Leaflet: information for the user

Seguril 40 mg tablets

Furosemide

Read this leaflet carefully before you start taking 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Seguril 40 mg tablets, 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 for treatment under the prescription of your doctor:

- Edema (swelling due to accumulation of fluids) associated with congestive heart failure, liver cirrhosis (ascites), and kidney disease, including nephrotic syndrome (priority treatment of the underlying disease).

-Edemas subsequent to burns.

- Mild to moderate arterial hypertension.

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

Do not take 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”.

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 special 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 this medication, 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. You should correct dehydration or hypovolemia as well as any significant electrolyte and acid-base balance alterations. The treatment may need to be interrupted.

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 can produce a positive result in doping control tests.

Other medications and Seguril

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

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

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, kanamicin and tobramicin.
• Cancer medications (cisplatino).

Your doctor may need to change your dose and/or take other precautions if you are taking one of the following medications:

• Aliskireno - used to treat high blood pressure.

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

• Medications used to treat diabetes (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 as:

• Asthma medications (theophylline).

• Relaxants such as curare.
• Medications for depression (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 ACE inhibitor or an angiotensin II receptor antagonist.
• If diuretics, blood pressure medications, or other medications that may lower blood pressure are administered together with furosemide, a more pronounced drop in blood pressure should be anticipated.
• Medications toxic to 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.

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

Medications such as probenecid and methotrexate, or other medications that have a 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).
• Carbenoxolona (medication for the treatment of oral mucosa lesions).
• Significant amounts of licorice root.
• 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 a decrease in kidney function.

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

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

The concomitant administration of Seguril with risperidone in elderly patients with dementia may increase mortality.

High doses of furosemide administered with levotiroxine 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 or pharmacist 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 interrupt 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 side effects (e.g. an undesirable pronounced drop in blood pressure) may impair the ability to concentrate and react, and therefore constitute a risk in situations where these skills are of special importance (e.g. operating vehicles or machinery).

Seguril 40 mg tablets contain lactose

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

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

Remember to take your medication.

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

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

Your doctor will prescribe the minimum dose sufficient to produce the desired effect.

For adultsit is recommended to start treatment with half, one or two tablets (20 to80 mg of furosemide) per day. The maintenance dose is half to one tablet per day and the maximum dose will be indicated by your doctor and will depend on your response to treatment.

Use in children

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

Your doctor will indicate the duration of your treatment with this medication. Do not discontinue your treatment before.

If you take 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 Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

An accidental overdose could lead to a severe decrease in blood pressure (which may evolve into shock), kidney problems (acute renal insufficiency), coagulation problems (thrombosis), delirium, paralysis affecting soft muscles (flaccid paralysis), apathy, and confusion.

No specific antidote is known.

Treatment for overdose will be based on symptoms.

If you forgot to take Seguril

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

Like all medicines, this medicine mayproduceside 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 ones), dehydration, and a decrease in total blood volume (hypovolemia), particularly in elderly patients, elevated levels of creatinine and triglycerides in the blood.

Frequent(may affect up to1 in 10 patients)

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

Not very frequent(may affect up to1 in 100 patients)

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

• inflammation of the pancreas(acute pancreatitis).
• liver problem (cholestasis), increased levels of 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 levels of urea in the blood, metabolic alkalosis, pseudo-Bartter syndrome in the case of misuse and/or prolonged use of furosemide.
• alteration of blood coagulation(thrombosis).
• increased levels of sodium and chloride in the urine, urinary 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 alteration characterized by blistering and exfoliative lesions (toxic epidermal necrolysis), generalized acute pustular exanthema (PEGA), andsíndrome of hypersensitivity to drugs with eosinophilia and systemic symptoms (DRESS), lichenoid reactions,characterized by small lesions, which produce itching, red-purple in color, polygonal 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 "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, alterations in heart rhythm, 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 below 25°C.

Store in the original packaging to protect it 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. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Seguril 40 mg tablets

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

Appearance of the product and content of the packaging

Seguril 40 mg tablets are presented in packs of 30 tablets.

They are round tablets, white in color, scored on one face and with “DLI” engraved, and on the other face engraved “HOECHST”.

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

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)

Last review date of this leaflet: January 2024

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