Furosemide Pensa 40 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Furosemide pensa 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, 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 you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Furosemide pensa 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).

Under your 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 to take Furosemide pensa

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

Do not take Furosemide pensa

• If you are allergic to furosemide, to medicines of the Furosemide pensa type (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 dehydrated.

• 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 severely low levels of potassium in your blood (severe hypokalaemia) (see section 4, “Possible side effects”).

• If you have severe deficiency of sodium salts in the blood (severe hyponatraemia).

• 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 to take Furosemide pensa.

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 (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 severe 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, periodic monitoring of your blood levels of sodium, potassium, and creatinine is generally required, especially if you experience significant fluid loss due to vomiting, diarrhea, or heavy 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 when using risperidone and furosemide concomitantly. Risperidone is a medicine used to treat certain mental disorders, such as dementia (a disease characterized by several symptoms: memory loss, speech difficulties, thinking problems).

Use in athletes

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

Other medicines and Furosemida pensa

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 in the ear or 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), 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 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 treatment or receiving for the first time a high dose of an ACE inhibitor (Angiotensin-Converting Enzyme) or an angiotensin II receptor antagonist.
• 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 anticipated.
• Medicines toxic to the kidneys: concomitant administration may enhance the harmful effect of these medicines on the kidneys.

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.

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 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 lesions of the oral mucosa).
• 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 inducing QT interval prolongation syndrome).

Patients receiving furosemide and high doses of certain cephalosporins (antibiotics) may experience decreased 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 contrast agents) who receive furosemide are more likely to experience worsening of 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.

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 if there are medical reasons requiring it.

Furosemide must not be administered during breastfeeding. If its administration is essential, your doctor may advise you to discontinue 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).

Furosemida pensa contains sodium

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

3. How to take Furosemida pensa

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. 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 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 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 with this medicine should last. Do not stop treatment prematurely.

If you take more Furosemida pensa than you should

In case of overdose or accidental ingestion, consult your doctor immediately or go to the nearest hospital emergency department, bringing this leaflet with you, 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 a severe drop in blood pressure (which may progress to shock), kidney problems (acute renal failure), coagulation disorders (thrombosis), delirium, flaccid paralysis affecting soft muscles, apathy, and confusion.

No specific antidote is known.

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

If you forget to take Furosemida pensa

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 experiences 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 (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.
• auditory disturbances, although usually transient, 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 (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 mucosal reactions (Stevens-Johnson syndrome), serious 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, purple-red, 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 associated with severe hypokalemia (low blood potassium levels) (see section “Do not use Furosemida pensa”).

• 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, disturbances in heart rhythm, 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 pensa Storage

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

Store in the original packaging to protect from light.

This medicine does not require any special storage temperature.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Furosemida pensa

• The active substance is furosemide. Each tablet contains 40 mg of furosemide.
• The other components (excipients) are: maize starch, magnesium carbonate, pregelatinized maize starch, sodium lauryl sulfate, povidone K-30, magnesium stearate.

Nature of the product and contents of the pack

Furosemida pensa is available in packs containing 10 and 30 tablets.

Round, white tablets, 8 mm in diameter, with a score line on one side. The score line facilitates breaking the tablet into equal doses.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Industria Química y Farmacéutica VIR, S.A.

C/Laguna 66-70. Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid), Spain

Date of the most recent review of this leaflet: December 2023

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