Furosemidum Neupharm

Leaflet attached to the packaging: patient information

Furosemidum Neupharm, 10 mg/ml, solution for injection

Furosemidum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Furosemidum Neupharm, 10 mg/ml, solution for injection belongs to a group of diuretic (urinary) medicines.
Furosemidum Neupharm, 10 mg/ml, solution for injection is indicated when oral furosemide administration does not produce a sufficient urine output or when oral administration is not possible.
Furosemidum Neupharm is indicated:

• if there is fluid retention in tissues (edema) and (or) ascites caused by heart or liver disease,
• if there is fluid accumulation in tissue (edema) caused by kidney disease,
• if there is fluid accumulation in tissue (edema) caused by burns,
• in the case of fluid accumulation in lung tissue (pulmonary edema) (e.g. in acute heart failure),
• as a supportive measure in the case of fluid accumulation in brain tissue (cerebral edema),
• in the case of oliguria (reduced urine production) occurring as a result of pregnancy poisoning (gestosis), possibly after correcting fluid deficiencies (edema and (or) hypertension in gestosis are not indications!),
• if there is very high blood pressure that can lead to life-threatening conditions (hypertensive crisis).

How does Furosemidum Neupharm, 10 mg/ml, solution for injection work?

Furosemidum Neupharm helps to remove more water (urine) than usual.
In cases where excess water is not removed from the body, it can put additional strain on the heart, blood vessels, lungs, kidneys, or liver.

2. Important information before using Furosemidum Neupharm

When not to use Furosemidum Neupharm

• if the patient is allergic to furosemide, sulfonamides (possible cross-allergy with furosemide) or any of the other ingredients of this medicine (listed in section
• 6);
• if the patient has renal failure with oliguria, despite furosemide administration;
• if the patient is in a state of hepatic coma and pre-coma associated with hepatic encephalopathy;
• in cases of severe hypokalemia;
• in cases of severe hyponatremia;
• in cases of hypovolemia or dehydration;
• if the patient is breastfeeding (see also "Pregnancy, breastfeeding, and fertility").

Furosemidum Neupharm should not be used if any of the above conditions apply to the patient.
In case of doubts, before starting treatment with Furosemidum Neupharm, the patient should discuss it with their doctor or nurse.

Warnings and precautions

Before starting treatment with Furosemidum Neupharm, the patient should discuss it with their doctor, pharmacist, or nurse:

• if the patient has very low blood pressure;
• if the patient is elderly, taking other medicines that may cause a decrease in blood pressure, and if the patient has other diseases that may be associated with a risk of decreased blood pressure;
• in the case of diabetes or previously undiagnosed diabetes (overt or latent diabetes); regular monitoring of blood glucose levels is necessary;
• if the patient has gout, in which case regular monitoring of uric acid levels in the blood is necessary;
• if the patient has urinary tract obstruction (e.g. associated with prostate enlargement, hydronephrosis, ureteral stricture);
• in cases of decreased protein levels in the blood, e.g. in nephrotic syndrome (protein loss, lipid metabolism disorder, and fluid retention), careful dose selection is necessary;
• if the patient has rapidly progressive renal impairment associated with severe liver disease, e.g. liver cirrhosis (hepato-renal syndrome);
• if the patient has circulatory disorders in the brain or coronary arteries, due to the particular risk of undesirable significant blood pressure drop.

In patients with urinary disorders (e.g. due to prostate enlargement), Furosemidum Neupharm should only be used if there is a guarantee of free urine flow, as sudden onset of urine flow may lead to urinary retention (urinary retention).
Furosemidum Neupharm causes increased excretion of sodium and chlorides, and consequently water.
The excretion of other electrolytes (especially potassium, calcium, and magnesium) is increased. Since disturbances of water and electrolyte balance are often observed during treatment with Furosemidum Neupharm due to increased electrolyte excretion, regular monitoring of electrolyte levels in serum is recommended.
During long-term treatment with Furosemidum Neupharm, regular monitoring of electrolyte levels in serum (especially potassium, sodium, and calcium), bicarbonate, creatinine, urea, and uric acid, as well as blood sugar levels, is recommended.
Particular caution is necessary in patients with a high risk of developing electrolyte balance disorders or increased fluid loss (e.g. due to vomiting, diarrhea, or intense sweating). Hypovolemia or dehydration and other significant electrolyte or acid-base balance disorders should be corrected. This may require temporary discontinuation of Furosemidum Neupharm.
Underlying diseases (e.g. liver cirrhosis, heart failure), concomitantly used medicines, and diet may influence the development of electrolyte balance disorders.
Weight loss due to increased urine output should not exceed 1 kg of body weight per day, regardless of the volume of urine output.
In the case of nephrotic syndrome, the dose of the medicinal product should be carefully adjusted, due to the increased risk of adverse reactions.
The solution for injection should not be administered together with other medicines in the same syringe.
It should be ensured that the pH of the ready-to-use solution for injection is in the range from slightly alkaline to neutral (pH not less than 7). Acidic solutions should not be used, as this may lead to precipitation of the active substance.
Concomitant use with risperidone
In controlled placebo studies with risperidone in elderly patients with dementia, higher mortality was observed in patients treated with both furosemide and risperidone compared to patients treated with risperidone alone or furosemide alone. Therefore, caution should be exercised, and the doctor should consider the risk and benefits of such a combination or concomitant use with other potent diuretic medicines before making a decision on treatment. Dehydration should be avoided.

Children

In premature infants, special caution is required, as there is a risk of developing nephrocalcinosis or kidney stones.
Renal function and ultrasound examination of the kidneys should be monitored.
In premature infants with respiratory distress syndrome, diuretic treatment with Furosemidum Neupharm in the first weeks of life may increase the risk that the ductus arteriosus will not close before birth (persistent ductus arteriosus Botalli).
Doping control
The use of Furosemidum Neupharm may lead to positive doping control results. Moreover, improper use of Furosemidum Neupharm as a doping agent may pose a risk to the patient's health.

Furosemidum Neupharm and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should inform their doctor if they are taking any of the following medicines:

• Anti-inflammatory and anti-allergic medicines, such as glucocorticoids (cortisone), carbenoxolone (used to treat stomach ulcers), or laxatives (used to treat constipation) used with Furosemidum Neupharm may lead to increased potassium loss with a risk of developing hypokalemia. High doses of licorice have the same effect as carbenoxolone.
• Anti-inflammatory medicines (including non-steroidal anti-inflammatory drugs, e.g. indomethacin and acetylsalicylic acid) may weaken the effect of Furosemidum Neupharm. In patients who develop decreased blood volume or dehydration during furosemide treatment, concomitant administration of non-steroidal anti-inflammatory drugs may cause acute renal failure.
• Probenecid (used to treat gout), methotrexate (used to treat certain cancers and severe arthritis), and other medicines that, like furosemide, undergo significant renal tubular secretion may weaken the effect of Furosemidum Neupharm.
• It has been reported that concomitant administration of phenytoin (used to treat epilepsy) weakens the effect of furosemide.

The following medicines may increase the risk of side effects during treatment with Furosemidum Neupharm:

• Concomitant use of certain cardiac glycosides (e.g. digoxin) may increase the sensitivity of the heart muscle to these cardiac glycosides in patients who develop hypokalemia or hypomagnesemia during treatment with Furosemidum Neupharm. There is an increased risk of cardiac arrhythmias (ventricular arrhythmias, including torsades de pointes) when using certain medicines that can cause changes in the ECG (QT interval prolongation syndrome) (e.g. terfenadine - an anti-allergic medicine, certain anti-arrhythmic drugs - class I and III anti-arrhythmic drugs) and in the case of electrolyte balance disorders.
• Concomitant use of Furosemidum Neupharm with high doses of analgesic medicines (salicylates) may increase the adverse effects associated with salicylate use.
• Furosemidum Neupharm may enhance the harmful effects of nephrotoxic medicines (e.g. antibiotics such as aminoglycosides, cephalosporins, polymyxins). In patients receiving concomitantly Furosemidum Neupharm and high doses of certain cephalosporins, renal function impairment may occur.
• Ototoxicity (hearing damage) caused by antibiotics used to treat infections (e.g. aminoglycosides such as kanamycin, gentamicin, tobramycin) and other ototoxic medicines may be increased during concomitant administration of Furosemidum Neupharm. Hearing disorders may be irreversible. Therefore, concomitant use of these medicines should be avoided.
• Concomitant administration of cisplatin (an anti-cancer medicine) and Furosemidum Neupharm may lead to hearing damage. Furosemidum Neupharm should be administered with caution, as it may enhance the nephrotoxic effects of cisplatin.
• Concomitant administration of Furosemidum Neupharm and lithium (an anti-depressant medicine used to treat mood disorders) may lead to increased cardiotoxic and neurotoxic effects of lithium. Therefore, it is recommended to carefully monitor lithium levels in serum in patients receiving both furosemide and lithium.
• If Furosemidum Neupharm is used concomitantly with other antihypertensive medicines (especially ACE inhibitors or angiotensin II receptor antagonists), diuretics, or medicines with a hypotensive effect, a greater decrease in blood pressure should be expected. Significant blood pressure drop with shock and renal function impairment (in some cases acute renal failure) have been observed, especially when an ACE inhibitor (e.g. lisinopril) or an angiotensin II receptor antagonist (e.g. losartan) was administered for the first time or in high doses. Therefore, if possible, the use of Furosemidum Neupharm should be temporarily discontinued or the dose reduced before starting the administration of ACE inhibitors or angiotensin II receptor antagonists, or before increasing their dose.

Furosemidum Neupharm may reduce the renal elimination of probenecid (used to treat gout), methotrexate (used to treat certain cancers and severe arthritis), and other medicines that, like furosemide, undergo significant renal tubular secretion. In the case of high-dose treatment, this may lead to increased blood levels of the medicine and an increased risk of side effects.

• The effect of theophylline (a medicine for asthma) or muscle relaxants (curare derivatives) may be enhanced during treatment with Furosemidum Neupharm.
• The effect of medicines that lower blood sugar levels (anti-diabetic medicines, e.g. metformin and insulin) or medicines that increase blood pressure (sympathomimetics, e.g. adrenaline, noradrenaline) may be weakened during concomitant administration of Furosemidum Neupharm.
• Caution should be exercised in patients treated with risperidone (used to treat mental disorders), and the doctor should consider the risk and benefits of concomitant or simultaneous treatment with risperidone and Furosemidum Neupharm or other potent diuretics.
• Concomitant use of thyroid hormones (e.g. L-thyroxine) and high doses of furosemide may affect thyroid hormone levels. Therefore, in patients receiving this combination of medicines, thyroid hormone levels should be monitored.

Other interactions

• Concomitant use of cyclosporin A (used to prevent transplant rejection) and Furosemidum Neupharm is associated with an increased risk of developing gouty arthritis (joint pain) due to furosemide-induced increased uric acid levels in the blood and cyclosporin-related impaired uric acid excretion through the kidneys.
• In patients with a high risk of kidney damage associated with the use of contrast agents, renal function impairment occurred more frequently after contrast imaging using X-ray radiation in patients treated with Furosemidum Neupharm than in patients at risk who received only intravenous fluids for hydration before the contrast imaging.
• In single cases, intravenous administration of Furosemidum Neupharm may cause hot flashes, sweating, restlessness, nausea, increased blood pressure, and rapid heart rate (tachycardia) within 24 hours of taking chloral hydrate. Therefore, concomitant use of Furosemidum Neupharm and chloral hydrate is not recommended.

Furosemidum Neupharm with food and drink

High doses of licorice in combination with Furosemidum Neupharm may lead to increased potassium loss.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
Furosemidum Neupharm may be used during pregnancy only if the doctor considers it necessary, as furosemide crosses the placental barrier.
Furosemide passes into breast milk and may inhibit lactation. Therefore, breastfeeding women should not use Furosemidum Neupharm. If necessary, breastfeeding should be discontinued.

Driving and using machines

Even if Furosemidum Neupharm is used as intended, the medicine may affect the ability to react, impairing the ability to drive vehicles, operate machinery, or perform potentially hazardous activities. The risk is higher at the beginning of treatment, when the dose is increased, during changes in medication, and in combination with alcohol.

Furosemidum Neupharm contains sodium

This medicine contains 3.7 mg of sodium (a major component of common salt) per 1 ml. This corresponds to 0.2% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Furosemidum Neupharm

This medicine should always be used as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Furosemidum Neupharm is administered by a doctor or nurse by injection into a vein (intravenously) or into a muscle (intramuscularly).
Dosage
The dosage should be determined individually, especially after successful treatment. The smallest dose of the medicine that produces the desired effect should always be used.
Unless otherwise directed, the following dosage instructions apply to adults:

Adults and the elderly

Fluid retention (edema) and (or) ascites caused by heart or liver disease:
The initial dose of Furosemidum Neupharm is 2 - 4 ml (corresponding to 20 - 40 mg of furosemide) administered intravenously. In cases of persistent edema, if necessary, the dose should be repeated at appropriate intervals until urine output begins.
Fluid accumulation in tissue (edema) caused by kidney disease:
The initial dose of Furosemidum Neupharm is 2 - 4 ml (corresponding to 20 - 40 mg of furosemide) administered intravenously. In cases of persistent edema, if necessary, the dose should be repeated at appropriate intervals until urine output begins.
In patients with nephrotic syndrome, the dose should be carefully selected, due to the possibility of increased adverse reactions.
Fluid accumulation in tissue (edema) caused by burns:
The daily dose and (or) single dose of Furosemidum Neupharm may be 4 to 10 ml (corresponding to 40 - 100 mg of furosemide), exceptionally in cases of impaired renal function, the dose may be up to 25 ml (corresponding to 250 mg of furosemide). Reduction of intravascular volume should be corrected before administration of Furosemidum Neupharm.
Fluid accumulation in lung tissue (pulmonary edema, e.g. in acute heart failure):
Used in combination with other therapeutic measures. The initial dose of Furosemidum Neupharm is 2 - 4 ml (corresponding to 20 - 40 mg of furosemide) administered intravenously. If there is no increase in urine output, the dose should be repeated after 30-60 minutes, if necessary, administering a double dose.
As a supportive measure in the case of fluid accumulation in brain tissue (cerebral edema):
The daily dose and (or) single dose of Furosemidum Neupharm may be 4 to 10 ml (corresponding to 40 - 100 mg of furosemide), in exceptional cases, with impaired renal function, the recommended dose of the medicine may be up to 25 ml (corresponding to 250 mg of furosemide).
Reduced urine production (oliguria) due to pregnancy complications (gestosis):
Indication is very restrictive!
Reduction of intravascular volume should be corrected before administration of Furosemidum Neupharm. The dose of Furosemidum Neupharm may be 1 to 10 ml (corresponding to 10 - 100 mg of furosemide) per day.
Edema and (or) hypertension in gestosis are not indications for the use of Furosemidum Neupharm!
Hypertensive crisis:
From 2 to 4 ml of Furosemidum Neupharm (corresponding to 20-40 mg of furosemide), together with other therapeutic measures.

Use in children

Unless otherwise directed, in infants and children under 15 years of age, Furosemidum Neupharm should be administered parenterally, only in life-threatening conditions. The average daily dose of the medicine is 0.5 mg of furosemide/kg of body weight. In exceptional cases, the dose may be up to 1 mg of furosemide/kg of body weight administered intravenously.
This medicine should always be used as directed by the doctor, pharmacist, or nurse. In case of doubts, the patient should consult their doctor, pharmacist, or nurse.

Use of a higher than recommended dose of Furosemidum Neupharm

In the case of using a higher than recommended dose of Furosemidum Neupharm, the patient should immediately contact their doctor or pharmacist for advice. Depending on the severity of the overdose, the doctor may decide on additional measures that may be necessary. Symptoms of acute or chronic overdose depend on the degree of salt and fluid loss.
Overdose may lead to decreased blood pressure and circulatory disorders when changing from a lying to a standing position, electrolyte disturbances (decreased levels of potassium, sodium, and chlorides), or increased blood pH (alkalosis).
In the case of excessive fluid loss, dehydration and decreased blood volume may occur, leading to circulatory problems (leading to circulatory shock), especially in elderly patients and children, which may manifest as headache, dizziness, blurred vision, dry mouth, thirst, low blood pressure, and orthostatic hypotension.
In the case of rapid fluid and electrolyte loss, disorientation may occur.
In case of further questions about the use of this medicine, the patient should consult their doctor or pharmacist.
Blood tests
The doctor may recommend blood tests to check if the levels of certain electrolytes in the blood are normal.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects is defined according to the following criteria:
Very common: may affect more than 1 in 10 people
Common: occur in no more than 1 in 10 people
Uncommon: occur in no more than 1 in 100 people
Rare: occur in no more than 1 in 1,000 people
Very rare: occur in no more than 1 in 10,000 people
Frequency not known: frequency cannot be estimated from the available data
Blood and lymphatic system disorders
Common: hemoconcentration (in case of excessive urine output).
Uncommon: decreased platelet count (thrombocytopenia).
Rare: increased count of certain white blood cells (eosinophilia), decreased count of white blood cells (leukopenia).
Very rare: anemia caused by increased breakdown of red blood cells (hemolytic anemia), anemia caused by disorders of blood cell production in the bone marrow (aplastic anemia), significant decrease in the count of certain white blood cells with a tendency to infections and severe general symptoms (agranulocytosis).
Agranulocytosis may be indicated by: fever with chills, changes in the mucous membrane, and throat pain.
Immune system disorders
Uncommon: allergic skin and mucous membrane reactions (see "Skin and subcutaneous tissue disorders").
Rare: severe anaphylactic and anaphylactoid reactions, such as anaphylactic shock.
Frequency not known: exacerbation or activation of systemic lupus erythematosus.
Metabolic and nutritional disorders (see "Warnings and precautions")
Very common: electrolyte balance disorders (including symptomatic), dehydration, and hypovolemia (especially in the elderly), increased triglyceride levels in the blood.
Common: hyponatremia and hypochloremia (especially if sodium chloride intake is limited), hypokalemia (especially with reduced potassium intake and (or) increased potassium loss, e.g. due to vomiting or chronic diarrhea); increased cholesterol levels in the blood, increased uric acid levels in the blood, and gout attacks.
Uncommon: decreased glucose tolerance and hyperglycemia. In patients with diagnosed diabetes, this may lead to worsening of metabolic control. Latent diabetes may be revealed.
Rare: in the case of hypomagnesemia, tetany or cardiac arrhythmias have been observed.
Frequency not known: hypocalcemia, hypomagnesemia, metabolic alkalosis, pseudo-Bartter syndrome (renal function disorders associated with abuse and (or) long-term use of furosemide, characterized by increased blood pH, decreased sodium levels, and decreased blood pressure).
Commonly observed symptoms of sodium deficiency are apathy, calf cramps, loss of appetite, weakness, drowsiness, vomiting, and disorientation.
Symptoms of potassium deficiency may include: muscle weakness, discomfort in the limbs (e.g. tingling, numbness, or burning pain), paralysis, vomiting, constipation, excessive gas in the intestines, excessive urination, increased thirst, and irregular pulse (e.g. disorders in the formation and conduction of impulses in the heart). Severe potassium loss may lead to intestinal paralysis (paralytic ileus) or disorders of consciousness, and even coma.
Calcium deficiency may rarely cause a state of nervous and muscular hyperexcitability (tetany).
In the case of magnesium deficiency, tetany or cardiac arrhythmias have been observed in rare cases.
Nervous system disorders
Common: hepatic encephalopathy in patients with liver failure.
Rare: sensation of tingling or numbness of the skin (paresthesia).
Frequency not known: dizziness, fainting, and loss of consciousness, headache.
Ear and labyrinth disorders
Uncommon: hearing disorders, mainly reversible, especially in patients with renal failure or hypoproteinemia (decreased protein levels in the blood, e.g. in nephrotic syndrome) and (or) in the case of too rapid intravenous injection. Deafness (sometimes irreversible).
Rare: tinnitus.
Vascular disorders
Very common (in the case of intravenous administration): hypotension, including orthostatic syndrome.
Rare: vasculitis.
Frequency not known: thrombosis (especially in elderly patients). In the case of excessive urine output, circulatory problems (leading to circulatory shock) may occur, especially in elderly patients and children, which may manifest as headache, dizziness, blurred vision, dry mouth, thirst, low blood pressure, and orthostatic hypotension.
Gastrointestinal disorders
Uncommon: nausea.
Rare: vomiting, diarrhea.
Very rare: acute pancreatitis.
Hepatobiliary disorders
Very rare: intrahepatic cholestasis (bile stasis manifesting as yellowing of the skin or dark urine), increased transaminase activity.
Skin and subcutaneous tissue disorders
Uncommon: itching, urticaria, rash, bullous dermatitis, erythema multiforme, pemphigoid, exfoliative dermatitis, purpura, hypersensitivity to light.
Frequency not known: Stevens-Johnson syndrome (formation of blisters and peeling of the skin around the lips, eyes, mouth, nose, and genitals, flu-like symptoms, fever), toxic epidermal necrolysis (peeling of large areas of the skin, exposing the underlying skin), acute generalized exanthematous pustulosis (acute febrile drug rash), drug reaction with eosinophilia and systemic symptoms (so-called DRESS syndrome), lichenoid reactions (ulcers of the mucous membrane of the mouth).
Musculoskeletal and connective tissue disorders
Frequency not known: cases of rhabdomyolysis have been reported, often associated with severe hypokalemia (see "When not to use Furosemidum Neupharm").

Renal and urinary disorders

Very common: increased creatinine levels in the blood.
Common: increased urine output.
Rare: tubulointerstitial nephritis.
Frequency not known: increased sodium levels in urine, increased chloride levels in urine, increased urea levels in the blood, symptoms of urinary tract obstruction (e.g. in patients with prostate enlargement, hydronephrosis, and ureteral stricture) up to urinary retention (urinary retention) with secondary complications, nephrocalcinosis and (or) kidney stones in premature infants (see "Warnings and precautions"), renal failure (see "Furosemidum Neupharm and other medicines").

Congenital, familial, and genetic disorders

Frequency not known: increased risk that the ductus arteriosus will not close before birth (persistent ductus arteriosus Botalli), if premature infants are treated with furosemide in the first weeks of life.

General disorders and administration site conditions

Rare: fever.
Frequency not known: after intramuscular injection, local reactions may occur, such as pain.
If a side effect occurs suddenly or rapidly progresses, the patient should immediately inform their doctor, as some side effects of the medicine may be life-threatening. The doctor decides what measures should be taken and whether therapy can be continued.
At the first signs of an allergic reaction, Furosemidum Neupharm should not be used again.
If any side effect worsens or any side effects not listed in this leaflet occur, the patient should inform their doctor or pharmacist.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Furosemidum Neupharm

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: Expiry date (EXP) and ampoule after: EXP. The expiry date refers to the last day of the specified month.
There are no special storage instructions for the medicinal product.
Ampoules should be stored in the outer packaging to protect from light. Do not store in the refrigerator or freeze.
Do not use this medicine if the solution for injection contains visible particles or discoloration. The solution can only be used if it is clear, colorless, or slightly yellowish.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
Information on the storage of the diluted medicinal product is provided in section 6 "Information intended for healthcare professionals only".

6. Contents of the packaging and other information

What Furosemidum Neupharm contains

• The active substance of the medicine is furosemide. One 2 ml ampoule of solution for injection contains 21.3 mg of furosemide sodium (corresponding to 20 mg of furosemide).
• The other ingredients (excipients) are: sodium chloride, sodium hydroxide, water for injections.

What Furosemidum Neupharm looks like and contents of the pack

Furosemidum Neupharm is a clear, colorless, or slightly yellowish solution for injection.
Furosemidum Neupharm is available in packs containing 5 and 50 ampoules, each of 2 ml.

Marketing authorization holder and importer

Marketing authorization holder

Neupharm Sp. z o. o.
ul. Ługowa 85
96-320 Mszczonów
Poland
Phone: +48 22 49 21 301

Importer

SciencePharma Sp. z o. o.
ul. Chełmska 30/34
00-725 Warsaw
Poland
Date of last revision of the leaflet:July 2024

Information intended for healthcare professionals only.

Preparation of the medicinal product for use

For single use only. Use immediately after first opening.
The medicinal product Furosemidum Neupharm should not be mixed with solutions for injection/infusion that have an acidic or slightly acidic pH and significant buffering capacity in the acidic range. In the case of these mixtures, the pH value is shifted to the acidic range, and the poorly soluble furosemide precipitates as a crystalline sediment. It should be ensured that the pH of the ready-to-use solution for injection is in the range from slightly alkaline to neutral (pH not less than 7). Acidic solutions should not be used, as this may lead to precipitation of the active substance.
The product may be diluted with sodium chloride (0.9%), solution for injection (dilution ratio 1:9), which represents a physiological solution similar to blood serum. Since it is an aqueous solution, its mixing is easy and ensures safe administration of the diluted solution into the bloodstream.
Furosemidum Neupharm diluted to 1 mg/ml is compatible with 0.9% NaCl infusion solution for 12 hours at 25°C±2°C, protected from light.
Before administration, the solution should be inspected for the presence of solid particles and discoloration. The solution can only be used if it is clear, colorless, or slightly yellowish and does not contain visible particles.
Unused product or waste derived from it should be disposed of in accordance with local regulations.

Shelf life after dilution

Chemical and physical stability has been demonstrated in sodium chloride solution (0.9%) for 12 hours at 25°C±2°C, protected from light.
From a microbiological point of view, unless the method of opening/reconstitution/dilution excludes the risk of microbial contamination, the product should be used immediately. If the product is not used immediately, the in-use storage times and conditions are the responsibility of the user.