Furaginum Hasco

Package Leaflet: Information for the Patient

Furaginum Hasco, 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 or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If after 7-10 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet

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

1. What is Furaginum Hasco and what is it used for

Furaginum Hasco contains furazidine, also known as furagin, as the active substance.
Furazidine is a nitrofuran derivative that inhibits the growth of bacteria that cause urinary tract infections.
Furaginum Hasco is used to treat acute and recurrent uncomplicated lower urinary tract infections in patients over 15 years of age.

2. Important information before taking Furaginum Hasco

When not to take Furaginum Hasco

• If you are allergic to furazidine, nitrofuran derivatives, or any of the other ingredients of this medicine (listed in section 6).
• In the first three months of pregnancy.
• In the last month of pregnancy and during childbirth, due to the risk of hemolytic anemia in the newborn.
• In children and adolescents under 15 years of age.
• If you have kidney failure (creatinine clearance below 60 ml/min or elevated serum creatinine levels).
• If you have been diagnosed with polyneuropathy (a disorder of the nervous system associated with damage to peripheral nerves, which can cause motor or sensory disturbances), e.g., in diabetes.
• If you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (an enzyme involved in red blood cell metabolism).

Warnings and precautions

Before starting treatment with Furaginum Hasco, discuss it with your doctor, pharmacist, or nurse, especially if you have:

• kidney problems,
• liver problems,
• nervous system disorders,
• anemia,
• electrolyte disturbances,
• deficiency of vitamins B and folic acid,
• lung diseases,
• diabetes. In these cases, the use of furazidine increases the risk of nerve damage.

In patients treated with nitrofuran derivatives, peripheral nerve damage has been observed.
This disorder can be irreversible and life-threatening in severe cases. Therefore, you should stop taking Furaginum Hasco 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 Hasco, 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 used 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 of adverse reactions. The key issue is the earliest possible recognition of adverse reactions and discontinuation of the medicine. Pulmonary disorders can be irreversible. Chronic reactions occurred in patients taking furazidine for more than 6 months. Chronic pulmonary reactions (including pulmonary fibrosis and interstitial pneumonia) may occur, especially in elderly patients.
If you are taking the medicine for a long time, it may be necessary to perform blood tests and kidney and liver function tests.
If you experience severe and persistent diarrhea during or after treatment. This may be a symptom of pseudomembranous colitis - a complication that occurs sometimes after the use of antibacterial medicines. You should contact your doctor as soon as possible and not take anti-diarrheal medicines that inhibit intestinal peristalsis.
See also section 4, when to stop the medicine and consult a doctor.

Furaginum Hasco and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Be cautious when taking the following medicines:

• quinolone antibiotics (e.g., nalidixic acid, norfloxacin, oxolinic acid) - furazidine inhibits their bacteriostatic effect,
• aminoglycoside and tetracycline antibiotics - as they enhance the antibacterial effect of furazidine,
• chloramphenicol and ristomycin (antibiotics) - they increase the toxic effect of furazidine on red blood cells,
• medicines that increase uric acid excretion, such as probenecid (in high doses) or sulfinpyrazone - they decrease the concentration of furazidine in urine and may cause its accumulation in the body, reducing the effectiveness of treatment and increasing its toxicity,
• antacids containing magnesium trisilicate - they decrease the absorption of furazidine,
• atropine - it delays the absorption of furazidine, but the overall amount of absorbed substance does not change,
• vitamins B - they increase the absorption of furazidine.

Effect on laboratory tests
During treatment with furazidine, glucose tests in urine using Benedict's and Fehling's solutions may be falsely positive. Glucose tests in urine performed using enzymatic methods are usually correct.

Furaginum Hasco with food, drink, and alcohol

Furaginum Hasco should be taken orally during meals containing protein, which increases the absorption of the medicine.
You should avoid consuming alcohol during treatment with Furaginum Hasco.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Furaginum Hasco should not be used during the first three months of pregnancy (first trimester) or from the 38th week of pregnancy and during childbirth, as furazidine may cause hemolytic anemia in the newborn. Particular caution should be exercised during the last three months of pregnancy (third trimester).

• Furaginum Hasco should not be used during breastfeeding. Furazidine passes into breast milk and may harm the breastfed child.

Furazidine in Furaginum Hasco may adversely affect testicular function, causing decreased sperm motility and unfavorable changes in their structure, as well as reducing the overall amount of ejaculate.

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 Hasco contains sucrose

Each tablet contains 14 mg of sucrose. If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Furaginum Hasco

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor or pharmacist.
In case of doubt, consult your doctor or pharmacist.

Adults and adolescents over 15 years of age

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 furazidine. The score line on the tablet facilitates breaking the tablet for easier swallowing and is not intended for dividing the tablet into two equal doses.
The medicine is used for 7-10 days. If symptoms worsen or do not improve after 7-10 days, consult your doctor. If necessary, the treatment can be repeated after 10-15 days.

Use in children and adolescents under 15 years of age

Furaginum Hasco should not be used in children and adolescents under 15 years of age.

Overdose of Furaginum Hasco

In case of overdose, nausea, vomiting, headache, dizziness, allergic reactions, or anemia may occur.
If such symptoms occur, seek immediate medical attention at the nearest hospital, as specialized treatment (including gastric lavage and intravenous fluid administration, and 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 impaired kidney function.

Missed dose of Furaginum Hasco

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

Stopping treatment with Furaginum Hasco

Stopping treatment with Furaginum Hasco during the course of treatment may result in incomplete recovery from the lower urinary tract infection.
In case of any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Stop taking the medicine immediately and inform your doctor or go to the nearest hospital if you experience any of the following side effects (rare, occurring in 1 to 10 in 10,000 patients, or with unknown frequency):

• allergic reactions: itching, hives, rash (unknown frequency), anaphylactic reactions (sudden local or systemic allergic reactions), angioedema (a skin and subcutaneous tissue disorder characterized by limited swelling) (rare),
• severe skin reactions (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome - a blistering form of erythema multiforme) (rare),
• symptoms of drug-induced hepatitis, cholestatic jaundice (caused by an obstacle to bile flow), liver necrosis (usually during long-term use) (rare),
• asthmatic reaction (shortness of breath) in patients with asthma; hypersensitivity reactions affecting the respiratory system, including (unknown frequency):
• acute reactions - manifested by fever, chills, cough, chest pain, shortness of breath - usually resolving quickly after discontinuation of the medicine,
• chronic reactions - including changes in the lungs (e.g., pulmonary fibrosis, 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; after detecting an adverse reaction, it is necessary to discontinue the medicine immediately; pulmonary disorders can be irreversible,
• tingling, numbness, sensation of electric currents due to peripheral nerve damage (also with acute or irreversible course, especially in patients with impaired kidney function, anemia, diabetes, electrolyte disturbances, or vitamin B deficiency) (unknown frequency),
• pseudomembranous colitis (a severe disease of the small or large intestine, manifested by diarrhea, headache, and fever) (unknown frequency),
• methemoglobinemia; in people with glucose-6-phosphate dehydrogenase deficiency, the use of furazidine may lead to the development of megaloblastic or hemolytic anemia (unknown frequency).

Additionally, the following side effects have been observed in patients taking furazidine: Frequent (in 1 to 10 in 100 patients)

• nausea, excessive gas,
• headache.

Unknown frequency

• dizziness, drowsiness, vision disturbances,
• constipation, diarrhea, symptoms of indigestion,
• vomiting, abdominal pain, loss of appetite,
• salivary gland inflammation, pancreatitis,
• hair loss (transient),
• infections with microorganisms resistant to furazidine,
• fever, chills, malaise.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309,
e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Furaginum Hasco

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Store in the original packaging to protect from light.
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 month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your 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 Furaginum Hasco contains

• The active substance of the medicine is furazidine (Furazidinum), also known as furagin. 1 tablet contains 50 mg of furazidine.
• The other ingredients (excipients) are: maize starch, sucrose, colloidal anhydrous silica, stearic acid 50.

What Furaginum Hasco looks like and contents of the pack

The tablet is yellow, round, flat with beveled edges, and 6 mm in diameter, with a score line on one side.
The carton contains 30 or 60 tablets in blisters.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
Żmigrodzka 242 E
51-131 Wrocław

Medicine information

tel.: (22) 742 00 22
e-mail: informacjaoleku@hasco-lek.pl

Date of last revision of the leaflet: