NEOFURAGINA 100 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
2. What is neoFuragina and what is it used for
3. Important information before taking neoFuragina
   1. When not to take neoFuragina:
   2. Warnings and precautions
   3. Children and adolescents
   4. neoFuragina and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. neoFuragina contains lactose monohydrate and sucrose
4. How to take neoFuragina
   1. Adult administration
   2. Administration in children and adolescents
   3. Taking a higher dose of neoFuragina than recommended
   4. Missing a dose of neoFuragina
   5. Stopping treatment with neoFuragina
5. Possible side effects
   1. The patient should stop taking the medicine immediately and inform their doctor or go to the nearest hospital if they experience:
   2. Common (may affect up to 1 in 10 patients):
   3. Frequency not known (frequency cannot be estimated from the available data):
   4. Reporting side effects
6. How to store neoFuragina
7. Package contents and other information
   1. What neoFuragina contains
   2. What neoFuragina looks like and what the package contains
   3. Marketing authorization holder
   4. Manufacturer

Leaflet attached to the packaging: patient information

neoFuragina, 100 mg, tablets
Furazidinum

Read the 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 patient leaflet or as advised by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 7-8 days or the patient feels worse, they should contact their doctor.

Table of contents of the 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. Package contents and other information

1. What is neoFuragina and what is it used for

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

• The indication for using neoFuragina is the treatment of lower urinary tract infections.

2. Important information before taking neoFuragina

When not to take neoFuragina:

• if the patient is allergic to furazidin, nitrofuran derivatives, or any of the other ingredients of this medicine (listed in section 6)
• if the patient has polyneuropathy (a condition characterized by damage to the peripheral nerves, which can cause motor, sensory, or other neurological disorders), e.g., in diabetic patients
• if the patient has a deficiency of the enzyme glucose-6-phosphate dehydrogenase (a genetic disorder that affects the metabolism of red blood cells)
• if the patient has renal failure (creatinine clearance below 60 ml/min or elevated serum creatinine levels)
• in newborns, infants, children, and adolescents
• during the first three months of pregnancy (first trimester)
• during the last month of pregnancy (from the 38th week) and during childbirth, due to the risk of hemolytic anemia in the newborn.

Warnings and precautions

If the patient has any of the following conditions (see also section 4), they should discuss the use of neoFuragina with their doctor.

• If the patient has diabetes, renal impairment, liver dysfunction, neurological disorders, electrolyte disturbances, anemia, vitamin B deficiency, or lung disease, they should be particularly cautious when taking this medicine, as the risk of peripheral polyneuropathy is increased. This condition can be irreversible and life-threatening in severe cases. Therefore, neoFuragina should be discontinued if neurological symptoms occur (tingling, numbness, sensation of electric currents).
• If the patient experiences fever, chills, cough, chest pain, or shortness of breath, these may be symptoms of acute pulmonary reactions, which can occur in patients treated with nitrofuran derivatives. If such symptoms occur, the medicine should be discontinued immediately. Chronic reactions can occur in patients taking furazidin for more than 6 months. Chronic pulmonary reactions can occur, especially in elderly patients.
• If the medicine is used for a long time, blood tests may be necessary to monitor white blood cell count and renal and liver function.
• Alcohol should be avoided during treatment with furazidin (see separate section below).

Rarely, liver function disorders (jaundice, itching, pale stools, dark urine, abdominal pain, vomiting, nausea, loss of appetite, constant fatigue, and weight loss) may occur, including cholestatic jaundice (caused by an obstruction of bile flow) and chronic hepatitis. If liver function disorders are detected, treatment with furazidin should be discontinued immediately.

Children and adolescents

neoFuragina should not be used in children and adolescents (see "When not to take neoFuragina" in section 2).

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.

• streptomycin, chloramphenicol, sulfonamides (antibacterial chemotherapeutics) - increase the toxic effect of furazidin on the hematopoietic system;
• quinolone derivatives, e.g., nalidixic acid, norfloxacin, oxolinic acid (antibacterial medicines) - furazidin may inhibit their antibacterial effect;
• probenecid and sulfinpyrazone (medicines that increase the excretion of uric acid in the urine) - may decrease the excretion of furazidin 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;
• carbonic anhydrase inhibitors (sulfonamides) and medicines that increase the pH of urine (alkalizing) - may reduce the antibacterial activity of nitrofurans;
• vitamin B - increases the absorption of nitrofuran derivatives;
• atropine (a medicine that relaxes smooth muscles and dilates pupils) - may delay the absorption of furazidin, but the overall amount of absorbed substance does not change;
• antacids containing magnesium trisilicate reduce the absorption of furazidin - may decrease the antibacterial effect of furazidin.

The effect on laboratory tests: During the administration of furazidin, the results of glucose tests in urine using Benedict's and Fehling's solutions may be falsely positive. The results of glucose tests in urine performed using enzymatic methods are usually correct.

neoFuragina with food or alcohol

See section 3.

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 used during the first three months of pregnancy (first trimester) or in women with a advanced pregnancy (from the 38th week) and during childbirth.

Caution should be exercised when using neoFuragina during the last three months of pregnancy (third trimester), as furazidin may cause hemolytic anemia in the newborn.

Breastfeeding: neoFuragina should not be used during breastfeeding. Furazidin passes into breast milk and may harm the breastfed child.

Fertility: Nitrofuran derivatives may have a negative effect on testicular function, slightly or moderately reducing the total number of sperm in the semen.

Driving and using machines

There is no data on the effect of furazidin on the ability to drive vehicles and operate machines. However, some patients may experience side effects that can affect the ability to drive vehicles and operate machines (headache, dizziness, drowsiness, vision disturbances; see also section 4).

neoFuragina contains lactose monohydrate and 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 patient leaflet or as advised by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Adult administration

Day 1: 1 tablet (100 mg) 4 times a day.

Day 2-8: 1 tablet (100 mg) 3 times a day.

Treatment usually lasts 7-8 days. If necessary, treatment can be repeated after 10-15 days.

Method of administration: The medicine is taken orally. The line on the tablet is only to facilitate breaking the tablet, not to divide it into equal doses.

neoFuragina should be taken during meals. The patient should follow a high-protein diet and drink plenty of fluids.

If the patient misses one or more doses, they should continue treatment with the previously taken doses.

Administration in children and adolescents

neoFuragina should not be used in children and adolescents (see "When not to take neoFuragina" in section 2).

Taking a higher dose of neoFuragina than recommended

If the patient takes a higher dose of the medicine than recommended, they may experience nausea, vomiting, headache, dizziness, allergic reactions, or anemia. If any worrying symptoms occur, the patient should immediately consult their doctor, pharmacist, or the emergency department of the nearest hospital, as specialized treatment may be necessary. Gastric lavage and administration of large amounts of fluids are recommended to increase the excretion of the medicine in the urine. Blood morphology tests, liver function tests, and monitoring of lung function are also recommended. In severe cases, hemodialysis may be necessary.

Due to the excretion of the medicine by the kidneys, the risk of overdose is increased in patients with renal impairment.

Missing a dose of neoFuragina

If the patient misses one or more doses, they should continue treatment with the previously taken doses. They should not take a double dose to make up for the missed dose.

Stopping treatment with neoFuragina

Stopping treatment with neoFuragina during the course of treatment may result in the infection not being fully cured.

If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should stop taking the medicine immediately and inform their doctor or go to the nearest hospital if they experience:

• allergic reactions: rash, itching, hives, anaphylactic reactions (sudden local or systemic allergic reactions with symptoms such as:
• swelling of the face, lips, tongue, or throat
• difficulty breathing or swallowing
• hives, itching, including life-threatening anaphylactic shock), angioedema (a severe allergic reaction - sudden swelling of the face, limbs, or joints without itching or pain). Swelling in the head and neck area can cause difficulty swallowing and breathing;
• severe skin reactions (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome - a blistering multiforme erythema);
• symptoms of drug-induced hepatitis (jaundice, itching, pale stools, dark urine, abdominal pain, vomiting, nausea, loss of appetite, constant fatigue, and weight loss), cholestatic jaundice (caused by an obstruction of bile flow), liver necrosis (usually during long-term use); (with unknown frequency):
• asthmatic reactions (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 detecting a side effect, the medicine should be discontinued immediately; pulmonary function impairment may be irreversible
• methemoglobinemia, which can also cause fatigue, shortness of breath, headaches, dizziness, tachycardia, drowsiness, and coma;
• pseudomembranous colitis (a severe disease of the small or large intestine characterized by diarrhea, headache, and fever);
• peripheral nerve damage (also with acute or irreversible course, especially in patients with renal impairment, anemia, diabetes, electrolyte disturbances, or vitamin B deficiency).

Other side effects of neoFuragina may include:

Common (may affect up to 1 in 10 patients):

• nausea, excessive gas;
• headache.

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

• dizziness, drowsiness, vision disturbances;
• vomiting, constipation, diarrhea, symptoms of indigestion, abdominal pain, salivary gland inflammation, pancreatitis;
• hair loss (temporary);
• infections with microorganisms resistant to furazidin, fever, chills, malaise;
• in patients with glucose-6-phosphate dehydrogenase deficiency, the use of furazidin may lead to the development of megaloblastic or hemolytic anemia (due to a deficiency of vitamin B or folic acid) with symptoms such as: easy fatigue, general weakness, concentration problems, pain and dizziness, shortness of breath).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to: Department for Monitoring 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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store neoFuragina

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

There are no special precautions for storing the medicine.

Do not use the medicine after the expiry date stated on the packaging after EXP.

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

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

6. Package contents and other information

What neoFuragina contains

• The active substance of the medicine is furazidin. 1 tablet contains 100 mg of furazidin, also known as furagin.
• Other ingredients are: lactose monohydrate, potato starch, sucrose, Polysorbate 80, stearic acid.

What neoFuragina looks like and what the package contains

neoFuragina is available in the form of yellow or yellow-orange tablets, oval, biconvex, with a smooth surface, thickness 3.6 - 4.4 mm, length 9.3 - 9.7 mm, with a line on one side. The line on the tablet is only to facilitate breaking the tablet, not to divide it into equal doses.

The carton contains 15, 25, or 30 tablets in blisters and a patient 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 leaflet:March 2022