Furazek junior

Package leaflet: Information for the user

Furazek Junior, 15 mg/ml, powder for oral suspension
Furazidinum
Please read all of this leaflet carefully before taking this medicine, because it contains information important for the patient.

• 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 another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Furazek Junior is and what it is 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 pack and other information

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

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

The indication for the use of Furazek Junior is:

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

2. Important information before taking Furazek Junior

When not to use Furazek Junior:

• if the patient is allergic to furazidin or nitrofuran derivatives, or to any of the other ingredients of this medicine (listed in section 6)
• during the first trimester of pregnancy
• in late pregnancy (from week 38) and during childbirth, due to the risk of hemolytic anemia (anemia associated with the breakdown of red blood cells) 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 involving damage to the peripheral nerves, which may be characterized by motor, sensory, or other neurological disturbances)
• if the patient has glucose-6-phosphate dehydrogenase deficiency (a genetic disorder involving deficiency of an enzyme involved in red blood cell metabolism), as the drug may cause hemolysis (destruction of red blood cells and anemia)
• if the patient has renal failure (oliguria, anuria), and laboratory tests show creatinine clearance below 60 ml/min or elevated serum creatinine levels.

Warnings and precautions
Before starting treatment with Furazek Junior, consult a doctor or pharmacist if the patient has:

• impaired kidney function,
• impaired liver function,
• nervous system disorders,
• anemia,
• electrolyte imbalances (changes in blood ion concentrations), deficiency of B vitamins or folic acid,
• lung diseases.

Discontinue Furazek Junior immediately and seek medical advice if the patient experiences:

• neurological symptoms (tingling, numbness, sensation of electric shocks). These may indicate peripheral nerve damage (peripheral neuropathy), especially in patients with diabetes, which in severe cases may be irreversible and life-threatening. The drug should be discontinued immediately and medical advice sought.
• symptoms such as fever, chills, cough, chest pain, shortness of breath. These may be pulmonary reactions, which sometimes occur during treatment with nitrofuran derivatives (see also section 4).
• symptoms of impaired liver function (yellowing of the whites of the eyes, skin or mucous membranes, dark urine, 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 (sometimes leading to liver necrosis – fatal cases have been reported) may occur during long-term treatment with nitrofurans (usually longer than 6 months).

If the patient is taking the medicine long-term, blood tests and monitoring of kidney and liver function may be necessary.
Effect on laboratory tests
The medicine may cause false-positive results in urine glucose tests. Before submitting a urine sample for testing, inform medical personnel that the patient is taking Furazek Junior.

Children and adolescents
See section "When not to use Furazek Junior".

Furazek Junior and other medicines
Inform the doctor about all medicines currently used or recently taken by the patient, as well as any medicines the patient plans to take.

• Nitrofurans (including furazidin) should not be combined with chloramphenicol, ristomycin, levomycetin, or sulfonamides (antibacterial agents), as bone marrow suppression may occur.
• Do not use norfloxacin, nalidixic acid, or other quinolone derivatives simultaneously with furazidin, as antagonism (opposing action) is usually observed.
• Aminoglycoside and tetracycline antibiotics, when administered together with furazidin, enhance its antibacterial effect.
• Drugs increasing uric acid excretion, such as probenecid (in high doses) and sulfinpyrazone, reduce tubular excretion of nitrofuran derivatives and may cause accumulation of furazidin in the body, increasing its toxicity and reducing treatment efficacy.
• Concurrent administration of alkalizing agents containing magnesium trisilicate or carbonic anhydrase inhibitors inhibits absorption of furazidin and reduces its antibacterial activity.
• Do not combine with diphenylhydantoin (a drug used in epileptic conditions), as it may reduce its blood levels.
• Atropine slows down absorption of furazidin, although the total amount of absorbed active substance remains unchanged.
• Drugs that neutralize gastric acid inhibit absorption of furazidin.

Furazek Junior, food, drink, and alcohol
Furazek Junior should preferably be taken with meals containing protein, as this enhances drug absorption.
The medicine should be taken with plenty of fluids.
Alcohol consumption should be avoided during treatment with furazidin.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or 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
Furazek Junior should not be used during the first trimester of pregnancy or in women during late pregnancy (from week 38) and during childbirth, as furazidin may cause hemolytic anemia in the newborn. Particular caution is advised during use in the last three months of pregnancy (third trimester).

Breastfeeding
Due to passage of furazidin into human milk, the medicine should not be used during breastfeeding.

Fertility
In men of reproductive age – experimental studies and clinical observations in patients treated with nitrofurans (as well as certain antibiotics) have shown that these drugs may adversely affect testicular function, leading to reduced total sperm count and semen volume, decreased sperm motility, and structural abnormalities in sperm.

Driving and operating machinery
There is no data available on the effect of furazidin on the ability to drive or operate machinery. However, some patients may experience dizziness, drowsiness, or visual disturbances, which may affect the ability to drive or operate machinery.

Furazek Junior contains sucrose
Each 1 ml of prepared suspension contains 600 mg of sucrose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

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

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

Furazek Junior contains sulphites
Each 1 ml of prepared suspension contains 0.000002 mg of sulphites.
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 prepared suspension contains 0.172 mg of corn maltodextrin.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Furazek Junior

This medicine should always be taken according to the doctor's instructions. If in doubt, consult your doctor.

Oral administration. An oral syringe (10 ml) is attached to the package to facilitate dosing.
Furazek Junior should be administered during meals. A protein-rich diet should be maintained simultaneously, as it enhances drug absorption.

Recommended dosage
Use in adults and adolescents over 14 years of age
On the first day of treatment: 400 mg per day in four divided doses (6.5 ml of suspension every 6 hours).
In the following days: 300 mg per day in three divided doses (6.5 ml of suspension every 8 hours).
Treatment usually lasts 7–8 days. If necessary, treatment may be repeated after an interval of 10–15 days.

Use in children and adolescents from 3 months to 14 years of age
Furazek Junior should be administered at a dose of 5–7 mg/kg body weight per day in 2 or 3 divided doses.
The treatment lasts 7–8 days. If necessary, treatment may be repeated after an interval of 10–15 days.
An oral syringe for accurate dosing is supplied with the package.

Table 1. Dosing schedule for children and adolescents

Caution should be exercised when administering the medicine to young children due to the risk of choking.
Instructions for preparing the suspension
To prepare 100 ml of suspension, add 60 ml of boiled and cooled to room temperature water into the bottle. Before adding water, shake the bottle with the medicine to loosen the powder. Add the water in two 30 ml portions using the provided syringe. After each addition of water, invert the bottle and shake vigorously until a uniform suspension is obtained. Shake well before each use.
Store the prepared suspension in the refrigerator at 2–8°C for no longer than 15 days.
Overdose of Furazek Junior
In case of an overdose, seek immediate medical advice from a doctor or pharmacist.
Missed dose of Furazek Junior
If a dose has been missed once or several times, continue treatment with the previously prescribed doses. Do not use a double dose to make up for a missed dose.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.
If you have any further questions regarding the use of this medicine, consult your doctor.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The most common adverse effects observed during clinical trials, probably related to the use of the medicine, were: nausea (8%), headache (6%), and excessive flatulence (1.5%).
Other effects listed below occurred in no more than 1% of patients.
You should immediately stop using this medicine and inform your doctor or go to the nearest hospital if any of the following occur:

• allergic reactions: rash, itching, urticaria, anaphylactic reactions (sudden local or systemic allergic reactions, including life-threatening anaphylactic shock), angioedema (a 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 in swallowing and breathing;

• severe skin reactions (exfoliative dermatitis, erythema multiforme—red-blue skin lesions and (or) mucosal lesions, sometimes with blisters, fever and joint pain), Stevens-Johnson syndrome—appearance of blisters on the skin and (or) mucous membranes which, when ruptured, form painful sores, often accompanied by fever, muscle and joint pain);

• acute, subacute and chronic hypersensitivity reactions to nitrofuran derivatives. Chronic reactions occurred in patients treated for longer than 6 months. Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonia) may occur especially in elderly patients. Acute respiratory hypersensitivity reactions were manifested by fever, chills, cough, chest pain, and pleural effusion. These usually resolved quickly or very quickly after discontinuation of the medicine. In the case of chronic reactions, the severity of symptoms and their reversibility after stopping the medicine depend on how long treatment was continued after the first adverse symptoms appeared. Early recognition of adverse effects and prompt discontinuation of the medicine are crucial. Impairment of lung function may be irreversible;

• pseudomembranous colitis (a serious condition of the small or large intestine characterized by diarrhea, headache and fever);

• tingling, numbness, sensation of electric shocks due to peripheral neuropathy (damage to peripheral nerves), which may have an acute or irreversible course (patients particularly predisposed include those with renal impairment, anemia, diabetes, electrolyte disturbances, vitamin B deficiency);

• liver function disorders, symptoms of drug-induced hepatitis, cholestatic jaundice (caused by obstruction of bile flow), hepatic parenchymal necrosis (symptoms see section 2 “Warnings and precautions”).

In addition, the following adverse effects may occur:

• cyanosis due to methemoglobinemia (bluish-brown discoloration of the skin). In patients with glucose-6-phosphate dehydrogenase deficiency, the use of nitrofurantoin may lead to megaloblastic anemia (caused by vitamin B or folic acid deficiency) or hemolytic anemia (caused by rapid breakdown of red blood cells);
• dizziness, drowsiness, visual disturbances;
• constipation, diarrhea, dyspeptic symptoms (chronic upper abdominal pain);
• abdominal pain, vomiting;
• sialadenitis, pancreatitis;
• alopecia, exfoliative dermatitis;
• fever, chills, malaise;
• infections with microorganisms resistant to nitrofuran derivatives, most commonly Pseudomonas species or Candida species.

In patients taking nitrofurantoin, the following adverse effects have also been observed with unknown frequency:

• muscle cramps, muscle pain.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported directly to:
Department for Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects may also be reported to the marketing authorization holder.
Reporting adverse effects helps to collect more information on the safety of the medicine.

5. How to store Furazek Junior

Keep the medicine out of sight and reach of children.
There are no special storage temperature requirements for this medicine. Store in the original
packaging to protect from light.
The prepared suspension should be stored in the refrigerator at 2-8°C for no longer than 15 days.
Do not use this medicine after the expiry date stated on the packaging after: EXP. The expiry date
refers to the last day of the specified month.
Medicines must 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 Furazek Junior contains

• The active substance is furazidin, also known as furagin. 1 ml of suspension contains 15 mg of furazidin.
• Other ingredients are: sucrose, xanthan gum, sodium benzoate (E 211), sodium carboxymethyl starch (type A), strawberry flavour PHS-455920: natural flavouring substances, flavouring preparations, corn maltodextrin, sodium octenyl succinate starch.

What Furazek Junior looks like and contents of the pack
Powder for oral suspension. Yellow to slightly orange-coloured powder with a strawberry flavour, in a bottle. The bottle contains 63.04 g of powder for preparing 100 ml of suspension.
An oral syringe (10 ml) is included in the pack to facilitate accurate dosing of the prepared suspension.
Marketing Authorisation 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