FURAZEK 15 mg /Ml Powder

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Furazek Junior, 15 mg/ml, powder for oral suspension
   1. Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Furazek Junior and what is it used for
4. Important information before taking Furazek Junior
   1. When not to use Furazek Junior:
   2. Warnings and precautions
   3. Children and adolescents
   4. Furazek Junior and other medicines
   5. Furazek Junior with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and operating machinery
   8. Furazek Junior contains sucrose
   9. Furazek Junior contains sodium benzoate (E 211)
   10. Furazek Junior contains sodium
   11. Furazek Junior contains sulfites
   12. Furazek Junior contains corn maltodextrin, which is a source of glucose
5. How to take Furazek Junior
   1. Administration in adults and adolescents over 14 years of age
   2. Administration in children and adolescents from 3 months to 14 years of age
   3. Instructions for preparing the suspension
   4. Overdose of Furazek Junior
   5. Missed dose of Furazek Junior
6. Possible side effects
   1. The patient should immediately stop taking the medicine and inform their doctor or go to the nearest hospital if they experience:
   2. Reporting side effects
7. How to store Furazek Junior
8. Contents of the packaging and other information
   1. What does Furazek Junior contain
   2. What does Furazek Junior look like and what does the packaging contain
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of the last update of the leaflet

Leaflet attached to the packaging: information for the user

Furazek Junior, 15 mg/ml, powder for oral suspension

Furazidinum

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, please 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 possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Furazek Junior and what is it used for

Furazek Junior is a medicine in the form of a powder for oral suspension. It contains the active substance furazidine, also known as furagin, a nitrofuran derivative. Furazidine is an antibacterial medicine.

• The indication for the use of Furazek Junior is:

• treatment of acute and chronic uncomplicated lower urinary tract infections caused by Escherichia coli in adults and children.

2. Important information before taking Furazek Junior

When not to use Furazek Junior:

• if the patient is hypersensitive to furazidine or nitrofuran derivatives or to any of the other ingredients of this medicine (listed in section 6)
• in the first trimester of pregnancy
• during late pregnancy (from the 38th week) and childbirth, due to the risk of hemolytic anemia in the newborn
• in newborns and infants up to 3 months of age
• if the patient has peripheral neuropathy (e.g., diabetic neuropathy, a condition characterized by nerve damage, which may cause motor, sensory, or other neurological disorders)
• if the patient has a deficiency of the enzyme glucose-6-phosphate dehydrogenase (a genetic disorder that affects red blood cells), as the medicine may cause hemolysis (red blood cell damage and anemia)
• if the patient has renal failure (oliguria, anuria), and laboratory tests have shown a creatinine clearance of less than 60 ml/min or an elevated serum creatinine level.

Warnings and precautions

Before starting treatment with Furazek Junior, the patient should discuss with their doctor or pharmacist if they have:

• renal impairment
• liver dysfunction
• neurological disorders
• anemia
• electrolyte disturbances (changes in ion levels in the blood), vitamin B deficiency, and folic acid deficiency
• pulmonary diseases. The patient should immediately stop taking Furazek Junior and consult their doctor if:
• they experience neurological symptoms (tingling, numbness, sensation of electric currents). These may be symptoms of peripheral neuropathy, especially in diabetic patients, which can be irreversible and life-threatening. The medicine should be stopped immediately, and the patient should consult their doctor.
• they experience symptoms such as fever, chills, cough, chest pain, shortness of breath. These may be pulmonary reactions, which can occur during treatment with nitrofuran derivatives (see also section 4).
• they experience symptoms of liver dysfunction (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 (sometimes leading to liver necrosis - cases of death have been reported) occurs during long-term use of nitrofurans (usually more than six months).

If the patient is taking the medicine long-term, blood tests and liver and kidney function tests may be necessary.

The medicine may cause false-positive glucose test results in urine. Before providing a urine sample for such a test, the patient should inform the medical staff about taking Furazek Junior.

Children and adolescents

See the section "When not to use Furazek Junior".

Furazek Junior and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• Nitrofurans (including furazidine) should not be combined with chloramphenicol, ristomycin, levomycetin, sulfonamides (antibacterial medicines), as they may inhibit hematopoiesis.
• Furazidine should not be taken with norfloxacin, nalidixic acid, and other quinolone derivatives, as they usually exhibit antagonism (opposite effects).
• Aminoglycoside antibiotics and tetracyclines administered with furazidine enhance its antibacterial effect.
• Medicines that increase uric acid excretion, such as probenecid (in high doses) and sulfinpyrazone, reduce the renal excretion of nitrofuran derivatives and may cause furazidine accumulation in the body, increasing its toxicity and reducing the effectiveness of treatment.
• Concomitant administration of alkalizing agents containing magnesium trisilicate or anhydrase inhibitors reduces furazidine absorption and decreases its antibacterial activity.
• Furazidine should not be combined with diphenylhydantoin (a medicine used in epilepsy), as it may decrease its blood level.
• Atropine slows down furazidine absorption, but the overall amount of absorbed active substance remains unchanged.
• Antacids reduce furazidine absorption.

Furazek Junior with food, drink, and alcohol

Furazek Junior is best taken with meals containing protein, as it increases the absorption of the medicine.

The medicine should be taken with a large amount of fluid.

The patient should avoid consuming alcohol during treatment with furazidine.

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.

Pregnancy

Furazek Junior should not be used during the first trimester of pregnancy or in late pregnancy (from the 38th week) and childbirth, as furazidine may cause hemolytic anemia in the newborn.

Special caution is recommended during the last three months of pregnancy (third trimester).

Breastfeeding

Due to the penetration of furazidine into human milk, the medicine should not be used during breastfeeding.

Fertility

In men of reproductive age - as shown by experimental studies and clinical observations of patients taking nitrofurans (as well as some antibiotics), these medicines may adversely affect testicular function, as the overall sperm count and sperm motility decrease, and changes in sperm morphology occur.

Driving and operating machinery

There is no data on the effect of furazidine on the ability to drive vehicles and operate machinery. However, some patients may experience dizziness, drowsiness, vision disturbances, which may affect the ability to drive vehicles and operate machinery.

Furazek Junior contains sucrose

Each 1 ml of the prepared suspension contains 600 mg of sucrose.

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Furazek Junior contains sodium benzoate (E 211)

The medicine contains 4 mg of sodium benzoate (E 211) in each 1 ml of the prepared suspension.

Furazek Junior contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 1 ml of the prepared suspension, which means the medicine is considered "sodium-free".

Furazek Junior contains sulfites

Each 1 ml of the prepared suspension contains 0.000002 mg of sulfites.

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

Furazek Junior contains corn maltodextrin, which is a source of glucose

Each 1 ml of the prepared suspension contains 0.172 mg of corn maltodextrin.

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 Furazek Junior

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor.

Oral administration. A syringe (10 ml) is attached to the packaging to facilitate dosing.

Furazek Junior should be administered during meals. A protein-rich diet should be followed, which increases the absorption of the medicine.

Recommended dose.

Administration in adults and adolescents over 14 years of age

On the first day of administration: 400 mg per day in 4 divided doses (6.5 ml of suspension every 6 hours);

on subsequent days: 300 mg per day in 3 divided doses (6.5 ml of suspension every 8 hours). The treatment usually lasts 7-8 days. If necessary, the treatment can be repeated after 10-15 days.

Administration in children and adolescents from 3 months to 14 years of age

The medicinal product Furazek Junior should be administered at a dose of 5-7 mg/kg body weight per day in 2 or 3 divided doses.

The medicine is administered for 7-8 days. If necessary, the treatment can be repeated after 10-15 days.

A syringe is attached to the packaging to facilitate dosing.

Table 1. Dosing schedule for children and adolescents

Care should be taken when administering the medicine to small children due to the risk of choking.

Instructions for preparing the suspension

Preparing 100 ml of the suspension involves adding 60 ml of boiled water, cooled to room temperature, to the bottle. Before adding water, the bottle with the medicine should be shaken to loosen the powder. The water should be added in two portions of 30 ml using the attached syringe. After each addition of water, the bottle should be turned upside down and shaken vigorously until a uniform suspension is formed.

Before each use, the bottle should be shaken.

The prepared suspension should be stored in the refrigerator at a temperature of 2-8°C for no longer than 15 days.

Overdose of Furazek Junior

In case of an overdose, the patient should immediately consult their doctor or pharmacist.

Missed dose of Furazek Junior

If the patient misses one or more doses, they should continue treatment with the previously taken doses. A double dose should not be taken to make up for the missed dose.

If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

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

4. Possible side effects

Like all medicines, Furazek Junior can cause side effects, although not everybody gets them.

Among the side effects observed during clinical trials, the most common were:

nausea (8%), headache (6%), and excessive gas (1.5%).

The following side effects occurred in no more than 1% of patients.

The patient should immediately stop taking the medicine and inform their doctor or go to the nearest hospital if they experience:

• allergic reactions: rash, itching, hives, anaphylactic reactions (sudden local or systemic allergic reactions, including life-threatening anaphylactic shock), angioedema (severe allergic reaction - sudden swelling of the face, limbs, or joints without itching or pain). Swelling in the head and neck area may cause difficulty swallowing and breathing;
• severe skin reactions (exfoliative dermatitis, erythema multiforme - red-purple spots on the skin and/or mucous membranes, sometimes with blisters, fever, and joint pain, Stevens-Johnson syndrome - blisters on the skin and/or mucous membranes, which form painful sores after rupture, often accompanied by fever, muscle and joint pain);
• acute, subacute, and chronic hypersensitivity reactions to nitrofuran derivatives. Chronic reactions occurred in patients taking the medicine for more than six months. Chronic pulmonary reactions (including pulmonary fibrosis and interstitial pneumonia) may occur, especially in elderly patients. Acute hypersensitivity reactions affecting the respiratory system were characterized by fever, chills, cough, chest pain, and shortness of breath. They usually resolved quickly or very quickly after discontinuation of the medicine. In cases of chronic reactions, the severity of symptoms and their reversibility 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 function impairment may be irreversible;
• pseudomembranous colitis (a severe disease of the small or large intestine, characterized by diarrhea, headache, and fever);
• tingling, numbness, sensation of electric currents due to peripheral neuropathy (nerve damage), also with acute or irreversible course (the following conditions predispose to its occurrence: renal failure, anemia, diabetes, electrolyte disturbances, vitamin B deficiency);

The following side effects may also occur:

• cyanosis due to methemoglobinemia (blue discoloration of the skin with a chocolate-brown tint). In people with glucose-6-phosphate dehydrogenase deficiency, furagin may cause megaloblastic or hemolytic anemia;
• dizziness, drowsiness, vision disturbances;
• constipation, diarrhea, dyspeptic symptoms (chronic abdominal pain);
• abdominal pain, vomiting;
• salivary gland inflammation, pancreatitis;
• hair loss, exfoliative dermatitis;
• fever, chills, malaise;
• infections with microorganisms resistant to nitrofuran derivatives, most often Pseudomonas or Candida.

The patient has also reported the following side effects with an unknown frequency:

• muscle cramps, muscle pain.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to: Department for Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Furazek Junior

The medicine should be stored out of sight and reach of children.

There are no special recommendations for the storage temperature of the medicine. The medicine should be stored in its original packaging to protect it from light.

The prepared suspension should be stored in the refrigerator at a temperature of 2-8°C for no longer than 15 days.

The medicine should not be used after the expiration date stated on the packaging after EXP. The expiration date refers to the last day of the given month.

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. Contents of the packaging and other information

What does Furazek Junior contain

• The active substance of the medicine is furazidine, also known as furagin. 1 ml of the suspension contains 15 mg of furazidine.
• The other ingredients are: sucrose, xanthan gum, sodium benzoate (E 211), sodium carboxymethylcellulose (type A), strawberry flavor PHS-455920: natural flavoring substances, flavoring preparations, corn maltodextrin, sodium octenyl succinate starch.

What does Furazek Junior look like and what does the packaging contain

Powder for oral suspension. The powder is yellow to light orange in color with a strawberry flavor in a bottle. The bottle contains 63.04 g of powder to prepare 100 ml of the suspension.

A dosing syringe (10 ml) is attached to the packaging to facilitate dosing of the prepared suspension.

Marketing authorization holder

Adamed Pharma S.A., Pieńków, ul. M. Adamkiewicza 6A, 05-152 Czosnów

Manufacturer

Adamed Pharma S.A., Pieńków, ul. M. Adamkiewicza 6A, 05-152 Czosnów, Mako Pharma Sp. z o.o., ul. Kolejowa 231A, 05-092 Dziekanów Polski

Date of the last update of the leaflet