Patient Information Leaflet

Furosemide Solution for Infusion 250 mg/25 ml EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start using Furosemide Solution

3. How to use Furosemide Solution

4. Possible side effects

5. Storage of Furosemide Solution

6. Contents of the pack and additional information

Furosemida Sala 250 mg/ 25 ml solution for infusion is a diuretic belonging to the group of sulfonamides. It acts by increasing urine elimination (diuretic) and reducing blood pressure (antihypertensive).

This medication is indicated exclusively under the prescription of your doctor for the treatment of patients with:

- Kidney filtration problems (through the kidneys).

- Acute renal insufficiency, in order to maintain fluid elimination and facilitate parenteral nutrition, as long as some filtration capacity remains.

- Chronic renal insufficiency in the pre-dialysis stage, with fluid retention and hypertension.

- Terminal renal insufficiency, for maintenance of renal functional capacity.

- Nephrotic syndrome in patients for whom a daily dose of 120 mg of furosemida by oral route is insufficient; the treatment of the underlying disease has priority.

Please read carefully the instructions provided in section 3. “How to use Furosemide Sala”

Do not use Furosemide Sala

• If you are allergic to furosemide, to furosemide-type medications (sulfonamides), or to any of the other components of this medication (listed in section 6).
• If you have a decrease in your total blood volume (hypovolemia), or if you are dehydrated.
• If you have severe kidney problems, accompanied by a decrease in urine elimination (renal insufficiency with anuria), that does not respond to this medication.
• If you have a severe decrease in your blood potassium levels (severe hypokalemia). (see section 4. “Possible side effects”).
• If you have a severe deficiency of sodium salts in your blood (severe hyponatremia).
• If you are in a pre-comatose and comatose state (associated with hepatic encephalopathy).
• If you are breastfeeding a baby.
• If you are pregnant, see section “Pregnancy, lactation, and fertility”.

Furosemide Sala 250 mg/25 ml injectable solution should not be administered as a bolus intravenously. It should only be infused using infusion pumps that control the volume or rate to avoid the risk of accidental overdose.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Furosemide Sala 250 mg infusion solution:

Be especially careful with this medication:

• If you have problems with urine elimination, especially at the beginning of treatment.
• If your blood pressure is low (hypotension)
• If you have a high risk of experiencing a significant drop in blood pressure (for example, in patients with significant coronary or cerebral stenosis). If you have latent or manifest diabetes mellitus.
• If you have gout.
• If you have severe kidney problems, associated with severe liver disease (hepatorenal syndrome).
• If your blood protein levels are low (hypoproteinemia), in addition to having, for example, nephrotic syndrome (see “Possible side effects”).
• In premature children (see “Possible side effects”).
• There is a possibility of exacerbation or activation of systemic lupus erythematosus.
• If you are an elderly person, if you are being treated with medications that may cause a decrease in blood pressure, or if you have other medical conditions that are associated with the risk of decreased blood pressure.
• You are dehydrated (you have lost a large amount of body fluids because you have had intense diarrhea or have had vomiting); this could cause you to faint or form a blood clot.
• You have hearing problems.
• You are using sorbitol (a sugar substitute for people with diabetes).
• You have porphyria (a disease in which an alteration prevents the production of the molecule of red blood cells that binds to oxygen and urine becomes purple).

During your treatment with Furosemide Sala, you will generally require regular monitoring of your blood levels, sodium, potassium, and creatinine, and especially if you experience a significant loss of fluids, by vomiting, diarrhea, or intense sweating (dehydration or hypovolemia), as your doctor may require the interruption of treatment.

Patients with advanced age and dementia who are taking risperidone should be especially careful with the concomitant use of risperidone and furosemide. Risperidone is a medication used to treat certain mental illnesses, such as dementia (a disease characterized by several symptoms: memory loss, problems speaking, problems thinking).

Use in athletes

This medication contains furosemide, which can produce a positive result in doping control tests.

Use of Furosemide Sala with other medications:

Inform your doctor or pharmacist if you are using, have used recently, or may need to take any other medication.

The effect of treatment may be affected if Furosemide Sala is used at the same time as other medications. Do not recommend the concomitant administration of intravenous furosemide 24 hours after being administered chloral hydrate, as it may cause flushing, sweating, restlessness, nausea, hypertension, and tachycardia.

Some substances may increase their toxicity in the ear and kidneys if administered together with this medication. Therefore, if administered together, it should be under strict medical control.

These substances include:

- Aminoglycoside antibiotics (medications for infections) such as gentamicin, kanamycin, and tobramycin.

- Cancer medications (cisplatin).

The concomitant use of Furosemide Sala with other medications may weaken the effect of other medications:

- Medications used for diabetes (antidiabetic medications).

- Medications used to raise blood pressure (sympathomimetics with hypertensive effect, for example, epinephrine and norepinephrine).

In other cases, the concomitant use may increase the action of other medications such as:

- Medications for asthma (theophylline).

- Muscle relaxants such as curare.

- Medications for depression (lithium salts), which may increase the risk of lithium toxicity, including the risk of adverse effects on the heart or brain.

• Patients being treated with diuretics may experience severe hypotension and deterioration of renal function, especially when administered for the first time or administered for the first time a high dose of an ACE inhibitor or an angiotensin II receptor antagonist.
• If medications are administered to treat high blood pressure, diuretics, or other medications that may lower blood pressure, together with furosemide, a more pronounced decrease in blood pressure should be anticipated.

- Toxic medications for the kidneys: The concomitant administration may potentiate the harmful effect of these medications on the kidneys.

- Some anti-inflammatory and pain medications (non-steroidal anti-inflammatory drugs, including aspirin) and medications for epilepsy (phenytoin and phenobarbital) may reduce the effect of Furosemide Sala. Furosemide may increase the toxicity of salicylates.

Medications such as probenecid and methotrexate, or other medications that undergo significant renal excretion, may reduce the effect of Furosemide Sala. In high-dose treatment, they may increase serum levels and increase the risk of adverse effects due to furosemide or concomitant administration.

Medications used to reduce cholesterol or lipid levels, such as cholestyramine, colestipol, and fibrates (such as clofibrate) and methotrexate may reduce the effect of furosemide.

Medications for diabetes, such as metformin and insulin, as they may increase blood sugar levels.

Medications such as theophylline (for asthma) may increase the effect of furosemide. Aminoglutethimide (used to inhibit the production of corticosteroids, such as in Cushing's syndrome) or carbamazepine (used to treat epilepsy or schizophrenia) may increase the side effects of furosemide.

Sucralfate (used to treat stomach ulcers). Do not use furosemide in the two hours prior to taking sucralfate, as the effect of furosemide would be reduced.

The following substances may increase the risk of reducing blood potassium levels (hypokalemia) if administered with Furosemide Sala:

- Anti-inflammatory medications (corticosteroids).

- Carbenoxolone (medication for the treatment of oral mucosa lesions).

- Significant amounts of licorice.

- Prolonged use of laxatives for constipation.

Some electrolyte alterations (for example, a decrease in blood potassium levels (hypokalemia) or magnesium (hypomagnesemia) may increase the toxicity of some medications (for example, digitalis and medications that induce the QT interval prolongation syndrome).

Patients being treated with Furosemide Sala and receiving high doses of some cephalosporins (antibiotics) may experience a decrease in renal function.

The concomitant administration of Furosemide Sala and cyclosporine A (medication used to prevent transplant rejection) is associated with a high risk of gouty arthritis.

Patients with a high risk of nephropathy (kidney disease) due to radiocontrast who receive Furosemide Sala have a higher risk of kidney function deterioration.

The concomitant administration of Furosemide Sala and risperidone in elderly patients with dementia may increase mortality.

High doses of furosemide administered with levotiroxine may cause an initial transient increase in free thyroid hormones, followed by a general decrease in total thyroid hormone levels.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

If you are pregnant, you will only use Furosemide Sala if there are medical reasons that require it.

During breastfeeding, Furosemide Sala should not be administered, as it passes into breast milk. If its administration is necessary, your doctor may require you to interrupt breastfeeding.

Driving and operating machines

This medication may cause dizziness or somnolence. This may occur more frequently at the beginning of treatment, when your doctor increases your dose, or if you consume alcohol. Do not drive or operate tools or machines if you feel dizzy or somnolent.

Some adverse effects (for example, a significant and undesirable drop in blood pressure) may impair your ability to concentrate and react, and therefore constitute a risk in situations where these skills are of special importance (for example, operating vehicles or machinery).

Furosemide Sala 250 mg/ 25 mlinfusion solution contains sodium:Patients with low-sodium diets should be aware that this medication contains 86.3 mg (3.75 mmol) of sodium per 25 ml vial.

Follow exactly the administration instructions of this medication as indicated by your pharmacist or nurse. In case of doubt, consult your pharmacist or nurse again.

Furosemide Injection 250 mg/25 ml for infusionshould not be administered as an intravenous bolus.

It should be used exclusively by intravenous infusion.

Only infuse using infusion pumps that control the volume or rate to avoid a possible risk of accidental overdose.

The active substance furosemide by intravenous route should be infused slowly, at a rate not exceeding 4 mg per minute. In patients with severe kidney problems (serum creatinine?5 mg/dl), it is recommended that the infusion rate not exceed 2.5 mg per minute.

Furosemide in injectable solution form should not be mixed in the same syringe or infused with other medications.

Your doctor or nurse should note that the pH value of the infusion solution should be neutral or slightly alkaline and therefore should not use acidic solutions as the active principle could precipitate. Isotonic saline solution is the suitable diluent. It is recommended that the ready-to-use solution be used as soon as possible.

Your doctor will indicate your daily dose and the duration of your treatment. Do not discontinue your treatment prematurely. The dose is specific to you and may be modified by your doctor based on your response to treatment.

In adults, the maximum recommended dose of furosemide is 1500 mg per day, although in exceptional cases it may reach 2000 mg.

Use in children and adolescents

In children, the maximum recommended daily dose in intravenous or intramuscular injection is 1 mg of furosemide per kg of body weight up to a maximum of 20 mg of furosemide per day. As soon as possible, switch to oral treatment.

In infants and children and adolescents under 15 years, parenteral administration (eventually by slow infusion) is contraindicated, only in cases where it would pose a vital risk.

In these cases, the presentation of furosemide 20 mg/2 ml injectable solution may be used.

If you use more Furosemide Sala than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call theToxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Your doctor or nurse will ensure that you receive the correct dose.

An accidental overdose could lead to a severe drop in blood pressure (which may evolve into shock), kidney problems (acute renal insufficiency), coagulation problems (thrombosis), delirium, paralysis affecting soft muscles (flaccid paralysis), apathy, and confusion.

No specific antidote is known.

In case of overdose, treatment will be based on symptoms.

If you forgot to use Furosemida Sala

Do not use a double dose to compensate for the missed doses.

Like all medications, Furosemida Sala 250 mg/ 25 ml solution for infusion may cause adverse effects, although not everyone will experience them.

Adverse effects have been grouped by their frequency:

Very frequent(may affect more than 1 in 10 patients)

?electrolyte imbalances (including symptomatic), dehydration, and a decrease in total blood volume (hypovolemia), particularly in elderly patients, elevated levels of creatinine and triglycerides in the blood.

?with intravenous infusion: a decrease in blood pressure (hypotension, including orthostatic hypotension (problems maintaining an upright position)).

Frequent(may affect up to 1 in 10 patients)

?decreased levels of sodium (hyponatremia), chloride (hypochloremia), potassium (hypokalemia), increased levels of cholesterol and uric acid in the blood, and gout attacks.

?an increase in urine volume.

?mental alterations (hepatic encephalopathy) in patients with liver problems (hepatocellular insufficiency).

?an increase in blood viscosity (hemoconcentration).

Occasional(may affect up to 1 in 100 patients)

?alteration of glucose tolerance. A latent diabetes mellitus may manifest.

?nausea.

?auditory disturbances, although usually of a transient nature, especially in patients with renal insufficiency, decreased levels of proteins in the blood (hypoproteinemia), and/or after a too rapid intravenous administration of furosemide.Sudden hearing loss (occasionally irreversible).

?itching, rash, eruptions, blisters, and more severe reactions such as erythema multiforme, pemphigoid, exfoliative dermatitis, purpura, and photosensitivity reaction.

?decreased levels of platelets (thrombocytopenia).

Rare(may affect up to 1 in 1,000 patients)

?allergic inflammation of blood vessels (vasculitis).

?allergic renal reaction (tubulointerstitial nephritis).

?malaise, vomiting, diarrhea, constipation, loss of appetite, mouth and stomach discomfort.

?subjective sensation of ringing in the ears (tinnitus).

?severe allergic reactions (anaphylactic or anaphylactoid) (e.g., with shock).

?sensation of tingling in the extremities (paresthesias).

?decreased levels of white blood cells (leukopenia), increased levels of a type of white blood cell, eosinophils (eosinophilia).

?fever.

• muscle problems, including muscle weakness and leg cramps
• blurred vision, confusion, drowsiness.
• dry mouth.

Very rare(may affect up to 1 in 10,000 patients)

?inflammation of the pancreas (acute pancreatitis).

?liver problem (cholestasis), increased levels of liver enzymes (transaminases).

?decreased levels of a type of white blood cell, granulocytes (agranulocytosis), decreased levels of red blood cells (aplastic anemia or hemolytic anemia).

• severe muscle problems, such as spasms, cramps, and tetanus.

Frequency unknown(cannot be estimated from available data)

?decreased levels of calcium (hypocalcemia), magnesium (hypomagnesemia), increased levels of urea in the blood, metabolic alkalosis, pseudo-Bartter syndrome in the case of misuse and/or prolonged use of furosemide.

?alteration of blood coagulation (thrombosis).

?increased levels of sodium and chloride in the urine, retention of urine (in patients with partial obstruction of urine flow), formation of kidney stones (nephrocalcinosis/nephrolithiasis) in premature infants, renal failure.

?severe vesicular reactions of the skin and mucous membranes (Stevens-Johnson syndrome), severe skin alteration characterized by the formation of blisters and exfoliative lesions (toxic epidermal necrolysis), generalized acute pustular exanthema (PEGA), and drug hypersensitivity syndrome with eosinophilia and systemic symptoms (DRESS), lichenoid reactions, characterized by small lesions, which produce itching, red-purple, polygonal, appearing on the skin, genitals, or mouth.

• exacerbation or activation of systemic lupus erythematosus.

?dizziness, fainting, and loss of consciousness, headache.

?cases of rhabdomyolysis have been reported, often in cases of severe hypokalemia (see "Do not use Furosemida Sala").

?increased risk of persistence of the "ductus arteriosus permeable" when furosemide is administered to premature infants during the first weeks of life.

• after intramuscular injection of furosemide, local reactions such as pain at the injection site may appear.

Like other diuretics, after prolonged administration of this medication, the elimination of sodium (hyponatremia), chloride (alkalosis hypochloremia), and consequently water may increase. It may also increase the loss of potassium (hypokalemia), calcium, and magnesium. These alterations manifest with intense thirst, headache, confusion, muscle cramps, painful muscle contractions, especially in the extremities (tetanus), muscle weakness, alterations in heart rhythm, and gastrointestinal symptoms.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Store the vials in the outer packaging.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Furosemida Sala 250 mg/ 25 mlinfusion solution

• The active ingredient is furosemida. Each vial of 25 ml contains 250 mg of furosemida.
• The other components (excipients) are: sodium hydroxide, sodium chloride, and injection water.

Appearance of the product and contents of the packaging

Furosemida Sala 250 mg/ 25 ml infusion solution, is presented in boxes that contain 4 vials of 25 ml.

EC: 50 vials.

Holder of the marketing authorization and responsible for manufacturing:

Laboratorio Reig Jofré, S.A.

C/ Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

Date of the last review of this leaflet:October 2022

“Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”