Furaginum Us Pharmacia

Package Leaflet: Information for the User

Furaginum US Pharmacia, 50 mg, Tablets

Furazidine

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 or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If after 7-8 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet

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

1. What is Furaginum US Pharmacia and what is it used for

Furaginum US Pharmacia contains furazidine, also known as furagin, as the active substance. Furazidine is a nitrofuran derivative that inhibits the growth of bacteria, both Gram-positive and Gram-negative, causing urinary tract infections.

The indication for the use of Furaginum US Pharmacia is:

• -treatment of acute and recurrent uncomplicated lower urinary tract infections.

If after 7-8 days there is no improvement or you feel worse, you should consult your doctor.

2. Important information before taking Furaginum US Pharmacia

When not to take Furaginum US Pharmacia

• If you are allergic (hypersensitive) to furazidine, other nitrofuran derivatives, or any of the other ingredients of Furaginum US Pharmacia.
• In the first trimester of pregnancy.
• From the 38th week and during delivery, due to the risk of developing hemolytic anemia (anemia related to red blood cell breakdown) in the newborn.
• In children and adolescents under 15 years of age.
• If you have kidney failure and laboratory tests have shown a creatinine clearance of less than 60 ml/min or an elevated serum creatinine level.
• If you have been diagnosed with polyneuropathy (nerve system disorder), e.g., in the course of diabetes.

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• If you have a deficiency of glucose-6-phosphate dehydrogenase (an enzyme involved in red blood cell metabolism).

Warnings and precautions

If you are affected by the circumstances described below, you should discuss the use of Furaginum US Pharmacia with your doctor.

• If you have kidney, liver, or nervous system disorders, anemia, electrolyte disturbances, vitamin B or folic acid deficiency, or lung disease.
• If you have diabetes - furazidine may cause nerve damage. Peripheral nerve damage has been observed in patients treated with nitrofuran derivatives. This disorder can be irreversible and life-threatening in severe cases. Therefore, you should stop taking Furaginum US Pharmacia if you experience symptoms of nervous system disorders (tingling, numbness, sensation of electric currents).
• If you experience fever, chills, cough, chest pain, or shortness of breath while taking Furaginum US Pharmacia. These may be symptoms of acute pulmonary reactions, which are sometimes observed in patients treated with nitrofuran derivatives. If such symptoms occur, you should immediately stop taking the medicine - these symptoms usually resolve quickly or very quickly after discontinuation of the medicine. If the medicine was taken for a long time, the severity of symptoms and their resolution after discontinuation of the medicine depend on the duration of treatment after the first symptoms appeared. Early recognition of the adverse effect and discontinuation of the medicine are crucial. Pulmonary disorders can be irreversible. Chronic reactions occurred in patients who took furazidine for more than 6 months. Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonia) may occur, especially in elderly patients.
• If you are taking the medicine for a long time - it may be necessary to have blood tests to monitor white blood cell count and kidney and liver function.
• If you experience severe and persistent diarrhea during or after treatment. This may be a symptom of pseudomembranous colitis - a complication that sometimes occurs after the use of antibacterial medicines. You should contact your doctor as soon as possible and not take anti-diarrheal medicines that slow down intestinal motility.

Furaginum US Pharmacia and other medicines

If you are taking any of the following medicines, you should consult your doctor or pharmacist before starting to take Furaginum US Pharmacia.

• 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 urine) - reduce furazidine excretion and may cause its accumulation in the body, increasing its toxicity and reducing its concentration in urine, which may lead to reduced efficacy.

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• Antacids containing magnesium trisilicate - reduce furazidine absorption.
• Atropine - delays furazidine absorption, but the overall amount of absorbed substance does not change.
• Vitamin B - increases furazidine absorption.

Effect on laboratory tests

During treatment with 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 accurate.

Taking Furaginum US Pharmacia with food and drink

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

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Furaginum US Pharmacia should not be taken during the first three months of pregnancy (first trimester) or from the 38th week and during delivery, as furazidine may cause hemolytic anemia in the newborn. Particular caution should be exercised during the last three months of pregnancy (third trimester).

Furaginum US Pharmacia should not be taken during breastfeeding. Furazidine passes into breast milk and may harm the breastfed baby.

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 (dizziness, drowsiness, vision disturbances).

Furaginum US Pharmacia contains lactose and sucrose

Each tablet contains 18.8 mg of lactose and 10 mg of sucrose. If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Furaginum US Pharmacia

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Adultsand adolescents over 15 years of age

First day of treatment: 2 tablets 4 times a day; subsequent days: 2 tablets 3 times a day.

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

The medicine is taken for 7-8 days. If after this time the symptoms worsen or do not improve, you should consult your doctor.

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

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Use in children and adolescents

Furaginum US Pharmacia should not be taken by children and adolescents under 15 years of age.

Overdose of Furaginum US Pharmacia

If you take more than the recommended dose of Furaginum US Pharmacia, you may experience the following symptoms: headache, dizziness, allergic reactions, nausea, vomiting, anemia.

If you experience such symptoms, you 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 by the kidneys, the risk of overdose is increased in patients with impaired kidney function.

Missed dose of Furaginum US Pharmacia

If you miss a dose of Furaginum US Pharmacia, you should continue treatment with the previously taken doses. Do not take a double dose to make up for the missed dose.

If you have any further doubts about the use of the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Furaginum US Pharmacia can cause side effects, although not everybody gets them.

Among the side effects observed during clinical trials, the most common were: nausea (8%), headache (6%), and excessive gas (1.5%). The following side effects occurred in less than 1% of patients and are listed by system affected.

You should immediately stop taking the medicine and inform your doctor or go to the nearest hospital if you experience:

• severe skin reactions with exfoliation or blistering (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, or bullous erythema multiforme);
• anaphylactic reactions (sudden local or systemic allergic reactions), angioedema (a skin and subcutaneous tissue disorder characterized by the formation of swelling that can make breathing difficult, usually in the face, throat, or tongue);
• symptoms of drug-induced hepatitis, cholestatic jaundice (caused by an obstacle to bile flow), liver necrosis;
• cyanosis, megaloblastic anemia (anemia due to vitamin B12 or folic acid deficiency) or hemolytic anemia (caused by excessive breakdown of red blood cells);
• peripheral nerve disorders (including acute or irreversible courses, especially in patients with kidney failure, anemia, diabetes, electrolyte disturbances, or vitamin B deficiency);
• infections with furazidine-resistant microorganisms;
• fever, chills, malaise;
• pancreatitis manifesting as severe abdominal pain;

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• pseudomembranous colitis (diarrhea with crampy abdominal pain, slightly elevated body temperature; severe colitis);
• respiratory hypersensitivity reactions
• acute reactions - manifesting as fever, chills, cough, chest pain, shortness of breath, effusion into the pleural space, changes in the radiological image of the lungs, and an increase in the number of a specific type of white blood cell called eosinophils; usually resolve quickly or very quickly 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 appeared; after identifying the adverse effect, it is necessary to immediately discontinue the medicine; pulmonary disorders can be irreversible;

Other side effects:

• nausea, excessive gas;
• headache.
• dizziness, drowsiness, vision disturbances;
• constipation, diarrhea, dyspeptic symptoms (e.g., feeling of fullness after meals, bloating), abdominal pain, vomiting, parotitis;
• hair loss;
• pruritus, urticaria, rash.

Nitrofuran derivatives may negatively affect testicular function and cause a decrease in sperm motility, reduced sperm secretion, and unfavorable changes in sperm morphology.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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, e-mail: [email protected] Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Furaginum US Pharmacia

Keep the medicine out of the sight and reach of children.

Do not store above 25°C. Store in the original packaging to protect from light and moisture.

Do not use the medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month.

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Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Other information

What Furaginum US Pharmacia contains

The active substance of the medicine is furazidine, also known as furagin. 1 tablet contains 50 mg of furazidine.

The other ingredients of the medicine are: lactose, gelatinized starch, sucrose, polysorbate 80, stearic acid.

What Furaginum US Pharmacia looks like and contents of the pack

Uncoated tablets, flat on both sides, yellow-orange in color.

Cartons containing 30 tablets in blisters.

Marketing authorization holder

US Pharmacia Sp. z o.o.

ul. Ziębicka 40

50-507 Wrocław

Manufacturer

Olpha AS

Rupnicu Iela 5, Olaine,

Olaines Novads, 2114

Latvia

To obtain more detailed information, please contact the representative of the marketing authorization holder:

USP Zdrowie Sp. z o.o.

ul. Poleczki 35

02-822 Warsaw

Tel.: +48 (22) 543 60 00

Date of approval of the leaflet: October 2024

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