Seguril 250 mg/25 ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Seguril 250 mg/25 ml injectable solution

Furosemide

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

Package leaflet contents:

1. What Seguril is and what it is used for

2. What you need to know before using Seguril

3. How to use Seguril

4. Possible side effects

5. Storage of Seguril

6. Contents of the container and additional information

1. What Seguril is and what it is used for

Seguril 250 mg/25 ml infusion solution for injection is a diuretic belonging to the sulfonamide group. It works by increasing urine elimination (diuretic effect) and reducing blood pressure (antihypertensive effect).

Under medical prescription only, 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-dialysis stage, with fluid retention and hypertension.
• End-stage renal failure, for maintenance of residual kidney functional capacity.
• 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 Seguril

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

Do not use Seguril

• If you are allergic to furosemide, to medicines of the Seguril type (sulfonamides), or to any of the other components of this medicine (listed in section 6).

• If you have a decreased total blood volume (hypovolemia) or are dehydrated.

• If you have severe kidney problems associated with reduced urine output (renal failure with anuria) that do not respond to this medicine.

• If you have severely low potassium levels in your blood (severe hypokalaemia) (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 breastfeeding a baby.

• If you are pregnant, see section “Pregnancy, lactation and fertility”.

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

Warnings and precautions

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

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 special risk of experiencing a marked drop in blood pressure (for example, in 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, for example, nephrotic syndrome (see section 4, “Possible adverse effects”).
• In premature children (see section 4, “Possible adverse effects”).
• There is a possibility of exacerbation or activation of systemic lupus erythematosus.
• If you are elderly, if you are being treated with medicines that may cause a decrease in blood pressure, or if you have other medical conditions associated with a risk of decreased blood pressure.

During your treatment with Seguril, periodic monitoring of your blood levels of sodium, potassium, and creatinine is generally required, especially if you experience significant fluid loss due to vomiting, diarrhea, or excessive sweating. Dehydration or hypovolemia, as well as any significant electrolyte or acid-base imbalances, should be corrected, as this may require interruption of treatment.

Elderly patients with dementia who are taking risperidone should be especially cautious about 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, problems with speaking, problems with thinking).

Use in athletes

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

Use of Seguril with other medicines

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

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

The intravenous administration of furosemide is not recommended within 24 hours after administration of chloral hydrate, as this could lead to flushing, sweating, restlessness, nausea, hypertension, and tachycardia.

The ototoxicity and nephrotoxicity of certain substances may be increased when administered together with this medicine. Therefore, they should only be administered together if there are medical reasons requiring it.

These substances include:

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

Concomitant use of Seguril with other medicines may weaken the effect of these medicines, such as:

• Medicines used for diabetes (antidiabetics).
• Medicines used to raise 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).

• Curare-type muscle relaxants.

• 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 therapy may experience severe hypotension and deterioration of renal function, especially when an ACE (Angiotensin-Converting Enzyme) inhibitor or an angiotensin II receptor antagonist is administered for the first time or when a high dose is initiated.

• If 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.

• Medicines that are nephrotoxic: concomitant administration may enhance the harmful effects of these medicines on the kidneys.

Some medicines for inflammation and pain (non-steroidal anti-inflammatory drugs including acetylsalicylic acid) and medicines for epilepsy (phenytoin) may reduce the effect of Seguril.

Furosemide may increase the toxicity of salicylates.

Medicines such as probenecid and methotrexate, or other medicines that are significantly eliminated by the kidneys, may reduce the effect of Seguril. When used at high doses, 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 lowering potassium levels in the blood (hypokalemia) when administered with Seguril:

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

Some electrolyte imbalances (e.g., decreased blood levels of potassium (hypokalemia) or magnesium (hypomagnesemia)) could increase the toxicity of certain medicines (e.g., digitalis medicines and medicines inducing QT interval prolongation syndrome).

Patients receiving treatment with Seguril and high doses of certain cephalosporins (antibiotics) may experience a decrease in kidney function.

Concomitant administration of Seguril 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 renal excretion of urea.

Patients at high risk of developing contrast-induced nephropathy (kidney disease due to radiocontrast agents) who receive Seguril have a higher likelihood of experiencing deterioration in kidney function.

Administration of Seguril 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 should only use Seguril if there are medical reasons requiring it.

Seguril must not be administered during breastfeeding. If its administration is considered essential, your doctor may require you to discontinue breastfeeding, as furosemide passes into breast milk.

Driving and use of machines

This medicine may cause dizziness or drowsiness. 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 machinery if you feel dizzy or drowsy.

Some adverse effects (e.g., a marked, undesirable drop in blood pressure) may impair your ability to concentrate and react, and therefore pose a risk in situations where these skills are particularly important (e.g., operating vehicles or machinery).

Seguril 250 mg/25 ml injectable solution contains sodium

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

3. How to use Seguril

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

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

It must be administered intravenously exclusively by infusion.

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

The active substance furosemide, when given intravenously, must 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), 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 medicines.

Your doctor or nurse should be aware that the pH value of the solution to be infused should 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. The prepared solution for administration should be used as soon as possible.

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

In adults: the recommended maximum daily dose of furosemide is 1500 mg, although in exceptional cases it may reach up to 2000 mg.

Use in children and adolescents

In children, the recommended maximum 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, treatment should be switched to oral administration.

In infants and children under 15 years of age: parenteral administration of furosemide (possibly by slow infusion) is contraindicated, and should only be performed when there is a life-threatening condition.

In these cases, the Seguril 20 mg/2 ml injectable solution formulation may be used.

If you use more Seguril 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 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 progress to shock), kidney problems (acute renal failure), coagulation disorders (thrombosis), delirium, flaccid paralysis affecting soft muscles, apathy, and confusion.

No specific antidote is known.

In case of overdose, treatment will be based on the symptoms.

If you forget to use Seguril

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

4. Possible adverse effects

Like all medicines, this medicine may cause 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 people)

• electrolyte disturbances (including symptomatic ones), dehydration, and decreased 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 people)

• decreased levels of sodium (hyponatremia), chloride (hypochloremia), potassium (hypokalemia); increased cholesterol and uric acid levels 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 people)

• impaired glucose tolerance. Latent diabetes mellitus may become apparent.
• nausea.
• hearing disturbances, 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 severe 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 people)

• allergic inflammation of blood vessels (vasculitis).
• allergic-type kidney reaction (tubulointerstitial nephritis).
• vomiting, diarrhea.
• subjective sensation of ringing in the ears (tinnitus).
• severe allergic (anaphylactic or anaphylactoid) reactions (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 people)

• inflammation of the pancreas (acute pancreatitis).
• liver problems (cholestasis), increased liver enzymes (transaminases).
• decreased levels of a type of white blood cells, granulocytes (agranulocytosis), decreased number of red blood cells (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 misuse and/or prolonged use of furosemide.

• blood coagulation disorders (thrombosis).

• increased levels of sodium and chloride in urine, urinary retention (in patients with partial obstruction of urine 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), 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 of severe hypokalemia (low potassium levels in blood) (see section “Do not use Seguril”).

• 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 Seguril

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

Protect from light.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Seguril 250 mg/25 ml injectable solution

• The active substance is furosemide. Each 25 ml ampoule contains 266.6 mg of sodium furosemide, 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 injections.

Appearance of the product and contents of the pack

It is a clear, practically colourless solution.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Manufacturer

Delpharm Dijon

6 Boulevard de l’Europe

21800 Quetigny

France

or

Chinoin Private Co. Ltd

Csanyikvölgy site, 3510 Miskolc

Csanyikvölgy

Hungary

Date of the most recent revision of this package leaflet: October 2022

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