Package Insert: Information for the Patient

FurosemideSala 20 mg/2 ml Injectable Solution EFG

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert.

1. What isFurosemide Salaand how is it used

2. What you need to know before starting to useFurosemide Sala

3. How to useFurosemide Sala

4. Possible adverse effects

5. Storage ofFurosemide Sala

6. Contents of the package and additional information

Furosemida Sala20 mg/2 mlinjectable solution is a diuretic belonging to the sulfonamide group. It acts by increasing the elimination of urine (diuretic) and reducing blood pressure (anti-hypertensive).

This medication is always prescribed by your doctor and is indicated for the treatment of:

• Swelling due to fluid retention (edema) associated with heart difficulties in pumping blood to the rest of the body (congestive heart failure), liver cirrhosis, ascites (fluid accumulation in the abdomen), and kidney disease, including nephrotic syndrome (priority should be given to the treatment of the underlying disease).

-Pulmonary edema (fluid accumulation in the lungs). Its administration is carried out in conjunction with other therapeutic measures.

-Oliguria (reduced urine production) due to complications of pregnancy (gestosis) after compensation of the total blood volume (volemia).

-Supportive measure in cerebral edema.

-Edemas following burns.

-Hypertensive crises, in conjunction with other hypotensive measures.

-Forced diuresis in cases of poisoning.

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

Do not use Furosemide Tablets:

• If you are allergic to furosemide, to other 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 or comatose state (associated with hepatic encephalopathy).
• If you are breastfeeding a baby.
• If you are pregnant, see section “Pregnancy, lactation, and fertility”).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Furosemide Tablets:

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, 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), and you also have, 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 can cause a decrease in blood pressure, or if you have other medical conditions that are associated with a risk of decreased blood pressure.
• If you are dehydrated (you have lost a large amount of body fluids because you have had intense diarrhea or vomiting); 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 that binds to oxygen in red blood cells, and urine becomes purple).

- Your skin has a high sensitivity to sunlight (photosensitivity).

During your treatment with Furosemide Tablets, you will generally require regular monitoring of your blood levels, of sodium, potassium, and creatinine, and especially if you experience a significant loss of fluids, through vomiting, diarrhea, or intense sweating. You should correct dehydration or hypovolemia, as well as any significant electrolyte or acid-base balance alterations, as your doctor may require the interruption of treatment.

Patients with advanced age and dementia who are taking risperidone should be especially careful when using risperidone and furosemide concomitantly. 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.

Other medications and Furosemide Tablets

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 you use Furosemide Tablets at the same time as other medications.

It is not recommended to administer furosemide intravenously 24 hours after administering chloral hydrate, as this could lead to 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 they are administered concomitantly, it should be under strict medical control.

These substances include:

- Aminoglycoside antibiotics (infection medications) such as gentamicin, kanamycin, and tobramycin

- Cancer medications (cisplatin)

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

- Medications used to treat diabetes (antidiabetic medications)

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

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

- Asthma medications (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 renal function deterioration, especially when administered for the first time or when 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. Concomitant administration may potentiate the harmful effect of these medications on the kidneys.

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

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

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 reduce blood potassium levels (hypokalemia) if administered with Furosemide Tablets:

- Medications for inflammation (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, digitals and medications that induce the QT interval prolongation syndrome).

Patients being treated with Furosemide Tablets and receiving high doses of some cephalosporins (antibiotics) may experience renal function deterioration.

The concomitant administration of Furosemide Tablets and cyclosporine A (medication used to prevent transplant rejection) is associated with an increased risk of gouty arthritis (inflammation of the joints) secondary to increased blood urea levels (hyperuricemia) and renal elimination problems.

Patients with a high risk of radiocontrast-induced nephropathy who receive Furosemide Tablets have a higher risk of renal function deterioration.

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

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

Pregnancy, lactation, and fertility

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 Tablets if there are medical reasons that require it.

During breastfeeding, Furosemide Tablets should not be administered, as they pass into breast milk. Your doctor may require you to stop breastfeeding if necessary.

Driving and operating machinery:

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 side effects (for example, an 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 Tablets contain sodium.

This medication contains less than 23 mg (1 mmol) of sodium per ampoule, so it is considered essentially “sodium-free”.

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

Furosemide Sala can be administered intravenously or intramuscularly. These routes are indicated when intestinal absorption is altered or rapid liquid elimination is necessary. Intramuscular administration will be used when oral or intravenous administration is not possible. This route is not recommended in severe cases such as pulmonary edema.

Intravenous furosemide should be injected or 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 Sala 20 mg injectable solution 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 solution to be infused 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 stop your treatment prematurely. The dose is specific to you and may be modified by your doctor based on your response to treatment.

The maximum recommended daily dose of furosemide in adults is 1500 mg, 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 under 15 years old, parenteral administration (eventually in slow infusion) is contraindicated, only in cases where it would pose a vital risk.

If you estimate that the action of Furosemide Sala is too strong or too weak, inform your doctor or pharmacist.

If you use more Furosemide Sala than you should:

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

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.

Treatment will be based on symptoms in case of overdose.

If you forgot to use Furosemide Sala

If you think you have forgotten an injection, consult your doctor or nurse. Do not use a double dose to compensate for the missed doses.

Like all medicines, Furosemida Sala 20 mg/2 ml injectable solution may cause side effects, although not everyone will experience them.

Side effects have been grouped by their frequency:

Very common(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 (including orthostatic hypotension (problems maintaining an upright position)).

Common(may affect up to 1 in 10 patients)

?decreased levels of sodium (hyponatremia), chloride (hypochloremia), and 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).

Uncommon(may affect up to 1 in 100 patients)

?alteration of glucose tolerance. 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. Deafness (occasionally irreversible).

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

?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 (leucopenia), 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, including spasms, cramps, and tetanus (also known as "tetanus").

Frequency not known(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 in color, with a polygonal 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 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 (hypochloremic alkalosis), 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 (tetany), muscle weakness, alterations in heart rhythm, and gastrointestinal symptoms.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side 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 ampoules 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. Dispose of the packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Furosemida Sala 20 mg/2 mlinjectable solution

• The active ingredient is furosemida. Each vial contains 20 mg of furosemida.
• The other components (excipients) are: sodium chloride, sodium hydroxide, and injection water.

Appearance of the product and contents of the packaging

Furosemida Sala 20 mg injectable solution, is presented in boxes containing 5 vials of 2 ml.

EC: 100 vials

Holder of the marketing authorization and Responsible for the manufacture:

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

“The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”