Seguril 40 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Seguril 40 mg tablets

Furosemide

Read the entire leaflet carefully before you start taking 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 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, since it could 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.

Leaflet contents:

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

1. What Seguril is and what it is used for

Seguril 40 mg tablets is a diuretic belonging to the sulfonamide group. It works by increasing urine elimination (diuretic effect) and reducing blood pressure (antihypertensive effect).

Under your doctor's prescription, this medicine is indicated for the treatment of:

• Edema (swelling due to fluid accumulation) associated with congestive heart failure, hepatic cirrhosis (ascites), and kidney disease, including nephrotic syndrome (treatment of the underlying disease takes priority).
• Edema following burns.
• Mild and moderate arterial hypertension.

2. What you need to know before starting to take Seguril

Read carefully the instructions provided in section 3, "How to take Seguril".

Do not take 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 marked decrease in your total blood volume (hypovolemia) or if you are dehydrated.

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

• If you have severely low potassium levels in your blood (severe hypokalemia) (see section 4, "Possible side effects").

• If you have severely low levels 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, breastfeeding and fertility".

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 serious 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 an elderly person, 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 this medicine, 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 any significant electrolyte or acid-base imbalances, should be corrected. Interruption of treatment may be necessary.

Elderly patients with dementia who are taking risperidone should exercise special caution 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, difficulty speaking, difficulty thinking).

Use in athletes

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

Other medicines and Seguril

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

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

The toxicity of certain substances in the ear and kidneys may be increased if 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).

Your doctor may need to adjust your dose and/or take other precautions if you are taking any of the following medicines:

• Aliskiren – used to treat high blood pressure.

The 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), 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 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 treatment with diuretics may experience severe hypotension and worsening of kidney function, especially when starting treatment or when initiating treatment with a high dose of an ACE (Angiotensin-Converting Enzyme) inhibitor or an angiotensin II receptor antagonist.
• 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 toxic to the kidneys: concomitant administration may enhance the harmful effect 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.

This medicine and sucralfate should not be administered together within an interval of less than 2 hours, as the effect of Seguril may be reduced.

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) if 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.

The 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 an increase in blood urea levels (hyperuricemia) and impaired urea elimination by the kidneys.

Patients at high risk of developing contrast-induced nephropathy (kidney disease) who receive Seguril are more likely to experience worsening kidney function.

The 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 plan to become pregnant, consult your doctor or pharmacist 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 essential, your doctor may require you to stop 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 40 mg tablets contain lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Seguril

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

Remember to take your medicine.

Take Seguril on an empty stomach, swallowing it without chewing and with sufficient liquid.

If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

Your doctor will prescribe the lowest effective dose required to achieve the desired effect.

In adults, treatment should be started with half, one, or two tablets (20 to 80 mg of furosemide) daily. The maintenance dose is half to one tablet per day, and the maximum dose will be determined by your doctor and depends on your response to treatment.

Use in children

In infants and children, a daily dose of 2 mg/kg body weight is recommended, up to a maximum of 40 mg per day.

Your doctor will indicate the duration of your treatment with this medicine. Do not stop treatment prematurely.

If you take more Seguril than you should

In case of overdose or accidental ingestion, immediately consult your doctor or go to the nearest hospital emergency department, taking this leaflet with you, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

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.

No specific antidote is known.

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

If you forget to take Seguril

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

4. Possible adverse effects

Like all medicines, this medicine can 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 patients)

• Electrolyte disturbances (including symptomatic ones), dehydration, and reduced total blood volume (hypovolemia), particularly in elderly patients, elevated creatinine and triglyceride levels in blood.

Common (may affect up to 1 in 10 patients)

• Decreased levels of sodium (hyponatremia), chloride (hypochloremia), and 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 patients)

• Impaired glucose tolerance. Latent diabetes mellitus may become apparent.
• Nausea.
• Hearing disorders, although usually temporary, 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 (anaphylactic or anaphylactoid) reactions (e.g., with shock).
• Tingling sensation in the limbs (paresthesia).
• Decreased white blood cell count (leukopenia), increased levels of 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 problems (cholestasis), increased liver enzymes (transaminases).
• Decreased levels of granulocytes (a type of white blood cells) (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 urinary flow), formation of kidney stones (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 hypersensitivity syndrome 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 associated with severe hypokalemia (low blood potassium levels) (see section “Do not take Seguril”).

• Increased risk of persistence of the “patent 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 may 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 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.

Store below 25°C.

Keep in the original packaging to protect from light.

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.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Seguril 40 mg tablets

• The active substance is furosemide. Each tablet contains 40 mg of furosemide.
• The other components are: monohydrate lactose, corn starch, pregelatinized corn starch, talc, magnesium stearate, colloidal anhydrous silica.

Appearance of the product and contents of the pack

Seguril 40 mg tablets are supplied in packs containing 30 tablets.

They are round, white tablets, scored on one side and marked with "DLI".

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Manufacturer

Famar Health Care Services Madrid, S.A.U.

Avda. de Leganés, 62

28923 Alcorcón (Madrid)

(Spain)

or

Opella Healthcare International SAS

56, Route de Choisy

60200 Compiègne

(France)

or

Sanofi S.r.l.

Strada Statale 17, Km 22

67019 Scoppito (L’Aquila)

Italy

Date of the most recent revision of this leaflet: January 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/