urofuraginum

Package Leaflet: Information for the Patient

uroFuraginum, 50 mg, tablets
Furazidinum

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

This medicine should always be taken exactly as described in the package leaflet for the patient or as advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If after 7-8 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet:

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

1. What is uroFuraginum and what is it used for

uroFuraginum contains the active substance furazidine, also known as furagin. Furazidine is a nitrofuran derivative that inhibits the growth of bacteria that cause urinary tract infections.

The indication for the use of uroFuraginum is:

• lower urinary tract infection.

If after 7-8 days there is no improvement or you feel worse, you should consult a doctor.

2. Important information before taking uroFuraginum

When not to take uroFuraginum

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6), or other nitrofuran derivatives,
• in the first trimester of pregnancy,
• during the last trimester of pregnancy (from the 38th week) and childbirth, due to the risk of hemolytic anemia (anemia related to red blood cell destruction) in the newborn,
• in children and adolescents,
• if you have renal failure, and laboratory tests have shown a creatinine clearance below 60 ml/min or an elevated serum creatinine level,
• if you have diagnosed polyneuropathy (nerve system disorder), e.g. in diabetes,
• if you have a deficiency of glucose-6-phosphate dehydrogenase (an enzyme involved in red blood cell metabolism).

Warnings and precautions

Before starting to take uroFuraginum, discuss it with your doctor or pharmacist:

• if you have kidney, liver, or nervous system disorders, anemia, electrolyte disturbances, vitamin B or folic acid deficiency, or lung disease,
• if you have diabetes, as furazidine may cause nerve damage. Peripheral nerve damage has been observed in patients treated with nitrofuran derivatives. This disorder can be irreversible and life-threatening in severe cases. Therefore, uroFuraginum should be discontinued if symptoms of nervous system disorders occur (tingling, numbness, sensation of electric currents),
• if you experience fever, chills, cough, chest pain, shortness of breath. These may be symptoms of acute pulmonary reactions, which are sometimes observed in patients treated with nitrofuran derivatives. If such symptoms occur, the medicine should be discontinued immediately - they usually resolve quickly or very quickly after discontinuation of the medicine. In cases of chronic reactions, the severity of symptoms and their reversibility after discontinuation of the medicine depend on the duration of treatment after the first symptoms appear. Early detection of the adverse reaction and discontinuation of the medicine are crucial. Pulmonary function impairment may be irreversible. Chronic reactions occurred in patients taking furazidine for more than 6 months. Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonia) may occur, especially in elderly patients,
• if the medicine is taken for a long time. Blood tests may be necessary to monitor white blood cell count and kidney and liver function.

Children and adolescents

uroFuraginum should not be taken by children and adolescents.

uroFuraginum and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

• Nalidixic acid (antibiotic) - furazidine inhibits its bacteriostatic effect.
• Aminoglycosides and tetracyclines (antibiotics) - enhance the antibacterial effect of furazidine.
• Chloramphenicol and ristomycin (antibiotics) - increase the toxic effect of furazidine on red blood cells.
• Probenecid (in high doses) and sulfinpyrazone (medicines that increase uric acid excretion in urine) - decrease furazidine excretion and may cause its accumulation in the body, increasing its toxicity and reducing its concentration in urine, which may lead to a decrease in its effectiveness.
• Antacids containing magnesium trisilicate - reduce furazidine absorption.
• Atropine - delays furazidine absorption, but the overall amount of absorbed substance does not change.
• Vitamin B - increases furazidine absorption.

Effect on laboratory tests

During furazidine administration, glucose tests in urine using Benedict's and Fehling's solutions may give false-positive results. Glucose tests in urine performed using enzymatic methods are usually accurate.

uroFuraginum with food, drink, or alcohol

uroFuraginum should be taken orally during meals containing protein, which increases the absorption of the medicine.

Avoid consuming alcohol while taking the medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

uroFuraginum should not be taken during the first three months of pregnancy (first trimester) or in late pregnancy and childbirth. Particular caution should be exercised during the last three months of pregnancy (third trimester). Furazidine may cause hemolytic anemia in the newborn.

uroFuraginum should not be taken during breastfeeding. Furazidine passes into breast milk and may harm the breastfed child.

Driving and using machines

There is no data on the effect of furazidine on the ability to drive and use machines.

However, some patients may experience side effects that may affect the ability to drive (dizziness, drowsiness, vision disturbances).

uroFuraginum contains 13.75 mg of sucrose in one tablet.If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take uroFuraginum

This medicine should always be taken exactly as described in the package leaflet for the patient or as advised by a doctor or pharmacist.

Recommended dose

Adults

First day of treatment: 100 mg (2 tablets) 4 times a day; subsequent days: 100 mg (2 tablets) 3 times a day.

uroFuraginum should be taken orally during meals containing protein, which increases the absorption of the medicine.

The medicine is taken for 7-8 days. If symptoms worsen or do not improve after 7-8 days, you should consult a doctor.

Use in children and adolescents

uroFuraginum should not be taken by children and adolescents.

Taking a higher dose of uroFuraginum than recommended

If a higher dose of uroFuraginum than recommended is taken, the following symptoms may occur: headache, dizziness, allergic reactions, nausea, vomiting, anemia. If such symptoms occur, you should immediately consult the emergency department of the nearest hospital, as specialized treatment may be necessary (including gastric lavage and intravenous fluid administration, and in severe cases, hemodialysis). Due to the excretion of the medicine by the kidneys, the risk of overdose is increased in patients with impaired renal function.

Missing a dose of uroFuraginum

If a dose of uroFuraginum is missed, treatment should be continued with the previously taken doses of the medicine. Do not take a double dose to make up for the missed dose.

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

4. Possible side effects

Like all medicines, uroFuraginum can cause side effects, although not everybody gets them.

Common side effects (in 1 to 10 patients in 100):

• nausea, excessive gas;
• headache.

Uncommon side effects (in 1 to 100 patients):

• cyanosis, megaloblastic anemia (anemia due to vitamin B12 or folic acid deficiency) or hemolytic anemia;
• dizziness, drowsiness, vision disturbances, peripheral nerve damage (also acute or irreversible, especially in patients with renal failure, anemia, diabetes, electrolyte disturbances, vitamin B deficiency),
• respiratory hypersensitivity reactions, acute reactions - manifested by fever, chills, cough, chest pain, shortness of breath, exudate in the chest cavity, changes in the lung radiograph, and an increase in the number of a specific type of white blood cell; usually resolve quickly or very quickly after discontinuation of the medicine; chronic reactions - including pulmonary fibrosis and diffuse interstitial pneumonia; the severity of symptoms and their reversibility after discontinuation of the medicine depend on the duration of treatment after the first symptoms appear; after identifying the adverse reaction, the medicine should be discontinued immediately; pulmonary function impairment may be irreversible;
• constipation, diarrhea, dyspeptic symptoms (e.g. feeling of postprandial fullness, bloating), abdominal pain, vomiting, salivary gland inflammation, pancreatitis, pseudomembranous colitis;
• hair loss, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (vesicular erythema multiforme);
• fever, chills, malaise, infections with microorganisms resistant to furazidine;
• itching, urticaria, anaphylactic reactions (sudden local or systemic allergic reactions), angioedema (a skin and subcutaneous tissue disease characterized by the formation of limited edema), rash;
• symptoms of drug-induced hepatitis, cholestatic jaundice (caused by an obstacle to bile flow), liver necrosis.

Rare side effects (frequency not known):

• muscle cramps, muscle pain.

Nitrofuran derivatives may negatively affect testicular function and cause a decrease in sperm motility, a decrease in sperm secretion, and unfavorable changes in sperm structure.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, tell 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.: 22 49-21-301, fax: 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 uroFuraginum

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

Store in a dry place.

Do not use this medicine after the expiry date stated on the blister and carton after: EXP:.

The expiry date refers to the last day of the month.

Batch number (Lot).

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 uroFuraginum contains

• The active substance of the medicine is furazidine, also known as furagin. One tablet contains 50 mg of furazidine.
• The other ingredients are: cornstarch, sucrose, colloidal anhydrous silica, stearic acid.

What uroFuraginum looks like and contents of the pack

Tablets are uncoated, flat, yellow-orange in color, with a dividing line on one side. The tablet can be divided into halves.

Cartons contain 30 tablets in blisters.

Marketing authorization holder

Adamed Pharma S.A.

Pieńków, ul. M. Adamkiewicza 6A

05-152 Czosnów

Manufacturer

Adamed Pharma S.A.

Pieńków, ul. M. Adamkiewicza 6A

05-152 Czosnów

Date of last revision of the leaflet:

• 03.2023