Furosemide Vir 40 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Furosemide Vir 40 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 should not give it to others, 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 Furosemida Vir is and what it is used for
2. What you need to know before taking Furosemida Vir
3. How to take Furosemida Vir
4. Possible adverse effects
5. How to store Furosemida Vir
6. Contents of the pack and other information

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

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

Always under the prescription of your doctor, 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 Furosemida Vir

Read carefully the instructions provided in section 3, “How to take Furosemida Vir”.

Do not take Furosemida Vir

• If you are allergic to furosemide, to medicines of the type Furosemida Vir (sulfonamides), or to any of the other components of this medicine (listed in section 6).

• If you have a decreased total blood volume (hypovolemia) or are suffering from dehydration.

• If you have severe kidney problems accompanied by a marked reduction in urine output (renal failure with anuria) that do not respond to this medicine.

• If you have a severe decrease in potassium levels in the blood (severe hypokalemia) (see section 4, “Possible adverse effects”).

• If you suffer from 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 a baby.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take furosemide.

Exercise particular caution 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 (for example, in 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 4. “Possible adverse effects”).
• In premature children (see section 4. “Possible adverse 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 medicines that may cause low blood pressure, or if you have other medical conditions associated with a risk of low blood pressure.

During your treatment with this medicine, regular 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 any significant electrolyte or acid-base imbalances, should be corrected. Interruption of treatment may be necessary.

Elderly patients with dementia who are taking risperidone should exercise special caution with the concomitant use of risperidone and furosemide. Risperidone is a medicine used to treat certain mental disorders, such as dementia (a condition characterized by several symptoms: memory loss, speech difficulties, thinking problems).

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Use in athletes

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

Use of Furosemide Vir with other medicines

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

Tell your doctor if you are being treated with medicines for:

• High blood pressure (aliskiren)

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

Some substances may have increased toxicity in the ear or kidneys when administered together with this medicine. Therefore, they should only be used 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).

The 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 (sympathomimetic hypertensive agents), for example, epinephrine and norepinephrine.

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

• Medicines for asthma (theophylline).
• Muscle relaxants of the curare type.
• Medicines for depression (lithium salts): may increase the risk of lithium toxicity, including the risk of harmful effects on the heart or brain.
• Patients receiving diuretic treatment may experience severe hypotension and worsening of kidney function, especially when starting or increasing the dose of an ACE (Angiotensin-Converting Enzyme) inhibitor or an angiotensin II receptor antagonist for the first time.
• If medicines used to treat 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 expected.
• Medicines toxic to the kidneys: concomitant administration may enhance the harmful effects 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 that are 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 its concomitant administration.

The following substances may increase the risk of lowering potassium levels in the blood (hypokalemia) when administered with furosemide:

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

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

Patients receiving furosemide and 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 increased 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.

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

High doses of furosemide administered with levotyroxine may lead to an initial transient increase in free thyroid hormones, followed by a general decrease in total thyroid hormone levels.

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.

You should only use furosemide during pregnancy if there are medical reasons requiring it.

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

Driving and use of machines

This medicine may cause dizziness or drowsiness. 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 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).

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

3. How to take Furosemida Vir

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Take this medicine on an empty stomach, swallowing it whole 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 dose sufficient to achieve the desired effect.

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, and 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 should last. Do not stop your treatment prematurely.

If you take more Furosemida Vir than you should

In case of overdose or accidental ingestion, contact your doctor immediately or go to the nearest hospital emergency department, bringing this leaflet with you, 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), coagulation disorders (thrombosis), delirium, paralysis affecting soft muscles (flaccid paralysis), apathy, and confusion.

There is no known specific antidote.

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

If you forget to take Furosemida Vir

Do not take a double dose to make up for missed 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 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 cholesterol and uric acid levels 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 transient, especially in patients with renal insufficiency, decreased blood protein levels (hypoproteinemia), and/or following 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 (anaphylactic or anaphylactoid) reactions (e.g., with shock).
• Tingling sensation in the limbs (paresthesias).
• 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 disorder (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 clotting disorders (thrombosis).

• Increased levels of sodium and chloride in urine, urinary retention (in patients with partial obstruction of urine flow), kidney stone formation (nephrocalcinosis/nephrolithiasis) in premature infants, renal failure.

• Severe blistering skin and mucous membrane reactions (Stevens-Johnson syndrome), severe skin disorder characterized by blistering and exfoliative lesions (toxic epidermal necrolysis), acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), 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 cases involving severe hypokalemia (low blood potassium levels) (see section “Do not use Furosemida Vir”).

• 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 Vir Storage

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

Light-sensitive. Store in the original packaging.

This medicine does not require special storage temperature conditions.

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

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Furosemide Vir

• The active substance is furosemide. Each tablet contains 40 mg of furosemide.
• The other components (excipients) are: corn starch, magnesium carbonate, pregelatinized corn starch, sodium lauryl sulfate, povidone, magnesium stearate.

Appearance of the product and contents of the pack

Furosemide Vir is available in packs of 10, 28 and 30 tablets.

Round, white tablets, 8 mm in diameter, scored on one side. The score allows the tablet to be divided into equal doses.

Marketing Authorization Holder and Manufacturer

Industria Química y Farmacéutica VIR, S.A.
C/Laguna 66-68-70. Polígono Industrial Urtinsa II
28923 Alcorcón (Madrid)
Spain

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

Detailed and up-to-date 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/