Furosemide Altan 250 mg/25 ml solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Furosemide Altan 250 mg/25 ml solution for infusion EFG

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

If you have any questions, consult your doctor or pharmacist.

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

Package leaflet

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

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

Furosemide is a diuretic belonging to the sulfonamide group. It works 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 predialytic stage, with fluid retention and hypertension.

• End-stage renal failure, for maintenance of residual renal function.

• Nephrotic syndrome in patients in whom an oral dose of furosemide of 120 mg per day is insufficient; treatment of the underlying disease takes priority.

2. What you need to know before using 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 type Furosemide Altan (sulfonamides), or to any of the other ingredients of this medicine (listed in section 6)

• if you have a reduced total blood volume (hypovolemia), or if you are dehydrated

• if you have severe kidney problems accompanied by a marked decrease in urine output (renal failure with anuria) that does not respond to this medicine

• if you have severely low levels of potassium in your blood (severe hypokalemia) (see section 4, “Possible side effects”)

• if you have severe deficiency of sodium salts in your blood (severe hyponatremia)

• if you are in a pre-comatose or comatose state (associated with hepatic encephalopathy)

• if you are pregnant or breastfeeding (see “Pregnancy, lactation and fertility”).

Warnings and precautions

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

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 high risk of experiencing a pronounced drop in blood pressure (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 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.
  • during your treatment with Furosemide Altan, periodic monitoring of blood levels of sodium, potassium, and creatinine is generally required, especially if you experience severe fluid loss due to vomiting, diarrhea, or excessive sweating (dehydration or hypovolemia), as your doctor may need to interrupt treatment.
  • 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 Altan, periodic monitoring of blood levels of sodium, potassium, and creatinine is generally required, especially if you experience severe fluid loss due to vomiting, diarrhea, or excessive sweating. Dehydration or hypovolemia, as well as significant electrolyte imbalances and acid-base disturbances, should be corrected, as this may require interruption of treatment.

Elderly patients with dementia who are taking risperidone should exercise special caution when using risperidone and furosemide concomitantly. Risperidone is a medicine used to treat certain mental disorders, such as dementia (a condition characterized by several symptoms: memory loss, difficulty speaking, difficulty thinking).

Use of Furosemide Altan with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

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

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

The risk of toxicity to the ear and kidneys may be increased when certain substances are administered together with this medicine. Therefore, such substances should only be administered concomitantly if there are specific medical reasons to do so.

These substances include:

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

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 hypertensive effect, e.g., epinephrine and norepinephrine).

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

• Medicines for asthma (theophylline).
• Muscle relaxants of the curare type.
• Medicines for depression (lithium salts) – may increase 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, particularly when starting treatment or increasing the dose of an ACE (Angiotensin-Converting Enzyme) inhibitor or an angiotensin II receptor antagonist for the first time.

• When medicines used to treat high blood pressure, diuretics, or other medicines that may lower blood pressure are administered together with furosemide, a more pronounced decrease in blood pressure should be anticipated.

• Nephrotoxic medicines: concomitant administration may enhance the harmful effects 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 significantly eliminated by the kidneys, may reduce the effect of Furosemide Altan. When used at high doses, they may increase serum levels and raise the risk of adverse effects due to furosemide or concomitant administration.

The following substances may reduce blood potassium levels (hypokalemia) when administered with Furosemide Altan:

• Medicines for inflammation (corticosteroids)
• Carbenoxolone (a medicine used to treat oral mucosal lesions)
• Large amounts of liquorice
• Prolonged use of laxatives for constipation

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

Patients receiving Furosemide Altan who are also given high doses of certain cephalosporins (antibiotics) may experience reduced kidney function.

Concomitant administration of Furosemide Altan 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 contrast-induced nephropathy (kidney disease due to radiocontrast agents) who receive Furosemide Altan are more likely to experience worsening of kidney function.

Administration of Furosemide Altan 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, breastfeeding and fertility

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

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

Furosemide Altan must not be administered during breastfeeding. If administration is absolutely necessary, your doctor may advise you to interrupt breastfeeding, as furosemide passes into breast milk.

Driving and operating machinery:

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 machines 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 your reaction time, and therefore may represent a risk in situations where these skills are particularly 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 corresponds to 0.034% of the maximum daily recommended sodium intake for an adult.

Use in athletes:

This medicine contains furosemide, which may lead to a positive result in doping control tests.

3. How to use Furosemide Altan

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

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

It must be administered intravenously by infusion only.

The infusion must only be administered using infusion pumps that control volume or rate to avoid the potential risk of accidental overdose.

The active substance, furosemide, must be injected or infused intravenously slowly, 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 injectable solution form must not be mixed in the same syringe or infused together with other medications.

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

Your doctor will determine your daily dose and the duration of your treatment. Do not stop treatment prematurely. The dosage is individualized for you and may be adjusted by your doctor depending on your response to treatment.

In adults: The maximum recommended dose is 1500 mg daily, although in exceptional cases it may be increased up to 2000 mg.

Use in children and adolescents

In children, the maximum recommended daily dose for intravenous or intramuscular injection is 1 mg of furosemide per kg of body weight, up to a maximum of 20 mg. Oral treatment should be initiated as soon as possible.

In infants and children under 15 years of age, parenteral administration (even by slow infusion) is contraindicated, except when there is a life-threatening condition.

In such cases, the 20 mg/2 ml injectable solution formulation should be used.

If you are given more Furosemide Altan 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 medication and the amount ingested or administered.

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

An accidental overdose may 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.

Treatment in case of overdose will depend on the symptoms presented.

If you forget to use Furosemide Altan

Do not use a double dose to make up for a missed dose.

If you stop using Furosemide Altan

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

4. Possible adverse effects

Like all medicines, Furosemide Altan may have 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 reduction in 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), 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 disturbances, although usually transient, 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 serious 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) (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), increased 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 inappropriate and/or prolonged use of furosemide.

? Impaired 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 mucous membrane 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, red-purple, 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 Furosemide Altan”).

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

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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Furosemide Altan.

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

Keep this medicine out of the sight and reach of children.

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

Do not use Furosemide Altan if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Furosemida Altan

The active substance is furosemide. Each 25 ml ampoule contains 250 mg of furosemide (266.6 mg of sodium furosemide) 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 contents of the pack

Furosemida Altan is supplied in packs containing 10 or 50 ampoules of 25 ml.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Altan Pharmaceuticals, S.A.

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

Las Rozas, 28230 Madrid

Spain

Manufacturer:

Laboratoire RENAUDIN

"Z.A.Errobi" 64250 Itxassou FRANCE

Date of the most recent review of this leaflet: May 2025

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