Furaginum hasco

Patient Information Leaflet

Furaginum Hasco, 50 mg/5 ml, oral suspension
Furazidinum
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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 pack 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 lower urinary tract infections in children, adolescents, and adults.

2. Important information before using Furaginum Hasco

When not to use Furaginum Hasco:

• 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,
• in late 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 under 3 months of age,
• if the patient has renal failure (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, which may manifest as motor or sensory disturbances), e.g., in the course of diabetes,
• if the patient has glucose-6-phosphate dehydrogenase deficiency (an enzyme involved in metabolism within red blood cells).

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

• impaired kidney function,
• impaired liver function,
• nervous system disorders,
• anemia,
• electrolyte imbalances,
• deficiency of vitamin B group and folic acid,
• lung diseases,
• diabetes. In the above-mentioned cases, the use of nitrofurantoin increases the risk of nerve damage.

Immediately discontinue taking Furaginum Hasco and seek medical advice:

• if the patient develops symptoms of nervous system dysfunction (tingling, numbness, sensation of electric currents). Peripheral nerve damage has been observed in patients treated with nitrofuran derivatives. This disorder, in severe cases, may be irreversible and life-threatening;
• if during treatment fever, chills, cough, chest pain, or shortness of breath occur. 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 drug. If the drug has been used long-term, the severity of symptoms and their resolution after stopping 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 dysfunction may become irreversible. Chronic pulmonary reactions have occurred in patients taking nitrofurantoin for longer than 6 months. Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonia) may particularly affect elderly patients;
• if the patient develops symptoms of liver dysfunction (jaundice of the eyes, skin, and mucous membranes, dark urine, skin itching, pale stools, abdominal pain, nausea, vomiting, persistent fatigue, loss of appetite, and weight loss). Jaundice may occur during short-term use of nitrofurans (within two weeks). Chronic hepatitis may develop during long-term use of nitrofurans (usually beyond 6 months);
• 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. Contact a doctor immediately and do not take antidiarrheal medications that inhibit intestinal peristalsis.

If the patient is using the drug long-term, the doctor will order blood tests and assessments of kidney and liver function.

Effect on laboratory tests
Furaginum Hasco may cause false-positive results in urine glucose tests using Benedict's or Fehling's solutions. Before submitting a urine sample for such testing, inform medical personnel about taking Furaginum Hasco.
Results of urine glucose tests performed by enzymatic methods are usually accurate.

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

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

Furaginum Hasco, food, drink, and alcohol
Furaginum Hasco should be taken orally during meals containing protein, 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 is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Furaginum Hasco must not be used during the first three months of pregnancy (first trimester) due to lack of clinical data on safety during this period.
Particular caution is required when using the drug during the last three months of pregnancy (third trimester). The drug may be used in the third trimester only after consultation with a doctor.
The drug must not be used from week 38 of pregnancy and during delivery, as nitrofurantoin may cause hemolytic anemia in the newborn.

Breastfeeding
Furaginum Hasco should not be used during breastfeeding. Nitrofurantoin passes into breast milk and may harm the breastfed infant.

Fertility
Nitrofurantoin may adversely affect testicular function, leading to reduced sperm motility and unfavorable changes in sperm morphology, as well as decreased 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 driving ability (dizziness, drowsiness, visual disturbances) – see section 4 "Possible side effects".

Furaginum Hasco contains non-crystallizing liquid sorbitol 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 dietary sodium intake for adults.
Sorbitol is a source of fructose. If intolerance to certain sugars or hereditary fructose intolerance—a rare genetic disorder in which the patient's body cannot metabolize fructose—has previously been diagnosed in the patient (or their child), the patient should consult a doctor before taking the medicine or administering it to the child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.

3. How to use Furaginum Hasco

This medicine should always be taken as directed by the physician. In case of doubt, consult your doctor.
The medicine should be taken orally during protein-containing meals, which enhance the absorption of furazidin.
Before each use, shake the bottle vigorously.
The prescribed dose should be measured using the oral syringe provided in the package, with a capacity of 5 millilitres. The syringe is graduated to allow measurement of the dose volume with an accuracy of 0.1 millilitre (i.e. 1 mg of furazidin).

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 treatment should last for 7–10 days. If necessary, the physician may repeat the course after 10–15 days.

Children over 3 months of age
Recommended dose: 5–7 mg/kg body weight per day, in 2 or 3 divided doses.
The treatment should last for 7–10 days. If necessary, the physician may repeat the course after 10–15 days.
Furaginum Hasco may be used in children over 3 months of age.

Overdose of Furaginum Hasco
If an overdose of Furaginum Hasco is taken, symptoms such as nausea, vomiting, headache, dizziness, allergic reactions, and anaemia 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 administration of fluids; in severe cases, hemodialysis may be necessary). Due to the renal excretion of the drug, the risk of overdose is increased in patients with impaired kidney 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
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must immediately stop taking this medicine and contact your doctor or go to the
nearest hospital if any of the following adverse reactions occur
[which occurred rarely, i.e. in 1 to 10 out of 10,000 patients, or with unknown frequency (frequency
cannot be estimated from the available data)]:

• allergic reactions: itching, urticaria, rash (frequency not known), anaphylactic reactions (sudden local or systemic allergic reactions), angioedema (a skin and subcutaneous tissue disorder 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 prolonged treatment) (rare),
• asthmatic reaction (shortness of breath) in patients with asthma; hypersensitivity reactions affecting the respiratory system, including (frequency not known):
• 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 onset of the first adverse symptoms; once an adverse reaction is detected, the medicine must be discontinued immediately; lung function impairment may be irreversible,
• tingling, numbness, sensation of electric currents due to peripheral nerve damage (also with acute or irreversible course, especially in patients with impaired renal function, anemia, diabetes, electrolyte disturbances or vitamin B deficiency) (frequency not known),
• pseudomembranous colitis (a severe disease of the small or large intestine manifested by diarrhea, headache and fever) (frequency not known),
• cyanosis due to methemoglobinemia; in patients with glucose-6-phosphate dehydrogenase deficiency, administration of furazidin may lead to megaloblastic or hemolytic anemia (frequency not known).

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

• nausea, excessive flatulence,
• headache.

Frequency not known (frequency cannot be estimated from the available data):

• dizziness, drowsiness, visual disturbances,
• constipation, diarrhea, symptoms of indigestion,
• vomiting, abdominal pain, loss of appetite,
• sialadenitis, pancreatitis,
• transient hair loss,
• infections with microorganisms resistant to furazidin,
• fever, chills, malaise.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, you should inform your doctor or pharmacist. Adverse reactions 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,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows the collection of further 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 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. The expiry date refers to the last day of the stated month.
Shelf-life after first opening of 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. These measures will help protect the environment.

6. Contents of the package and other information

What Furaginum Hasco contains

• The active substance is furazidinum (furazidin), also known as furagin. 5 ml of the suspension contains 50 mg of furazidin.
• The other components (excipients) are: sorbitol liquid, 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
Furaginum Hasco is a yellow suspension.
One package contains 140 ml of suspension in an amber glass bottle with a polyethylene closure and a polyethylene cap with a tamper-evident ring, together with an oral syringe made of PE with a plunger made of PS, all contained in a cardboard box.

Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
ul. Żmigrodzka 242 E, 51-131 Wrocław, Poland

Information on the medicinal product
Tel.: 22 742 00 22
E-mail: [email protected]