FUROSEMIDE ALTAN 250mg/ 25ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Furosemide Altan 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, 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 Package Leaflet

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

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

Furosemide is a diuretic belonging to the group of sulfonamides. It acts by increasing urine elimination (diuretic) and reducing blood pressure (antihypertensive).

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

• Kidney 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-dialytic stage, with fluid retention and hypertension.
• Terminal renal failure, to maintain renal functional capacity.
• Nephrotic syndrome in patients in whom a dose of furosemide of 120 mg per day orally is not sufficient; priority is given to the treatment of the underlying disease.

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

Read carefully the instructions provided in section 3. “How to use Furosemide Altan”.

Do not use Furosemide Altan

• if you are allergic to the active substance (furosemide), to medicines of the Furosemide Altan type (sulfonamides), or to any of the other components of this medicine (included in section 6)

• in case of decreased total blood volume (hypovolemia), or if you are dehydrated
• if you have severe kidney problems, accompanied by a decrease in urine elimination (renal failure 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 you are in a pre-comatose and comatose state (associated with hepatic encephalopathy)
• if you are pregnant or breastfeeding a baby (see “Pregnancy, breastfeeding and fertility”).

Warnings and precautions

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

Be especially careful with this medicine:

• if you have urine elimination problems, especially at the start of treatment
• if your blood pressure is low (hypotension)
• if you have a high risk of suffering a pronounced drop in blood pressure (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 children (see section 4. “Possible side effects”)
• there is a possibility of exacerbation or activation of systemic lupus erythematosus.
• during your treatment with Furosemide Altan, periodic control 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 your doctor may require the interruption of treatment.
• If you are an elderly person, if you are being treated with medicines 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 Altan, periodic control 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 balance alterations, should be corrected, as this may require the interruption of treatment.

Elderly patients with dementia who are taking risperidone should be especially careful with 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, speech problems, thinking problems).

Using Furosemide Altan with other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, even those obtained without a prescription.

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

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

Certain substances may have their toxicity increased in the ear and kidney if they are administered together with this medicine. Therefore, they should only be administered together if there are medical reasons that require it.

These substances include:

- Aminoglycoside antibiotics (infection medicines) such as gentamicin, kanamycin, and tobramycin.

- Cancer medicines (cisplatin).

The concomitant use of Furosemide Altan with other medicines may weaken the effect of these medicines, such as:

- Medicines used for diabetes (antidiabetics).

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

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

- Medicines for asthma (theophylline)

- Muscle relaxants such as curare

- Medicines for depression (lithium salts) 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 renal 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 medicines for high blood pressure, diuretics, or other medicines that can lower blood pressure are administered together with furosemide, a more pronounced drop in blood pressure should be expected.
• Nephrotoxic medicines: concomitant administration may potentiate the harmful effect 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) may reduce the effect of Furosemide Altan. Furosemide may increase the toxicity of salicylates.

Medicines such as probenecid and methotrexate or other medicines that have significant renal elimination may reduce the effect of Furosemide Altan. 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 reduce potassium levels in the blood (hypokalemia) if administered with Furosemide Altan.

- Medicines for inflammation (corticosteroids)

- Carbenoxolone (medicine for the treatment of oral mucosa lesions)

- Significant amounts of licorice

- Prolonged use of laxatives for constipation.

Certain electrolyte disturbances (e.g., decreased potassium levels in the blood (hypokalemia) or magnesium (hypomagnesemia)) may increase the toxicity of certain heart medicines (e.g., digitalis and medicines that induce the QT interval prolongation syndrome).

Patients being treated with Furosemide Altan and receiving high doses of certain cephalosporins (antibiotics) may suffer from a decrease in kidney function.

The concomitant administration of Furosemide Altan and cyclosporin A (a medicine used to prevent transplant rejection) is associated with an increased risk of gouty arthritis (joint inflammation) secondary to an increase in blood urea levels and kidney urea elimination problems.

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

The administration of Furosemide Altan together with risperidone in elderly patients with dementia could increase mortality

.

High doses of furosemide administered with levothyroxine may lead to a transient initial increase in free thyroid hormones, followed by a general decrease in total thyroid hormone levels.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before using this medicine.

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

During breastfeeding, Furosemide Altan 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 happen more often at the start of treatment, when your doctor increases the dose, or if you consume alcohol. Do not drive or use tools or machines if you feel dizzy or drowsy.

Certain side effects (e.g., a pronounced undesirable drop in blood pressure) may impair the 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 Altan contains sodium:

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

Use in athletes

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

3. How to use Furosemide Altan

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

Furosemide 250 mg/25 ml should not be administered as an intravenous bolus.

It should be used exclusively by intravenous perfusion.

It should only be perfused using perfusion pumps that control the volume or speed to avoid a possible risk of accidental overdose.

The active substance furosemide should be injected or perfused 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 perfusion rate does not exceed 2.5 mg per minute.

Furosemide in the form of injectable solution should not be mixed in the same syringe or perfused together with other medicines.

Your doctor or nurse should take into account 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 substance 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 dosage is individual for you and may be modified by your doctor based on your response to treatment.

In adults: the recommended maximum dose is 1500 mg per day, although in exceptional cases it may be up to 2000 mg.

Use in children and adolescents

In children, the recommended maximum daily dose by 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, treatment will be switched to oral administration.

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

In these cases, the 20 mg/2ml injectable solution presentation 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 emergency department of the nearest hospital, accompanied by this leaflet, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine 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 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 Altan

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

If you stop treatment with Furosemide Altan

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

4. Possible Adverse Effects

Like all medicines, Furosemida Altan can have 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.

Common (may affect up to 1 in 10 patients)

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

? increase in urine volume.

? mental disorders (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 be revealed.

? nausea.

? hearing disorders, 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 more severe reactions such as erythema multiforme, pemphigoid, exfoliative dermatitis, purpura, and photosensitivity reaction.

Rare (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 (tinnitus).

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

? sensation of tingling in the limbs (paresthesia).

? decrease in white blood cell count (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 the available data)

? decrease in calcium (hypocalcemia), magnesium (hypomagnesemia) levels, increase in blood urea level, metabolic alkalosis, pseudo-Bartter syndrome in case of improper 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), kidney stone formation (nephrocalcinosis/nephrolithiasis) in premature infants, renal failure.

? severe vesicular reactions of the skin and mucous membranes (Stevens-Johnson syndrome), severe skin disorder characterized by blistering 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, reddish-purple lesions, polygonal in shape, that appear 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 section "Do not use Furosemida Altan").

• increased risk of persistence of the "ductus arteriosus permeable" when furosemide is administered to premature infants during the first weeks of life.

As with other diuretics, after prolonged administration of this medication, there may be an increase in the elimination of sodium, chloride, water, potassium, calcium, and magnesium. These alterations are manifested with intense thirst, headache, confusion, muscle cramps, painful contraction of the muscles, 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 is not listed 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 Altan

Keep the ampoules in the outer packaging to protect them from light.

Keep this medication out of the 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 away through the drains or into the trash. Ask your pharmacist how to dispose of the packaging and medications that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Furosemida Altan

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

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

Appearance of the Product and Package Contents

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

The marketing authorization holder:

Altan Pharmaceuticals, S.A.

C/ Cólquide, Nº 6, Portal 2, 1ª Planta, Oficina F. Edificio Prisma

Las Rozas, 28230 Madrid

Spain

The manufacturer:

Laboratoire RENAUDIN

“Z.A.Errobi” 64250 Itxassou FRANCE

Date of the Last Revision of this Prospectus:May 2025

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/’’