Furaginum hasco

Package leaflet: Information for the patient

Furaginum Hasco, 50 mg, tablets
Furazidinum
Read carefully the entire leaflet before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the
physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement or if the patient feels worse after 7–10 days, contact a physician.

Contents of the leaflet

1. What Furaginum Hasco is and what it is 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 package and other information

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

Furaginum Hasco contains furazidin, also known as furagin, as the active substance.
Furazidin is a nitrofuran derivative that inhibits the growth of bacteria causing urinary tract infections.
Furaginum Hasco is used in the treatment of acute and recurrent uncomplicated infections of the lower urinary tract in individuals over 15 years of age.

2. Information before using Furaginum Hasco

When not to use Furaginum Hasco

• If the patient is allergic to furazidin, nitrofuran derivatives, or any of the other ingredients of this medicine (listed in section 6).
• During the first three months of pregnancy.
• In the term pregnancy (from week 38) and during delivery, due to the risk of 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 impairment (in laboratory tests, creatinine clearance below 60 mL/min or elevated serum creatinine levels).
• If the patient has been diagnosed with peripheral neuropathy (a nervous system disorder involving damage to peripheral nerves, possibly manifesting as motor or sensory disturbances), e.g., in diabetes.
• If the patient has glucose-6-phosphate dehydrogenase deficiency (an enzyme involved in red blood cell metabolism).

Warnings and precautions
Before starting treatment with Furaginum Hasco, discuss it with a doctor, pharmacist, or nurse, especially if the patient has:

• kidney function disorders,
• liver function disorders,
• nervous system disorders,
• anemia,
• electrolyte imbalances,
• vitamin B complex and folic acid deficiency,
• lung diseases,
• diabetes. In these cases, the use of furazidin increases the risk of nerve damage.

Peripheral nerve damage has been observed in patients treated with nitrofuran derivatives.
This disorder may, in severe cases, be irreversible and life-threatening. Therefore, the patient should discontinue use of Furaginum Hasco immediately if symptoms of nervous system dysfunction occur (tingling, numbness, sensation of electric currents).
If, during treatment with Furaginum Hasco, the patient develops 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. If such symptoms occur, the drug should be discontinued immediately — these symptoms usually resolve quickly or very rapidly after stopping the medication. If the drug has been used long-term, the severity of symptoms and their resolution after discontinuation 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. Lung function disorders may be irreversible. Chronic pulmonary reactions have occurred in patients taking furazidin for longer than 6 months. Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonia) may particularly affect elderly patients.
If the patient uses the drug long-term, blood tests and monitoring of kidney and liver function may be necessary.
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 doctor immediately and should not take antidiarrheal medications that inhibit intestinal peristalsis.
See also section 4, when to stop taking the medicine and consult a doctor.

Furaginum Hasco and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Exercise caution when using the following medicines concomitantly:

• quinolone antibiotics (e.g., nalidixic acid, norfloxacin, oxolinic acid) — furazidin inhibits their bacteriostatic effect,
• aminoglycoside and tetracycline antibiotics — these enhance the antibacterial effect of furazidin,
• chloramphenicol and ristomycin (antibiotics) — increase the toxic effect of furazidin on red blood cells,
• drugs that increase uric acid excretion, such as probenecid (at high doses) or sulfinpyrazone — these reduce furazidin concentration in urine and may cause its accumulation in the body, reducing treatment efficacy and increasing toxicity,
• antacids containing magnesium trisilicate — reduce absorption of furazidin,
• atropine — delays absorption of furazidin, although total absorbed amount remains unchanged,
• vitamin B complex — enhance 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.

Furaginum Hasco, food, drink, and alcohol
Furaginum Hasco should be taken orally during protein-containing meals, which enhances drug absorption.
Alcohol consumption should be avoided during treatment with Furaginum Hasco.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Furaginum Hasco must not be used during the first three months of pregnancy (first trimester) or from week 38 onwards and during delivery, as furazidin may cause hemolytic anemia in the newborn. Particular caution is required during use in the last three months of pregnancy (third trimester).
Furaginum Hasco should not be used during breastfeeding. Furazidin passes into breast milk and may harm the breastfed infant.
Furazidin contained in Furaginum Hasco may adversely affect testicular function, causing reduced sperm motility and unfavorable changes in sperm morphology, as well as decreasing total ejaculate volume.

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

Furaginum Hasco contains sucrose
Each tablet contains 14 mg of sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Furaginum Hasco

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

Adults and adolescents over 15 years of age
First day of treatment: 100 mg (2 tablets) four times daily; subsequent days: 100 mg (2 tablets) three times daily.
The medicine should be taken orally during meals containing protein, as protein increases the absorption of furazidin. The score line on the tablet facilitates breaking it for easier swallowing and is not intended for dividing the tablet into two equal doses.
The treatment should last 7–10 days. If symptoms worsen or do not improve after 7–10 days, consult a doctor. If necessary, the treatment may be repeated after 10–15 days.

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

Use of a higher than recommended dose of Furaginum Hasco
If a higher than recommended dose of Furaginum Hasco is taken, symptoms such as nausea, vomiting, headache, dizziness, allergic reactions, and anemia may occur.
If such symptoms occur, seek immediate medical attention at the nearest hospital emergency department, as specialized treatment may be required (including gastric lavage, intravenous fluid administration, and, in severe cases, hemodialysis). Due to the excretion of the drug via the kidneys, the risk of overdose is increased in patients with impaired renal function.

Missed dose of Furaginum Hasco
If a dose of Furaginum Hasco is missed, continue treatment with the previously prescribed doses. Do not take a double dose to make up for the missed dose.

Discontinuation of Furaginum Hasco
Stopping treatment with Furaginum Hasco during therapy may result in failure to cure the lower urinary tract infection.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
You should immediately stop taking this medicine and contact your doctor or go to the
nearest hospital if any of the following adverse effects occur
(these have occurred rarely, i.e. in 1 to 10 out of 10,000 patients, or frequency unknown):

• allergic reactions: itching, urticaria, rash (frequency unknown), anaphylactic reactions (sudden local or systemic allergic reactions), angioedema (a skin and subcutaneous tissue disorder characterized by the development of localized swelling) (rare),
• severe skin reactions (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome - bullous erythema multiforme) (rare),
• drug-induced hepatitis symptoms, cholestatic jaundice (caused by obstruction of bile flow), liver necrosis (usually during long-term use) (rare),
• asthmatic reaction (shortness of breath) in patients with asthma; respiratory hypersensitivity reactions, including (frequency unknown):
• acute reactions - manifested by fever, chills, cough, chest pain, dyspnea - usually resolve quickly after discontinuation of the drug,
• chronic reactions - including pulmonary changes (e.g. pulmonary fibrosis, pneumonia) - severity and reversibility of symptoms after discontinuation of the drug depend on the duration of treatment after onset of the first adverse effects; immediate discontinuation of the drug is required upon detection of an adverse effect; lung function impairment may be irreversible,
• tingling, numbness, sensation of electric currents due to peripheral nerve damage (including acute or irreversible course, especially in patients with impaired renal function, anemia, diabetes, electrolyte disturbances, or vitamin B deficiency) (frequency unknown),
• pseudomembranous colitis (a severe disease of the small or large intestine characterized by diarrhea, headache, and fever) (frequency unknown),
• cyanosis due to methemoglobinemia; in patients with glucose-6-phosphate dehydrogenase deficiency, nitrofurantoin use may lead to megaloblastic or hemolytic anemia (frequency unknown).

Additionally, the following adverse effects have been observed in patients taking nitrofurantoin:
Common (in 1 to 10 out of 100 patients)

• nausea, excessive flatulence,
• headache.

Frequency not known

• dizziness, drowsiness, visual disturbances,
• constipation, diarrhea, dyspeptic symptoms,
• vomiting, abdominal pain, loss of appetite,
• sialadenitis, pancreatitis,
• alopecia (transient),
• infections with microorganisms resistant to nitrofurantoin,
• fever, chills, malaise.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported
directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309,
e-mail: [email protected].
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Furaginum Hasco

Keep this medicine out of sight and reach of children.
Store below 25°C.
Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging following "Tw." The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Furaginum Hasco contains

• The active substance is furazidinum (furazidin), also known as furagin. Each tablet contains 50 mg of furazidin.
• The other ingredients (excipients) are: pregelatinized maize starch, sucrose, colloidal anhydrous silica, stearic acid 50.

What Furaginum Hasco looks like and contents of the pack
A tablet with a uniform yellow surface, round, flat with bevelled edges, 6 mm in diameter, with a dividing line on one side.
The cardboard box contains 30 or 60 tablets in blisters.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
ul. Żmigrodzka 242 E
51-131 Wrocław
Medicinal product information
tel.: (22) 742 00 22
e-mail: [email protected]