Neofuragina

Patient Information Leaflet

neoFuragina, 50 mg, tablets
( Furazidinum )
Please read this leaflet carefully before taking this medicine, as 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 side effects, including any possible side effects not listed in this leaflet, you should inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7–8 days, or if you feel worse, you should contact your doctor.

Contents of the leaflet

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

neoFuragina is available as tablets for oral administration. It contains furazidin (also known as furagin) as the active substance. Furazidin is a nitrofuran derivative that inhibits the growth of bacteria causing urinary tract infections.
The indication for use of neoFuragina is:

• infection of the lower urinary tract.

2. Important information before using the medicine neoFuragina

When not to use neoFuragina

• If the patient is allergic to furazidin, nitrofuran derivatives, or any of the other ingredients of this medicine (listed in section 6).
• During the first three months of pregnancy.
• During term pregnancy (from week 38) and 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 failure (laboratory findings showing creatinine clearance below 60 ml/min or elevated serum creatinine levels).
• If the patient has peripheral neuropathy (a nervous system disorder involving damage to peripheral nerves, which may manifest as motor or sensory disturbances).
• If the patient has glucose-6-phosphate dehydrogenase deficiency (a genetic disorder involving deficiency of an enzyme involved in red blood cell metabolism), due to the risk of hemolysis when the medicine is taken orally.

Warnings and precautions
If any of the following situations apply to the patient, 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 signs of peripheral nerve damage (peripheral neuropathy), which in severe cases may be irreversible and life-threatening. The medicine should be discontinued immediately and medical advice sought.
• Particular caution should be exercised when using the medicine if the patient has diabetes, kidney dysfunction, liver dysfunction, neurological disorders, anemia, electrolyte imbalances (changes in blood ion concentrations), vitamin B deficiency, or lung disease, as the risk of developing peripheral neuropathy is increased.
• If the patient develops symptoms such as fever, chills, cough, chest pain, or shortness of breath, the medicine should be discontinued immediately and medical advice sought. These may be pulmonary reactions, which may occasionally occur during treatment with nitrofuran derivatives (see also section 4).
• If the patient is taking the medicine long-term, regular blood tests and monitoring of kidney and liver function may be necessary. Rarely, liver function disorders may occur, including cholestatic jaundice and chronic hepatitis. If liver function abnormalities occur (such as pain in the right hypochondrium, yellowing of the skin), treatment with furazidin should be stopped immediately.
• Alcohol consumption should be avoided during treatment with furazidin.

Children and adolescents
neoFuragina should not be used in children and adolescents.
Interaction of neoFuragina with other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for use.
Particular caution is required when using the following medicines concurrently:

• Quinolone derivatives (e.g. nalidixic acid, norfloxacin, oxolinic acid – antibacterial agents): furazidin may inhibit their antibacterial activity;
• Aminoglycoside and tetracycline antibiotics: when administered together with furazidin, they enhance its antibacterial effect;
• Rystomycin, chloramphenicol, sulfonamides, chloramphenicol (antibiotics): possible risk of suppression of hematopoietic function;
• Probenecid and sulfinpyrazone (medicines increasing urinary excretion of uric acid): may reduce furazidin excretion, leading to its accumulation in the body, increasing its toxicity and reducing its urinary concentration, which may weaken its effect;
• Medicines neutralizing gastric juice containing magnesium trisilicate: may inhibit absorption of furazidin and reduce its antibacterial activity;
• Carbonic anhydrase inhibitors (sulfonamides, diuretics, or medicines used in glaucoma treatment) and medicines increasing urine pH (alkalinizing agents): may reduce the antibacterial activity of nitrofurans;
• Vitamin B complex or increased dietary salt intake: may increase absorption of nitrofuran derivatives;
• Atropine: may delay absorption of furazidin, although the total amount absorbed remains unchanged.

Effect on laboratory test results
During administration of furazidin, urine glucose tests using copper sulfate-containing solutions (e.g. Benedict's or Fehling's reagent) may yield false-positive results. Urine glucose tests performed by enzymatic methods give accurate results.
neoFuragina with food or alcohol
neoFuragina should be taken orally during meals containing protein, which enhances absorption of furazidin.
Alcohol consumption should be avoided during treatment with neoFuragina due to the possibility of a disulfiram-like reaction, with symptoms such as flushing, abdominal pain, nausea, vomiting, and sinus tachycardia.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
neoFuragina should not be used during the first three months of pregnancy or in women during term pregnancy (from week 38) and during childbirth. Particular caution is required during use in the last three months of pregnancy. Furazidin may cause hemolytic anemia (anemia associated with red blood cell breakdown) in the newborn.
Breastfeeding
neoFuragina should not be used during breastfeeding. Furazidin passes into human milk and may harm the breastfed infant.
Effect on fertility
Nitrofuran derivatives may adversely affect testicular function, slightly or moderately reducing the total sperm count in semen.
Driving and operating machinery
There is no data on the effect of furazidin on the ability to drive or operate machinery. However, in some patients, adverse effects may occur that could affect the ability to drive or operate machinery (dizziness, drowsiness, visual 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 certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use neoFuragina

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults
First day of treatment: 100 mg (2 tablets) 4 times daily; subsequent days: 100 mg (2 tablets) 3 times daily.
neoFuragina should be taken orally during meals containing protein, as protein increases the absorption of furazidin.
The medicine should be used for 7–8 days. If symptoms worsen or do not improve after 7–8 days, consult a doctor.
If necessary, treatment may be repeated after 10–15 days.
Use in children
neoFuragina should not be used in children and adolescents.
Taking more neoFuragina than recommended
If more neoFuragina is taken than recommended, nausea, vomiting, headache, dizziness, allergic reactions, or anemia may occur.
If any disturbing symptoms occur, seek immediate advice from a doctor or pharmacist, as specialist treatment may be necessary. Due to the elimination of the medicine from the body via the kidneys, the risk of overdose is increased in patients with impaired kidney function.
Missed dose of neoFuragina
If a dose of neoFuragina is missed, continue treatment with the previously prescribed doses. Do not take a double dose to make up for the missed dose.
Stopping neoFuragina treatment
Stopping treatment with neoFuragina during therapy may result in failure to cure the lower urinary tract infection.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If serious adverse effects occur, administration of the medicine should be discontinued immediately and the doctor should be contacted without delay:

Rarely occurring ( less than 1 in 1,000 people) :

• anaphylactic reactions (sudden local or systemic allergic reactions), angioedema (which may impair breathing and swallowing)
• severe skin reactions (exfoliative dermatitis, erythema multiforme, bullous erythema multiforme – Stevens-Johnson syndrome)
• drug-induced liver inflammation symptoms, cholestatic jaundice (caused by obstruction of bile outflow), liver necrosis (usually during long-term use)

Occurring with unknown frequency ( cannot be estimated from available data) :

• asthmatic reaction (dyspnoea) in patients with asthma; respiratory system hypersensitivity reactions, including:

• acute reactions – manifested by fever, chills, cough, chest pain, dyspnoea – usually resolve quickly after discontinuation of the medicine;
• chronic reactions – including lung changes (e.g. pulmonary fibrosis, pneumonia) – severity of symptoms and reversibility after discontinuation of the medicine depend on the duration of treatment after onset of first adverse symptoms; immediate discontinuation of the medicine is required upon detection of an adverse effect; lung function impairment may be irreversible; chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonia) may occur especially in elderly patients.
• infections with microorganisms resistant to furazidin, fever, chills, malaise;
• cyanosis due to methemoglobinemia;
• in patients with glucose-6-phosphate dehydrogenase deficiency, furazidin use may lead to megaloblastic or hemolytic anemia;
• pseudomembranous colitis (diarrhea with crampy abdominal pain, slightly elevated body temperature; severe inflammation of the large intestine);
• pancreatitis manifested by severe pain in the epigastrium;
• peripheral nerve damage (including acute or irreversible course, especially in patients with impaired renal function, anemia, diabetes, electrolyte disorders or vitamin B deficiency).

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

• nausea, excessive flatulence;
• headache.

Frequency unknown (frequency cannot be estimated from available data):

• itching, urticaria, rash;
• dizziness, drowsiness, visual disturbances;
• vomiting, constipation, diarrhoea, dyspeptic symptoms, abdominal pain, loss of appetite, sialadenitis;
• alopecia (transient).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects allows the collection of further information on the safety of the medicine.

5. How to store neoFuragina

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following:
Expiry date (Exp). The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Contents of the pack and other information

What neoFuragina contains

• The active substance is furazidinum (furazidin). Each tablet contains 50 mg of furazidin.
• The other ingredients are: monohydrate lactose, potato starch, sucrose, polysorbate 80, stearic acid.

What neoFuragina looks like and contents of the pack
neoFuragina is a yellow or yellow-orange, round tablet with a uniform surface.
The cardboard box contains 30 tablets in blisters and a patient leaflet.

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

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