Furosemide Physan 20 mg/2 ml solution for injection EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Furosemide Physan 20 mg/2 ml Injection Solution EFG

Furosemide

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents:

1. What Furosemide Physan 20 mg/2 ml injection solution is and what it is used for
2. What you need to know before using Furosemide Physan 20 mg/2 ml injection solution
3. How to use Furosemide Physan 20 mg/2 ml injection solution
4. Possible side effects
5. How to store Furosemide Physan 20 mg/2 ml injection solution
6. Contents of the pack and other information

1. What is Furosemide Physan 20 mg/2 ml injectable solution and what is it used for

Furosemide is a diuretic (a substance that increases urine excretion and reduces blood pressure) belonging to the sulfonamide group.

Always under the prescription of your doctor, this medicine is indicated for the treatment of:

• Edema (swelling due to fluid accumulation) associated with congestive heart failure, hepatic cirrhosis (ascites), and renal disease, including nephrotic syndrome (treatment of the underlying disease takes priority).
• Pulmonary edema (administration is carried out in conjunction with other therapeutic measures).
• Oliguria (reduced urine production) resulting from pregnancy complications (gestosis), after compensation of blood volume (total blood volume in a person).
• As an adjunctive measure in cerebral edema.
• Edemas following burns.
• Hypertensive crises, along with other antihypertensive measures.
• Maintenance of forced diuresis in intoxications.

2. What you need to know before using Furosemide Physan

Do not use Furosemide Physan:

• if you are allergic to furosemide, to drugs of the furosemide type (sulfonamides), or to any of the other ingredients of this medicine (listed in section 6).
• if your total blood volume is reduced (hypovolemia) or if you are dehydrated.
• if you have severe kidney problems associated with reduced urine output (renal failure with anuria) that does not respond to this medicine.
• if you have severely low potassium levels in the blood (severe hypokalemia), see section 4 “Possible side effects”.
• if you have a severe deficiency of sodium salts in the blood (severe hyponatremia).
• if you are in a pre-comatose or comatose state due to liver disease (hepatic encephalopathy).
• if you are breastfeeding.
• if you are pregnant, see section 2 “Pregnancy, breastfeeding and fertility”.

Warnings and precautions

Talk to your doctor or pharmacist before taking Furosemide Physan:

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 special risk of experiencing a pronounced drop in blood pressure (e.g., 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 section 4 “Possible side effects”).
• in premature infants (see section 4 “Possible side 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 low blood pressure, or if you have other medical conditions associated with a risk of low blood pressure.

During treatment with furosemide, periodic monitoring of blood levels of sodium, potassium, and creatinine is generally required, especially if you experience significant fluid loss due to vomiting, diarrhea, or excessive sweating. Dehydration or hypovolemia, as well as significant electrolyte and acid-base imbalances, should be corrected, as this may require interruption of treatment.

Elderly patients with dementia who are taking risperidone should be especially cautious about the concomitant use of risperidone and furosemide. Risperidone is a medicine used to treat certain mental illnesses, such as dementia (a disease characterized by several symptoms: memory loss, difficulty speaking, difficulty thinking).

Other medicines and Furosemide Physan

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

Intravenous furosemide is not recommended within 24 hours after administration of chloral hydrate, as it may cause flushing, sweating, restlessness, nausea, hypertension, and tachycardia.

Some substances may have increased toxicity to the ear and kidneys when administered together with this medicine. Therefore, if used concomitantly, they must be under strict medical supervision. These substances include:

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

This medicine may weaken the effect of other medicines such as:

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

It may also increase the action of other medicines such as:

• Medicines for asthma (theophylline).
• Curare-type muscle relaxants.
• Medicines for depression (lithium), potentially increasing the risk of lithium toxicity, including the risk of harmful effects on the heart or brain.
• Patients receiving diuretic treatment may experience severe hypotension and worsening of kidney function, especially when initiating treatment or increasing the dose of an ACE inhibitor (Angiotensin-Converting Enzyme inhibitor) or an angiotensin II receptor antagonist.
• If medicines used to treat high blood pressure, diuretics, or other medicines that may lower blood pressure are used together with furosemide, a more pronounced drop in blood pressure should be expected.
• Nephrotoxic medicines: concomitant administration may enhance the harmful effects of these medicines on the kidneys.

Some medicines for inflammation and pain (non-steroidal anti-inflammatory drugs, including acetylsalicylic acid) may reduce the effect of furosemide.

Medicines such as probenecid and methotrexate, or other medicines significantly eliminated by the kidneys, may reduce the effect of furosemide. When used at high doses, they may increase serum levels and the risk of adverse effects due to furosemide or concomitant administration.

The following substances may increase the risk of low potassium levels in blood (hypokalemia) when administered with furosemide:

• 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 (e.g., low blood potassium levels (hypokalemia) or low magnesium levels (hypomagnesemia)) may increase the toxicity of certain medicines (e.g., digitalis medicines and medicines inducing QT interval prolongation syndrome).

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

Concomitant administration of furosemide and cyclosporine A (a medicine used to prevent transplant rejection) is associated with an increased risk of gouty arthritis (joint inflammation) secondary to elevated blood urea levels (hyperuricemia) and impaired urea excretion by the kidneys.

Patients at high risk of radiocontrast-induced nephropathy (kidney disease) who receive furosemide are more likely to experience deterioration in kidney function.

The administration of furosemide 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 breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

If you are pregnant, furosemide should only be administered under strict medical indication.

Furosemide must not be used during breastfeeding. If its administration is essential, your doctor may require you to discontinue breastfeeding, as furosemide passes into breast milk.

Driving and using machines

This medicine may cause dizziness or drowsiness. This is more likely 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 pronounced, undesirable drop in blood pressure) may impair your ability to concentrate and react, and therefore pose a risk in situations where these skills are particularly important (e.g., operating vehicles or machinery).

Furosemide Physan contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per ampoule, i.e., essentially “sodium-free”.

3. How to use Furosemide Physan 20 mg/2 ml injection solution

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Furosemide can be administered by intravenous or intramuscular route. These routes are indicated when intestinal absorption is impaired or when rapid fluid elimination is required.

Intramuscular administration should be used only when oral or intravenous administration is not possible. This route is not recommended in serious conditions such as pulmonary edema.

The active substance furosemide should be administered intravenously by slow injection or infusion 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 the form of injection solution must not be mixed in the same syringe or co-administered by infusion with other medicines.

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

Your doctor will determine your daily dose and the duration of your treatment. Do not discontinue 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 maximum recommended daily dose of furosemide is 1,500 mg, although in exceptional cases it may reach up to 2,000 mg.

Use in children and adolescents

The maximum recommended daily dose of furosemide in children for parenteral administration 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 should be switched to oral administration.

In infants and children under 15 years of age: parenteral administration of furosemide (even by slow infusion) is contraindicated, and should only be performed when there is a life-threatening risk.

If you use more Furosemide Physan 20 mg/2 ml Injection Solution than you should

In case of overdose or accidental ingestion, contact your doctor immediately or go to the nearest hospital emergency department, bringing this leaflet with you, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested or administered.

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

There is no known specific antidote.

In case of overdose, treatment will depend on the symptoms presented.

If you forget to use Furosemide Physan 20 mg/2 ml injection solution

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

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Furosemida Physan can cause adverse effects, although not everyone experiences 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), and 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 temporary, 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 severe 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 kidney reaction (tubulointerstitial nephritis).
• vomiting, diarrhea.
• subjective sensation of ringing in the ears (tinnitus).
• severe allergic reactions (anaphylactic or anaphylactoid reactions) (e.g., with shock).
• tingling sensation in the limbs (paresthesia).
• decreased levels of white blood cells (leukopenia), increase in a type of white blood cells, eosinophils (eosinophilia).
• fever.

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

• inflammation of the pancreas (acute pancreatitis).
• liver disorder (cholestasis), increase in liver enzymes (transaminases).
• decrease in a type of white blood cells, granulocytes (agranulocytosis), decrease in red blood cell count (aplastic anemia or hemolytic anemia).

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.
• disturbance of blood coagulation (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 mucosal reactions (Stevens-Johnson syndrome), severe skin disorder characterized by blistering 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, purple-red, 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 potassium levels in blood) (see section “Do not use Furosemida Physan”).
• increased risk of persistence of the "patent ductus arteriosus" when furosemide is administered to premature infants during the first weeks of life.
• following 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, chloride, water, potassium, calcium, and magnesium. 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Furosemide Physan 20 mg/2 ml Injection Solution

Keep this medicine out of sight and reach of children.

Store in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the ampoule and outer packaging, after EXP. The expiry date refers to the last day of the month indicated.

Unused solution must be disposed of according to local regulations.

Medicines should not be disposed of via wastewater drains or household waste. If you are unsure how to dispose of unused medicines or their packaging, consult your pharmacist. This helps protect the environment.

6. Contents of the pack and other information

Composition of Furosemida Physan 20 mg/2 ml Injectable solution

The active substance is furosemide. Each 2 ml ampoule contains 20 mg of furosemide, equivalent to 10 mg of furosemide per ml of injectable solution.

The other components are: sodium chloride, sodium hydroxide, and water for injections.

Appearance of the medicinal product and contents of the pack

Furosemida Physan 20 mg/2 ml Injectable solution is packaged in glass ampoules.

This medicine is available in cardboard packs containing 5 ampoules, 50 ampoules (hospital pack), or 100 ampoules (hospital pack) of 2 ml glass ampoules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laphysan S.A.U.

Anabel Segura, 11 Edificio A, Planta 4, Puerta D

28108 Alcobendas (Madrid)

Spain

Manufacturer

Laboratorios Inibsa, S.A. Ctra. Sabadell a Granollers, km 14,5

08185 Lliçà de Vall – Barcelona

Spain

Or

Laboratorios Basi-Industria farmacéutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, nº 8, 15 y 16.

3450-232 Mortágua - Portugal

Date of the most recent revision of this package leaflet: February 2023

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

This information is intended for healthcare professionals only

Furosemide must not be mixed in the same syringe with any other medication.

Furosemide is soluble in alkaline medium as an anthranilate. The parenteral administration solution contains the sodium salt of the carboxylic acid without any solubilizing agent; it has a pH of 9 and possesses no buffering capacity, so a pH value below 7 may precipitate the active substance. Mixtures may be stored for up to a maximum of 24 hours if the final solution pH is neutral or weakly alkaline.

In poisonings caused by acidic or basic substances, the elimination rate may be increased as a result of urine acidification or alkalinization.