Furaginum Hasco

Package Leaflet: Information for the Patient

Furaginum Hasco, 50 mg/5 ml, Oral Suspension

Furazidinum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

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 children, adolescents, and adults.

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),
• during the first three months of pregnancy,
• during the period of gestation (from the 38th week) and childbirth, due to the risk of hemolytic anemia in the newborn,
• in children under 3 months 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 may be characterized by 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 the above cases, the use of furazidine increases the risk of nerve damage.

Stop taking Furaginum Hasco immediately and consult your doctor:

• if you experience symptoms of nervous system disorders (tingling, numbness, sensation of electric currents). Peripheral nerve damage has been observed in patients treated with nitrofuran derivatives. This disorder can be irreversible and life-threatening in severe cases;
• if you experience fever, chills, cough, chest pain, shortness of breath during treatment. These may be symptoms of acute pulmonary reactions, which are sometimes observed in patients treated with nitrofuran derivatives. These symptoms usually resolve quickly or very quickly after discontinuation of the medicine. If the medicine has been 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 appear. 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 you experience symptoms of liver disorders (jaundice, dark urine, pale stools, abdominal pain, nausea, vomiting, persistent fatigue, loss of appetite, and weight loss). Jaundice may occur during short-term use of nitrofurans (up to two weeks). Chronic hepatitis occurs during long-term use of nitrofurans (usually more than 6 months);
• 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.

If you are taking the medicine for a long time, your doctor will order blood tests and kidney and liver function tests.
Effect on laboratory tests
The medicine may cause false-positive glucose test results in urine using Benedict's and Fehling's solutions. Before submitting a urine sample for such a test, inform the medical staff that you are taking Furaginum Hasco.
Glucose test results in urine using enzymatic methods are usually normal.

Children

Furaginum Hasco oral suspension can be used in children over 3 months of age.

Furaginum Hasco and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Caution is required when taking the following medicines:

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

Furaginum Hasco with food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Furaginum Hasco should not be used during the first three months of pregnancy (I trimester) due to the lack of clinical data on safety during this period.
Caution should be exercised when using the medicine in the last three months of pregnancy (III trimester). The medicine can be used in the III trimester after consulting a doctor.
The medicine should not be used from the 38th week of pregnancy and during childbirth, as furazidine may cause hemolytic anemia in the newborn.
Breastfeeding
Furaginum Hasco should not be used during breastfeeding. Furazidine passes into breast milk and may harm the breastfed child.
Fertility
Furazidine may adversely affect 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 the ability to drive (dizziness, drowsiness, vision disturbances) - see section 4 "Possible side effects".

Furaginum Hasco contains sorbitol liquid, non-crystallizing, and sodium benzoate

The medicine contains 2250.09 mg of sorbitol and 29.5 mg of sodium benzoate in 5 ml of suspension.
The medicine contains 13.15 mg of sodium (main component of table salt) in 5 ml of suspension. This corresponds to 0.66% of the maximum recommended daily sodium intake in the diet for adults.
Sorbitol is a source of fructose. If you have previously been diagnosed with intolerance to some sugars or have a rare genetic disorder, hereditary fructose intolerance, in which your body does not break down fructose, you should consult your doctor before taking the medicine or giving it to your child.
Sorbitol may cause gastrointestinal discomfort and have a mild laxative effect.

3. How to take Furaginum Hasco

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
Take the medicine orally during meals containing protein, which increases the absorption of furazidine.
Shake the bottle well before each use.
The prescribed dose of the medicine is measured using the enclosed oral syringe with a capacity of 5 milliliters. The syringe scale allows for measuring the dose volume with an accuracy of 0.1 milliliters (i.e., 1 mg of furazidine).

Adults and adolescents

First day of treatment: 400 mg per day in 4 divided doses (10 ml of suspension every 6 hours).
Subsequent days: 300 mg per day in 3 divided doses (10 ml of suspension every 8 hours).
The medicine is used for 7-10 days. If necessary, the doctor may repeat the treatment after 10-15 days.

Children over 3 months of age

The recommended dose is: 5-7 mg/kg body weight per day, in 2 or 3 divided doses.
The medicine is used for 7-10 days. If necessary, the doctor may repeat the treatment after 10-15 days.
The medicine can be used in children over 3 months of age.

Using a higher dose of Furaginum Hasco than recommended

If you take more Furaginum Hasco than you should, you may experience nausea, vomiting, headaches, dizziness, allergic reactions, anemia.
If you experience these symptoms, seek immediate medical attention at the nearest hospital emergency department, as you may need specialized treatment (including gastric lavage and intravenous fluid administration, and in severe cases, hemodialysis). Due to the elimination of the medicine from the body by the kidneys, the risk of overdose is increased in patients with impaired kidney function.

Missing a dose of Furaginum Hasco

If you miss a dose of Furaginum Hasco, 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

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking Furaginum Hasco and inform your doctor or go to the nearest hospital immediately if you experience any of the following side effects [rare (affecting 1 to 10 in 10,000 patients) or unknown frequency (cannot be estimated from available data)]:

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 - characterized by fever, chills, cough, chest pain, shortness of breath - usually resolve quickly after discontinuation of the medicine,
• chronic reactions - including pulmonary changes (e.g., pulmonary fibrosis, pneumonia) - the severity of symptoms and their reversibility after discontinuation of the medicine depend on the duration of treatment after the first symptoms appear; 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 acute or irreversible, 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 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).

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

• nausea, excessive gas,
• headaches.

Unknown frequency (cannot be estimated from available data):

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

Reporting side effects

If you experience any side effects, including those not listed in this 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
Phone: 22 49 21 301,
Fax: 22 49 21 309,
Website: https://smz.ezdrowie.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 this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Shelf life after first opening the bottle: 6 months.
Medicines should 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. Contents of the pack and other information

What Furaginum Hasco contains

• The active substance of the medicine is furazidine (Furazidinum), also known as furagin. 5 ml of suspension contains 50 mg of furazidine.
• The other ingredients (excipients) are: liquid sorbitol, non-crystallizing (E 420), citric acid, sodium citrate, glycerol, xanthan gum, banana flavor, sodium benzoate (E 211), polysorbate 80, purified water.

What Furaginum Hasco looks like and contents of the pack

The medicine is a yellow suspension.
One pack of the medicine contains 140 ml of suspension in an orange glass bottle with a polyethylene cap and a polyethylene ring, with an oral syringe made of PE, with a plunger made of PS, in a cardboard box.

Marketing authorization holder and manufacturer

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

Information about the medicine

phone: 22 742 00 22
e-mail: [email protected]

Date of last revision of the leaflet: