Furosemide Cinfa 40 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Furosemide cinfa 40 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. 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 you should not give it to other people, even if they have the same symptoms as you. 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.

Contents of this leaflet

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

1. What furosemide cinfa is and what it is used for

Furosemide cinfa is a diuretic belonging to the sulfonamide group. It works by increasing urine elimination (diuretic effect) and reducing blood pressure (antihypertensive effect).

Always under a 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 to moderate arterial hypertension.

2. What you need to know before starting furosemide cinfa

Do not take furosemide cinfa

• If you are allergic to furosemide, to medicines belonging to the sulfonamide group, 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 reduced urine output (renal failure with anuria) that do not respond to this medicine.
• If you have severely low levels of potassium in your blood (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 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 furosemide cinfa.

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 (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 severe liver disease (hepatorenal syndrome).
• If you have low levels of protein in your blood (hypoproteinemia), especially if you also have, for example, 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 elderly, if you are being treated with medicines that may cause low blood pressure, or if you have other medical conditions associated with a risk of low blood pressure.

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 well as significant electrolyte and acid-base imbalances, should be corrected. Treatment interruption may be necessary.

Elderly patients with dementia who are taking risperidone should exercise particular caution when using risperidona and furosemide concomitantly. 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 result in a positive outcome in doping control tests.

Taking furosemide cinfa with other medicines

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 furosemide is used at the same time as other medicines.

Some substances may have increased toxicity to the ear and kidneys when 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).

Concomitant use of furosemide 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, e.g., epinephrine and norepinephrine).

In other cases, concomitant use may increase the effects of these medicines, such as:

• Medicines for asthma (theophylline).
• Curare-type muscle relaxants.
• Medicines for depression (lithium salts): may increase the risk of lithium toxicity, including risk of harmful effects on the heart or brain.
• Patients receiving diuretic treatment may experience severe hypotension and worsening of kidney function, especially when an ACE inhibitor (Angiotensin-Converting Enzyme inhibitor) or an angiotensin II receptor antagonist is administered for the first time or when a high dose is initiated.
• If medicines for high blood pressure, diuretics, or other medicines that may lower blood pressure are administered together with furosemide, a more pronounced drop in blood pressure should be anticipated.
• Nephrotoxic medicines: 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 furosemide.

Furosemide may increase the toxicity of salicylates.

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

Medicines such as probenecid and methotrexate, or other medicines significantly eliminated by the kidneys, may reduce the effect of furosemide. 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 blood (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 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 treated with furosemide who receive high doses of certain cephalosporins (antibiotics) may experience reduced kidney function.

Concomitant administration of furosemide and cyclosporine A (a medicine used to prevent transplant rejection) is associated with an increased risk of gouty arthritis (joint inflammation) secondary to elevated blood urea levels (hyperuricemia) and impaired kidney excretion of urea.

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

Administration of furosemide 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.

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.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might 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 if there are medical reasons requiring it.

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

Driving and using 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.

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).

Furosemide cinfa contains sodium

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

3. How to take furosemide cinfa

Follow exactly the instructions for use of this medicine 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.

The tablet may be divided into equal doses.

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

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

Use in adults

Treatment should be initiated with half, one, or two tablets (20 to 80 mg of furosemide) daily. The maintenance dose is half to one tablet per day. 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 how long your treatment with this medicine should last. Do not stop treatment prematurely.

If you take more furosemide cinfa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

An accidental overdose could lead to severe drop in blood pressure (which may progress to shock), kidney problems (acute renal failure), coagulation disorders (thrombosis), delirium, paralysis affecting soft muscles (flaccid paralysis), apathy, and confusion.

No specific antidote is known.

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

If you forget to take furosemide cinfa

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

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 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 levels of cholesterol and uric acid 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 severe 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 reactions (anaphylactic or anaphylactoid), 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 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), kidney stone formation (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), 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 patients with severe hypokalemia (low potassium levels in blood) (see section “Do not take furosemide cinfa”).
• increased risk of persistence of the ductus arteriosus (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. Furosemide cinfa storage

Keep this medicine out of the sight and reach of children.

Store in the original packaging to protect it from light.

Do not use this medicine after the expiry date stated on the container following “EXP”. The expiry date refers to the last day of the month indicated.

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

6. Contents of the container and other information

Composition of furosemida cinfa

• The active substance is furosemide.
• The other components are: magnesium carbonate (E-504), pregelatinized corn starch, corn starch, magnesium stearate (E-470b), sodium lauryl sulfate, and povidone (E-1201).

Appearance of the product and contents of the container

White, cylindrical, biconvex tablets, scored on one side and marked with the code “FU” on the other.

furosemida cinfa is available in packs containing 10, 30, or 500 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10 - Polígono Industrial Areta.
31620 Huarte (Navarra) - Spain

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

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

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the package leaflet and carton with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/64140/P_64140.html

QR code links to: https://cima.aemps.es/cima/dochtml/p/64140/P_64140.html