FUROSEMIDE SANDOZ 40 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Furosemide Sandoz 40 mg Tablets EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Furosemide Sandoz and what is it used for
2. What you need to know before taking Furosemide Sandoz
3. How to take Furosemide Sandoz
4. Possible side effects
5. Storage of Furosemide Sandoz
6. Package contents and additional information.

1. What is Furosemide Sandoz and what is it used for

Furosemide is a diuretic belonging to the group of sulfonamides. It acts by increasing urine elimination (diuretic) and reducing blood pressure (antihypertensive).

Always 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 is given to treating the underlying disease).
• Edema following burns.
• Mild and moderate arterial hypertension.

2. What you need to know before taking Furosemide Sandoz

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

Do not take Furosemide Sandoz:

• If you are allergic to furosemide, to medications of the furosemide type (sulfonamides), or to any of the other components of this medication (listed in section 6).
• In case of decreased total blood volume (hypovolemia) or dehydration.
• 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 severely decreased potassium level in the blood (severe hypokalemia).
• If you have a severe deficiency of sodium salts in the blood (severe hyponatremia).
• In case of pre-coma and coma 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 Furosemide Sandoz:

• if you have urine elimination problems, especially at the start of treatment,
• if you have low blood pressure (hypotension),
• if you are at special risk of experiencing a pronounced drop in blood pressure (e.g., 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 severe liver disease (hepato-renal syndrome),
• if your blood protein levels are low (hypoproteinemia), in addition to suffering from, for example, nephrotic syndrome (see section "Possible side effects"),
• in premature infants (see section "Possible side effects"),
• there is a possibility of exacerbation or activation of systemic lupus erythematosus,

During treatment with this medication, periodic monitoring of your blood levels of sodium, potassium, creatinine, and especially if you experience severe fluid loss due to vomiting, diarrhea, or intense sweating (dehydration or hypovolemia), as your doctor may consider it necessary to interrupt treatment.

Patients of advanced age with dementia who are taking risperidone should be especially careful when taking this medication. Risperidone is a medication used to treat certain mental illnesses, such as dementia (a disease characterized by several symptoms: memory loss, speech problems, thinking problems).

Athletes

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

Other medications and Furosemide Sandoz

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

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

Among these medications are:

• aminoglycoside antibiotics (infection medications) such as gentamicin, kanamycin, and tobramycin,
• 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 can weaken the effect of other medications such as:

• medications used for diabetes (antidiabetics),
• medications used to increase blood pressure (sympathomimetics with a hypertensive effect, such as epinephrine and norepinephrine).

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

• medications for asthma (theophylline),
• muscle relaxants such as curare,
• medications for depression (lithium salts), which can potentiate the harmful effects of lithium on the heart or brain,
• salicylates: furosemide can increase the toxicity of salicylates,
• hypotensive medications (to decrease blood pressure), such as diuretics, ACE inhibitors, or an angiotensin II receptor antagonist,
• medications toxic to the kidneys: furosemide can 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) can reduce the effect of furosemide.

Additionally, they can reduce the effect of furosemide or increase its side effects (by reducing the renal elimination of these medications), medications such as probenecid and methotrexate or other medications that have significant elimination through the kidneys.

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

• Medications for inflammation (corticosteroids).
• Carbenoxolone (medication for the treatment of oral mucosa lesions).
• Large amounts of licorice.
• Prolonged use of laxatives for constipation.

Some electrolyte disturbances (e.g., decreased potassium levels in the blood (hypokalemia) or magnesium (hypomagnesemia)) could increase the toxicity of some heart medications (e.g., digitalis medications and medications that induce the QT interval prolongation syndrome).

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

The combined administration of furosemide and cyclosporin A can produce gouty arthritis.

Those patients at high risk of suffering from nephropathy (kidney disease) due to contrast media who receive furosemide have a higher likelihood of suffering from kidney function deterioration.

The administration of furosemide together with risperidone in elderly patients with dementia could increase mortality.

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 medication.

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

During breastfeeding, furosemide should not be administered. If it is essential, your doctor may require you to interrupt breastfeeding, as furosemide passes into breast milk.

Driving and using machines

This medication can cause dizziness or drowsiness. This may occur more frequently when starting treatment, when your doctor increases the dose, or if you consume alcohol. Do not drive or operate tools or machines if you feel dizzy or drowsy.

Furosemide Sandoz contains lactose and sodium

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

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

3. How to take Furosemide Sandoz

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

Remember to take your medication.

Take furosemide on an empty stomach, swallowing it whole 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 lowest sufficient dose to produce the desired effect.

In adults

The recommended dose to start treatment is 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 indicated by your doctor and will depend on your response to treatment.

Use in children

In infants and children, the recommended dose is the 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 Furosemide Sandoz. Do not suspend treatment before.

If you take more Furosemide Sandoz than you should

If you have taken more Furosemide 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 can 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 cases of overdose, treatment will be based on symptoms.

If you forget to take Furosemide Sandoz

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

4. Possible side effects

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

Side effects have been grouped by frequency:

Very common(may affect more than 1 in 10 patients)

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

Common(may affect up to 1 in 10 patients)

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

Uncommon(may affect up to 1 in 100 patients)

• altered glucose tolerance. Latent diabetes mellitus may be revealed,
• nausea,
• hearing disorders, although usually transient, especially in patients with renal insufficiency, hypoproteinemia, and/or after too rapid intravenous administration of furosemide. Deafness (sometimes irreversible),
• itching, rash, eruptions, blisters, and more severe reactions such as erythema multiforme, pemphigoid, exfoliative dermatitis, purpura, and photosensitivity reaction,
• decreased platelet levels (thrombocytopenia).

Rare(may affect up to 1 in 1,000 patients)

• allergic inflammation of blood vessels (vasculitis),
• renal allergic reaction (tubulointerstitial nephritis),
• vomiting, diarrhea,
• subjective sensation of ringing (tinnitus),
• severe allergic reactions (anaphylactic or anaphylactoid) (e.g., with shock),
• tingling sensation in the limbs (paresthesia),
• decreased white blood cell count (leukopenia), increased eosinophil count (eosinophilia),
• fever.

Very rare(may affect up to 1 in 10,000 patients)

• inflammation of the pancreas (acute pancreatitis),
• liver problem (cholestasis), increased liver enzymes (transaminases),
• decreased granulocyte count (agranulocytosis), decreased red blood cell count (aplastic anemia or hemolytic anemia).

Frequency not known(cannot be estimated from available data)

• decreased calcium (hypocalcemia), magnesium (hypomagnesemia) levels, increased urea level in the blood, metabolic alkalosis, pseudo-Bartter syndrome in the case of misuse and/or prolonged use of furosemide,
• altered blood coagulation (thrombosis),
• increased sodium and chloride levels in the urine, urine retention (in patients with partial obstruction of urine flow), kidney stone formation (nephrocalcinosis/nephrolithiasis) in premature infants, kidney failure,
• severe skin and mucous membrane reactions (Stevens-Johnson syndrome), severe skin alteration characterized by blistering and exfoliative lesions (toxic epidermal necrolysis), acute generalized exanthematous pustulosis (AGEP), 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 where there is a severe decrease in potassium levels in the blood (hypokalemia) (see section "Do not take Furosemide Sandoz"),
• increased risk of persistence of the "ductus arteriosus permeable" when furosemide is administered to premature infants during the first weeks of life.

As with other diuretics, after prolonged administration of this medication, there may be an increase in the elimination of sodium, chloride, water, potassium, calcium, and magnesium. These disturbances manifest with intense thirst, headache, confusion, muscle cramps, painful muscle contraction, especially in the limbs (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 not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Furosemide Sandoz

Keep this medication out of sight and reach of children.

No special storage conditions are required.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Furosemide Sandoz

• The active ingredient is furosemide. Each tablet contains 40 mg of furosemide.
• The other components are: sodium carboxymethyl starch (type A) of potato, cornstarch, microcrystalline cellulose, magnesium stearate, and lactose monohydrate.

Appearance of the product and package contents:

Furosemide Sandoz 40 mg are white, round, slightly convex tablets with a notch on one side. The tablet can be divided into equal doses.

It is presented in packages of 10 or 30 tablets.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Sandoz Farmacéutica, S.A. Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmBH

Otto Von Guericke Allee 1

39179 Barleben

Germany

Date of the last revision of this package leaflet:June 2024

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