FUROSEMIDE PHYSAN 20mg/2ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the Patient

Furosemide Physan 20 mg/2 ml Solution for Injection EFG

Furosemide

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

Furosemide is a diuretic (an agent that increases urine production and reduces blood pressure) belonging to the group of sulfonamides.

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, liver cirrhosis (ascites), and kidney disease, including nephrotic syndrome (priority is given to the treatment of the underlying disease).
• Pulmonary edema (its administration is performed together with other therapeutic measures).
• Oliguria (decreased urine production) derived from pregnancy complications (gestosis) after compensation of volemia (total blood volume in a person).
• As an adjuvant measure in cerebral edema.
• Edema following burns.
• Hypertensive crises, together with other hypotensive measures.
• Maintenance of forced diuresis in intoxications.

2. What you need to know before you use Furosemide Physan

Do not use Furosemide Physan:

• if you are allergic to furosemide, to furosemide-like medications (sulfonamides) or to any of the other components of this medicine (included in section 6).
• In case of decreased total blood volume (hypovolemia) or dehydration.
• if you have severe kidney problems, accompanied by a decrease in urine production (renal insufficiency with anuria), that do 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 of pre-comatose and comatose hepatic state (associated with hepatic encephalopathy).
• if you are breastfeeding a baby
• if you are pregnant, see section 2 "Pregnancy, breastfeeding and fertility".

Warnings and precautions

Consult your doctor or pharmacist before starting to take Furosemide Physan:

Be especially careful with this medicine:

• If you have urine production problems, especially at the start of treatment.
• If your blood pressure is low (hypotension).
• If you are at special 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 suffer from 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 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 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 have associated risk of decreased blood pressure.

During your treatment with furosemide, periodic monitoring of your blood levels of sodium, potassium, and creatinine will generally be required, especially if you suffer from severe fluid loss due to vomiting, diarrhea, or intense sweating. Dehydration or hypovolemia, as well as any significant electrolyte and acid-base imbalance, should be corrected, as this may require interruption of treatment.

Elderly patients with 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, speech problems, thinking problems).

Other medicines and Furosemide Physan

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

It is not recommended to administer furosemide intravenously during the 24 hours after chloral hydrate has been administered, as it could lead to flushing, sweating, restlessness, nausea, hypertension, and tachycardia.

Certain substances may increase their toxicity 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 medications) such as gentamicin, kanamycin, and tobramycin.
• Cancer medications (cisplatin).

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

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

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

• Asthma medications (theophylline).
• Muscle relaxants such as curare.
• Medications for depression (lithium), which may increase the risk of lithium toxicity, including the risk of harmful effects on the heart or brain.
• Patients being treated with diuretics may suffer from severe hypotension and deterioration of kidney 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 medications for high blood pressure, diuretics, or other medications that can decrease blood pressure are administered concomitantly with furosemide, a more pronounced decrease in blood pressure should be expected.
• Nephrotoxic medications: concomitant administration may potentiate the harmful effect of these medications on the kidneys.

Certain anti-inflammatory and pain medications (non-steroidal anti-inflammatory drugs, including acetylsalicylic acid) may reduce the effect of furosemide.

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

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

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

Certain electrolyte disturbances (for example, decreased potassium or magnesium levels in the blood) may increase the toxicity of certain medications (for example, digitalis medications and medications that induce QT interval prolongation syndrome).

Patients being treated with furosemide and receiving high doses of certain cephalosporins (antibiotics) may suffer from decreased kidney function.

Concomitant administration of furosemide and cyclosporin A (a medication used to prevent transplant rejection) is associated with an increased risk of gouty arthritis (joint inflammation) secondary to increased blood urea levels and kidney problems.

Patients at high risk of suffering from nephropathy (kidney disease) due to contrast media who receive furosemide are more likely to suffer from kidney function deterioration.

Administration of furosemide together with risperidone in elderly patients with dementia could 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 are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

In case of pregnancy, furosemide will only be administered under strict medical indication.

During breastfeeding, furosemide should not be administered. If its administration is essential, your doctor may require you to interrupt breastfeeding, as furosemide 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., a pronounced undesirable drop in blood pressure) may impair your ability to concentrate and react, and therefore constitute a risk in situations where these skills are especially 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., it is essentially "sodium-free".

3. How to use Furosemide Physan 20 mg/2 ml Solution for Injection

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

Furosemide can be administered intravenously or intramuscularly. These routes are indicated when intestinal absorption is altered or rapid fluid elimination is necessary.

Intramuscular administration will be used when oral or intravenous administration is not possible. This route is not recommended in severe situations such as pulmonary edema.

The active substance furosemide should be injected or infused slowly intravenously 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 does not exceed 2.5 mg per minute.

Furosemide in the form of solution for injection should not be mixed in the same syringe or infused together with other medications.

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 1,500 mg per day, although in exceptional cases it may reach 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 will be switched to oral administration.

In infants and children under 15 years: parenteral administration of furosemide is contraindicated, it will only be performed in cases where it poses a vital risk.

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

In case of overdose or accidental ingestion, consult your doctor or go to the emergency department of the nearest hospital, accompanied by this leaflet, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested or administered.

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 Physan 20 mg/2 ml Solution for Injection

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

If you have any other 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 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), dehydration, and decrease in total blood volume (hypovolemia), particularly in elderly patients, elevated creatinine, and triglyceride levels in blood.
• with intravenous perfusion: decrease in blood pressure (hypotension, including orthostatic hypotension, problems maintaining an upright position).

Common(may affect up to 1 in 10 patients)

• decrease in sodium (hyponatremia), chloride (hypochloremia), potassium (hypokalemia) levels, increase in cholesterol and uric acid levels in blood, and gout attacks.
• increase in urine volume.
• mental alterations (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 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 1000 patients)

• allergic inflammation of blood vessels (vasculitis).
• allergic renal reaction (tubulointerstitial nephritis).
• vomiting, diarrhea.
• 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 levels (leukopenia), increase in a type of white blood cell, eosinophils (eosinophilia).
• fever.

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).

Frequency Not Known(cannot be estimated from available data)

• decrease in calcium (hypocalcemia), magnesium (hypomagnesemia) levels, increase in urea level in blood, 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), 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 blister formation 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, red-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 Physan").
• 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, chloride, water, potassium, calcium, and magnesium may increase. These alterations manifest with intense thirst, headache, confusion, muscle cramps, painful muscle contraction, especially in the limbs (tetany), 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 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 medication.

5. Conservation of Furosemida Physan 20mg/2ml Injectable Solution

Keep this medication out of sight and reach of children.

Store in the original packaging to protect it from light.

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

The unused solution must be eliminated according to local regulations.

Medicines should not be thrown down the drain or into the trash. In case of doubt, ask your pharmacist how to dispose of packaging and medications that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofFurosemida Physan20 mg/2 ml Injectable Solution

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

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

Appearance of the Product and Package Contents

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

This medication is presented in boxes containing 5 ampoules, 50 ampoules (clinical packaging), or 100 ampoules (clinical packaging) of 2 ml glass.

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 Last Revision of thisProspectus:February 2023

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

This information is intended only for doctors or healthcare professionals

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

Furosemide is soluble in alkaline medium in the form of antranilate. The solution for parenteral administration contains the sodium salt of the carboxylic acid without any solubilizer; it has a pH of 9 and does not have a buffering action, so a pH value below 7 can precipitate the active ingredient. Mixtures can be stored for up to 24 hours if the pH of the final solution is neutral or slightly alkaline.

In cases of poisoning by acidic or basic substances, the elimination rate may increase as a result of acidification or alkalization of the urine.