Furaginum Hasco Forte

Leaflet attached to the packaging: patient information

Furaginum Hasco Forte, 100 mg/5 ml, oral suspension

Furazidinum

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Furaginum Hasco Forte and what is it used for
• 2. Important information before taking Furaginum Hasco Forte
• 3. How to take Furaginum Hasco Forte
• 4. Possible side effects
• 5. How to store Furaginum Hasco Forte
• 6. Package contents and other information

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

Furaginum Hasco Forte 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 Forte is used to treat acute and recurrent uncomplicated lower urinary tract infections in children, adolescents, and adults.

2. Important information before taking Furaginum Hasco Forte

When not to take Furaginum Hasco Forte:

• 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 period of carried pregnancy (from the 38th week) and childbirth, due to the risk of hemolytic anemia in the newborn,
• in children under 3 months of age,
• if the patient has renal failure (creatinine clearance below 60 ml/min or elevated serum creatinine),
• 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 Forte, the patient should discuss it with their doctor, pharmacist, or nurse, especially if they have:

• kidney function disorders,
• liver function disorders,
• nervous system disorders,
• anemia,
• electrolyte disturbances,
• deficiency of vitamins from group B and folic acid,
• lung diseases,
• diabetes.

In the above-mentioned cases, the use of furazidine increases the risk of nerve damage.

The patient should stop taking Furaginum Hasco Forte immediately and seek medical advice:

• if they 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 they experience fever, chills, cough, chest pain, or 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 who took furazidine for more than 6 months. Chronic pulmonary reactions (including pulmonary fibrosis and interstitial pneumonia) may occur, especially in elderly patients;
• if they experience symptoms of liver function disorders (jaundice of the eyes, skin, and mucous membranes, dark urine, itching, pale stools, abdominal pain, nausea, vomiting, constant 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 they 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. The patient should contact their doctor as soon as possible and not take anti-diarrheal medicines that slow down intestinal motility.

If the patient is taking the medicine for a long time, the 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, the patient should inform the medical staff about taking Furaginum Hasco Forte.
Glucose test results in urine performed using enzymatic methods are usually normal.

Children

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

Furaginum Hasco Forte 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 using 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,
• vitamins from group B - increase furazidine absorption.

Furaginum Hasco Forte with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Furaginum Hasco Forte 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.
Special caution should be exercised during use in the last three months of pregnancy (III trimester). The medicine can be used in the III trimester only after prior agreement with the doctor.
The medicine should not be used during the period from the 38th week of pregnancy and during childbirth, as furazidine may cause hemolytic anemia in the newborn.
Breastfeeding
Furaginum Hasco Forte should not be used during breastfeeding. Furazidine passes into breast milk and may harm the breastfed child.
Fertility
Furazidine may adversely affect testicular function, causing reduced sperm motility and 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 Forte 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 less than 1 mmol (23 mg) of sodium per 5 ml of suspension, which means the medicine is considered "sodium-free".
Sorbitol is a source of fructose. If the patient has been diagnosed with intolerance to some sugars or has a rare genetic disorder, fructose intolerance, they should consult their doctor before taking the medicine or giving it to their child.
Sorbitol may cause gastrointestinal discomfort and have a mild laxative effect.

3. How to take Furaginum Hasco Forte

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor.
The medicine should be taken orally during meals containing protein, which increases the absorption of furazidine.
Before each use, the bottle should be shaken vigorously.
The dose of the medicine prescribed by the doctor should be measured using the oral syringe provided with the packaging, with a capacity of 5 milliliters. The syringe scale allows for measuring the dose volume with an accuracy of 0.1 milliliters (i.e., 2 mg of furazidine).

Adults and adolescents

First day of treatment: 400 mg per day in 4 divided doses (5 ml of suspension every 6 hours).
Subsequent days: 300 mg per day in 3 divided doses (5 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 Forte than recommended

In case of using a higher dose of Furaginum Hasco Forte than recommended, the patient may experience nausea, vomiting, headaches, dizziness, allergic reactions, or anemia.
If such symptoms occur, the patient should immediately consult 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 through the kidneys, the risk of overdose is increased in patients with kidney function disorders.

Missing a dose of Furaginum Hasco Forte

In case of missing a dose of Furaginum Hasco Forte, the treatment should be continued using the previously taken doses of the medicine. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Furaginum Hasco Forte

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Furaginum Hasco Forte 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 [which occurred rarely, i.e., in 1 to 10 out of 10,000 patients, or with an unknown frequency (the frequency cannot be determined based on available data)]:

They should:

• allergic reactions: itching, hives, rash (unknown frequency), anaphylactic reactions (local or systemic allergic reactions), angioedema (a skin and subcutaneous tissue disease characterized by limited swelling) (rare),
• severe skin reactions (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome - a blistering multiforme erythema) (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 - 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) - 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 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 acute or irreversible, especially in patients with kidney function disorders, anemia, diabetes, electrolyte disturbances, or vitamin B deficiency) (unknown frequency),
• pseudomembranous colitis (a severe disease of the small or large intestine manifested by diarrhea, headache, and fever) (unknown frequency),
• methemoglobinemia-induced cyanosis; 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 (in 1 to 10 out of 100 patients):

• nausea, excessive gas,
• headaches.

Unknown frequency (the frequency cannot be determined based on available data):

• dizziness, drowsiness, vision disturbances,
• constipation, diarrhea, symptoms of indigestion,
• 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw,
Phone: +48 22 49 21 301,
Fax: +48 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 gather more information on the safety of the medicine.

5. How to store Furaginum Hasco Forte

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 expiration date stated on the packaging. The expiration date is the last day of the specified month.
Shelf life after first opening the bottle: 6 months.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Furaginum Hasco Forte contains

• The active substance of the medicine is furazidine ( Furazidinum), also known as furagin. 5 ml of suspension contains 100 mg of furazidine.
• Other ingredients (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 Forte looks like and what the package contains

The medicine is a yellow suspension.
One package of the medicine contains 100 ml or 140 ml of suspension in an orange glass bottle with a polyethylene closure and a polyethylene cap with a guarantee 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.
ul. Żmigrodzka 242 E, 51-131 Wrocław

Information about the medicine

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

Date of the last update of the leaflet: