Label: information for the user

Seguril 250 mg/25 ml injectable solution

Furosemide

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

• Keep this label as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

Contents of the label:

1. What Seguril is and for what it is used
2. What you need to know before starting to use Seguril
3. How to use Seguril
4. Possible adverse effects
5. Storage of Seguril

6. Contents of the package and additional information

Seguril 250 mg/25 ml injectable solution for infusion, is a diuretic belonging to the group of sulfonamides. It acts by increasing the elimination of urine (diuretic) and reducing blood pressure (antihypertensive).

This medication is indicated exclusively under the prescription of your doctor 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 daily dose of 120 mg of furosemide by oral route is not sufficient; the treatment of the underlying disease has priority.

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

Do not use Seguril

• If you are allergic to furosemide, to the type of medications known as Seguril (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 side effects”).

• If you have a severe deficiency of sodium salts in your blood (severe hyponatremia).
• If you are in a pre-comatose and comatose state associated with hepatic encephalopathy.
• If you are breastfeeding a baby.
• If you are pregnant, see section “Pregnancy, lactation and fertility”.

Seguril 250 mg/25 ml injectable solution should not be administered as a bolus intravenously. It should only be infused using infusion pumps that control the volume or rate to avoid the risk of accidental overdose.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use Seguril.

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 significant 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 (hepato-renal syndrome).
• If your blood protein levels are low (hypoproteinemia), in addition to having, for example, a 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.
• 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 your treatment with Seguril, you will generally require periodic monitoring of your blood levels of sodium, potassium and creatinine, and especially if you have a severe loss of fluids, by 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 discontinuation of treatment.

Patients with advanced age and dementia who are taking risperidone should be especially careful with the concomitant use of risperidone and furosemide. 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 in athletes

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

Use of Seguril with other medications

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

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

Furosemide intravenous administration is not recommended during the 24 hours after chloral hydrate administration, as it may cause flushing, sweating, restlessness, nausea, hypertension and tachycardia.

Some substances may increase their toxicity in the ear, kidneys, if administered together 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, kanamycin and tobramycin.

- Cancer medications (cisplatin).

The concomitant use of Seguril with other medications may weaken the effect of these medications, such as:

- Diabetes medications (antidiabetics).

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

In other cases, the concomitant use may increase the effects of these medications, such 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-lowering medications, diuretics, or other medications that may lower blood pressure are administered together with furosemide, a more pronounced decrease 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 Seguril.

Furosemide 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 Seguril. 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) if administered with Seguril:

- 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 Seguril and receiving high doses of some cephalosporins (antibiotics) may experience renal function deterioration.

The concomitant administration of Seguril and cyclosporine A (medication used to prevent transplant rejection) is associated with an elevated risk of gouty arthritis (inflammation of the joints) secondary to an increase in blood urea levels (hyperuricemia) and renal elimination problems.

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

The concomitant administration of Seguril 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, lactation and fertility

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

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

During breastfeeding, Seguril 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 your 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).

Seguril 250 mg/25 ml injectable solution contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per 1 ml of injectable solution; it is essentially “sodium-free”.

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

Seguril 250 mg/25 mg solution should not be administered as an intravenous bolus.

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 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 discontinue 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 1500 mg per day, although in exceptional cases it can reach 2000 mg.

Use in children and adolescents

In children, the maximum recommended daily dose of furosemide 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: the administration of furosemide by parenteral route (eventually by slow infusion) is contraindicated, only in cases where it poses a vital risk.

In these cases, the presentation of Seguril 20 mg/2 ml injectable solution can be used.

If you use more Seguril 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 can 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 forgot to use Seguril

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Side effects have been grouped according to their frequency:

Very frequent(may affect more than1 in 10 patients)

• electrolyte imbalances (including symptomatic), dehydration, and decreased total blood volume (hypovolemia), particularly in elderly patients, elevated creatinine and triglyceride levels in blood.
• with intravenous administration: decreased blood pressure (hypotension including orthostatic hypotension (problems maintaining an upright position)).

Frequent(may affect up to1 in 10 patients)

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

Occasional(may affect up to1 in 100 patients)

• glucose tolerance alteration. May manifest latent diabetes mellitus.
• nausea.
• tinnitus, although normally of transient nature, especially in patients with renal insufficiency, decreased blood protein levels (hypoproteinemia), and/or after a rapid intravenous administration of furosemide. Deafness (occasionally, irreversible).
• itching, prickling, rashes, blisters, and more severe reactions such as erythema multiforme, pemphigoid, exfoliative dermatitis, purpura, and photosensitivity reaction.
• decreased platelet levels (thrombocytopenia).

Rare(may affect up to1 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).
• sensation of numbness in the extremities (paresthesias).
• decreased white blood cell levels (leucopenia), increased levels of a type of white blood cell, eosinophils (eosinophilia).
• fever.

Very rare(may affect up to1 in 10,000 patients)

• pancreatitis (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 unknown(cannot be estimated from available data)

• decreased levels ofcalcium(hypocalcemia), magnesium (hypomagnesemia), increased urea levels in blood, metabolic alkalosis, pseudo-Bartter syndrome in the case of misuse and/or prolonged use of furosemide.
• blood coagulation alteration(thrombosis).
• increased 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 skin and mucous membrane reactions (Stevens-Johnson syndrome), severe skin alteration characterized by blister formation and exfoliative lesions (toxic epidermal necrolysis), generalized acute pustular exanthema (PEGA), anddrug hypersensitivity syndrome with eosinophilia and systemic symptoms (DRESS), lichenoid reactions,characterized as 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 severe hypokalemia (potassium deficiency) is present (see "Do not use Seguril").
• increased risk of persistence of the "ductus arteriosus permeable" when furosemide is administered to premature infants during the first weeks of life.

Like other diuretics, prolonged administration of this medicine may increase the elimination of sodium, chloride, water, potassium, calcium, and magnesium. These alterations manifest with intense thirst, headache, confusion, muscle cramps, painful muscle contractions, especially in the extremities (tetany), muscle weakness, cardiac rhythm alterations, 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 of 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 medicine.

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

Store protected from light.

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Seguril 250 mg/25 ml injectable solution

- The active ingredient is furosemide. Each ampoule of 25 ml contains 266.6 mg of furosemide sodium, equivalent to 250 mg of furosemide, at a concentration of 10 mg of furosemide per ml of injectable solution.

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

Appearance of the product and content of the packaging

It is a transparent and practically colorless solution.

Each package contains 6 ampoules of 25 ml of injectable solution.

Holder of the marketing authorization and responsible for manufacturing

Holder

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Responsible for manufacturing

Delpharm Dijon

6 Boulevard de l’Europe

21800 Quetigny

France

or

Chinoin Private Co. Ltd

Csanyikvölgy site, 3510 Miskolc

Csanyikvölgy

Hungary

Last review date of this leaflet: October 2022

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/