Leaflet: information for the patient

Furosemida Physan 20 mg/2 ml injectable solution EFG

Furosemide

Read this leaflet carefully before starting to use this medicine, as it contains important information for you.

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

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

2. What you need to know before using Furosemida Physan 20 mg/2 ml injectable solution

3. How to use Furosemida Physan 20 mg/2 ml injectable solution

4. Possible side effects

5. Storage of Furosemida Physan 20 mg/2 ml injectable solution

6. Contents of the pack and additional information

Furosemidais a diuretic (agent that increases urine elimination and decreases blood pressure) that belongs to the sulfonamides group.

Under the prescription of your doctor, this medication 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 treatment of the underlying disease).
• - Pulmonary edema (its administration is performed jointly with other therapeutic measures).
• - Oliguria (decreased urine production) resulting from complications of pregnancy (gestosis) after compensating for the total blood volume.
• - As an auxiliary measure in cerebral edema.
• - Edemas subsequent to burns.
• - Hypertensive crises, along with other hypotensive measures.
• - Maintenance of forced diuresis in intoxications.

No use Furosemida Physan:

• If you are allergic to furosemide, to 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 are dehydrated.
• If you have severe kidney problems, accompanied by a decrease in urine elimination (renal insufficiency with anuria), that do not respond to this medication.
• If you have a severe decrease in your blood potassium level (severe hypokalemia), see section 4 "Possible adverse effects".
• If you have a severe deficiency of sodium salts in the blood (severe hyponatremia).
• If you are in a pre-comatose and comatose hepatic state (associated with hepatic encephalopathy).
• If you are breastfeeding a baby.
• If you are pregnant, see section 2 "Pregnancy, lactation, and fertility".

Warnings and precautions

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

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 special risk of experiencing 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 a severe liver disease (hepatorenal syndrome).
• If your blood protein levels are low (hypoproteinemia), in addition to having, for example, a nephrotic syndrome (see section 4 "Possible adverse effects").
• In premature children (see section 4 "Possible adverse effects").
• There is a possibility of exacerbating or activating systemic lupus erythematosus.
• If you are an elderly person, if you are being treated with medications that may cause a decrease in blood pressure, or if you have other medical conditions associated with the risk of decreased blood pressure.

During treatment with furosemide, regular monitoring of your blood levels of sodium, potassium, and creatinine is usually required, and especially if you experience a severe loss of fluids, by vomiting, diarrhea, or intense sweating. Correct dehydration or hypovolemia, as well as any significant electrolyte and acid-base balance alterations, as this may require discontinuation of treatment.

Older patients with dementia taking risperidone should be especially careful 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, problems speaking, thinking problems).

Other medications and Furosemida Physan

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

It is not recommended to administer furosemide intravenously during the 24 hours after being administered chloral hydrate, as it may cause flushing, sweating, restlessness, nausea, hypertension, and tachycardia.

Some substances may increase their toxicity in the ear and kidneys when administered with this medication. Therefore, if administered together, it should be under strict medical control. These substances include:

• Aminoglycoside antibiotics (infection medications) such as gentamicin, kanamicin, and tobramicin.
• Cancer medications (cisplatino).

This medication may weaken the effect of other medications such as:

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

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

• Asthma medications (theophylline).
• Muscle relaxants such as curare.
• Depression medications (lithium), 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 angiotensin-converting enzyme inhibitor or an angiotensin II receptor antagonist.
• When administering medications to treat high blood pressure, diuretics, or other medications that may lower blood pressure, concomitantly with furosemide, a more pronounced drop in blood pressure should be anticipated.
• Toxic medications for the kidneys: the concomitant administration may potentiate the harmful effect of these medications on the kidneys.

Some 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. In high-dose treatment, they may increase serum levels and increase the risk of adverse effects due to furosemide or concomitant administration.

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

- Anti-inflammatory medications (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, digitalis medications and medications that induce the QT interval prolongation syndrome).

Patients being treated with furosemide and receiving high doses of some cephalosporins (antibiotics) may experience a decrease in renal function.

The concomitant administration of furosemide and cyclosporine A (medication used to prevent transplant rejection) is associated with a high risk of secondary gouty arthritis (inflammation of the joints) due to an increase in blood urea levels (hyperuricemia) and problems with urea elimination by the kidneys.

Patients with a high risk of developing nephropathy (kidney disease) due to radiocontrast agents who receive furosemide have a higher risk of renal function deterioration.

The concomitant administration of furosemide 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 and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

During pregnancy, furosemide should only be administered under strict medical indication.

During lactation, furosemide should not be administered. If its administration is necessary, your doctor may require you to stop breastfeeding, as furosemide passes into breast milk.

Driving and operating machines

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 adverse effects (for example, a pronounced and undesirable drop in blood pressure) may impair the 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).

Furosemida Physan contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per ampoule, which is essentially "sodium-free".

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

Furosemidecan be administered via intravenous or intramuscular routes. 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.

The active substance furosemide via intravenous route 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 in injectable solution form 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.

In adults: the maximum recommended dose of furosemide is 1,500 mg per day, although in exceptional cases it can 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, switch to oral treatment.

In infants and children under 15 years: parenteral administration of furosemide (eventually in slow infusion) is contraindicated, only in cases where it would pose a vital risk.

If you use moreFurosemida Physan20 mg/2 ml Injectable Solution than you should

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

An accidental overdose could lead to a severe decrease in blood pressure (which can 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 Furosemida Physan 20 mg/2 ml solution

Do not use a double dose to compensate for the missed doses

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

Like all medications, Furosemida Physan 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 ones), dehydration, and a decrease in total blood volume (hypovolemia), particularly in elderly patients, elevated creatinine and triglyceride levels in the blood.
• with intravenous administration: a decrease in blood pressure (hypotension, including orthostatic hypotension (problems maintaining an upright position).

Common(may affect up to 1 in 10 patients)

• decreased sodium (hyponatremia), chloride (hypochloremia), and potassium (hypokalemia) levels, increased cholesterol and uric acid levels in the blood, and gout attacks.
• increased urine volume.
• mental alterations (hepatic encephalopathy) in patients with liver problems (hepatic cell insufficiency).
• increased blood viscosity (hemoconcentration).

Uncommon(may affect up to 1 in 100 patients)

• alteration of glucose tolerance. May manifest latent diabetes mellitus.
• nausea.
• auditory disturbances, although usually of a transient nature, especially in patients with renal insufficiency, decreased protein levels in the blood (hypoproteinemia), and/or after a rapid intravenous administration of furosemide. Deafness (sometimes irreversible).
• itching, hives, rashes, blisters, and 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 1000 patients)

• allergic inflammation of blood vessels (vasculitis).
• allergic renal reaction (tubulointerstitial nephritis).
• vomiting, diarrhea.
• subjective sensation of ringing in the ears (tinnitus).
• severe allergic reactions (anaphylactic or anaphylactoid) (e.g., with shock).
• sensation of numbness in the extremities (paresthesias).
• decreased white blood cell levels (leukopenia), increased levels of 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), increased liver enzymes (transaminases).
• decreased levels of a type of white blood cell, granulocytes (agranulocytosis), decreased red blood cell count (aplastic anemia or hemolytic anemia).

Frequency not known(cannot be estimated from available data)

• decreased calcium (hypocalcemia), magnesium (hypomagnesemia) levels, increased urea levels 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 sodium and chloride levels in the urine, urinary 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 alteration characterized by blistering 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, 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 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 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 prospectus. 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 in the original packaging to protect it from light.

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

Unused solution must be disposed of in accordance with local regulations.

Medications should not be thrown away through drains or in the trash. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

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 content of the container

Furosemida Physan20 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.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laphysan S.A.U.

Anabel Segura, 11 Building A, 4th Floor, Door D

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

Laboratorios Inibsa, S.A. Ctra. Sabadell to Granollers, km 14.5

08185 Lliçà de Vall – Barcelona

Spain

Or

Laboratorios Basi-Industrial Pharmacy, S.A.

Manuel Lourenço Ferreira Industrial Park, nº 8, 15 and 16.

3450-232 Mortágua-Portugal

Revision date of thisleaflet:February 2023

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

This information is intended solely for doctors or healthcare professionals

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

Furosemide is soluble in a medium alkaline 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 less than 7 may precipitate the active ingredient. Mixtures may be stored, for a maximum of 24 hours, if the pH of the final solution is neutral or weakly alkaline.

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