Furagina Apteo Med

Package Leaflet: Information for the User

FURAGINA APTEO MED, 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.

• This 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 or the patient feels worse after 7-8 days, they should contact their doctor.

Table of Contents of the Package Leaflet:

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

1. What the medicine is and what it is used for

The medicine contains furazidine as the active substance. Furazidine is a nitrofuran derivative that inhibits the growth of bacteria sensitive to furazidine, causing lower urinary tract infections.

The indication for use of the medicine is:

• lower urinary tract infection.

2. Important information before taking the medicine

When not to take the medicine

• If the patient is allergic to furazidine, other nitrofuran derivatives, or any of the other ingredients of this medicine (listed in section 6).
• In the first trimester of pregnancy.
• In the period of advanced pregnancy (from the 38th week) and childbirth, due to the risk of hemolytic anemia (anemia associated with red blood cell breakdown) in the newborn.
• In children and adolescents.
• If the patient has renal failure, and laboratory tests have shown a creatinine clearance of less than 60 ml/min or an elevated serum creatinine level.
• If the patient has diagnosed polyneuropathy (nerve system disorder), e.g., in the course of diabetes.
• If the patient has a deficiency of glucose-6-phosphate dehydrogenase (an enzyme involved in red blood cell metabolism).

Warnings and precautions

Before starting to take the medicine, the patient should discuss it with their doctor or pharmacist:

• If the patient has kidney, liver, or nervous system disorders, anemia, electrolyte disturbances, vitamin B or folic acid deficiency, or lung disease.
• If the patient has diabetes, as furazidine may cause nerve damage. Peripheral neuropathy has been observed in patients treated with nitrofuran derivatives. This disorder can be irreversible and life-threatening in severe cases. Therefore, the medicine should be discontinued if symptoms of nervous system disorders 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 are sometimes observed in patients treated with nitrofuran derivatives (see section 4). If such symptoms occur, the medicine should be discontinued immediately - they usually resolve quickly or very quickly after discontinuation of the medicine. In the case 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 of adverse reactions appear. The key issue is the earliest possible recognition of the adverse reaction and discontinuation of the medicine. 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 used for a long time. Blood tests may then be necessary to monitor the white blood cell count and kidney and liver function.

Children and adolescents

The medicine should not be used in children and adolescents.

Interaction with other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they 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 the urine) - reduce the excretion of furazidine and may cause its accumulation in the body, increasing its toxicity and reducing its concentration in the urine, which may lead to a decrease in the effectiveness of the medicine.
• Antacids containing magnesium trisilicate - reduce the absorption of furazidine.
• Atropine - delays the absorption of furazidine, but the overall amount of absorbed substance does not change.
• Vitamin B - increases the absorption of furazidine.

Effect on laboratory tests

During administration of furazidine, 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 correct.

With food, drink, and alcohol

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

Alcohol should be avoided during treatment with the medicine.

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

The medicine should not be used during the first three months of pregnancy (first trimester) or in advanced pregnancy and childbirth. Particular caution should be exercised when using the medicine in the last three months of pregnancy (third trimester). Furazidine may cause hemolytic anemia in the newborn.

Breastfeeding

The medicine should not be used during breastfeeding. Furazidine passes into human 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 can affect the ability to drive (dizziness, drowsiness, vision disturbances). If the patient experiences these side effects, they should not drive or operate machines.

The medicine contains sucrose

One tablet of the medicine contains 13.75 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 the medicine

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

Method of administration

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

The medicine is used for 7-8 days. If symptoms worsen or do not improve after 7-8 days, the patient should consult their doctor.

Use in children and adolescents

The medicine should not be used in children and adolescents.

Overdose

In case of overdose, the following symptoms may occur: headache, dizziness, allergic reactions, nausea, vomiting, anemia. If such symptoms occur, the patient should immediately contact 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 from the body through the kidneys, the risk of overdose is increased in patients with impaired renal function.

Missed dose

In case of a missed dose, 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.

If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Discontinuation of treatment

In case of any further doubts about the use of this medicine, the patient should consult their doctor.

4. Possible side effects

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

The patient should immediately stop taking the medicine and inform their doctor or go to the nearest hospital if they experience any of the following side effects that occur rarely (may affect up to 1 in 1000 people):

• Cyanosis, megaloblastic anemia (anemia due to vitamin B or folic acid deficiency) or hemolytic anemia;
• Tingling, numbness, sensation of electric currents due to peripheral neuropathy (peripheral nerve damage), also of acute or irreversible course (particularly predisposed: renal failure, anemia, diabetes, electrolyte disturbances, vitamin B deficiency);
• Acute, subacute, and chronic hypersensitivity reactions to nitrofuran derivatives. Chronic reactions occurred in patients taking the medicine for more than 6 months. Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonia) may occur, especially in elderly patients. Acute hypersensitivity reactions affecting the respiratory system were characterized by fever, chills, cough, chest pain, and shortness of breath. They usually resolved quickly or very quickly after discontinuation of the medicine. In the case 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 of adverse reactions appear. The key issue is the earliest possible recognition of the adverse reaction and discontinuation of the medicine. Pulmonary function impairment may be irreversible;
• Pseudomembranous colitis (severe small or large intestine disease characterized by diarrhea, headache, and fever);
• Severe skin reactions (exfoliative dermatitis, erythema multiforme - red-purple spots on the skin and/or mucous membranes, sometimes with blisters, fever, and joint pain, Stevens-Johnson syndrome - blisters on the skin and/or mucous membranes that form painful sores after rupture, often accompanied by fever, muscle and joint pain);
• Itching, urticaria, anaphylactic reactions (sudden local or systemic allergic reactions), angioedema (disease of the skin and subcutaneous tissue characterized by the formation of limited edema), rash;
• Symptoms of drug-induced hepatitis, cholestatic jaundice (caused by an obstacle to bile flow), liver necrosis (symptoms see "Warnings and precautions" in section 2).

In addition, the following side effects may occur:

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

• Nausea, excessive gas;
• Headache.

Rare (may affect up to 1 in 1000 people):

• Dizziness, drowsiness, vision disturbances;
• Fever, chills, malaise;
• Infections with microorganisms resistant to nitrofuran derivatives, most often Pseudomonas or Candida;
• Alopecia;
• Constipation, diarrhea, dyspeptic symptoms (e.g., feeling of postprandial fullness, bloating), abdominal pain, vomiting, salivary gland inflammation, pancreatitis.

Nitrofuran derivatives may have a negative effect on testicular function and cause a decrease in sperm motility, reduced sperm secretion, and unfavorable changes in sperm structure.

Reporting side effects

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, 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.: +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, it is possible to gather more information on the safety of the medicine.

5. How to store the medicine

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

Store in the original packaging to protect from light.

Do not use the medicine after the expiry date stated on the blister and carton 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. Contents of the pack and other information

What the medicine contains

• The active substance of the medicine is furazidine (Furazidinum). One tablet contains 50 mg of furazidine.
• The other ingredients are: corn starch, sucrose, colloidal anhydrous silica, stearic acid.

What the medicine looks like and contents of the pack

Uncoated tablets, flat on both sides, yellow-orange in color with a line engraving on one side. The line (engraving) is not intended for dividing the tablet into equal doses.

Cartons containing 30 tablets in blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder

Synoptis Pharma Sp. z o.o.

ul. Krakowiaków 65

02-255 Warsaw

Manufacturer

Adamed Pharma S.A.

ul. Marszałka Józefa Piłsudskiego 5

95-200 Pabianice

To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:

Synoptis Pharma Sp. z o.o.

Tel: +48 22 32 16 240

Date of approval of the package leaflet: