Furosemidum Polpharma

Package Leaflet: Information for the User

Furosemidum Polpharma, 10 mg/ml (20 mg/2 ml), Solution for Injection

Furosemidum

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• 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 experience any side effects, including any not listed in this leaflet, please inform your doctor or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Furosemidum Polpharma and what is it used for
• 2. Important information before using Furosemidum Polpharma
• 3. How to use Furosemidum Polpharma
• 4. Possible side effects
• 5. How to store Furosemidum Polpharma
• 6. Contents of the pack and other information

1. What is Furosemidum Polpharma and what is it used for

Furosemide is a potent diuretic.
The antihypertensive effect of furosemide is due to a decrease in blood volume.
Furosemide also reduces the tension of blood vessel walls.
After intravenous administration of furosemide, diuretic action occurs within 5 minutes and lasts for about 2 hours, with a maximum effect occurring after 20-60 minutes.

Furosemidum Polpharma is indicated for the treatment of:

• edema associated with congestive heart failure, liver cirrhosis, and kidney disease, including pulmonary edema, when the use of potent and rapidly acting diuretics is indicated;
• acute hemodynamic pulmonary edema - also associated with hypertensive crisis or acute kidney failure; In hypertensive crisis, furosemide should be used in combination with other rapidly acting antihypertensive drugs.
• increased calcium ion concentration in the blood (hypercalcemia); Furosemide is used in combination with isotonic sodium chloride solution to increase urine production (diuresis) and increase calcium ion excretion in the urine.

2. Important information before using Furosemidum Polpharma

When not to use Furosemidum Polpharma

• if the patient is hypersensitive to furosemide, sulfonamides, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has anuria or renal failure with anuria that does not respond to furosemide;
• if the patient has hypovolemia (a state of decreased blood volume)

or is dehydrated;

• if the patient has renal failure caused by nephrotoxic or hepatotoxic substances or renal failure associated with hepatic coma;
• if the patient has severe hypokalemia and severe hyponatremia;
• if the patient is in a pre-comatose or comatose state associated with hepatic encephalopathy;
• if the patient is breastfeeding.

Warnings and precautions

Before starting treatment with Furosemidum Polpharma, discuss it with your doctor.
Particular caution should be exercised:

• if the patient has prostatic hyperplasia or other disorders that make urination difficult due to the increased risk of acute urinary retention during furosemide treatment;
• if there is a significant decrease in urine output, the drug should be discontinued and the doctor consulted;
• if the patient has liver cirrhosis; Patients with liver cirrhosis should start furosemide treatment in the hospital.
• if the patient has severe renal failure or is taking furosemide and aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs, as hearing disturbances, tinnitus, and deafness may occur more frequently; If such symptoms occur, the doctor should be informed as soon as possible.
• if the patient is allergic to sulfonamides, as hypersensitivity reactions to furosemide may occur; During furosemide treatment, symptoms of systemic lupus erythematosus may worsen.
• if the patient has diabetes, as furosemide treatment may increase blood glucose levels; Diabetic patients should more frequently check their blood and/or urine glucose levels.
• if furosemide is used in newborns, as it increases the risk of persistent ductus arteriosus;
• if the patient is elderly, taking other medications that may cause hypotension, or has other medical conditions that increase the risk of hypotension.

During furosemide treatment, dehydration and electrolyte disturbances in the blood serum may occur. Frequent monitoring of electrolyte levels in the blood serum (especially potassium), creatinine, urea, and acid-base balance parameters is necessary.
Close monitoring of the patient's condition is necessary:

• in patients with hypotension;
• in patients at risk of significant blood pressure drops;
• in patients with gout;
• in patients with hepatorenal syndrome;
• in patients with hypoproteinemia, e.g., associated with nephrotic syndrome (furosemide's effect may be weakened, and its ototoxic effect may be enhanced); Caution is required when adjusting the dose.
• in preterm infants (due to the possibility of nephrocalcinosis/kidney stones, kidney function should be monitored and an ultrasound examination of the kidneys should be performed).

Excessive dehydration may cause circulatory disorders (e.g., fainting).
In the treatment of edema, the patient's weight loss should not exceed 1 kg per day.
If necessary, hypotension and hypovolemia should be corrected before starting therapy.
Furosemide should not be administered as a diuretic agent in patients at high risk of developing nephropathy due to the administration of contrast agents during radiological examinations.

Furosemidum Polpharma and other medications

Tell your doctor about all medications you are currently taking or have recently taken, as well as any medications you plan to take.

• Diuretics from other pharmacological groups used with furosemide enhance its diuretic effect.
• Potassium-sparing diuretics used concomitantly with furosemide reduce potassium excretion in the urine and prevent hypokalemia (decreased potassium levels). Some electrolyte disturbances (e.g., hypokalemia, hypomagnesemia) may increase the toxicity of certain medications (e.g., digitalis products and medications that cause QT interval prolongation).
• Furosemide prolongs the duration of neuromuscular blockade caused by neuromuscular blocking agents (e.g., tubocurarine).
• Furosemide may reduce the effect of catecholamines on smooth muscle.
• Concomitant use with corticosteroids may cause sodium retention.
• Systemic corticosteroids, carbenoxolone, licorice, beta-sympathomimetics used in large quantities, long-term use of laxatives, reboxetine, corticotropin, and amphotericin B increase the risk of hypokalemia.
• Furosemide increases lithium toxicity when used concomitantly. Concomitant use of these medications is not recommended. If such treatment is necessary, the patient should be hospitalized and lithium levels in the blood serum should be monitored.
• Furosemide reduces the effectiveness of insulin and oral antidiabetic medications.
• Furosemide enhances the effect of other antihypertensive medications, salicylates, and enhances the ototoxic effect of aminoglycoside antibiotics, cisplatin, and other ototoxic medications.
• After adding ACE inhibitors and angiotensin II receptor antagonists to furosemide therapy or increasing their dose, a significant decrease in blood pressure and worsening of kidney function may be observed. The dose of furosemide should be reduced or the medication should be discontinued for at least three days before starting treatment or increasing the dose of ACE inhibitors and angiotensin II receptor antagonists.
• Indomethacin and other nonsteroidal anti-inflammatory medications may weaken the diuretic and antihypertensive effects of furosemide. Concomitant use of these medications increases the risk of acute kidney failure.
• Phenytoin and its derivatives used for a long time weaken the diuretic effect of furosemide.
• Concomitant use of furosemide with antibiotics that have nephrotoxic effects (toxic effects on the kidneys) increases their nephrotoxicity.
• Concomitant use with carbamazepine or aminoglutethimide may increase the risk of hyponatremia (decreased sodium levels).
• Probenecid, methotrexate, and other medications that, like furosemide, are excreted in large quantities through the renal tubules may reduce the effect of furosemide. On the other hand, furosemide may reduce the tubular excretion of these medications. The use of high doses (both furosemide and other medications) may lead to increased serum levels and an increased risk of adverse reactions attributed to furosemide or other concomitantly used medications.
• Oral administration of furosemide and sucralfate should be separated by at least a two-hour interval, as sucralfate reduces the absorption of furosemide from the gastrointestinal tract, thereby reducing its effect.
• When used concomitantly with risperidone, caution should be exercised and the benefit-risk ratio should be assessed, due to the increased risk of mortality.
• In patients receiving high doses of certain cephalosporins concomitantly with furosemide, impaired kidney function may occur.
• Concomitant administration of cyclosporine and furosemide may increase the risk of gout.
• When furosemide injection is used in combination with solutions with low pH (e.g., glucose solutions), furosemide may precipitate.
• The medication should not be mixed in a syringe with other medications.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy
Furosemide may be used during pregnancy, only for a short period, if the benefits to the mother outweigh the risk to the fetus.
The use of furosemide during pregnancy requires monitoring of the fetus.
Breastfeeding
The use of furosemide during breastfeeding is contraindicated.
Furosemide passes into breast milk and may inhibit lactation.

Driving and using machines

Some side effects that occur in patients taking furosemide, such as dizziness, excessive drowsiness, blurred vision, may slightly or moderately impair physical and mental performance. In case of doubt, consult your doctor.

The medicine contains sodium

The medicine contains 3.83 mg of sodium (the main component of common salt) per 1 ml of solution. 2 ml of solution (one ampoule) contains 7.66 mg of sodium, which corresponds to 0.38% of the maximum recommended daily intake of sodium in the diet for adults.
The medicine may be diluted. The sodium content from the diluent should be taken into account when calculating the total sodium content in the prepared dilution of the medicine. To obtain accurate information about the sodium content in the solution used for dilution, refer to the package leaflet or characteristics of the diluent used.
In patients with reduced kidney function and patients controlling their sodium intake, the sodium content in the medicine should be considered.

3. How to use Furosemidum Polpharma

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor.
The dose is determined individually by the doctor for each patient.
For detailed dosing and administration instructions, see the end of the package leaflet, under "Information intended for healthcare professionals only".

Using a higher dose of Furosemidum Polpharma than recommended

If you think you have received too much of the medicine, inform your doctor.
Symptoms of overdose depend mainly on the extent and consequences of fluid and electrolyte loss, such as hypovolemia (decreased blood volume), dehydration, hemoconcentration, and disturbances in heart rhythm caused by excessive diuretic effect. Severe hypotension (leading to shock), acute kidney failure, thrombosis, seizures, flaccid paralysis, apathy, and fatigue may occur.
Treatment aims to replenish fluids and correct electrolyte disturbances. At the same time, the doctor will closely monitor the patient's condition.

Missing a dose of Furosemidum Polpharma

If you think you have missed a dose of the medicine, inform your doctor as soon as possible.
If you have any further questions about using this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, Furosemidum Polpharma can cause side effects, although not everybody gets them.
Furosemide is generally well-tolerated. Side effects are usually mild, most often transient, and only occasionally require discontinuation of the medication.

Furosemidum Polpharma may cause the following side effects:

• hemolytic anemia, thrombocytopenia (decreased platelet count), anemia, aplastic anemia, leukopenia (decreased white blood cell count), agranulocytosis (decreased neutrophil count), eosinophilia (decreased eosinophil count);
• bone marrow suppression, in which case the medication should be discontinued;
• rash, photosensitivity, vasculitis, fever, interstitial nephritis, anaphylactic shock; If any of these reactions occur, furosemide administration should be discontinued.
• severe anaphylactic or anaphylactoid reactions;
• loss of appetite, severe dehydration, hyperglycemia;
• restlessness;
• headache, dizziness, paresthesia (abnormal sensation);
• hearing disturbances and tinnitus, although usually transient, may rarely occur, usually in patients with renal failure, hypoproteinemia (e.g., in nephrotic syndrome), and/or when furosemide is administered intravenously too quickly;
• orthostatic hypotension exacerbated by alcohol, barbiturates, or narcotic analgesics;
• abdominal cramps, diarrhea, constipation, stomach upset, nausea, vomiting, and in rare cases, during long-term use, acute pancreatitis;
• jaundice, intrahepatic cholestasis (bile stasis);
• In patients with liver cell damage, hepatic encephalopathy may occur.
• exfoliative dermatitis, erythema multiforme, pemphigoid, urticaria, rash, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis;
• polyuria;
• In preterm infants, nephrocalcinosis/kidney stones have been observed.
• Increased urine production may cause or worsen symptoms in patients with difficulty urinating. Therefore, in patients with urinary retention disorders, prostatic hyperplasia, or urethral stricture, acute urinary retention may occur with the possibility of secondary complications.
• weakness, fever;
• after intramuscular administration - pain at the injection site.

Uncommon side effects (occurring in less than 1 in 100 patients):

• deafness, sometimes irreversible.

Side effects of unknown frequency (frequency cannot be estimated from available data):

• acute generalized exanthematous pustulosis (acute febrile rash - AGEP);
• dizziness, fainting, and loss of consciousness (due to symptomatic hypotension).

Like other diuretics, furosemide may disturb the balance of electrolytes and water during long-term use. Furosemide causes increased excretion of sodium and chloride, and thus water. Additionally, during furosemide therapy, the excretion of other electrolytes (especially potassium, calcium, and magnesium) increases. Symptoms of electrolyte imbalance and metabolic alkalosis may develop as a gradually increasing electrolyte deficiency or (e.g., when higher doses of furosemide are administered to patients with normal kidney function) acute and severe electrolyte loss. Symptoms accompanying electrolyte deficiency include increased thirst, headache, hypotension, confusion, muscle cramps, tetany, muscle weakness, arrhythmias, and gastrointestinal disturbances.
During furosemide treatment, existing metabolic alkalosis (e.g., in uncontrolled liver cirrhosis) may worsen.
Furosemide's diuretic effect may lead to or contribute to hypovolemia and dehydration, especially in elderly patients. Significant fluid loss may lead to hemoconcentration with the possibility of thrombosis.
Furosemide administered to preterm infants in the first weeks of life may increase the persistence of the ductus arteriosus.

Diagnostic tests

Glycosuria, increased liver transaminase levels, decreased serum calcium levels, and in very rare cases, tetany have been observed.
During furosemide therapy, serum cholesterol and triglyceride levels may increase. After long-term therapy, their levels will return to normal within six months.
Furosemide administration may decrease glucose tolerance. In diabetic patients, this may lead to metabolic disturbances and the manifestation of latent diabetes.
Like other diuretics, furosemide may cause a transient increase in serum creatinine and urea levels. Serum uric acid levels may increase, and gout attacks may occur.
If you experience any of the following symptoms: fever, rash, weakness, dizziness, drowsiness, blurred vision, discontinue Furosemidum Polpharma and immediately consult your doctor.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, inform your doctor or nurse. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel. +48 22 49 21 301, fax +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Furosemidum Polpharma

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Store in the original package.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the month.
The inscription on the package after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot indicates the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Furosemidum Polpharma contains

• The active substance is furosemide. Each ampoule (2 ml solution) contains 20 mg of furosemide.
• The other ingredients are sodium hydroxide, disodium edetate, sodium chloride, water for injections.

What Furosemidum Polpharma looks like and contents of the pack

Clear, colorless solution for injection in orange glass ampoules. The package contains 5 or 50 ampoules of 2 ml each.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01

Date of last revision of the package leaflet: ---------------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:

Furosemidum Polpharma, 10 mg/ml (20 mg/2 ml), Solution for Injection

Furosemidum

Information for patients on a low-sodium diet and with reduced kidney function

The medicine contains 3.83 mg of sodium per 1 ml of solution. 2 ml of solution (one ampoule) contains 7.66 mg of sodium, which corresponds to 0.38% of the maximum recommended daily intake of sodium in the diet for adults.
The medicine may be diluted. The sodium content from the diluent should be taken into account when calculating the total sodium content in the prepared dilution of the medicine. To obtain accurate information about the sodium content in the solution used for dilution, refer to the package leaflet or characteristics of the diluent used.
In patients with reduced kidney function and patients controlling their sodium intake, the sodium content in the medicine should be considered.
Furosemidum Polpharma should be administered as a slow intravenous injection, intravenous infusion (at a rate not exceeding 4 mg per minute), or intramuscular injection.
Intramuscular administration of furosemide should be limited to exceptional situations when oral or intravenous administration cannot be performed. Note that intramuscular administration is not recommended for the treatment of acute conditions, such as pulmonary edema.
The medicine should be used immediately after opening the ampoule.
Do not use the medicine if the solution has changed color or visible impurities have appeared.

Use in adults

Edema associated with congestive heart failure, liver cirrhosis, and kidney disease:

20-40 mg of furosemide (1-2 ampoules) as a single dose intravenously or intramuscularly at a rate not exceeding 4 mg/minute. Depending on the need, a subsequent dose of 20 mg of the medicine can be administered every 2 hours until the desired therapeutic effect is achieved. If a higher dose is indicated, the medicine should be administered as an intravenous infusion.
The maximum recommended daily dose of furosemide administered intravenously to adults is 1500 mg.
Furosemide in the form of injections should be used for a short period.
During the use of furosemide in high doses or for a longer period, frequent monitoring of electrolyte levels in the blood serum, acid-base balance, and serum creatinine and urea levels is necessary.

Pulmonary edema

The initial dose is usually 40 mg (2 ampoules) of furosemide intravenously. If necessary, after 30 minutes, a dose of 40-80 mg can be administered.

Hypertensive crisis

In patients with normal kidney function, the initial dose is usually 40-80 mg (2-4 ampoules) of furosemide intravenously, in combination with other rapidly acting antihypertensive medications.
In patients with concomitant pulmonary edema or acute kidney failure, 100-200 mg (5-10 ampoules) of furosemide.

Hypercalcemia

Intravenously, 80-100 mg (4-5 ampoules) at intervals of 2-12 hours for 24 hours, in combination with isotonic sodium chloride solution. After completing hypercalcemia treatment, hypokalemia caused by furosemide may occur, which should be corrected.

Use in elderly patients

In elderly patients, furosemide is eliminated from the body more slowly, which may require dose reduction.

Use in infants and children

In infants and children, furosemide is used in a dose of 0.5-1.5 mg/kg body weight per day. The maximum daily dose is 20 mg, regardless of the child's body weight.

Use in acute and chronic kidney failure

In these conditions, usually 80-120 mg (4-6 ampoules) per day are administered.
In patients with severe kidney failure (serum creatinine >5 mg/dl), the infusion rate should not exceed 2.5 mg per minute.