Levels: Taking BURINEX may increase the amount of calcium passing into the urine. This can lead to low calcium levels in your blood.
- Dope Tests: BURINEX is banned for use in sports. Taking BURINEX will lead to disqualification for athletes. This drug can be detected in the urine during routine dope testing.
Testing and Check-Ups: Your healthcare professional will do check-ups and tests while you are taking BURINEX. These may include regular blood tests to check your:
- potassium levels,
- electrolyte levels.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with BURINEX:
- drugs used to treat heart conditions (such as digoxin) and drugs used to treat irregular heartbeats (such as antiarrhythmic drugs).
- muscle relaxants given by injection before a general anaesthetic.
- lithium, a drug used to treat mood disorders. Do not take Lithium while taking BURINEX.
- non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and swelling. You should avoid taking these drugs while taking BURINEX. Using BURINEX with NSAIDs can be harmful to your kidneys.
- probenecid, a drug used to treat gout. You should avoid taking this drug while taking BURINEX.
- anti-hypertensive drugs used to treat high blood pressure.
- anti-depressants that can cause low blood pressure.
- drugs that affect the amount of potassium in your blood.
- aminoglycoside antibiotics (such as neomycin) which can affect hearing. You should avoid taking this drug while taking BURINEX. Using BURINEX with aminoglycoside antibiotics can be harmful to your kidneys.
How to take BURINEX:
Take BURINEX exactly as your healthcare professional has told you. If you are unsure, ask your healthcare professional.
Usual dose:
Your healthcare professional will decide the right dose and frequency of BURINEX for you. This may depend on your health (e.g., if you have liver problems) and how you react to BURINEX.
The usual adult dose of BURINEX may range from 0.5 mg to 2 mg per day. The maximum dose is 10 mg per day.
Children under 18 years old should not use BURINEX.
Overdose:
Taking too much BURINEX can lead to:
- excessive water loss.
- a lower amount of electrolytes. You may feel weak, dizzy, confused, tired, have cramps or vomiting if your electrolytes are low.
- dehydration.
- low blood volume.
- circulatory failure.
You should stop taking BURINEX and restore the loss of water and electrolytes.
If you think you, or a person you are caring for, have taken too much BURINEX, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed dose:
If you forget to take a dose, take it as soon as you remember. If your next dose is due in less than 4 hours wait and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
Possible side effects from using BURINEX:
These are not all the possible side effects you may have when taking BURINEX. If you experience any side effects not listed here, tell your healthcare professional.
Side effects include:
- muscle cramps,
- dizziness,
- low blood pressure,
- headache,
- nausea,
- abnormal brain function in patients who have liver disease.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Common | |||
| Decreased levels of potassium in the blood: irregular heartbeats, muscle weakness and generally not feeling well | X | ||
| Electrolyte imbalance: weakness, drowsiness, muscle pain or cramps, irregular heartbeat | X | ||
| Increased production of urine: loss of water and electrolytes | X | ||
| Low blood pressure: dizziness when standing up, light-headedness | X | ||
| Muscle problems: muscle pain, tenderness, weakness, cramps | X | ||
| Uncommon | |||
| Allergic reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | X | ||
| Dehydration: dry mouth, increased thirst, feeling tired or sleepy, passing less urine, headache, dizziness | X | ||
| Hearing problems: deafness, sometimes non-reversible | X | ||
| Increased blood sugar: frequent urination, thirst and hunger | X | ||
| Kidney disease: more or less urine than usual, passing red urine or passing urine at night, difficulty or inability to pass urine | X | ||
| Unknown | |||
| Severe skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TENS): reddish circular patches, blisters, peeling of the skin, severe skin rash, fever, flu-like symptoms, itchiness, chills, headache, cough, body aches, swollen glands, or ulcers of mouth, throat, nose, genitals and eyes | X | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
- 1 mg tablet: Store below 30 °C.
- 5 mg tablet: Store at 15-25 °C.
Keep the blisters in the carton to protect from light. Do not use after the expiry date (EXP).
Keep out of reach and sight of children.
If you want more information about BURINEX:
- Talk to your healthcare professional.
- Find the full Product Monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); and contacting the sponsor, Karo Pharma AB, at medinfoca@karo.com.
Date of Authorization: 2026-03-25