Furosemide Sala 250 mg/25 ml solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Furosemide Sala 250 mg/25 ml solution for infusion EFG

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

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

Contents of the leaflet

1. What Furosemide Sala is and what it is used for
2. What you need to know before using Furosemide Sala
3. How to use Furosemide Sala
4. Possible side effects
5. How to store Furosemide Sala
6. Contents of the pack and other information

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

Furosemide Sala 250 mg/25 ml solution for infusion is a diuretic belonging to the sulfonamide group. It works by increasing urine elimination (diuretic effect) and reducing blood pressure (antihypertensive effect).

Always under a doctor's prescription, this medicine is indicated exclusively for the treatment of patients with:

• Renal filtration problems (through the kidneys).
• Acute renal failure, in order to maintain fluid elimination and to facilitate parenteral nutrition, as long as some filtration capacity remains.
• Chronic renal failure in the pre-dialysis stage, with fluid retention and hypertension.
• End-stage renal failure, for maintenance of residual renal functional capacity.
• Nephrotic syndrome in patients in whom an oral dose of furosemide of 120 mg per day is insufficient; treatment of the underlying disease takes priority.

2. What you need to know before using Furosemida Sala

Read carefully the instructions provided in section 3, “How to use Furosemida Sala”

Do not use Furosemida 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).
• If you have a reduced total blood volume (hypovolemia) or are dehydrated.
• If you have severe kidney problems accompanied by a marked decrease in urine output (renal failure with anuria) that does not respond to this medicine.
• If you have severely low levels of potassium in your blood (severe hypokalaemia). (See section 4, “Possible side effects”).
• If you have severe deficiency of sodium salts in your blood (severe hyponatraemia).
• 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, breastfeeding and fertility”.

Furosemida 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 volume or rate to avoid the risk of accidental overdose.

Warnings and precautions

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

Take special care with this medicine:

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

During your treatment with Furosemida Sala, periodic monitoring of blood levels of sodium, potassium, and creatinine will generally be required, especially if you experience severe fluid loss due to vomiting, diarrhea, or excessive sweating (dehydration or hypovolemia), as your doctor may need to discontinue treatment.

Elderly patients with dementia who are taking risperidone should exercise special caution when using risperidone and furosemide concomitantly. Risperidone is a medication used to treat certain mental disorders, such as dementia (a disease characterized by several symptoms: memory loss, difficulty speaking, difficulty thinking).

Use in athletes

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

Use of Furosemide Sala with other medicines:

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The effect of treatment may be affected when Furosemide Sala is used at the same time as other medicines. The intravenous administration of furosemide is not recommended within 24 hours after administration of chloral hydrate, as this may lead to flushing, sweating, restlessness, nausea, hypertension, and tachycardia.

Some substances may have increased toxicity in the ear and kidneys when administered together with this medicine. Therefore, if they are administered concomitantly, it must be under strict medical supervision.

These substances include:

• Aminoglycoside antibiotics (medicines for infections) such as gentamicin, kanamycin, and tobramycin.
• Medicines for cancer (cisplatin).

Concomitant use of Furosemide Sala with other medicines may weaken the effect of those medicines:

• Medicines used for diabetes (antidiabetics).
• Medicines used to raise blood pressure (sympathomimetics with hypertensive effect), for example, epinephrine and norepinephrine.

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

• Medicines for asthma (theophylline).

• Curare-type muscle relaxants.

• Medicines for depression (lithium salts), which may increase the risk of lithium toxicity, including the risk of harmful effects on the heart or brain.

  • Patients receiving diuretics may experience severe hypotension and worsening of renal function, especially when an ACE (Angiotensin-Converting Enzyme) inhibitor or an angiotensin II receptor antagonist is initiated or when a high dose is first administered.
  • If medicines for high blood pressure, diuretics, or other medicines that may lower blood pressure are administered together with furosemide, a more pronounced decrease in blood pressure should be anticipated.

• Nephrotoxic medicines: Concomitant administration may enhance the harmful effects of these medicines on the kidneys.

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

Medicines such as probenecid and methotrexate, or other medicines that undergo significant renal secretion, may reduce the effect of Furosemide Sala. When used at high doses, they may increase serum levels and raise the risk of adverse effects due to furosemide or concomitant administration.

Medicines to lower 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, may lead to increased blood sugar levels.

Medicines such as theophylline (for asthma) may enhance the effect of furosemide. Aminoglutethimide (used to inhibit corticosteroid production, 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 take furosemide within two hours before taking sucralfate, as the effect of furosemide may be reduced.

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

• Medicines for inflammation (corticosteroids).
• Carbenoxolone (a medicine used to treat oral mucosal lesions).
• Large amounts of licorice.
• Prolonged use of laxatives for constipation.

Some electrolyte imbalances (for example, decreased blood levels of potassium (hypokalemia) or magnesium (hypomagnesemia)) could increase the toxicity of certain medicines (e.g., digitalis and medicines that induce QT interval prolongation syndrome).

Patients receiving Furosemide Sala and high doses of certain cephalosporins (antibiotics) may experience reduced kidney function.

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

Patients at high risk of contrast-induced nephropathy (kidney disease) who receive Furosemide Sala are more likely to experience worsening of kidney function.

Administration of Furosemide Sala together with risperidone in elderly patients with dementia may increase mortality.

High doses of furosemide administered with levothyroxine may lead to 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, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

During breastfeeding, Furosemide Sala must not be administered. If its administration is considered essential, your doctor may instruct you to discontinue breastfeeding, as Furosemide Sala passes into breast milk.

Driving and use of machines:

This medicinal product may cause dizziness or somnolence. This is more likely to occur at the beginning of treatment, when your doctor increases your dose, or if you consume alcohol. Do not drive or operate tools or machinery if you feel dizzy or drowsy.

Some adverse effects (e.g. a marked, undesirable drop in blood pressure) may impair concentration and reaction ability, and therefore constitute a risk in situations where these skills are of particular importance (e.g. operating vehicles or machinery).

Furosemide Sala 250 mg/25 ml solution for infusion contains sodium: Patients on sodium-restricted diets should be aware that this medicinal product contains 86.3 mg (3.75 mmol) of sodium per 25 ml vial.

3. How to use Furosemide Sala

Follow exactly the instructions for administration of this medicine given by your doctor, pharmacist, or nurse. If in 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 injection.

It must be administered intravenously exclusively by infusion.

Infusion must only be performed using infusion pumps that control volume or rate to avoid the potential risk of accidental overdose.

The active substance furosemide administered intravenously must be infused slowly, at a rate not exceeding 4 mg per minute. In patients with severe kidney problems (serum creatinine ≥5 mg/dl), the infusion rate should not exceed 2.5 mg per minute.

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

Your doctor or nurse must be aware that the pH value of the solution to be infused should be neutral or slightly alkaline; therefore, acidic solutions must not be used, as the active ingredient may precipitate. Isotonic saline solution is the appropriate diluent. It is recommended that the ready-to-administer solution be used as soon as possible.

Your doctor will determine your daily dose and the duration of your treatment. Do not stop your treatment prematurely. The dose is specific to you and may be adjusted by your doctor depending on your response to treatment.

In adults, the recommended maximum daily dose of furosemide is 1500 mg, although in exceptional cases it may be increased up to 2000 mg.

Use in children and adolescents

In children, the recommended maximum daily dose for 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. Oral treatment should be initiated as soon as possible.

In infants and children and adolescents under 15 years of age, parenteral administration (possibly by slow infusion) is contraindicated, except in cases where there is a life-threatening risk.

In such cases, the furosemide 20 mg/2 ml injectable solution formulation may be used.

If you use more Furosemide Sala than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

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

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

There is no known specific antidote.

In case of overdose, treatment will be based on the 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 infusion may cause adverse effects, although not all people will experience 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 decreased total blood volume (hypovolemia), particularly in elderly patients, elevated creatinine and triglyceride levels in blood.

? With intravenous infusion: decrease in blood pressure (hypotension, including orthostatic hypotension (problems maintaining upright posture)).

Common (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 blood; and gout attacks.

? Increased urine volume.

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

? Increased blood viscosity (hemoconcentration).

Uncommon (may affect up to 1 in 100 patients)

? Impaired glucose tolerance. Latent diabetes mellitus may become apparent.

? Nausea.

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

? Itching, rash, eruptions, blisters, and other more serious reactions such as erythema multiforme, pemphigoid, exfoliative dermatitis, purpura, and photosensitivity reactions.

? Decreased platelet levels (thrombocytopenia).

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

? Allergic inflammation of blood vessels (vasculitis).

? Allergic-type renal reaction (tubulointerstitial nephritis).

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

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

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

? Tingling sensation in the extremities (paresthesias).

? Decreased levels of white blood cells (leukopenia), increased levels of a type of white blood cells, 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 disorder (cholestasis), increased liver enzymes (transaminases).

? Decrease in a type of white blood cells, granulocytes (agranulocytosis), decreased number of red blood cells (aplastic anemia or hemolytic anemia).

• Severe muscle problems such as jerks, spasms, and cramps (also known as "tetany").

Frequency not known (cannot be estimated from available data)

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

? Blood coagulation disorders (thrombosis).

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

? Severe blistering skin and mucous membrane reactions (Stevens-Johnson syndrome), severe skin disorder characterized by blister formation and exfoliative lesions (toxic epidermal necrolysis), acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), lichenoid reactions characterized by small, itchy, red-purple, polygonal lesions 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, frequently in cases associated with severe hypokalemia (low blood potassium levels) (see section “Do not use Furosemida Sala”).

? Increased risk of persistence of the ductus arteriosus (patent ductus arteriosus) 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, prolonged administration of this medicine may increase the excretion of sodium (hyponatremia), chloride (hypochloremic alkalosis), and consequently water. Loss of potassium (hypokalemia), calcium, and magnesium may also be increased. These disturbances manifest as intense thirst, headache, confusion, muscle cramps, painful muscle contractions 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 leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Furosemide 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

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

• The active substance 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 medicinal product and contents of the pack

Furosemida Sala 250 mg/25 ml solution for infusion 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 most recent review of this leaflet: October 2022

“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”