Furosemidum Polpharma

Package Leaflet: Information for the Patient

Furosemidum Polpharma, 40 mg, Tablets

Furosemidum

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

The active substance of Furosemidum Polpharma is furosemide, which belongs to the group of diuretic medicines. Furosemide increases the amount of urine produced by the body, which helps to alleviate symptoms caused by excessive fluid in the body.
Furosemide is used in adults and children to treat edema associated with congestive heart failure, liver cirrhosis, and kidney disease, when the use of potent and rapidly acting diuretics is indicated.
Furosemide is also used to treat hypertension in adults.

2. Important information before taking Furosemidum Polpharma

When not to take Furosemidum Polpharma:

• if you are allergic to furosemide, sulfonamides, or any of the other ingredients of this medicine (listed in section 6);
• if you have renal failure and anuria despite furosemide administration;
• if you have a low intravascular volume (decreased blood vessel filling) or are dehydrated (loss of a significant amount of fluid, e.g., due to severe diarrhea or vomiting);
• if you have renal failure caused by toxic substances to the kidneys and liver or renal failure associated with hepatic coma;
• if you have low potassium or sodium levels in the blood;
• if you are in a pre-coma or coma state due to liver failure;
• if you are breastfeeding.

Warnings and precautions

Before starting treatment with Furosemidum Polpharma, discuss it with your doctor.
Particular caution is required:

• if you have prostatic hyperplasia or other disorders that cause difficulty in urinating, due to the increased risk of acute urinary retention during furosemide treatment;
• if there is a significant decrease in urine output - the medicine should be discontinued and the doctor consulted;
• if you have liver disease;
• if you have severe renal impairment or are taking furosemide and aminoglycoside antibiotics, ethacrynic acid, or other medicines that can damage hearing, as hearing disturbances, tinnitus, and deafness occur more frequently - if such symptoms occur, the doctor should be informed as soon as possible;
• if you are allergic to sulfonamides, as hypersensitivity reactions to furosemide may occur;
• if you have systemic lupus erythematosus, as furosemide treatment may exacerbate the symptoms of this disease;
• if you have diabetes, as furosemide treatment may increase blood glucose levels - diabetic patients should monitor their blood glucose levels more frequently;
• if you have porphyria (a disease in which oxygen binding by red blood cells is impaired and urine turns purple);
• if you are elderly, taking other medicines that can lower blood pressure, or have other medical conditions that increase the risk of low blood pressure.

During furosemide treatment, dehydration and electrolyte disturbances may occur. Therefore, the doctor will more frequently monitor the levels of electrolytes, particularly potassium, in the blood serum, as well as creatinine and urea levels, and acid-base balance parameters.
The doctor will carefully monitor the patient in case of:

• hypotension - significant hypotension can cause fainting and lead to shock;
• patients at risk of myocardial infarction or stroke in case of significant blood pressure reduction (patients with cerebral circulation disorders or coronary heart disease);
• patients with gout;
• patients with hepatorenal syndrome (liver cirrhosis with concurrent deterioration of kidney function);
• patients with decreased protein levels in the blood (hypoproteinemia), e.g., associated with nephrotic syndrome (furosemide's effect may be weakened, and its ototoxic effect may be enhanced).

Children

Furosemidum Polpharma tablets should not be used in infants and children who cannot swallow tablets.

Furosemidum Polpharma and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• diuretics from other pharmacological groups, as they enhance furosemide's diuretic effect when used together,
• potassium-sparing diuretics, as they reduce potassium excretion in the urine when administered with furosemide,

which can alleviate hypokalemia (decreased potassium levels),

• theophylline (a medicine used to treat asthma), as furosemide may enhance its effect,
• digitalis glycosides and medicines that prolong the QT interval, as furosemide may increase their toxicity and cause life-threatening arrhythmias,
• muscle relaxants (e.g., tubocurarine),
• antibiotics (e.g., cephalosporins or aminoglycosides),
• sucralfate (a medicine that protects the stomach lining) - furosemide should be taken orally at least 2 hours apart, as sucralfate reduces furosemide absorption from the gastrointestinal tract, thereby weakening its effect,
• systemic corticosteroids, carbenoxolone (a medicine used to treat peptic ulcer disease), licorice, beta-sympathomimetics used in high doses, long-term laxative use, reboxetine (used to treat severe depression), corticotropin (a pituitary hormone), and amphotericin B (an antifungal antibiotic), due to the increased risk of hypokalemia (decreased potassium levels),
• medicines that increase blood pressure, such as norepinephrine, dopamine, and epinephrine (catecholamines), as furosemide may reduce their effect on blood vessels,
• lithium - it is not recommended to use lithium with furosemide. The doctor may prescribe both medicines together only if necessary. In such cases, the doctor will monitor lithium levels in the blood and adjust the lithium dose.
• cyclosporine (a medicine used to prevent organ rejection), as concomitant use with furosemide increases the risk of gout,
• antihypertensive medicines (e.g., enalapril, captopril, valsartan, telmisartan), as furosemide may cause excessive blood pressure reduction. The doctor will reduce the furosemide dose or discontinue it at least 3 days before starting or increasing the dose of antihypertensive medicine.
• aliskiren (a medicine used to treat hypertension) - the doctor may adjust the dose and/or take other precautions,
• insulin and oral antidiabetic medicines, as furosemide weakens their effect,
• indomethacin and other nonsteroidal anti-inflammatory medicines, as they may weaken furosemide's diuretic and antihypertensive effects. Concomitant use of these medicines with furosemide increases the risk of acute renal failure.
• phenytoin and its derivatives (used to treat epilepsy), as long-term use weakens furosemide's diuretic effect,
• salicylates, as furosemide enhances their effect,
• cisplatin (a medicine used to treat cancer), as furosemide may enhance cisplatin's adverse effects,
• carbamazepine (used to treat epilepsy) or aminoglutethimide (used to treat Cushing's syndrome), as concomitant use with furosemide may increase the risk of hyponatremia (decreased sodium levels in the blood),
• probenecid (a medicine used to treat gout), as it may weaken furosemide's effect,
• methotrexate (a medicine used to treat severe arthritis and cancer), as it may weaken furosemide's effect,
• risperidone (a medicine used to treat certain mental illnesses) - the doctor will assess the benefit-risk ratio of using it.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
The medicine may be used in pregnant women only if the doctor considers it absolutely necessary.
Furosemide may inhibit lactation. Furosemide passes into breast milk, so breastfeeding is contraindicated.

Driving and using machines

Some side effects that occur in patients taking furosemide, such as dizziness, excessive drowsiness, blurred vision, may slightly or moderately impair physical and mental performance. If such symptoms occur, do not drive or operate machinery. In case of doubt, consult your doctor.

Furosemidum Polpharma contains lactose

Each tablet contains 30 mg of lactose monohydrate.
If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Furosemidum Polpharma

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
Adults
The initial single dose taken in the morning is 40 to 80 mg (1 to 2 tablets).
The doctor may recommend taking a fixed single dose once or twice a day, every other day, or for 2 to 4 consecutive days each week.
In long-term treatment of edema, the daily maintenance dose is usually 40 mg to 80 mg. In the treatment of severe edema, the maximum daily dose is 600 mg, administered in 3 or 4 divided doses.
Children and adolescents
Due to the pharmaceutical form of the medicine - tablets, Furosemidum Polpharma should not be used in infants and children who cannot swallow tablets.
Usually, doses of 1 mg to 3 mg/kg of body weight are used once a day. Do not use doses higher than 40 mg per day, regardless of the child's body weight.
Elderly patients
Dose adjustment in elderly patients is not usually necessary.
Method of administration
The medicine can be taken with or without food.

Using more than the recommended dose of Furosemidum Polpharma

If you have taken more than the recommended dose of the medicine, immediately consult your doctor or go to the emergency department of the nearest hospital.
Overdose symptoms are related to the enhancement of diuretic effect, which causes dehydration, hypotension, dizziness, blurred vision, fainting.
Treatment involves increasing blood volume and replenishing electrolyte deficiencies.

Missing a dose of Furosemidum Polpharma

If you miss a dose, take it as soon as possible. Do not take a double dose to make up for the missed dose.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Furosemide is generally well tolerated. Side effects are usually mild, most often transient, and only rarely require discontinuation of the medicine.

Stop taking Furosemidum Polpharma and immediately consult your doctor if you experience any of the following symptoms:

• difficulty breathing, facial or lip swelling - these may be symptoms of a severe allergic reaction
• skin rash, itching
• severe abdominal pain radiating to the back, which may be a symptom of pancreatitis
• easy bruising, frequent infections, weakness, or fatigue - these may be symptoms of blood disorders
• increased thirst, pain, and dizziness, fainting, confusion, muscle or joint pain, muscle cramps, arrhythmias - these may be symptoms of dehydration and electrolyte disturbances
• jaundice and dark urine - these may be symptoms of liver disorders
• blisters and skin peeling, especially around the lips and eyes, with fever and flu-like symptoms - these may be symptoms of severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

The following side effects have been observed during furosemide treatment.
Very common side effects (affecting more than 1 in 10 patients):

• water and electrolyte disturbances (including symptomatic), dehydration, hypovolemia (decreased blood vessel filling), particularly in elderly patients, increased creatinine levels, increased triglyceride levels in the blood
• hypotension, including orthostatic hypotension.

Common side effects (affecting less than 1 in 10 patients):

• hemoconcentration
• hyponatremia (decreased sodium levels in the blood), hypochloremia (decreased chloride levels in the blood), hypokalemia (decreased potassium levels in the blood), increased cholesterol levels, increased uric acid levels in the blood and gout attacks, increased urine output
• hepatic encephalopathy in patients with liver failure.

Uncommon side effects (affecting less than 1 in 100 patients):

• decreased platelet count
• glucose tolerance disturbances
• deafness, sometimes irreversible, hearing disturbances
• nausea
• itching, urticaria, rash, bullous dermatitis, erythema multiforme, autoimmune bullous dermatosis (pemphigoid), exfoliative dermatitis, purpura, hypersensitivity to light.

Rare side effects (affecting less than 1 in 1000 patients):

• decreased white blood cell count, increased eosinophil count
• severe allergic reactions
• paresthesia (tingling or numbness)
• vasculitis
• vomiting, diarrhea
• interstitial nephritis
• fever.

Very rare side effects (affecting less than 1 in 10,000 patients):

• agranulocytosis (decreased granulocyte count), anemia
• tinnitus
• acute pancreatitis
• bile stasis, increased liver enzyme activity in the blood.

Side effects of unknown frequency (frequency cannot be estimated from available data):

• bone marrow suppression
• exacerbation or activation of systemic lupus erythematosus (SLE)
• hypocalcemia (decreased calcium levels in the blood), hypomagnesemia (decreased magnesium levels in the blood), increased urea levels in the blood, metabolic alkalosis (acid-base balance disorder), pseudo-Bartter syndrome (hypokalemic alkalosis due to high doses of diuretics), anorexia, hyperglycemia (increased blood sugar levels)
• headache, dizziness, fainting, and loss of consciousness (due to symptomatic hypotension), restlessness
• blurred vision, yellow vision
• thrombosis
• abdominal cramps, constipation, stomach upset
• jaundice
• Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis (acute febrile rash), drug rash with eosinophilia and systemic symptoms (DRESS)
• increased sodium levels in urine, increased chloride levels in urine, urinary retention (in patients with urinary outflow obstruction), renal failure, frequent urination, glycosuria (glucose in urine)
• weakness,
• increased risk of premature closure of the ductus arteriosus in the child, which normally closes after birth (if Furosemidum Polpharma was administered to premature infants in the first weeks of life).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Furosemidum Polpharma

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT indicates the batch number.
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 Polpharma contains

• The active substance of the medicine is furosemide. Each tablet contains 40 mg of furosemide.
• The other ingredients are: lactose monohydrate, potato starch, gelatin, talc, magnesium stearate.

What Furosemidum Polpharma looks like and contents of the pack

White or yellowish-white, round, biconvex tablets.
The pack contains 30 tablets.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Date of the last update of the leaflet: