Furosemide Sandoz 40 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Furosemide Sandoz 40 mg tablets EFG

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because 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 Furosemide Sandoz is and what it is used for
2. What you need to know before taking Furosemide Sandoz
3. How to take Furosemide Sandoz
4. Possible side effects
5. How to store Furosemide Sandoz
6. Contents of the pack and other information

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

Furosemide 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, 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 to moderate arterial hypertension.

2. What you need to know before starting to take Furosemide Sandoz

Carefully read the instructions provided in section 3, “How to take Furosemide Sandoz”.

Do not take Furosemide Sandoz:

• If you are allergic to furosemide, to medicines of the furosemide type (sulfonamides), or to any of the other components of this medicine (listed in section 6).
• If your total blood volume is reduced (hypovolemia) or if you are dehydrated.
• If you have severe kidney problems associated with a marked decrease in urine output (renal failure with anuria) that do not respond to this medicine.
• If your blood potassium levels are severely low (severe hypokalemia).
• If you have a severe deficiency of sodium salts in the blood (severe hyponatremia).
• If you are in a pre-comatose or comatose state associated with hepatic encephalopathy.
• If you are breastfeeding.

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

Warnings and precautions

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

• 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 pronounced drop in blood pressure (e.g., 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 “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 medicine, periodic monitoring of 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 your doctor may consider it necessary to discontinue treatment.

Elderly patients with dementia who are taking risperidone should exercise special caution when taking this medicine. Risperidone is a medicine used to treat certain mental illnesses such as dementia (a condition characterized by several symptoms: memory loss, speech difficulties, thinking problems).

Use in athletes

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

Other medicines and Furosemide Sandoz

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

The toxicity of certain medicines to the ear and kidneys may be increased when administered together with this medicine. Therefore, if they are used concurrently, it must be under strict medical supervision.

These medicines include:

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

This medicine and sucralfate should not be administered together within less than a 2-hour interval, as the effect of furosemide may be reduced.

This medicine may weaken the effect of other medicines such as:

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

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

• asthma medicines (theophylline),
• curare-type muscle relaxants,
• medicines for depression (lithium salts), which may enhance the harmful effects of lithium on the heart or brain,
• salicylates: furosemide may increase the toxicity of salicylates,
• antihypertensive medicines (to lower blood pressure), such as diuretics, ACE inhibitors, or angiotensin II receptor antagonists,
• medicines toxic to the kidneys: furosemide may enhance the harmful effects of these medicines on the kidneys.

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

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

Additionally, medicines such as probenecid and methotrexate, or other medicines that are significantly eliminated by the kidneys, may reduce the effect of furosemide or increase its adverse effects (by reducing the renal elimination of these medicines).

The following medicines may reduce blood potassium levels (hypokalemia) when administered with furosemide:

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

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

Some patients receiving high doses of cephalosporin-type antibiotics may experience reduced kidney function.

The concomitant administration of furosemide and cyclosporine A may cause gouty arthritis.

Patients at high risk of contrast-induced nephropathy (kidney disease due to radiocontrast agents) who receive furosemide are more likely to experience deterioration in kidney function.

The administration of furosemide together with risperidone in elderly patients with dementia may 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 medicine.

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

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

Driving and use of machines

This medicine may cause dizziness or drowsiness. This is more likely to occur 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.

Furosemide Sandoz contains lactose and sodium

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

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

3. How to take Furosemida Sandoz

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 furosemide 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 needed to achieve the desired effect.

In adults

The recommended starting dose 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 determined by your doctor and depends on your response to treatment.

Use in children

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

Your doctor will indicate how long your treatment with Furosemida Sandoz should last. Do not stop treatment prematurely.

If you take more Furosemida Sandoz than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 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), blood clotting disorders (thrombosis), delirium, paralysis affecting soft muscles (flaccid paralysis), apathy, and confusion.

There is no known specific antidote.

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

If you forget to take Furosemida Sandoz

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 will experience 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 decreased 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 levels of cholesterol and uric acid in blood, and gout attacks;
• increased urine volume;
• mental disturbances (hepatic encephalopathy) in patients with liver problems (hepatic 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 levels of white blood cells (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 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 urinary flow), formation of kidney stones (nephrocalcinosis/nephrolithiasis) in premature infants, renal failure;
• severe blistering skin and mucous membrane reactions (Stevens-Johnson syndrome), serious skin disorder 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-type 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, frequently in cases associated with severe hypokalemia (low potassium levels in blood) (see section “Do not take Furosemide Sandoz”);
• 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 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. Furosemide Sandoz Storage

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Furosemide Sandoz

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

Appearance of the product and contents of the pack:

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

They are available in packs of 10 or 30 tablets.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.
Parque Norte Business Park
Roble Building
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer

Salutas Pharma GmbH
Otto Von Guericke Allee 1
39179 Barleben
Germany

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

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