neofuragina

Package Leaflet: Information for the Patient

neoFuragina, 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 directed by a doctor or pharmacist.

• The package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 7-8 days or if the patient feels worse, they should contact their doctor.

Table of Contents of the Package Leaflet

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

1. What is neoFuragina and what is it used for

neoFuragina is available in the form of tablets for oral administration. It contains furazidine, also known as furagin, as the active substance. Furazidine is a nitrofuran derivative that inhibits the growth of bacteria that cause urinary tract infections.

The indication for the use of neoFuragina is:

• lower urinary tract infection.

2. Important information before taking neoFuragina

When not to take neoFuragina

• If the patient is allergic to furazidine, nitrofuran derivatives, or any of the other ingredients of this medicine (listed in section 6).
• In the first three months of pregnancy.
• During late pregnancy (from the 38th week) and childbirth, due to the risk of hemolytic anemia in the newborn.
• In children and adolescents.
• If the patient has renal impairment (creatinine clearance below 60 ml/min or elevated serum creatinine levels).
• If the patient has polyneuropathy (a nervous system disorder associated with peripheral nerve damage, which may be characterized by motor or sensory disturbances).
• If the patient has a deficiency of the enzyme glucose-6-phosphate dehydrogenase (a genetic disorder associated with a deficiency of the enzyme involved in red blood cell metabolism), due to the risk of hemolysis when taking the medicine orally.

Warnings and precautions

If the patient has any of the following conditions, the use of neoFuragina should be discussed with a doctor.

• If the patient experiences neurological symptoms (tingling, numbness, sensation of electric currents). These may be symptoms of peripheral nerve damage (peripheral polyneuropathy), which in severe cases can be irreversible and life-threatening. The medicine should be discontinued immediately and a doctor consulted.
• If the patient has diabetes, kidney or liver dysfunction, neurological disorders, anemia, electrolyte disturbances (changes in blood ion concentration), or vitamin B deficiency, or lung disease, they should exercise caution when taking the medicine, as there is an increased risk of peripheral polyneuropathy.
• If the patient experiences symptoms such as fever, chills, cough, chest pain, shortness of breath, the medicine should be discontinued immediately and a doctor consulted. These may be pulmonary reactions, which can occur during treatment with nitrofuran derivatives (see also section 4).
• If the patient is taking the medicine long-term, regular blood tests and kidney and liver function tests may be necessary. Rarely, liver function disorders, including cholestatic jaundice and chronic hepatitis, can occur. If liver function disorders are detected (such as right upper quadrant pain, yellowing of the skin), treatment with furazidine should be discontinued immediately.
• Alcohol should be avoided during treatment with furazidine.

Children and adolescents

neoFuragina should not be taken by children and adolescents.

neoFuragina and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• quinolone derivatives (e.g., nalidixic acid, norfloxacin, oxolinic acid - antibacterial medicines) - furazidine may inhibit their antibacterial activity;
• aminoglycoside and tetracycline antibiotics - when given with furazidine, they enhance its antibacterial activity;
• ristomycin, levomycetin, sulfonamides, chloramphenicol (antibiotics) - possible risk of bone marrow suppression;
• probenecid and sulfinpyrazone (medicines that increase uric acid excretion in the urine) - may reduce furazidine excretion and cause its accumulation in the body, increasing its toxicity and reducing its concentration in the urine, which may lead to a decrease in its effectiveness;
• antacids containing magnesium trisilicate, which inhibit furazidine absorption - may reduce the antibacterial activity of furazidine;
• carbonic anhydrase inhibitors (sulfonamides, diuretics, or medicines used to treat glaucoma) and medicines that increase urine pH (alkalizing) - may decrease the antibacterial activity of nitrofurans;
• vitamin B or increased salt intake - increase the absorption of nitrofuran derivatives;
• atropine - may delay furazidine absorption, but the total amount of absorbed substance does not change.

Effect on laboratory test results

During furazidine administration, glucose tests in urine using copper sulfate solutions (e.g., Benedict's or Fehling's solution) may give false-positive results.

Glucose tests in urine performed using enzymatic methods are accurate.

neoFuragina with food or alcohol

neoFuragina should be taken orally during meals containing protein, which increases furazidine absorption.

Alcohol should be avoided during treatment with neoFuragina due to the possibility of a disulfiram-like effect with symptoms such as a feeling of heat, abdominal pain, nausea, vomiting, and tachycardia.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

neoFuragina should not be taken during the first three months of pregnancy or in late pregnancy (from the 38th week) and childbirth. Particular caution should be exercised when taking the medicine during the last three months of pregnancy. Furazidine may cause hemolytic anemia in the newborn.

Breastfeeding

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

Fertility

Nitrofuran derivatives may have an adverse effect on testicular function, slightly or moderately reducing the total number of sperm in the semen.

Driving and using machines

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

However, some patients may experience side effects that can affect the ability to drive and use machines (dizziness, drowsiness, vision disturbances, see also section 4).

neoFuragina contains lactose monohydrate and sucrose

One tablet contains 18.80 mg of lactose monohydrate and 10.00 mg of sucrose.

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take neoFuragina

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

In case of doubt, a doctor or pharmacist should be consulted.

Adults

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

neoFuragina should be taken orally during meals containing protein, which increases furazidine absorption.

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

If necessary, the treatment can be repeated after 10-15 days.

Use in children

neoFuragina should not be taken by children and adolescents.

Overdose of neoFuragina

In case of overdose, nausea, vomiting, headache, dizziness, allergic reactions, or anemia may occur.

If any worrying symptoms occur, a doctor or pharmacist should be consulted immediately, as specialized treatment may be necessary. Due to the excretion of the medicine from the body through the kidneys, the risk of overdose is increased in patients with impaired renal function.

Missed dose of neoFuragina

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

Discontinuation of neoFuragina

Discontinuation of neoFuragina during treatment may result in incomplete cure of the lower urinary tract infection.

In case of any further doubts about the use of this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

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

If severe side effects occur, the medicine should be discontinued and a doctor consulted immediately:

Rare side effects (less than 1 in 1,000 people):

• anaphylactic reactions (sudden local or systemic allergic reactions), angioedema (which can make breathing and swallowing difficult)
• severe skin reactions (exfoliative dermatitis, erythema multiforme, blistering erythema multiforme - Stevens-Johnson syndrome)
• symptoms of drug-induced hepatitis, cholestatic jaundice (caused by an obstacle to bile flow), liver necrosis (usually during long-term use). Frequency not known (cannot be estimated from the available data):
• asthmatic reaction (shortness of breath) in patients with asthma; hypersensitivity reactions affecting the respiratory system, including:
• acute reactions - characterized by fever, chills, cough, chest pain, shortness of breath - usually resolve quickly after discontinuation of the medicine;
• chronic reactions - including changes in the lungs (e.g., pulmonary fibrosis, 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 detection of a side effect, the medicine should be discontinued immediately; pulmonary impairment may be irreversible; chronic pulmonary reactions (including pulmonary fibrosis and interstitial pneumonia) may occur, especially in elderly patients.
• infections with furazidine-resistant microorganisms, fever, chills, malaise;
• methemoglobinemia-induced cyanosis;
• in patients with glucose-6-phosphate dehydrogenase deficiency, furazidine may cause megaloblastic or hemolytic anemia;
• pseudomembranous colitis (diarrhea with abdominal cramps, slightly elevated body temperature; severe colitis);
• pancreatitis characterized by severe abdominal pain;
• peripheral nerve damage (also with acute or irreversible course, especially in patients with impaired renal function, anemia, diabetes, electrolyte disturbances, or vitamin B deficiency).

Other side effects:

Common side effects (may occur in less than 1 in 10 people):

• nausea, excessive gas;
• headache.

Frequency not known (frequency cannot be estimated from the available data):

• itching, urticaria, rash;
• dizziness, drowsiness, vision disturbances;
• vomiting, constipation, diarrhea, symptoms of indigestion, abdominal pain, loss of appetite, parotid gland inflammation;
• hair loss (transient).

Reporting side effects

If any side effects occur, including any side effects not listed in the package leaflet, the patient should inform their doctor or pharmacist.

Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, 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.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store neoFuragina

Store in a temperature below 25°C.

The medicine should be stored out of sight and reach of children.

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

Expiry date (Exp). The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What neoFuragina contains

• The active substance of the medicine is furazidine (Furazidinum). One tablet contains 50 mg of furazidine.
• The other ingredients are: lactose monohydrate, potato starch, sucrose, polysorbate 80, stearic acid.

What neoFuragina looks like and contents of the pack

neoFuragina is available in the form of yellow or orange-yellow, round tablets with a smooth surface.

The carton contains 30 tablets in blisters and a patient information leaflet.

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, Tel: (22) 345 93 00

Manufacturer

Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków

Date of last revision of the package leaflet:April 2022