Package leaflet: Information for the patient

Furaginum Hasco MAX, 100 mg, tablets
Furazidinum
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet or as directed by
the physician or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult 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 or if you feel worse after 7–10 days, you should contact your doctor.

Table of contents

What Furaginum Hasco MAX is and what it is used for
Important information before taking Furaginum Hasco MAX
How to take Furaginum Hasco MAX
Possible side effects
How to store Furaginum Hasco MAX
Contents of the pack and other information

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

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

2. Important information before using Furaginum Hasco MAX

When not to use Furaginum Hasco MAX

If the patient is allergic to nitrofurantoin, nitrofuran derivatives, or any of the other ingredients of this medicine (listed in section 6).
During the first three months of pregnancy.
During full-term pregnancy (from week 38) and childbirth, due to the risk of hemolytic anemia (anemia caused by red blood cell breakdown) 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 causing motor or sensory disturbances), e.g., in the course of diabetes.
If the patient has glucose-6-phosphate dehydrogenase deficiency (an enzyme involved in metabolic processes in red blood cells).

Warnings and precautions
Before starting treatment with Furaginum Hasco MAX, 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,
deficiency of B vitamins and folic acid,
lung diseases,
diabetes. In these cases, the use of nitrofurantoin 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 MAX if symptoms of
neurological dysfunction occur (tingling, numbness, sensation of electric currents).
If, during treatment with Furaginum Hasco MAX, the patient develops fever, chills, cough,
chest pain, or shortness of breath, these may be symptoms of acute pulmonary reactions,
which have been observed occasionally in patients treated with nitrofuran derivatives.
If such symptoms occur, the drug should be discontinued immediately – these symptoms
usually resolve quickly or very quickly 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 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 nitrofurantoin for more than 6 months. Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonia) may occur especially in 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 as soon as possible and should not take antidiarrheal drugs that inhibit intestinal peristalsis.
See also section 4, when to discontinue the drug and consult a doctor.

Furaginum Hasco MAX 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 concurrently:

quinolone antibiotics (e.g., nalidixic acid, norfloxacin, oxolinic acid) – nitrofurantoin inhibits their bacteriostatic action,
aminoglycoside and tetracycline antibiotics – they enhance the antibacterial effect of nitrofurantoin,
chloramphenicol and ristomycin (antibiotics) – they increase the toxic effect of nitrofurantoin on blood cells,
drugs increasing uric acid excretion, such as probenecid (in high doses) or sulfinpyrazone – they reduce the urinary concentration of nitrofurantoin and may cause its accumulation in the body, weakening treatment efficacy and increasing toxicity,
antacids containing magnesium trisilicate – they reduce the absorption of nitrofurantoin,
atropine – delays absorption of nitrofurantoin, but the total amount absorbed remains unchanged,
B vitamins – increase the absorption of nitrofurantoin.

Effect on laboratory tests
During treatment with nitrofurantoin, 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 MAX with food, drink, and alcohol
Furaginum Hasco MAX should be taken orally during meals containing protein, which enhances drug absorption.
Alcohol consumption should be avoided during treatment with Furaginum Hasco MAX.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Furaginum Hasco MAX must not be used during the first three months of pregnancy (first trimester) or from week 38 and during childbirth, as nitrofurantoin 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 Hasco MAX should not be used during breastfeeding. Nitrofurantoin passes into breast milk and may harm the breastfed infant.
Nitrofurantoin contained in Furaginum Hasco MAX 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 nitrofurantoin on the ability to drive or operate machinery.
However, some patients may experience adverse effects that could affect their ability to drive (dizziness, drowsiness, visual disturbances).

Furaginum Hasco MAX contains sucrose
Each tablet contains 28 mg of sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.

3. How to use Furaginum Hasco Max

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults and adolescents over 15 years of age
First day of treatment: 100 mg (1 tablet) four times daily; subsequent days: 100 mg (1 tablet) three times daily.
The medicine should be taken orally during meals containing protein, which enhances the absorption of furazidin. The score line on the tablet allows it to be divided into two equal doses.
The medicine should be used for 7–10 days. If symptoms worsen or do not improve after 7–10 days, consult a doctor. If necessary, treatment may be repeated after 10–15 days.
Use in children and adolescents under 15 years of age
Furaginum Hasco Max must not be used in children and adolescents under 15 years of age.
Taking more than the recommended dose of Furaginum Hasco Max
If more than the recommended dose of Furaginum Hasco Max 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 specialist treatment may be required (including gastric lavage and intravenous fluids; in severe cases, hemodialysis may be necessary). Due to renal excretion of the drug, the risk of overdose is increased in patients with impaired kidney function.
Missed dose of Furaginum Hasco Max
If a dose of Furaginum Hasco Max is missed, continue treatment with the previously prescribed doses. Do not take a double dose to make up for the missed dose.
Stopping treatment with Furaginum Hasco Max
Discontinuing treatment with Furaginum Hasco Max during therapy may result in failure to cure the lower urinary tract infection.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

allergic reactions: itching, urticaria, rash (frequency unknown), anaphylactic reactions (sudden local or systemic allergic reactions), angioedema (a disease of the skin and subcutaneous tissue characterized by development of localized swelling) (rare),
severe skin reactions (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome - bullous erythema multiforme) (rare),
symptoms of drug-induced hepatitis, 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; hypersensitivity reactions affecting the respiratory system, including (frequency unknown):
acute reactions - manifested by fever, chills, cough, chest pain, shortness of breath - usually resolve quickly after discontinuation of the medicine,
chronic reactions - including changes in the lungs (e.g. pulmonary fibrosis, pneumonia) - severity of symptoms and reversibility after discontinuation of the medicine depend on the duration of treatment after the first adverse effects appear; immediate discontinuation of the medicine is required upon detection of any 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 kidney function, anaemia, diabetes, electrolyte disturbances or vitamin B deficiency) (frequency unknown),
pseudomembranous colitis (a severe disease of the small or large intestine manifested by diarrhoea, headache and fever) (frequency unknown),
cyanosis due to methaemoglobinaemia; in patients with glucose-6-phosphate dehydrogenase deficiency, use of nitrofurantoin may lead to megaloblastic or haemolytic anaemia (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, diarrhoea, 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, inform your doctor or pharmacist. Adverse effects can be reported
directly to the Department of Monitoring 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 collect more information on the safety of using the medicine.

5. How to store Furaginum Hasco Max

Keep the medicine out of the 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 "Exp.". 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 in use. This will help protect the environment.

6. Contents of the packaging and other information

What Furaginum Hasco MAX contains

The active substance is furazidinum (Furazidinum), also known as furagin. One tablet contains 100 mg of furazidinum.
The other components (excipients) are: pregelatinized corn starch, sucrose, colloidal anhydrous silica, stearic acid 50.

What Furaginum Hasco Max looks like and contents of the pack
A tablet with a uniform yellow surface, oval-shaped, biconvex, measuring 11.1 mm x 6.3 mm, with a dividing score line on both sides.
The cardboard box contains 15 or 30 tablets in blisters.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
ul. Żmigrodzka 242 E
51-131 Wrocław
Product information
tel.: (22) 742 00 22
e-mail: [email protected]