Package Insert: Information for the Patient

Furosemide Sandoz 40 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only and should not be given 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 or pharmacist, even if they are not listed in this package insert. See section 4.

Furosemidais a diuretic belonging to the sulfonamide group. It acts by increasing urine elimination (diuretic) and reducing blood pressure (antihypertensive).

Under the prescription of your doctor, this medication is indicated for the treatment of:

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

Please read the instructions provided in section 3. “How to take Furosemida Sandoz” carefully.

Do not take Furosemida Sandoz:

• If you are allergic to furosemide, to furosemide-type medications (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 potassium levels in your blood (severe hypokalemia).
• 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.

If you are pregnant, see the section “Pregnancy, breastfeeding, and fertility”.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Furosemida Sandoz:

• If you have problems with urine elimination, especially at the beginning of treatment,
• If you have low blood pressure (hypotension),
• If you have a special risk of experiencing a significant 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 the section “Possible side effects”),
• In premature children (see the section “Possible side effects”),
• There is a possibility of exacerbating or activating systemic lupus erythematosus,

During treatment with this medication, you will generally require periodic monitoring of your blood levels, of sodium, potassium, creatinine, and especially if you experience severe fluid loss, by vomiting, diarrhea, or intense sweating (dehydration or hypovolemia), as your doctor may consider interrupting treatment.

Patients with advanced age and dementia, who are taking risperidone, should be especially careful when taking this medication. 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 Furosemida Sandoz

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

Some medications may increase their toxicity in the ear and kidneys if administered together with this medication. Therefore, if administered together, it should be under strict medical control.

These medications include:

• Aminoglycoside antibiotics (medications for infections) such as gentamicin, kanamicin, and tobramicin,
• Cancer medications (cisplatin).

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

This medication may weaken the effect of other medications such as:

• Medications used for diabetes (antidiabetics),
• Medications used to raise blood pressure (sympathomimetics with hypertensive effect such as, for example, epinephrine and norepinephrine).

It may also increase the action of certain medications such as:

• Asthma medications (theophylline),
• Muscle relaxants such as curare,
• Depression medications (lithium salts), which may potentiate the harmful effects of lithium on the heart or brain,
• Salicylates: furosemide may increase the toxicity of salicylates,
• Blood pressure-lowering medications, such as diuretics, ACE inhibitors, or angiotensin II receptor antagonists,
• Toxic medications for the kidneys: furosemide may potentiate the harmful effect of these medications on the kidneys.

Inform your doctor if you are being treated with medications for high blood pressure (aliskiren).

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

They may also reduce the effect of furosemide or increase its side effects (by reducing renal elimination of these medications), medications such as probenecid and methotrexate, or other medications that have significant renal elimination.

The following medications may reduce potassium levels in the blood (hypokalemia) if administered with furosemide.

• Medications for inflammation (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 certain heart medications (for example, digitalis medications and medications that induce the QT interval prolongation syndrome).

Some patients who receive high doses of cefalosporin-type antibiotics may experience a decrease in kidney function.

The administration of furosemide and cyclosporin A may produce gouty arthritis.

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

The administration of furosemide together with risperidone in patients with advanced age and dementia may increase mortality.

Pregnancy, breastfeeding, and fertility

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

If you are pregnant, you should only use furosemide under strict medical indication.

During breastfeeding, furosemide should not be administered, and if 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 when starting 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.

Furosemida Sandoz contains lactose and sodium

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

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

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 furosemida with 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 adults

The recommended starting dose is half, one, or two tablets (20 to 80 mg of furosemida) 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

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

Your doctor will indicate the duration of your treatment with Furosemida Sandoz. Do not discontinue treatment before.

If you take moreFurosemida Sandozthan you should

If you have taken more Furosemida Sandoz than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

An accidental overdose may lead to a severe decrease in blood pressure (which may progress to 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 cases will be based on symptoms.

If you forgot to takeFurosemida Sandoz

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

Like all medications,this medicationcan cause side effects, although not everyone will experience them.

Side effects have been grouped by their frequency:

Veryfrequent(can affect more than1 in 10 patients)

• electrolyte imbalances (including symptomatic ones), dehydration, and decreased total blood volume (hypovolemia), particularly in elderly patients, elevated creatinine and triglyceride levels in the blood.

Frequent(can affect up to1 in 10 patients)

• decreased sodium (hyponatremia), chloride (hypochloremia), and potassium (hypokalemia) levels, increased cholesterol and uric acid levels in the blood, and gout attacks,
• increased urine volume,
• mental changes (hepatic encephalopathy) in patients with liver problems (hepatic cell insufficiency),
• increased blood viscosity (hemoconcentration).

Infrequent(can affect up to1 in 100 patients)

• glucose intolerance. A latent diabetes mellitus may manifest,
• nausea,
• auditory disturbances, although usually transient, especially in patients with renal insufficiency, decreased protein levels in the blood (hypoproteinemia), and/or after a rapid intravenous administration of furosemide. Deafness (sometimes irreversible),
• itching, hives, rashes, blisters, and more severe reactions such as erythema multiforme, pemphigoid, exfoliative dermatitis, purpura, and photosensitivity reactions,
• decreased platelet levels (thrombocytopenia).

Rare(can 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 (leukopenia), increased levels of a type of white blood cell, eosinophils (eosinophilia),
• fever.

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

• inflammation of the pancreas (acute pancreatitis),
• liver problems (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 calcium (hypocalcemia), magnesium (hypomagnesemia) levels, increased urea levels 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 sodium and chloride levels 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), and drug hypersensitivity syndrome with eosinophilia and systemic symptoms (DRESS), lichenoid reactions,
• exacerbation or activation of systemic lupus erythematosus,
• dizziness, fainting, and loss of consciousness (caused by symptomatic hypotension), headache,
• cases of rhabdomyolysis have been reported, often in cases of severe hypokalemia (see "Do not take Furosemida Sandoz"),
• increased risk of persistence of the "ductus arteriosus permeable" when furosemide is administered to premature infants during the first weeks of life.

Like with other diuretics, prolonged administration of this medication 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.

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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 medication.

Keepthis medicationout of the sight and reach of children.

No special storage conditions are required.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD/EXP. 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 the 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 ofFurosemida Sandoz

• The active ingredient is furosemide. Each tablet contains 40 mg of furosemide.
• The othercomponentsare:carboxymethylcellulose sodium (type A) from potato, cornstarch, microcrystalline cellulose, magnesium stearate, and lactose monohydrate.

Appearance of the product and contents of the packaging:

Furosemida Sandoz40 mg are white, round, slightly convex tablets with a notch on one face. The tablet can be divided into equal doses.

It is presented in packs of 10 or 30 tablets.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Salutas Pharma GmBH

Otto Von Guericke Allee 1

39179 Barleben

Germany

Date of the last review of this leaflet:June 2024

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