Furaginum us pharmacia

Patient Information Leaflet

Furaginum US Pharmacia, 50 mg, tablets
Furazidinum
Please read this leaflet carefully before using the medicine, because
it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7–8 days, or if you feel worse, consult your doctor.

Table of Contents

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

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

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

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

2. Important information before using Furaginum US Pharmacia

When not to use Furaginum US Pharmacia

• If the patient is allergic (hypersensitive) to furazidin, other nitrofuran derivatives, or any of the other ingredients of Furaginum US Pharmacia.
• During the first trimester of pregnancy.
• From week 38 of gestation and during delivery, due to the risk of developing hemolytic anemia (anemia associated with the breakdown of red blood cells) in the newborn.
• In children and adolescents under 15 years of age.
• If the patient has renal insufficiency, and laboratory tests have shown a creatinine clearance below 60 ml/min or elevated serum creatinine levels.
• If the patient has been diagnosed with polyneuropathy (a disorder of the nervous system), e.g. in the course of diabetes.

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• If the patient has glucose-6-phosphate dehydrogenase deficiency (an enzyme involved in red blood cell metabolism).

Warnings and precautions
If any of the following conditions apply to the patient, the use of Furaginum US Pharmacia should be discussed with a physician.

• If the patient has impaired kidney or liver function, neurological disorders, anemia, electrolyte imbalances, deficiency of B-group vitamins or folic acid, or lung diseases.
• If the patient has diabetes – furazidin may cause nerve damage. Peripheral nerve damage has been observed in patients treated with nitrofuran derivatives. This disorder, in severe cases, may be irreversible and life-threatening. Therefore, the patient should discontinue use of Furaginum US Pharmacia immediately if symptoms of nervous system dysfunction occur (tingling, numbness, sensation of electric shocks).
• If fever, chills, cough, chest pain, or shortness of breath occur during treatment with 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, the drug should be discontinued immediately – symptoms usually resolve quickly or very quickly after stopping the medication. If the drug has been used long-term, the severity and resolution of symptoms depend on how long treatment was continued after the first adverse effects appeared. Early recognition of adverse effects and prompt discontinuation of the drug are crucial. Pulmonary dysfunction may become irreversible. Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonitis) have been reported in patients treated with furazidin for longer than 6 months, particularly in elderly patients.
• If the patient is taking the drug long-term – blood tests may be necessary to monitor white blood cell count and kidney and liver function.
• If the patient develops severe and persistent diarrhea during or after treatment. This may be a sign of pseudomembranous colitis – a complication that may occur occasionally after using antibacterial drugs. The patient should contact a physician immediately and should not take antidiarrheal agents that inhibit intestinal peristalsis.

Furaginum US Pharmacia and other medicines
If the patient is taking any of the following medicines, they should consult a physician or pharmacist before starting Furaginum US Pharmacia.

• Nalidixic acid (an antibiotic) – furazidin inhibits its bacteriostatic effect.
• Aminoglycosides and tetracyclines (antibiotics) – enhance the antibacterial effect of furazidin.
• Chloramphenicol and rystomycin (antibiotics) – increase the toxic effect of furazidin on blood cells.
• Probenecid (in high doses) and sulfinpyrazone (drugs that increase urinary excretion of uric acid) – reduce the excretion of furazidin and may lead to its accumulation in the body, increasing its toxicity and reducing its concentration in urine, thereby weakening its therapeutic effectiveness.
• Antacids containing magnesium trisilicate – reduce the absorption of furazidin.
• Atropine – delays the absorption of furazidin, although the total amount absorbed remains unchanged.
• B-group vitamins – increase the absorption of furazidin.

Effect on laboratory tests
During treatment with furazidin, urine glucose tests using Benedict's or Fehling's solutions may yield false-positive results. Urine glucose tests performed by enzymatic methods are usually accurate.

Taking Furaginum US Pharmacia with food and drink
Furaginum US Pharmacia should be taken orally during protein-containing meals, which enhances drug absorption.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a physician or pharmacist before using this medicine.
Furaginum US Pharmacia should not be used during the first three months of pregnancy (first trimester) or from week 38 of gestation and during delivery, as furazidin may cause hemolytic anemia in the newborn. Particular caution is required when using the drug during the last three months of pregnancy (third trimester).
Furaginum US Pharmacia should not be used during breastfeeding. Furazidin passes into breast milk and may harm the breastfed infant.

Driving and operating machinery
There is no data on the effect of furazidin on the ability to drive or operate machinery. However, some patients may experience adverse effects that could affect driving ability (dizziness, drowsiness, visual disturbances).

Furaginum US Pharmacia contains lactose and sucrose
Each tablet contains 18.8 mg of lactose and 10 mg of sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a physician before taking this medicine.

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3. How to use Furaginum US Pharmacia

This medicine should always be taken exactly as described in the patient leaflet or as directed by
your doctor. If in doubt, consult your doctor or pharmacist.
Adults and adolescents over 15 years of age
First day of treatment: 2 tablets four times daily; subsequent days: 2 tablets three times daily.
Furaginum US Pharmacia should be taken orally during meals containing protein, as protein
increases the absorption of the medicine.
The treatment should last 7–8 days. If symptoms worsen or do not improve after this time,
consult your doctor.
If necessary, the treatment course may be repeated after 10–15 days.
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Use in children and adolescents
Furaginum US Pharmacia should not be used in children and adolescents under 15 years of age.
Use of a higher than recommended dose of Furaginum US Pharmacia
If a higher than recommended dose of Furaginum US Pharmacia is taken, the following
symptoms may occur: headache, dizziness, allergic reactions, nausea, vomiting, and anemia.
If such symptoms occur, seek immediate medical attention at the nearest hospital emergency
department, as specialist treatment may be required (including gastric lavage and intravenous
fluids, and in severe cases, hemodialysis). Due to the excretion of the medicine via the kidneys,
the risk of overdose is increased in patients with impaired kidney function.
Missed dose of Furaginum US Pharmacia
If a dose of Furaginum US Pharmacia is missed, continue treatment with the previously
prescribed doses. Do not take a double dose to make up for the missed dose.
If you have any further questions about the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Among the adverse effects observed during clinical trials and considered most likely related to the use of the medicine, the most common were: nausea (8%), headache (6%), and excessive flatulence (1.5%). The remaining symptoms listed below occurred in no more than 1% of patients and are listed according to the affected body systems.
You should immediately stop using this medicine and contact your doctor or go to the nearest hospital if any of the following occur:

• severe skin reactions with peeling or blister formation (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, i.e. bullous erythema multiforme);
• anaphylactic reactions (sudden local or systemic allergic reactions), angioedema (a skin and subcutaneous tissue disorder characterized by swelling that may impair breathing, most commonly affecting the face, throat, or tongue);
• drug-induced hepatitis symptoms, cholestatic jaundice (caused by obstruction of bile flow), hepatic parenchymal necrosis;
• cyanosis, megaloblastic anemia (anemia due to vitamin B12 or folic acid deficiency), or hemolytic anemia (caused by excessive destruction of red blood cells);
• peripheral nerve disorders (including acute or irreversible forms, especially in patients with renal insufficiency, anemia, diabetes, electrolyte disturbances, or vitamin B deficiency);
• infections caused by microorganisms resistant to furazidin;
• fever, chills, malaise;
• pancreatitis presenting as severe upper abdominal pain;
• pseudomembranous colitis (diarrhea with cramping abdominal pain, slightly elevated body temperature; severe inflammation of the large intestine);
• hypersensitivity reactions affecting the respiratory system;
• acute reactions – characterized by fever, chills, cough, chest pain, dyspnea, pleural effusion, radiological lung abnormalities, and increased number of a specific type of white blood cells called eosinophils; these 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 stopping the medicine depend on how long treatment was continued after the first adverse symptoms appeared; once an adverse reaction is identified, the medicine must be discontinued immediately; lung function disorders may be irreversible;

Other adverse reactions:

• nausea, excessive flatulence;
• headache;
• dizziness, drowsiness, visual disturbances;
• constipation, diarrhea, dyspeptic symptoms (e.g. feeling of fullness after meals, bloating), abdominal pain, vomiting, sialadenitis;
• alopecia;
• itching, urticaria, rash.

Nitrofuran derivatives may negatively affect testicular function, reduce sperm motility, decrease semen secretion, and lead to unfavorable changes in sperm morphology.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
ul. Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Furaginum US Pharmacia

Keep this medicine out of 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 this medicine after the expiry date stated on the blister and carton.
The expiry date refers to the last day of the stated month.
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Medicines must 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 is furazidin, also known as furagin. One tablet contains 50 mg of furazidin.
The other ingredients are: lactose, pregelatinized starch, sucrose, polysorbate 80, stearic acid.

What Furaginum US Pharmacia looks like and contents of the pack
Uncoated tablets, biconvex, yellow-orange in colour.
Carton boxes containing 30 tablets in blisters.

Marketing Authorisation Holder
US Pharmacia Sp. z o.o.
Ziębicka 40
50-507 Wrocław
Poland

Manufacturer
Olpha AS
Rupnicu Iela 5, Olaine,
Olaines Novads, 2114
Latvia

For further information, please contact the representative of the Marketing Authorisation Holder:
USP Zdrowie Sp. z o.o.
Poleczki 35
02-822 Warsaw
Phone: +48 (22) 543 60 00

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