Furosemidum Polfarmex

Package Leaflet: Information for the User

Furosemidum Polfarmex, 40 mg, Tablets

Furosemidum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Furosemidum Polfarmex and what is it used for
• 2. Important information before taking Furosemidum Polfarmex
• 3. How to take Furosemidum Polfarmex
• 4. Possible side effects
• 5. How to store Furosemidum Polfarmex
• 6. Contents of the pack and other information

1. What is Furosemidum Polfarmex and what is it used for

Furosemidum Polfarmex contains furosemide, which is a potent diuretic, also lowering blood pressure.
Your doctor may prescribe Furosemidum Polfarmex for the following conditions:

• edema due to heart disease;
• edema due to liver disease;
• edema due to kidney disease;
• mild or moderate hypertension.

2. Important information before taking Furosemidum Polfarmex

When not to take Furosemidum Polfarmex:

• if you are allergic to furosemide, sulfonamides or any of the other ingredients of this medicine (listed in section 6);
• if you have kidney disease with significantly reduced urine excretion or anuria;
• if you have impaired consciousness with neurological symptoms due to chronic liver damage;
• if you have significantly reduced potassium or sodium levels in the blood (see section 4);
• if you have reduced blood volume or water deficiency in the body;
• during breastfeeding.

Warnings and precautions

Before starting treatment with Furosemidum Polfarmex, discuss it with your doctor or pharmacist.
Your doctor will recommend special caution in the following cases:

• if you have low blood pressure;
• if you have diabetes - you should regularly check your blood glucose levels;
• if you have gout - you should regularly check your uric acid levels in the blood;
• if you have urinary disorders (e.g. prostate enlargement, urethral stricture)

as a sudden flow of urine may lead to urinary retention with excessive bladder distension;

• if you have reduced protein levels in the blood (e.g. in certain kidney diseases with protein loss in the urine);
• if you have liver cirrhosis and concomitant kidney failure;
• if significant blood pressure reduction may cause myocardial infarction or stroke (e.g. in cases of cerebral circulatory disorders or coronary heart disease);
• if you are elderly, taking other blood pressure-lowering medicines, or suffering from other diseases that increase the risk of blood pressure reduction.

During treatment with Furosemidum Polfarmex, your doctor will recommend regular blood morphology tests and potassium and sodium level measurements (which is particularly important in case of vomiting and diarrhea), calcium, bicarbonate, creatinine, urea, uric acid, and glucose measurements.
Weight loss caused by increased urine excretion should not exceed 1 kg per day.
In case of significant dehydration during treatment with Furosemidum Polfarmex, do not take painkillers, antipyretics, and anti-inflammatory drugs (so-called non-steroidal anti-inflammatory drugs), as they may cause acute kidney failure.
To prevent potassium deficiency, a potassium-rich diet is recommended (lean meat, potatoes, bananas, tomatoes, cauliflower, spinach, dried fruits, etc.).
If Furosemidum Polfarmex is taken for a long time, vitamin B (thiamine) deficiency should be supplemented. Vitamin B supports heart function.
There is a risk of autoimmune diseases leading to inflammatory changes in all organs (frequent are joint pains, skin changes, and kidney disorders).
Taking Furosemidum Polfarmex may result in a positive doping control test.

Furosemidum Polfarmex and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Furosemidum Polfarmex may affect the action of other medicines, and other medicines may affect the action of Furosemidum Polfarmex.
Your doctor may recommend changing the dose and/or other precautions if you are taking any of the following medicines:

• Non-steroidal anti-inflammatory drugs (NSAIDs, painkillers, antipyretics, and anti-inflammatory drugs)
• may weaken the effect of furosemide. In patients with reduced intravascular volume, NSAIDs may cause acute kidney failure. Furosemide may enhance the toxic effect of salicylates.
• Antiepileptic drugs - when carbamazepine is used, the risk of low sodium levels increases, while phenytoin weakens the diuretic effect of furosemide.
• Sucralfate (a drug used in gastric ulcer disease) - reduces furosemide absorption from the intestine. When used concomitantly, take both medicines at an interval of at least 2 hours.
• Aliskiren - used in the treatment of hypertension.
• Antihypertensive drugs - possible enhancement of the hypotensive effect. Concomitant use of ACE inhibitors or angiotensin II receptor antagonists (AIIRA) may cause significant blood pressure reduction. Before starting treatment with an ACE inhibitor or AIIRA, your doctor will recommend discontinuing furosemide or reducing its dose.
• Other diuretic drugs - when used concomitantly, there is a risk of enhanced diuretic effect. When treated with thiazide diuretics, there is a high risk of reduced potassium levels. When used concomitantly with potassium-sparing diuretics (e.g. amiloride, spironolactone), there is a risk of increased potassium levels.

• Certain anesthetics (so-called anesthetics) and muscle relaxants with a structure similar to curare (used to relax skeletal muscles during anesthesia). Inform the anesthesiologist about taking Furosemidum Polfarmex.
• Probenecid (a drug used in the treatment of gout), methotrexate (an immunosuppressive drug used in the treatment of rheumatoid and autoimmune diseases), and other drugs excreted by the kidneys like furosemide - Furosemidum Polfarmex may enhance their effects and side effects. At the same time, these drugs may weaken the effect of furosemide.
• Theophylline (a drug used in the treatment of asthma).
• Corticosteroids (cortisone), carbenoxolone, amphotericin B (an antifungal drug), glycyrrhizin contained in licorice - concomitant use with furosemide may lead to increased potassium loss (risk of reduced potassium levels).
• Drugs that may cause changes in the ECG (QT interval prolongation), antiarrhythmic drugs (including amiodarone, disopyramide, flecainide, and sotalol), and cardiac glycosides - increased risk of toxic effects on the heart due to electrolyte disturbances, especially hypokalemia (low potassium levels in the blood).
• Antibiotics - concomitant use of aminoglycosides, polymyxins, or vancomycin increases the risk of toxic damage to hearing - your doctor will recommend such concomitant treatment only if necessary. When used concomitantly with aminoglycosides or cefaloridine, the risk of toxic effects on the kidneys increases. Furosemide may reduce vancomycin levels in serum in patients after cardiac surgery. Concomitant use of trimethoprim increases the risk of low sodium levels. In patients receiving furosemide and certain cephalosporins in high doses, kidney function disorders may occur.
• Cisplatin (an anticancer drug) - when used concomitantly with furosemide, there is a risk of toxic effects on the kidneys and hearing damage.
• Antidiabetic drugs - furosemide weakens the glucose-lowering effect of these drugs.
• Drugs that increase blood pressure (e.g. adrenaline, noradrenaline).
• Cyclosporine - risk of increased potassium levels and gouty arthritis.
• Tacrolimus - risk of increased potassium levels.
• Lithium (used in the treatment of depression): concomitant administration of Furosemidum Polfarmex may lead to enhanced toxic effects of lithium on the heart and nervous system. Your doctor will recommend monitoring lithium levels in the blood.
• Antipsychotic drugs - low potassium levels caused by furosemide increase the risk of toxic effects on the heart. Avoid concomitant use of pimozide. When used concomitantly with amisulpride or sertindole, there is an increased risk of ventricular arrhythmias, and when used concomitantly with phenothiazines - enhancement of the hypotensive effect. When used concomitantly with risperidone, your doctor will consider the benefit-risk ratio of concomitant treatment with furosemide.
• Vasodilators, nitrates - enhancement of the blood pressure-lowering effect.
• Antidepressant drugs - when used concomitantly with MAO inhibitors, there is an enhanced hypotensive effect, while when used concomitantly with tricyclic antidepressant drugs - increased risk of orthostatic hypotension. When used concomitantly with reboxetine, there is an increased risk of low potassium levels.
• Antihistamine drugs - low potassium levels with increased risk of toxic effects on the heart.
• Anxiolytic and sedative drugs - enhanced hypotensive effect.
• Central nervous system stimulants (used in the treatment of attention deficit hyperactivity disorder - ADHD) - low potassium levels increase the risk of ventricular arrhythmias.
• Potassium salts.
• Dopaminergic drugs - enhancement of the hypotensive effect of levodopa.
• Estrogens - weakening of the diuretic effect.
• Prostaglandins - enhancement of the hypotensive effect when used concomitantly with alprostadil.

Furosemidum Polfarmex with food and drink

To prevent significant potassium deficiency, a potassium-rich diet is recommended (lean meat, potatoes, bananas, tomatoes, cauliflower, spinach, dried fruits, etc.).
Large amounts of licorice in combination with Furosemidum Polfarmex may lead to increased potassium loss.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Since furosemide passes into the fetal circulation, Furosemidum Polfarmex should only be taken during pregnancy for a short period if your doctor considers it necessary. Inform your doctor about pregnancy or planned pregnancy.
If taking furosemide is necessary due to heart failure or chronic kidney disease in pregnant women, your doctor will recommend measuring electrolyte levels and hematocrit values and will monitor fetal development.
Furosemide passes into breast milk and inhibits lactation. Therefore, do not take furosemide during breastfeeding. If necessary, stop breastfeeding.

Driving and using machines

When taking furosemide, headache, dizziness, and drowsiness may occur, which may impair the ability to drive vehicles and operate machines.
In such cases, do not drive vehicles or operate machines.
Such symptoms occur especially at the beginning of treatment, when increasing the dose, and changing treatment.

Furosemidum Polfarmex contains lactose

If you have been diagnosed with intolerance to some sugars, contact your doctor before taking the medicine.
This medicine contains 0.0275 g of lactose (0.01375 g of glucose and 0.01375 g of galactose) in one tablet. This should be taken into account in patients with diabetes.

3. How to take Furosemidum Polfarmex

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
For adults and the elderly (>65 years), the recommended dose is:
In the treatment of edema due to heart, liver, and kidney diseases
1 tablet of Furosemidum Polfarmex per day.
Your doctor may increase the dose accordingly.
Treatment is most effective and gentle during intermittent treatment, every other day or for 2-4 consecutive days a week.
In the treatment of mild and moderate hypertension
1 tablet of Furosemidum Polfarmex per day, in monotherapy or in combination with other medicines. If it is necessary to take a so-called ACE inhibitor during treatment, your doctor will recommend discontinuing Furosemidum Polfarmex 2-3 days before starting ACE inhibitor administration. If this is not possible, your doctor will reduce the dose of Furosemidum Polfarmex.
Use in children and adolescents under 18 years of age
Usually, the dose is 1-2 mg/kg body weight, up to a maximum of 40 mg (1 tablet of Furosemidum Polfarmex per day).
Route of administration
Oral administration.
Tablets should be taken whole, before breakfast, with a sufficient amount of liquid (e.g. a glass of water), and should not be chewed.

Take more than the recommended dose of Furosemidum Polfarmex

If you have taken more than the recommended dose of Furosemidum Polfarmex, contact your doctor or go to the emergency department of the nearest hospital immediately.
Symptoms of acute or chronic overdose depend on the degree of fluid and electrolyte deficiency.
Overdose may lead to blood pressure reduction, circulatory disorders, and electrolyte balance disorders (e.g. reduced potassium, sodium, and chloride levels) or increased blood pH value.
Significant fluid loss may cause dehydration and, as a consequence, reduced blood volume, leading to shock and increased blood density with a tendency to thrombosis.
In case of significant water and electrolyte loss, consciousness disorders may occur.

Miss a dose of Furosemidum Polfarmex

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

Stop taking Furosemidum Polfarmex

Do not stop treatment without consulting your doctor. If you stop treatment, your disease symptoms may worsen. The duration of treatment is determined by your doctor.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects, listed below, is defined as follows:

• very common (occurring in at least 1 in 10 people);
• common (occurring in less than 1 in 10 people);
• uncommon (occurring in less than 1 in 100 people);
• rare (occurring in less than 1 in 1000 people);
• very rare (occurring in less than 1 in 10,000 people);
• not known (frequency cannot be estimated from the available data).

Very common

• Electrolyte balance disorders (reduced sodium, calcium, and magnesium levels), metabolic alkalosis, dehydration.
• Increased creatinine and triglyceride levels in the blood.
• Reduced blood pressure.
• Nephrocalcinosis in newborns.

Common

• Increased blood density.
• Electrolyte balance disorders (reduced chloride and potassium levels).
• Increased LDL cholesterol levels in the blood.
• Increased urea, uric acid, and glucose levels in the blood, hyperuricemia, gout.
• Hypovolemia (a condition in which there is too little blood in the blood vessels, causing circulatory disorders).
• Hepatic encephalopathy in patients with liver failure.
• Increased urine volume.

Uncommon

• Reduced platelet count (thrombocytopenia), causing bleeding risk and increased bruising, aplastic anemia.

• Increased blood glucose levels, which may cause latent diabetes to manifest, and in patients with existing diabetes, may worsen glucose metabolism.
• Reduced HDL cholesterol levels.
• Heart rhythm disorders.
• Dryness of the mucous membranes of the mouth, thirst, nausea, intestinal motility disorders, vomiting, diarrhea, constipation.
• Reduced diuresis, urinary incontinence, urinary retention (prostate enlargement, bladder emptying disorders, or urethral stricture).
• Visual disturbances (blurred vision, yellow vision, worsening of existing myopia).
• Rash, itching, hypersensitivity to light, urticaria, exfoliative dermatitis, bullous dermatitis (Ritter's disease), purpura, erythema multiforme, hypersensitivity to light.
• Deafness, sometimes permanent.
• Muscle cramps, muscle weakness.
• Fatigue.

Rare

• Suppression of bone marrow function (requiring discontinuation of the medicine).
• Increased levels of certain white blood cells (eosinophilia), reduced levels of white blood cells (leukopenia).
• Acute kidney failure, interstitial nephritis.
• Toxic epidermal necrolysis.
• Intrahepatic cholestasis (inhibition of bile production), liver function disorders, increased liver enzyme activity.
• Acute pancreatitis.
• Severe hypersensitivity leading to shock (anaphylactic shock). The first symptoms of shock are, among others, skin reactions, such as sudden redness or urticaria, excessive sweating, paleness, as well as anxiety, nausea, headache, shortness of breath.
• Paresthesia (tingling or numbness of the limbs), confusion, headache, lethargy.
• Tinnitus, transient or permanent, hearing disorders.
• Vasculitis, thrombosis, shock.
• Feverish conditions.
• Malaise.

Very rare

• Hemolytic anemia, agranulocytosis.

Not known

• Tetany, worsening of existing metabolic alkalosis (in cases of uncorrected liver cirrhosis), pseudo-Bartter syndrome, and increased potassium excretion, which may cause symptoms from the nervous and muscular systems (muscle weakness, paralysis), gastrointestinal tract (vomiting, constipation, bloating), and kidney and heart symptoms. Significant potassium deficiency may cause paralytic ileus or confusion leading to coma.
• Increased sodium and chloride levels in the urine.
• Severe skin disease with general symptoms, formation of painful blisters on the skin, especially in the mouth, eye, and genital areas; severe skin and mucous membrane disease with blistering and redness of large skin areas.
• Inflammatory skin changes with pustule formation (AGEP - acute generalized exanthematous pustulosis; acute eczema-like drug-induced dermatitis with fever).
• Drug rash with increased white blood cell count and worsening of general condition (DRESS).
• Worsening or activation of systemic lupus erythematosus.
• Dizziness, fainting, or loss of consciousness (caused by symptomatic hypotension).
• Muscle damage (rhabdomyolysis), often associated with significant potassium level reduction in the blood (see section 2. "When not to take Furosemidum Polfarmex").

• Persistent ductus arteriosus, osteoclastic bone damage in newborns.

Reporting side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Furosemidum Polfarmex

Store in a temperature below 25°C.
Store in the original packaging to protect from light.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, box, or label: "EXP".
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Furosemidum Polfarmex contains

The active substance of the medicine is furosemide. One tablet contains 40 mg of furosemide.
The other ingredients are: cornstarch, povidone, magnesium stearate, lactose monohydrate.

What Furosemidum Polfarmex looks like and contents of the pack

Uncoated tablets, white or almost white, round, flat on both sides.
The pack contains 30 or 40 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland (Poland)
Tel.: +48 24 357 44 44
Fax: +48 24 357 45 45
e-mail: polfarmex@polfarmex.pl

Date of last revision of the leaflet: