Furaginum Hasco Max

Package Leaflet: Information for the Patient

Furaginum Hasco MAX, 100 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 a doctor or pharmacist.

• The package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 7-10 days, they should contact their doctor.

Table of Contents of the Package Leaflet

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

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

Furaginum Hasco MAX 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 MAX 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 MAX

When not to take Furaginum Hasco MAX

• If the patient is 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.
• During 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 the patient has renal impairment (creatinine clearance below 60 ml/min or elevated serum creatinine levels).
• If the patient has been diagnosed with polyneuropathy (a nervous system disorder related to peripheral nerve damage, which may be characterized by motor or sensory disturbances), e.g., in diabetes.
• If the patient has 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 MAX, the patient should discuss it with their doctor, pharmacist, or nurse, especially if they 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, the patient should stop taking Furaginum Hasco MAX if they experience symptoms of nervous system disorders (tingling, numbness, sensation of electric currents).
If the patient experiences fever, chills, cough, chest pain, or shortness of breath while taking Furaginum Hasco MAX, they should stop taking the medicine immediately - 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 reaction and discontinuation of the medicine are crucial. 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 the patient takes the medicine for a long time, blood tests and kidney and liver function tests may be necessary.
If the patient experiences severe and persistent diarrhea during or after treatment, they should contact their doctor immediately and not take anti-diarrheal medications that inhibit intestinal peristalsis.
See also section 4, when to stop the medicine and consult a doctor.

Furaginum Hasco MAX and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Caution should be exercised 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) - which increase the toxic effect of furazidine on red blood cells,
• medicines that increase uric acid excretion, such as probenecid (in high doses) or sulfinpyrazone - which reduce 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 - which reduce the absorption of furazidine,
• atropine - which delays the absorption of furazidine, but the overall amount of absorbed substance does not change,
• vitamins B - which 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 give false-positive results. Glucose tests in urine performed using 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 increases the absorption of the medicine.
Alcohol should be avoided during treatment with Furaginum Hasco MAX.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Furaginum Hasco MAX should not be taken 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 MAX should not be taken during breastfeeding. Furazidine passes into breast milk and may harm the breastfed child.
Furazidine in Furaginum Hasco MAX may have a negative effect on testicular function, reducing sperm motility and causing unfavorable changes in their structure, as well as reducing the overall amount of ejaculate.

Driving and using machines

There is 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 their ability to drive (dizziness, drowsiness, vision disturbances).

Furaginum Hasco MAX contains sucrose

Each tablet contains 28 mg of sucrose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Furaginum Hasco MAX

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

Adults and adolescents over 15 years of age

First day of treatment: 100 mg (1 tablet) 4 times a day; subsequent days: 100 mg (1 tablet) 3 times a day.
The medicine should be taken orally during meals containing protein, which increases the absorption of furazidine. The score line allows the tablet to be divided into two equal doses.
The treatment lasts for 7-10 days. If symptoms worsen or do not improve after 7-10 days, the patient should consult their doctor. If necessary, the treatment can be repeated after 10-15 days.

Use in children and adolescents under 15 years of age

Furaginum Hasco MAX should not be taken by children and adolescents under 15 years of age.

Overdose of Furaginum Hasco MAX

In case of overdose, the patient may experience nausea, vomiting, headache, dizziness, allergic reactions, or anemia.
If such symptoms occur, the patient 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 renal impairment.

Missed dose of Furaginum Hasco MAX

If a dose is missed, the treatment should be continued with the previously taken doses. A double dose should not be taken to make up for the missed dose.

Discontinuation of Furaginum Hasco MAX

Stopping treatment with Furaginum Hasco MAX during the course of treatment may result in incomplete recovery from the lower urinary tract infection.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Furaginum Hasco MAX can cause side effects, although not everybody gets them.

The patient should stop taking the medicine immediately and inform their doctor or go to the nearest hospital if they 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 treatment) (rare),
• asthmatic reaction (shortness of breath) in patients with asthma; hypersensitivity reactions affecting the respiratory system, including (unknown frequency):
• acute reactions - characterized 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, 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 detecting the adverse reaction, the medicine should be discontinued 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 renal impairment, anemia, diabetes, electrolyte disturbances, or vitamin B deficiency) (unknown frequency),
• pseudomembranous colitis (a severe disease of the small or large intestine characterized by diarrhea, headache, and fever) (unknown frequency),
• methemoglobinemia; in patients with glucose-6-phosphate dehydrogenase deficiency, furazidine may cause 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 the patient experiences any side effects, including any side effects not listed in the package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309,
e-mail: [email protected].
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 MAX

The medicine should be stored out of 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. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Furaginum Hasco MAX contains

• The active substance of the medicine is furazidine ( Furazidinum), also known as furagin. 1 tablet contains 100 mg of furazidine.
• The other ingredients (excipients) are: maize starch, sucrose, colloidal silica, stearic acid 50.

What Furaginum Hasco MAX looks like and contents of the pack

The tablet is yellow, oval, biconvex, with a score line on both sides, and measures 11.1 mm x 6.3 mm.
The cardboard box contains 15 or 30 tablets in blisters.

Marketing authorization holder and manufacturer

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

Medicine information

tel.: (22) 742 00 22
e-mail: [email protected]

Date of last revision of the package leaflet: