Patient Information Leaflet

Furosemida Altan 250 mg/25 ml Infusion Solution EFG

Read this 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 only, and you must not give it to others 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.

Table of Contents

1. What Furosemida Altan is and what it is used for.
2. What you need to know before using Furosemida Altan.
3. How to use Furosemida Altan.
4. Possible side effects.
5. Storage of Furosemida Altan.
6. Contents of the pack and additional information

Furosemida is a diuretic belonging to the group of sulfonamides. It acts by increasing the elimination of urine (diuretic) and reducing blood pressure (anti-hypertensive).

Under the prescription of your doctor, this medication is indicated exclusively for the treatment of patients with:

• Renal filtration problems (through the kidneys).

-Acute renal insufficiency, in order to maintain the elimination of fluid and to facilitate parenteral nutrition, as long as there is some capacity for filtration.

-Chronic renal insufficiency in the pre-dialysis stage, with fluid retention and hypertension.

-Terminal renal insufficiency, for maintenance of renal functional capacity.

-Nephrotic syndrome in patients for whom a dose of 120 mg of furosemida per day by oral route is not sufficient; the treatment of the underlying disease has priority.

Please read carefully the instructions provided in section 3. “How to use Furosemida Altan”.

Do not use Furosemida Altan

• if you are allergic to the active ingredient (furosemida), to Furosemida Altan-type medications (sulfonamides), or to any of the other components of this medication (listed in section 6)

• if you have decreased 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 does not respond to this medication
• if you have severe low potassium levels in the blood (severe hypokalemia) (see section 4. “Possible side effects”).
• if you have severe sodium deficiency in the blood (severe hyponatremia)
• if you are in a pre-comatose and comatose state (associated with hepatic encephalopathy)
• if you are pregnant or breastfeeding a baby (see “Pregnancy, lactation, and fertility”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Furosemida Altan.

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 (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), in addition to suffering, for example, nephrotic syndrome (see section 4. “Possible side effects”)

• in premature children (see section 4. “Possible side effects”)
• there is a possibility of exacerbation or activation of systemic lupus erythematosus.
• During treatment with Furosemida Altan, regular blood tests will usually be required to check your levels of sodium, potassium, and creatinine, and especially if you experience severe fluid loss, by vomiting, diarrhea, or intense sweating (dehydration or hypovolemia), as your doctor may require the interruption of treatment.
• 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 that are associated with the risk of a decrease in blood pressure.

During treatment with Furosemida Altan, regular blood tests will usually be required to check your levels of sodium, potassium, and creatinine, and especially if you experience severe fluid loss, by vomiting, diarrhea, or intense sweating. Severe dehydration or hypovolemia, as well as any significant electrolyte and acid-base balance alterations, should be corrected, as this may require the interruption of treatment.

Patients with advanced age and dementia who are taking risperidone should be especially careful when using risperidone and furosemida concomitantly. Risperidone is a medication used to treat certain mental disorders, such as dementia (a disease characterized by several symptoms: memory loss, problems speaking, problems thinking).

Use of Furosemida Altan with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

The effect of treatment may be affected if Furosemida Altan is used at the same time as other medications.

The concomitant administration of intravenous furosemide during the 24 hours after administration with chloral hydrate may lead to flushing, sweating, restlessness, nausea, hypertension, and tachycardia.

Some substances may increase their toxicity in the ear and kidneys if administered with this medication. Therefore, they should only be administered together if there are medical reasons that require it.

These substances include:

-Aminoglycoside antibiotics (infection medications) such as gentamicin, kanamicin, and tobramicin.

-Cancer medications (cisplatino).

The concomitant use of Furosemida Altan with other medications may weaken the effect of these medications as:

-Diabetes medications (antidiabetics).

-Blood pressure medications (sympathomimetics with a hypertensive effect, for example, epinephrine and norepinephrine).

In other cases, the concomitant use may increase the effects of these medications as:

-Asthma medications (theophylline)

-Muscle relaxants such as curare

-Depression medications (lithium salts) 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.

-If blood pressure medications, diuretics, or other medications that may lower blood pressure are administered concomitantly with furosemida, 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 aspirin) and epilepsy medications (phenytoin) may reduce the effect of Furosemida Altan. Furosemida 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 Furosemida Altan. In high-dose treatment, they may increase serum levels and increase the risk of adverse effects due to furosemida or concomitant administration.

The following substances may reduce potassium levels in the blood (hypokalemia) if administered with Furosemida Altan:

-Inflammatory medications (corticosteroids)

-Carbenoxolona (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 heart medications (for example, digitals and medications that induce the QT interval prolongation syndrome).

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

The concomitant administration of Furosemida Altan 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 who receive Furosemida Altan have a higher risk of renal function deterioration.

The concomitant administration of Furosemida Altan and risperidone in elderly patients with dementia may increase mortality.

High doses of furosemida 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, lactation, and fertility

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

If you are pregnant, you will only use Furosemida Altan if there are medical reasons that require it.

During lactation, Furosemida Altan should not be administered. If its administration is necessary, your doctor may require you to interrupt lactation, as furosemida 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 (e.g. a significant and 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 (e.g. operating vehicles or machinery).

Furosemida Altan contains sodium:

This medication contains 0.69 mg of sodium (main component of table salt/for cooking) in each ml. This is equivalent to 0.034% of the maximum daily sodium intake recommended for an adult..

Use in athletes

This medication contains furosemida, which may produce a positive result in doping control tests.

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

Furosemide250 mg/25 mlshould not be administered as a bolus intravenously.

It should be used exclusively by intravenous infusion.

Only infuse using infusion pumps that control the volume or rate to avoid a possible risk of accidental overdose.

The active substance furosemide by 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, therefore acidic solutions should not be used 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 discontinue your treatment prematurely. The dosage is individual for you and may be modified by your doctor based on your response to treatment.

In adults: the maximum recommended daily dose 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. As soon as possible, switch to oral treatment.

In infants and children under 15 years, parenteral administration (eventually by slow infusion) is contraindicated, only in cases where it poses a vital risk.

In these cases, the 20 mg/2ml injectable solution will be used.

If you are given more Furosemide Altan 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 Toxicology Information Service, phone 91 562 04 20 indicating the medication and the amount ingested or administered.

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

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 Altan

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

If you interrupt treatment with Furosemide Altan

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

Like all medicines, Furosemida Altan may cause side effects, although not everyone will experience them.

The side effects have been grouped according to their frequency:

Very common (may affect more than 1 in 10 patients)

- electrolyte imbalances (including symptomatic), dehydration and a decrease in the total blood volume (hypovolemia), particularly in elderly patients, high 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)

? a decrease in sodium levels (hyponatremia), chloride (hypochloremia), potassium (hypokalemia), an increase in cholesterol and uric acid levels in the blood and gout attacks.

? an increase in urine volume.

? mental alterations (hepatic encephalopathy) in patients with liver problems (hepatic insufficiency).

? an increase in blood viscosity (hemoconcentration).

Uncommon (may affect up to 1 in 100 patients)(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, a decrease in blood protein levels (hypoproteinemia) and/or after a rapid intravenous administration of furosemide. Deafness (occasionally, irreversible).

- itching, hives, rashes, blisters and other more severe reactions such as erythema multiforme, pemphigoid, exfoliative dermatitis, purpura and photosensitivity reaction.

- a decrease in platelet levels (thrombocytopenia).

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

? a sensation of tingling in the extremities (paresthesias).

? a decrease in white blood cell levels (leukopenia), an increase in a type of white blood cell, eosinophils (eosinophilia).

? fever.

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

? inflammation of the pancreas (acute pancreatitis).

- liver problem (cholestasis), increase in liver enzymes (transaminases).

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

Frequency not known(cannot be estimated from available data)

? a decrease in calcium levels (hypocalcemia), magnesium (hypomagnesemia), an increase in urea levels in the blood, metabolic alkalosis, pseudo-Bartter syndrome in the case of improper use and/or prolonged use of furosemide.

? alteration of blood coagulation (thrombosis).

? an increase in 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 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, 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 where there is a severe decrease in potassium levels in the blood (hypokalemia) (see "Do not use Furosemida Altan").

- an increase in the risk of persistence of the "ductus arteriosus permeable" when furosemide is administered to premature infants during the first weeks of life.

Like other diuretics, after prolonged administration of this medication, it may increase the elimination of sodium, chloride, water, potassium, calcium and magnesium. These alterations manifest with intense thirst, headache, confusion, muscle cramps, painful muscle contraction, 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.

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Keep the ampoulesin the outer packaging to protect them from light.

Keep this medication out of sight and reach of children.

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.

Do not use Furosemida Altan if you observe visible signs of deterioration.

Medicines should not be thrown down the drains or in the trash..Ask your pharmacist how to dispose ofthe packaging and themedicines that you no longerneed. This will help protect the environment.

Composition of Furosemida Altan

The active ingredient is furosemida. Each ampoule of 25 ml contains 250 mg of furosemida, (266.6 mg of furosemida sodium), in injectable aqueous solution, at a concentration of 10 mg/ml.

The other components (excipients) are: sodium hydroxide, mannitol, and injection water.

Appearance of the product and contents of the packaging

Furosemida Altan. It is presented in packaging containing 10 or 50 ampoules of 25 ml.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

The holder of the marketing authorization:

Altan Pharmaceuticals, S.A.

C/ Cólquide, Nº 6, Portal 2, 1st Floor, Office F. Edificio Prisma

The Rozas, 28230 Madrid

Spain

The responsible for manufacturing:

Laboratoire RENAUDIN

“Z.A.Errobi” 64250 Itxassou FRANCE

Date of the last review of this leaflet:May 2025

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