Furosemid Accord

Package Leaflet: Information for the Patient

Furosemide Accord, 10 mg/ml, Solution for Injection or Infusion

Furosemide
The name of this medicine is Furosemide Accord, 10 mg/ml, Solution for Injection or Infusion, but it will be referred to as Furosemide Accord throughout the rest of this leaflet.

Read this leaflet carefully before taking this medicine, as it contains important information for you.

• You should 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What Furosemide Accord is and what it is used for
• 2. Important information before taking Furosemide Accord
• 3. How to take Furosemide Accord
• 4. Possible side effects
• 5. How to store Furosemide Accord
• 6. Contents of the pack and other information

1. What Furosemide Accord is and what it is used for

The active substance of Furosemide Accord is furosemide.
Furosemide belongs to a group of medicines called diuretics. Furosemide increases the amount of urine produced by the body, helping to relieve symptoms caused by excess fluid in the body.

Your doctor has prescribed Furosemide Accord for one of the following reasons:

• when rapid and effective removal of excess fluid is required;
• when you cannot take this type of medicine orally or in emergency situations;
• if you have too much fluid around your heart, lungs, liver, or kidneys;
• in cases of very high blood pressure that can lead to life-threatening conditions (hypertensive emergency).

Furosemide Accord should only be administered under medical supervision.

2. Important information before taking Furosemide Accord

When not to take Furosemide Accord:

• if you are allergic (hypersensitive) to furosemide or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to sulfonamide antibiotics;
• in cases of significant dehydration (loss of fluids, e.g., due to severe diarrhea or vomiting);
• in cases of kidney failure and lack of urine production, despite furosemide administration;
• in cases of kidney failure caused by toxic substances to the kidneys or liver;
• if you have significantly low levels of potassium or sodium in your blood;
• if you are in a coma caused by liver failure;
• during breastfeeding. If you have any further questions, ask your doctor or pharmacist.

When to be cautious with Furosemide Accord:

• if you have urinary disorders caused by narrowing of the urinary tract (e.g., due to prostate enlargement);
• if you have diabetes;
• if you have low blood pressure or experience sudden drops in blood pressure;
• if you have liver disease (e.g., cirrhosis);
• if you have kidney function disorders (e.g., nephrotic syndrome);
• if you are dehydrated (loss of fluids due to severe diarrhea or vomiting), which can lead to shock or thrombosis;
• if you have gout (pain or inflammation of the joints) caused by high levels of uric acid in the blood;
• if you have systemic lupus erythematosus (an inflammatory disease).
• if you have hearing disorders;
• if you are taking sorbitol (a sugar substitute for diabetic patients);
• if you have porphyria (a disease where the production of a substance that binds oxygen in red blood cells is disrupted, and urine turns purple);
• if you have increased skin sensitivity to sunlight;
• if you are elderly, taking other medications that may lower blood pressure, or have other conditions that increase the risk of low blood pressure. Administration of furosemide to premature infants may cause kidney stones, kidney calcification, or a heart defect where the vessel connecting the pulmonary artery to the aorta, which is open in the fetus, does not close (patent ductus arteriosus). If any of the above applies to you, your doctor may want to change your treatment or provide special advice. Your doctor may recommend regular monitoring of blood sugar or uric acid levels. They may also recommend monitoring the levels of important electrolytes, such as sodium and potassium, which is particularly important if you experience vomiting or diarrhea.

Furosemide Accord and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, including those obtained without a prescription. This is important because some medicines should not be taken with furosemide injection or infusion solution. In particular, tell your doctor or pharmacist if you are taking:

• lithium, used for mood disorders, as taking it with furosemide may increase its effects and side effects. Your doctor will only recommend taking them together if absolutely necessary and will monitor your lithium blood levels and may adjust the dose;
• heart medicines, such as digoxin. Your doctor may adjust the dose of the other medicine;
• medicines used to treat high blood pressure, including thiazide diuretics (such as bendroflumethiazide or hydrochlorothiazide), ACE inhibitors (e.g., lisinopril), angiotensin II receptor antagonists (e.g., losartan), as furosemide may cause excessive lowering of blood pressure. Your doctor may adjust the dose of furosemide;
• cholesterol and lipid-lowering medicines, such as colestyramine, colestipol, and fibrates (e.g., clofibrate), as they may reduce the effect of furosemide;
• diabetes medicines, such as metformin and insulin, as they may increase blood sugar levels;
• anti-inflammatory medicines, including NSAIDs (e.g., aspirin and celecoxib), as they may reduce the effect of furosemide. High doses of painkillers (salicylates) may increase the side effects of furosemide;
• anti-inflammatory and anti-allergic medicines, such as corticosteroids, carbenoxolone (used to treat stomach ulcers), or laxatives. When taken with furosemide, they may affect sodium and potassium levels in the blood. Your doctor will recommend monitoring potassium levels in the blood;
• medicines given by injection during surgical procedures, including tubocurarine, curare derivatives, and succinylcholine;
• chloral hydrate, used for sleep disorders (in single cases, intravenous administration of furosemide within 24 hours before administration of chloral hydrate may cause sudden redness of the face, excessive sweating, anxiety, nausea, increased blood pressure, and rapid heartbeat). Therefore, concomitant use of furosemide and chloral hydrate is not recommended;
• phenytoin or phenobarbital, used to treat epilepsy, as they may reduce the effect of furosemide;
• theophylline, used to treat asthma, as furosemide may increase its effect;
• antibiotics, such as cephalosporins, polymyxins, aminoglycosides, or quinolones, and other medicines that may affect kidney function, such as immunosuppressants, iodine-based contrast agents, foscarnet, or pentamidine, as furosemide may increase their effect;
• probenecid, used with other medicines to protect the kidneys, as it may reduce the effect of furosemide;
• platinum-based compounds, used to treat certain cancers, as furosemide may increase the side effects of these medicines;
• methotrexate, used to treat certain cancers and severe arthritis, as it may reduce the effect of furosemide;
• medicines that increase blood pressure (vasopressors), as concomitant use with furosemide may reduce their effect;
• aminoglutethimide, used to inhibit the production of corticosteroids (Cushing's syndrome), as it may increase the side effects of furosemide;
• carbamazepine, used to treat epilepsy or schizophrenia, as it may increase the side effects of furosemide;
• sucralfate, used to treat stomach ulcers. Do not take furosemide within 2 hours of taking sucralfate, as the effect of furosemide may be reduced;
• cyclosporine, used to prevent transplant rejection, as there is a risk of gout (joint pain).
• medicines that affect heart function, such as amiodarone, sotalol, dofetilide, ibutilide, as furosemide may increase their effect;
• risperidone, used to treat mental disorders;
• other diuretics, such as bendroflumethiazide and metolazone;
• medicines used to treat thyroid disorders, such as levothyroxine.

Furosemide Accord with food, drink, and alcohol

Food is not expected to affect the action of this medicine when given intravenously.
Prolonged moderate or excessive alcohol consumption increases blood pressure and reduces the effectiveness of antihypertensive medicines. Patients may experience dizziness and fainting soon after drinking alcohol during treatment.

Pregnancy and breastfeeding

Furosemide should not be used during pregnancy unless clearly necessary. Furosemide passes into breast milk, so breastfeeding should be avoided during treatment with this medicine.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Do not drive or operate machinery, as furosemide may impair your ability to concentrate.

Important information about some of the ingredients of Furosemide Accord

Furosemide Accord, 10 mg/ml, Solution for Injection or Infusion (2 ml, 4 ml, and 5 ml)
This medicine contains less than 1 mmol sodium (23 mg) per ampoule, i.e., it is essentially 'sodium-free'.
This should be taken into consideration for patients on a controlled sodium diet.
Furosemide Accord, 10 mg/ml, Solution for Injection or Infusion (25 ml)
This medicine contains approximately 93 mg of sodium per vial. This should be taken into consideration for patients on a controlled sodium diet.

3. How to take Furosemide Accord

Furosemide Accord is given:

• by slow injection into a vein (intravenously) or
• in exceptional cases, into a muscle (intramuscularly). Your doctor will determine the required dose, administration time, and duration of treatment. This will depend on your age, weight, medical history, other medicines you are taking, and the type and severity of your condition.

General

• Parenteral administration of furosemide is indicated when oral administration is impossible or ineffective (e.g., in cases of reduced gastrointestinal absorption), or when rapid action is required.
• When parenteral administration is used, it is recommended to switch to oral administration as soon as possible.
• To achieve optimal efficacy and prevent rebound reactions, continuous infusion of furosemide is generally preferred over multiple bolus injections (rapid injections).
• If continuous infusion of furosemide is not possible during ongoing treatment after initial administration of one or more boluses, a regimen using low doses administered at short intervals (about 4 hours) is preferred over a regimen using high doses administered in larger intervals.
• Furosemide should be administered intravenously by slow injection or infusion. Do not exceed a rate of 4 mg per minute, and do not administer the medicine with other medicines in the same syringe.

Dosage

Adults

• In the absence of a need to reduce the dose (see below), the recommended initial dose for adults and adolescents over 15 years is 20 mg to 40 mg of furosemide administered intravenously (or in exceptional cases, intramuscularly); the maximum dose varies depending on the individual patient's response.
• If higher doses are required, they should be administered in increments of 20 mg and no more frequently than every two hours.
• The recommended maximum daily dose of furosemide for adults is 1500 mg.
• In certain circumstances, higher initial or maintenance doses may be required, depending on the patient's condition. This will be determined by your doctor. If such doses are required, they can be administered by continuous infusion.

Children and adolescents (up to 18 years)

• Experience with the use of furosemide in children and adolescents is limited. Intravenous administration of furosemide in children and adolescents under 15 years is recommended only in exceptional cases.
• Dosage should be adjusted according to body weight, with a recommended dose of 0.5 to 1 mg/kg body weight per day, up to a maximum total daily dose of 20 mg. Oral treatment should be started as soon as possible.

Kidney function disorders

• In patients with severe kidney function disorders (serum creatinine > 5 mg/dl), it is recommended not to exceed an infusion rate of 2.5 mg of furosemide per minute.

Elderly

• The recommended initial dose is 20 mg per day. The dose should be gradually increased to achieve the desired response.

Overdose of Furosemide Accord

If you think you have been given too much furosemide, contact your doctor or other healthcare professional immediately. Symptoms that may occur after overdose include dry mouth, increased thirst, irregular heartbeat, changes in mood, muscle cramps or pain, nausea or vomiting, feeling tired or weak, slow pulse, or loss of appetite.

Missed dose of Furosemide Accord

If you think you may have missed a dose of furosemide, contact your doctor or other healthcare professional immediately.

While taking Furosemide Accord

If you experience severe allergic reactions, such as swelling of the face and/or throat or fever, contact your doctor or other healthcare professional immediately.

Stopping Furosemide Accord

If you stop treatment too early, excess fluid may have a significant impact on your heart, lungs, and kidneys.
If you have any further questions, ask your doctor or other healthcare professional.

4. Possible side effects

Like all medicines, Furosemide Accord can cause side effects, although not everybody gets them.

Seek immediate medical attention if you experience any of the following serious side effects – you may need urgent medical attention.

Very common (affects more than 1 in 10 people)

• Increased thirst, headache, dizziness or feeling faint, fainting, disorientation, muscle pain, joint pain or weakness, cramps, stomach upset, or irregular heartbeat. These may be symptoms of dehydration or electrolyte imbalance. Severe dehydration can lead to concentrated blood or blood clots.

Common (affects less than 1 in 10 people)

• In patients with existing liver disorders, a more severe liver disease called hepatic encephalopathy may occur. Symptoms include memory disturbances, seizures, mood changes, and coma.

Rare (affects less than 1 in 1000 people)

• An allergic reaction. Symptoms include difficulty breathing, swelling, dizziness, cold, clammy skin, paleness, rapid heartbeat, and loss of consciousness.
• Bruising, more frequent infections, greater than usual weakness or fatigue. Furosemide may affect blood cell counts, leading to serious blood disorders.
• Vasculitis. Symptoms may include fever, loss of appetite, weight loss, and pain.
• Kidney inflammation with blood in the urine, fever, and pain in the lower back (interstitial nephritis). Rarely, it may lead to acute kidney failure.

Very rare (affects less than 1 in 10,000 people)

• Severe abdominal or back pain. These may be symptoms of pancreatitis.

Frequency not known

• Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome)
• Difficulty urinating. This may be a symptom of acute urinary retention.
• Kidney disease characterized by an increased amount of calcium in the kidneys. This may be a symptom of nephrocalcinosis.
• Blood in the urine or pain in the lower abdomen or groin. This may be a symptom of kidney stones.
• Blisters or peeling of the skin around the lips, eyes, mouth, nose, and genitals, flu-like symptoms, and fever. This may be Stevens-Johnson syndrome. In its more severe form, called toxic epidermal necrolysis, the skin layers may peel off, leaving large areas of exposed skin on the body.
• Blood clots; symptoms may include sudden shortness of breath, chest pain, swelling of the leg or arm, pain or tenderness in the leg, redness or discoloration of the leg or arm, sudden vision changes.
• A red, peeling, widespread rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
• A lichenoid reaction with small, itchy, reddish-purple, polygonal skin lesions, on the skin, genitals, or in the mouth.
• Weakness, tenderness, or pain in the muscles. Feeling unwell or having a high fever. Rhabdomyolysis, a rare but serious and potentially life-threatening condition.

If you experience any of the following side effects, tell your doctor immediately:

Very common (affects more than 1 in 10 people)

• Headache or dizziness when standing up quickly. Difficulty concentrating, slowed reactions, drowsiness or weakness, vision problems, dry mouth. This may be due to low blood pressure.
• Changes in the levels of certain minerals (such as calcium, potassium, magnesium, sodium, and chlorides) that are essential for the body to function properly. Symptoms include increased thirst, headache, low blood pressure, disorientation, muscle cramps, weakness, rapid or irregular heartbeat, and stomach upset.

Common (affects less than 1 in 10 people)

• Gout caused by high levels of uric acid in the blood, characterized by painful joint inflammation

Uncommon (affects less than 1 in 100 people)

• Rash, itching, skin discoloration, purple spots resembling bruises, numerous blisters on the skin, changes resembling a target, peeling skin, and increased sensitivity to sunlight
• Hearing disorders
• Deafness (sometimes irreversible)

Rare (affects less than 1 in 1000 people)

• Feeling of tingling or numbness in the skin

Very rare (affects less than 1 in 10,000 people)

• Ringing in the ears (tinnitus). This is more common in people with existing kidney disorders.
• Decreased blood cell count, which may cause bruising, increased risk of infection, pale skin, weakness, or shortness of breath (anemia)

Frequency not known

• Changes in the levels of certain minerals (such as sodium or chloride) in the urine
• Dizziness, fainting, or loss of consciousness (due to symptomatic hypotension or other causes), headache
• Exacerbation of systemic lupus erythematosus (a disease where the body's immune system attacks healthy tissue, causing symptoms such as joint swelling, fatigue, and rash)

If you experience any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Common (affects less than 1 in 10 people)

• Passing more urine than usual. This usually occurs 1 or 2 hours after taking this medicine.

Uncommon (affects less than 1 in 100 people)

• Nausea
• In diabetic patients, blood sugar control may be impaired.

Rare (affects less than 1 in 1000 people)

• Diarrhea and vomiting
• Fever

Very rare (affects less than 1 in 10,000 people)

• A disease where bile accumulates in the liver (cholestasis). Symptoms include jaundice, rash, or fever, and the urine becomes darker.
• Increased liver enzyme activity

Frequency not known

• Pain at the injection site. This occurs when the medicine is administered intramuscularly.

Blood tests
Furosemide may change liver enzyme activity and lipid levels, such as cholesterol and triglycerides.
Blood tests may show changes in kidney function, indicating significant impairment.

Reporting side effects

If you experience any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) using the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). You can also report side effects directly to the manufacturer.

5. How to store Furosemide Accord

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not refrigerate.
Ampoules/vials should be stored in the outer carton to protect from light.
For single use only. Use immediately after opening. Do not use this medicine after the expiry date stated on the ampoule and carton after 'EXP'. The expiry date refers to the last day of the month stated.
Shelf life of the reconstituted/diluted product, see below: The following information is intended for healthcare professionals only.

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 protect the environment.

6. Contents of the pack and other information

What Furosemide Accord contains

The active substance is furosemide.
1 ml of solution contains 10 mg of the active substance, furosemide.
2 ml of sterile solution for injection contains 20 mg of furosemide.
4 ml of sterile solution for injection contains 40 mg of furosemide.
5 ml of sterile solution for injection contains 50 mg of furosemide.
25 ml of sterile solution for injection contains 250 mg of furosemide.
The other ingredients are sodium chloride, sodium hydroxide, and water for injections.

What Furosemide Accord looks like and contents of the pack

Furosemide Accord is a colorless or almost colorless sterile solution for injection or infusion.
20 mg in 2 ml: ampoule made of orange glass with two white rings and a white spot OPC, containing 2 ml of solution.
40 mg in 4 ml: 5 ml ampoule made of type I orange glass with a white snap-off closure and a blue ring, containing 4 ml of solution.
50 mg in 5 ml: 5 ml ampoule made of type I orange glass with a white snap-off closure and a white ring, containing 5 ml of solution.
250 mg in 25 ml: vial made of type I orange glass, closed with a chlorobutyl rubber stopper and an aluminum cap with a red flip-off seal, containing 25 ml of solution.
Pack sizes:
Ampoules: 5, 10 x 2 ml
Ampoules: 1, 5, 10 x 4 ml
Ampoules: 5, 10 x 5 ml
Vials: 1, 5, 10 x 25 ml
Not all pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warszawa
Tel: + 48 22 577 28 00

Manufacturer

Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: November 2024

The following information is intended for healthcare professionals only.

Unused solution should be disposed of in accordance with local requirements.

Instructions for use

For single use only.
Do not use this medicine after the expiry date stated on the ampoule and carton after 'EXP'. The expiry date refers to the last day of the month stated.
Furosemide Accord diluted to 1 mg/ml is compatible with 0.9% sodium chloride solution and Ringer's solution with lactate for infusion for 24 hours.
Dilution of the injection or infusion solution should be performed under aseptic conditions.
Before use, inspect visually for particulate matter and discoloration.
The solution should only be used if it is clear and free from particles.
Unused product or waste materials should be disposed of in accordance with local requirements. Do not use a product that contains visible particles.
For single use only.
After use, discard the remaining product.
Furosemide Accord, 10 mg/ml, Solution for Injection or Infusion should not be mixed with other medicines in the same injection vial.

Storage conditions

Do not store above 25°C.
Do not freeze.
Ampoules/vials should be stored in the outer carton to protect from light.
After first opening: the product should be used immediately after opening.
After dilution: the chemical and physical stability of the medicine has been demonstrated for 24 hours at 25°C, protected from light.