Furaginum Sema

Package Leaflet: Information for the User

FURAGINUM SEMA, 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 this package leaflet for the patient or as advised 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 those not listed in this package leaflet, the doctor or pharmacist should be informed. See section 4.
• If after 7-8 days there is no improvement or the patient feels worse, a doctor should be consulted.

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 the active substance furazidin, also known as furagin, a nitrofuran derivative that inhibits the growth of bacteria that cause urinary tract infections. The medicine is not effective against infections caused by the bacterium Pseudomonas aeruginosa and most strains of the bacterium Proteus mirabilis. The indication for use of the medicine is:

• lower urinary tract infection.

2. Important information before taking the medicine F S

When not to take the medicine

• if the patient is allergic to furazidin, other nitrofuran derivatives, or any of the other ingredients of this medicine (listed in section 6),
• in the first trimester of pregnancy,
• during late pregnancy (from the 38th week) and childbirth, due to the risk of hemolytic anemia (anemia related to the breakdown of red blood cells) in the newborn.
• in children and adolescents,
• if the patient has renal impairment, with a creatinine clearance of less than 60 mL/min or an elevated serum creatinine level,
• if the patient has been diagnosed with polyneuropathy (nerve damage), 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 a doctor or pharmacist if they have:

• kidney problems,
• liver problems,
• nervous system problems,
• anemia,
• electrolyte disturbances,
• a deficiency of vitamins from the B group and folic acid,
• lung disease,
• diabetes, as furazidin may cause nerve damage. Peripheral neuropathy has been observed in patients treated with nitrofuran derivatives. This condition 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, 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 - usually, they quickly or very quickly resolve after discontinuation of the medicine. In cases 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. Early recognition of adverse reactions and discontinuation of the medicine are crucial. Pulmonary function impairment may be irreversible. Chronic reactions have occurred in patients taking furazidin 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 and kidney and liver function tests may be necessary. See also section 4, when to discontinue the medicine and consult a doctor.

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. Special caution should be exercised when using the following medicines concomitantly.

• Nalidixic acid (antibiotic) - furazidin inhibits its bacteriostatic effect.
• Aminoglycosides and tetracyclines (antibiotics) - enhance the antibacterial effect of furazidin.
• Chloramphenicol and ristomycin (antibiotics) - increase the toxic effect of furazidin on red blood cells.
• Probenecid (in high doses) and sulfinpyrazone (medicines that increase the excretion of uric acid in the urine) - reduce the excretion of furazidin 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 furazidin.
• Atropine - delays the absorption of furazidin, but the overall amount of absorbed substance does not change.
• Vitamins from the B group - increase the absorption of furazidin.

Effect on laboratory tests During treatment with furazidin, 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 alcoholThe 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 a 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 late pregnancy (from the 38th week) and during childbirth. Particular caution should be exercised when using the medicine in the last three months of pregnancy (third trimester). Furazidin may cause hemolytic anemia in the newborn. Breastfeeding The medicine should not be used during breastfeeding. Furazidin passes into human milk and may harm the breastfed child. Fertility Nitrofuran derivatives may have a negative effect on testicular function, reducing sperm motility and causing unfavorable changes in their structure, as well as reducing sperm secretion.

Driving and using machines

There are no data on the effect of furazidin 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). If such side effects occur, the patient should not drive or operate machines.

The medicine contains 13.75 mg of sucrose.

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

3. How to take the medicine

This medicine should always be taken exactly as described in this package leaflet for the patient or as advised by a doctor or pharmacist. In case of doubts, a doctor or pharmacist should be consulted. 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. The medicine should be taken orally during meals containing protein, which increases the absorption of the medicine. The line (engraving) on the tablet is not intended for dividing the tablet into equal doses. The medicine is used for 7-8 days. If symptoms worsen or do not improve after 7-8 days, a doctor should be consulted.

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 consult 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 by the kidneys, the risk of overdose is increased in patients with renal impairment.

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 the missed dose. If the patient feels that the effect of the medicine is too strong or too weak, they should consult a doctor. In case of any further doubts about the use of this medicine, a doctor should be consulted.

4. Possible side effects

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

The medicine should be discontinued immediately and a doctor or pharmacist consulted if the following occur:

• itching, hives, anaphylactic reactions (sudden local or systemic allergic reactions), angioedema (severe allergic reaction - sudden swelling of the face, which can make breathing difficult, swelling of limbs or joints), rash;
• reactions related to hypersensitivity of the respiratory system (see also "Warnings and precautions" in section 2)
• acute reactions - characterized by fever, chills, cough, chest pain, shortness of breath, effusion into the pleural space, changes in the lung radiograph, and an increase in the number of a specific type of white blood cell; usually, they quickly or very quickly resolve after discontinuation of the medicine;
• chronic reactions - including pulmonary fibrosis and diffuse interstitial pneumonia; 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.
• severe skin reactions: exfoliative dermatitis, erythema multiforme (red-purple spots on the skin and/or mucous membranes), Stevens-Johnson syndrome (vesicular erythema multiforme; blisters on the skin and/or mucous membranes, which after rupture form painful sores, often accompanied by fever, muscle and joint pain);
• pseudomembranous colitis (severe disease of the large intestine characterized by diarrhea, headache, and fever);
• tingling, numbness, sensation of electric currents due to peripheral neuropathy (nerve damage, also of acute or irreversible course, especially in patients with renal impairment, anemia, diabetes, electrolyte disturbances, vitamin B deficiency);
• drug-induced hepatitis, cholestatic jaundice (caused by an obstacle to bile flow), characterized by yellowing of the sclera, skin, and mucous membranes, dark urine, itching of the skin, pale stools, abdominal pain, nausea, vomiting, constant fatigue, loss of appetite, and weight loss), liver necrosis;
• fever, chills, malaise, infections with microorganisms resistant to furazidin. The above side effects occur in less than 1 in 100 patients.

Additionally, the following side effects may occur

Common side effects (occurring in 1 to 10 in 100 patients):

• nausea, excessive gas;
• headache.

Uncommon side effects (occurring in less than 1 in 100 patients):

• cyanosis, megaloblastic anemia (anemia due to vitamin B or folic acid deficiency) or hemolytic anemia,
• dizziness, drowsiness, vision disturbances,
• constipation, diarrhea, symptoms of indigestion (e.g., feeling of postprandial fullness, bloating), abdominal pain, vomiting, parotitis, pancreatitis,
• hair loss.

In patients taking furazidin, the following have also been observed with an unknown frequency:

• muscle cramps, muscle pain.

Nitrofuran derivatives may have a negative effect on testicular function (see "Fertility" in section 2).

Reporting side effects

If side effects occur, including those not listed in this package leaflet, the doctor or pharmacist should be informed. 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, more information can be collected on the safety of the medicine.

5. How to store the medicine

The medicine should be stored out of sight and reach of children. The medicine should be stored in its original packaging to protect it from light. The medicine should not be used after the expiry date stated on the blister and carton after: Expiry date (EXP). The expiry date refers to the last day of the given month. Batch number The medicine 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 furazidin (Furazidinum), also known as furagin. One tablet contains 50 mg of furazidin.
• The other ingredients are: cornstarch, sucrose, colloidal anhydrous silica, stearic acid.

What the medicine looks like and contents of the pack

Tablets are uncoated, flat on both sides, orange-yellow in color with an engraving in the shape of a line on one side. The line (engraving) on the tablet is not intended for dividing the tablet into equal doses. The cartons contain 30 tablets in blisters.

Marketing authorization holder

Laboratoria Gemini Sp. z o.o. Al. Grunwaldzka 411 80-309 Gdańsk e-mail: [email protected]

Manufacturer

Adamed Pharma S.A. ul. Marszałka J. Piłsudskiego 5 95-200 Pabianice

Date of last revision of the package leaflet: