Urofuraginum

Package leaflet: Information for the patient

uroFuraginum, 50 mg, tablets
Furazidinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7–8 days, or if you feel worse, contact your doctor.

Contents of the leaflet:

1. What uroFuraginum is and what it is used for
2. What you need to know 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 uroFuraginum is and what it is used for

uroFuraginum contains as its active substance furazidinum, also known as furagin. Furazidinum is a nitrofuran derivative that inhibits the growth of bacteria causing urinary tract infections.
The indication for use of uroFuraginum is:

• lower urinary tract infections.

If there is no improvement after 7–8 days, or if you feel worse, consult your doctor.

2. Important information before using the medicine uroFuraginum

When not to use uroFuraginum

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6), or to other nitrofuran derivatives,
• during the first trimester of pregnancy,
• in full-term pregnancy (from week 38) and during childbirth, due to the risk of hemolytic anemia (anemia associated with the breakdown of red blood cells) in the newborn,
• in children and adolescents,
• if the patient has renal impairment and laboratory tests have shown creatinine clearance below 60 ml/min or elevated serum creatinine levels,
• if the patient has diagnosed polyneuropathy (a nervous system disorder), e.g. in the course of diabetes,
• if the patient has glucose-6-phosphate dehydrogenase deficiency (an enzyme involved in metabolic processes in red blood cells).

Warnings and precautions
Before starting treatment with uroFuraginum, discuss the following with your doctor or pharmacist:

• if the patient has impaired kidney or liver function, neurological disorders, anemia, electrolyte imbalances, vitamin B complex or folic acid deficiency, or lung diseases,
• if the patient has diabetes, because nitrofurantoin may cause nerve damage. Peripheral neuropathy has been observed in patients treated with nitrofuran derivatives. In severe cases, this disorder may be irreversible and life-threatening. Therefore, uroFuraginum should be discontinued if neurological symptoms occur (such as tingling, numbness, or electric shock sensations),
• if the patient develops fever, chills, cough, chest pain, or 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 – symptoms usually resolve quickly or very quickly after stopping the drug. In chronic reactions, the severity of symptoms and their reversibility after discontinuation depend on how long treatment was continued after the first adverse symptoms appeared. Early recognition of adverse effects and prompt discontinuation of the drug are crucial. Impaired lung function may be irreversible. Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonia) have been reported in patients treated with nitrofurantoin for longer than 6 months, particularly in elderly patients,
• if the medicine is used long-term. In such cases, blood tests may be necessary to monitor white blood cell count, and kidney and liver function.

Children and adolescents
uroFuraginum must not be used in children and adolescents.

uroFuraginum with other medicines
Inform your doctor or pharmacist about any other medicines the patient is currently taking, has recently taken, or plans to take.
Particular caution is required when using the following medicines concurrently:

• Nalidixic acid (an antibiotic) – nitrofurantoin inhibits its bacteriostatic effect.
• Aminoglycosides and tetracyclines (antibiotics) – enhance the antibacterial effect of nitrofurantoin.
• Chloramphenicol and rystomycin (antibiotics) – increase the toxic effect of nitrofurantoin on blood cells.
• Probenecid (in high doses) and sulfinpyrazone (medicines that increase urinary excretion of uric acid) – reduce the excretion of nitrofurantoin and may lead to its accumulation in the body, increasing its toxicity and decreasing its concentration in urine, thereby reducing its efficacy.
• Antacids containing magnesium trisilicate – reduce the absorption of nitrofurantoin.
• Atropine – delays the absorption of nitrofurantoin, although the total amount absorbed remains unchanged.
• Vitamin B complex – enhance the absorption of nitrofurantoin.

Effect on laboratory tests
During nitrofurantoin treatment, urine glucose tests using Benedict's or Fehling's solutions may yield false-positive results. Urine glucose tests performed by enzymatic methods are usually accurate.

uroFuraginum with food, drink, or alcohol
uroFuraginum should be taken orally during protein-containing meals, which enhances drug absorption.
Alcohol consumption should be avoided during treatment with this medicine.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
uroFuraginum must not be used during the first three months of pregnancy (first trimester) or in women with full-term pregnancy and during childbirth. Special caution is required during use in the last three months of pregnancy (third trimester). Nitrofurantoin may cause hemolytic anemia in the newborn.
uroFuraginum must not be used during breastfeeding. Nitrofurantoin passes into breast milk and may harm the breastfed infant.

Driving and operating machinery
There is no data on the effect of nitrofurantoin on the ability to drive or operate machinery. However, some patients may experience adverse effects that could affect driving ability (dizziness, drowsiness, visual disturbances).

uroFuraginum contains 13.75 mg of sucrose per tablet. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use the medicine uroFuraginum

This medicine should always be taken exactly as described in the patient leaflet or as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose
Adults
First day of treatment: 100 mg (2 tablets) four times daily; subsequent days: 100 mg (2 tablets) three times daily.

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

The medicine should be used for 7–8 days. If symptoms worsen or do not improve after 7–8 days, consult your doctor.

Use in children and adolescents
uroFuraginum must not be used in children and adolescents.

Overdose of uroFuraginum
If more than the recommended dose of uroFuraginum is taken, the following symptoms may occur: headache, dizziness, allergic reactions, nausea, vomiting, and anaemia. If such symptoms occur, seek immediate medical attention at the nearest hospital emergency department, as specialist treatment may be required (including gastric lavage and intravenous fluid administration; in severe cases, haemodialysis may be necessary). Due to renal excretion of the medicine, the risk of overdose is increased in patients with impaired kidney function.

Missed dose of uroFuraginum
If a dose of uroFuraginum is missed, continue treatment with the previously prescribed doses. Do not take a double dose to make up for the missed dose.

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

4. Possible adverse reactions

Like all medicines, uroFuraginum may cause adverse reactions, although not everyone experiences them.

Adverse reactions occurring frequently (in 1 to 10 out of 100 patients):

• nausea, excessive flatulence;
• headache.

Adverse reactions occurring no more frequently than in 1 out of 100 patients:

• cyanosis, megaloblastic anaemia (anaemia due to vitamin B12 or folic acid deficiency) or haemolytic anaemia;
• dizziness, somnolence, visual disturbances, peripheral nerve damage (including acute or irreversible forms, especially in patients with renal impairment, anaemia, diabetes, electrolyte disturbances, or vitamin B deficiency);
• hypersensitivity reactions affecting the respiratory system: acute reactions manifesting as fever, chills, cough, chest pain, dyspnoea, pleural effusion, radiological lung abnormalities, and increased levels of a specific type of white blood cells; these usually resolve quickly or very quickly after discontinuation of the drug; chronic reactions including pulmonary fibrosis and diffuse interstitial pneumonia; severity and reversibility after stopping the drug depend on how long treatment was continued after the first adverse symptoms appeared; once an adverse reaction is identified, the drug must be discontinued immediately; lung function impairment may be irreversible;
• constipation, diarrhoea, dyspeptic symptoms (e.g. postprandial fullness, bloating), abdominal pain, vomiting, sialadenitis, pancreatitis, pseudomembranous colitis;
• alopecia, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (bullous erythema multiforme);
• fever, chills, malaise, infections caused by microorganisms resistant to furazidin;
• pruritus, urticaria, anaphylactic reactions (sudden local or systemic allergic reactions), angioedema (a disease of the skin and subcutaneous tissue characterized by localized swelling), rash;
• drug-induced hepatitis, cholestatic jaundice (caused by obstruction of bile flow), hepatic parenchymal necrosis.

Adverse reactions occurring with unknown frequency:

• muscle cramps, muscle pain.

Nitrofuran derivatives may negatively affect testicular function, reduce sperm motility, decrease semen secretion, and lead to adverse changes in sperm morphology.

Reporting of adverse reactions

If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:

Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49-21-301, Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine uroFuraginum

Keep the medicine out of 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 following: EXP:.
The expiry date refers to the last day of the specified month.
Batch number (Lot).
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What uroFuraginum contains

• The active substance is furazidin, also known as furagin. One tablet contains 50 mg of furazidin.
• The other ingredients are: maize starch, sucrose, colloidal anhydrous silica, stearic acid.

What uroFuraginum looks like and contents of the pack
Uncoated tablets, biconvex, yellow-orange in colour, with a division line on one side. The tablet can be divided into halves.
Cartons containing 30 tablets in blisters.
Marketing Authorisation 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
03.2023