FUROSEMIDE SALA 250 mg / 25 ml SOLUTION FOR INFUSION

2. What you need to know before using Furosemide Sala

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 medicines of the furosemide type (sulfonamides), or to any of the other components of this medicine (listed in section 6).
• In the case of decreased total blood volume (hypovolemia), or if you are dehydrated.
• If you have severe kidney problems, accompanied by a decrease in urine elimination (renal failure with anuria), that does not respond to this medicine.
• If you have a severely decreased potassium level in your blood (severe hypokalemia). (See section 4. "Possible side effects").
• If you have a severe deficiency of sodium salts in your blood (severe hyponatremia).
• In case you are in a pre-comatose or comatose state (associated with hepatic encephalopathy).
• If you are breastfeeding a baby.
• If you are pregnant, see section "Pregnancy, breastfeeding, and fertility".

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

Warnings and precautions

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

Be especially careful with this medicine:

• If you have urine elimination problems, especially at the start of treatment.
• If your blood pressure is low (hypotension)
• If you have a high risk of suffering a pronounced 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 (hepato-renal syndrome).
• If your blood protein levels are low (hypoproteinemia), in addition to suffering from, 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 medicines that can cause a decrease in blood pressure or if you have other medical conditions that have associated risk of decreased blood pressure.
• If you are dehydrated (have lost a large amount of body fluids because you have had intense diarrhea or have vomited); this could cause you to faint or form a blood clot.
• If you have hearing problems.
• If you are using sorbitol (a sugar substitute for people with diabetes).
• If 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 acquires a purple color).

During your treatment with Furosemide Sala, periodic control of your blood levels of sodium, potassium, and creatinine will generally be required, and especially if you suffer from severe fluid loss, due to vomiting, diarrhea, or intense sweating (dehydration or hypovolemia), since your doctor may require the interruption of treatment.

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

Use in athletes

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

Use of Furosemide Sala with other medicines:

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

The effect of treatment may be affected if Furosemide Sala is used at the same time as other medicines. It is not recommended to administer furosemide intravenously 24 hours after chloral hydrate has been administered, as it could lead to flushing, sweating, restlessness, nausea, hypertension, and tachycardia.

Certain substances may have their toxicity increased in the ear and kidney if administered together with this medicine. Therefore, if they are administered concomitantly, it should be under strict medical control.

These substances include:

• Aminoglycoside antibiotics (infection medicines) such as gentamicin, kanamycin, and tobramycin.
• Cancer medicines (Cisplatin).

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

• Medicines used for diabetes (antidiabetics).
• Medicines used to increase blood pressure (sympathomimetics with a hypertensive effect, such as epinephrine and norepinephrine).

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

• Asthma medicines (theophylline).
• Muscle relaxants such as curare.
• Medicines for depression (lithium salts), may increase the risk of lithium toxicity, including the risk of harmful effects on the heart or brain.
• Patients who are being treated with diuretics may suffer from severe hypotension and deterioration of renal function, especially when an ACE inhibitor (Angiotensin-Converting Enzyme) or an angiotensin II receptor antagonist is administered for the first time or a high dose is administered for the first time.
• If medicines for treating high blood pressure, diuretics, or other medicines that can decrease blood pressure are administered together with furosemide, a more pronounced decrease in blood pressure should be anticipated.

• Nephrotoxic medicines: Concomitant administration may potentiate the harmful effect of these medicines on the kidneys.

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

Medicines such as probenecid and methotrexate or other medicines that undergo significant renal secretion 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.

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

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

Medicines 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 it would reduce the effect of furosemide.

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

• Anti-inflammatory medicines (corticosteroids).
• Carbenoxolone (medicine for the treatment of oral mucosa lesions).
• Large amounts of licorice.
• Prolonged use of laxatives for constipation.

Certain electrolyte disturbances (e.g., decreased potassium (hypokalemia) or magnesium (hypomagnesemia) levels in the blood) may increase the toxicity of certain medicines (e.g., digitalis and medicines that induce the QT interval prolongation syndrome).

Patients being treated with Furosemide Sala who receive high doses of certain cephalosporins (antibiotics) may suffer from decreased kidney function.

The concomitant administration of Furosemide Sala and cyclosporin A (a medicine used to prevent transplant rejection) is associated with an increased risk of gouty arthritis.

Those patients at high risk of nephropathy (kidney disease) due to contrast media who receive Furosemide Sala are more likely to suffer from deterioration of kidney function.

The administration of Furosemide Sala together with risperidone in elderly patients with dementia could increase mortality.

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

Pregnancy and breastfeeding

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 using this medicine.

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. If its administration is essential, your doctor may require you to interrupt breastfeeding, as Furosemide Sala passes into breast milk.

Driving and using machines:

This medicine may cause dizziness or drowsiness. This may occur more frequently at the start of treatment, when your doctor increases the dose, or if you consume alcohol. Do not drive or operate tools or machines if you feel dizzy or drowsy.

Certain side effects (e.g., an undesirable pronounced drop in blood pressure) may impair your ability to concentrate and react, and therefore constitute a risk in situations where these skills are particularly important (e.g., operating vehicles or machinery).

Furosemide Sala250 mg/25 mlsolution for infusion contains sodium: Patients on low-sodium diets should note that this medicine contains 86.3 mg (3.75 mmol) of sodium per 25 ml vial.

3. How to use Furosemide Sala

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

Furosemide Sala 250 mg/25 ml solution for infusion must not be administered as an intravenous bolus.

It should only be used by intravenous infusion.

It should only be infused using infusion pumps that control the volume or speed to avoid the risk of accidental overdose.

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

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

Your doctor or nurse should take into account that the pH value of the solution to be infused should be neutral or slightly alkaline, and therefore should not use acidic solutions, as the active ingredient could precipitate. Isotonic saline solution is the suitable diluent. It is recommended that the solution ready for administration be used as soon as possible.

Your doctor will indicate your daily dose and the duration of your treatment. Do not stop your treatment before. The dose is specific for 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 by 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, treatment will be switched to oral administration.

In infants and children and adolescents under 15 years, parenteral administration (eventually in slow infusion) is contraindicated, it will only be performed in cases where it poses a vital risk.

In these cases, the presentation of furosemide 20 mg/2 ml injectable solution can 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 the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

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

An accidental overdose could lead to a severe decrease in blood pressure (which may evolve into shock), kidney problems (acute renal failure), 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 forget to use Furosemide Sala

Do not use a double dose to make up for forgotten doses.

4. Possible Adverse Effects

Like all medicines, Furosemida Sala 250 mg/ 25 ml solution for perfusion may cause adverse effects, although not all people suffer from them.

Adverse effects have been grouped according to their frequency:

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

? electrolyte disturbances (including symptomatic ones), dehydration, and decrease in total blood volume (hypovolemia), particularly in elderly patients, elevated creatinine and triglyceride levels in the blood.

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

Common(may affect up to 1 in 10 patients)

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

? increase in urine volume.

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

? increase in blood viscosity (hemoconcentration).

Uncommon(may affect up to 1 in 100 patients)

? alteration of glucose tolerance. Latent diabetes mellitus may manifest.

? nausea.

? hearing disorders, although usually transient, especially in patients with renal insufficiency, decreased protein levels in the blood (hypoproteinemia), and/or after too rapid intravenous administration of furosemide. Deafness (sometimes irreversible).

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

? decrease in platelet levels (thrombocytopenia).

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

? allergic inflammation of blood vessels (vasculitis).

? allergic renal reaction (tubulointerstitial nephritis).

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

? subjective sensation of ringing (tinnitus).

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

? sensation of tingling in the limbs (paresthesia).

? decrease in white blood cell count (leukopenia), increase in 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), increase in liver enzymes (transaminases).

? decrease in a type of white blood cell, granulocytes (agranulocytosis), decrease in red blood cell count (aplastic or hemolytic anemia).

• severe muscle problems, such as spasms, cramps, and tetany (also called "tetanus").

Frequency Not Known(cannot be estimated from available data)

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

? alteration of blood coagulation (thrombosis).

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

? severe vesicular reactions of the skin and mucous membranes (Stevens-Johnson syndrome), severe skin disorder characterized by blistering and exfoliative lesions (toxic epidermal necrolysis), acute generalized exanthematous pustulosis (AGEP), and drug hypersensitivity syndrome with eosinophilia and systemic symptoms (DRESS), lichenoid reactions, characterized as small, itchy, reddish-purple lesions, polygonal in shape, 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 with severe hypokalemia (see section "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 occur.

As with other diuretics, after prolonged administration of this medicine, there may be an increase in sodium (hyponatremia), chloride (hypochloremic alkalosis), and consequently water elimination. There may also be an increase in potassium (hypokalemia), calcium, and magnesium loss. These alterations manifest as intense thirst, headache, confusion, muscle cramps, painful muscle contraction, especially in the limbs (tetany), muscle weakness, cardiac rhythm disturbances, 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 not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Furosemida Sala

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

Store the vials in the outer packaging.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Furosemida Sala 250 mg/ 25 ml solution for perfusion

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

Appearance of the Product and Package Contents

Furosemida Sala 250 mg/ 25 ml solution for perfusion is presented in boxes containing 4 vials of 25 ml.

EC: 50 vials.

Marketing Authorization Holder and Manufacturer:

Laboratorio Reig Jofré, S.A.

C/ Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

Date of the Last Revision of this Prospectus:October 2022

"Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/"