Furazek

Package Leaflet: Information for the User

Furazek, 100 mg, Tablets

Furazidinum

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

• Keep this leaflet, so you can read it again if you need to.
• If you have 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 Furazek and what is it used for
• 2. Important information before taking Furazek
• 3. How to take Furazek
• 4. Possible side effects
• 5. How to store Furazek
• 6. Contents of the pack and other information

1. What is Furazek and what is it used for

Furazek is a medicine in the form of tablets for oral administration. It contains furazidine as the active substance, also known as a nitrofuran derivative. Furazidine is an antibacterial medicine.
The indication for the use of Furazek is:

• treatment of uncomplicated lower urinary tract infections, including recurrent urinary tract infections in women caused by microorganisms such as Escherichia coli.

2. Important information before taking Furazek

When not to take Furazek

• if the patient is allergic 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 the period of gestation (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 (a syndrome of nerve damage that may be characterized by motor, sensory, or other neurological disorders)
• if the patient has a deficiency of the enzyme glucose-6-phosphate dehydrogenase (a disease related to a genetically determined enzyme deficiency involved in red blood cell metabolism), as the medicine may then 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 to take Furazek, the patient should discuss it with their doctor or pharmacist if they have:

• kidney problems,
• liver problems,
• neurological disorders,
• anemia,
• electrolyte disturbances (changes in ion concentration in the blood), vitamin B and folic acid deficiency
• lung disease. The patient should stop taking Furazek immediately and seek medical advice if 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).
• the patient experiences symptoms from the nervous system (tingling, numbness, sensation of electric currents). These may be symptoms of peripheral nerve damage (peripheral neuropathy), especially in diabetic patients, which in severe cases can be irreversible and life-threatening. The medicine should be stopped immediately and medical advice sought.
• the patient experiences symptoms of liver dysfunction (jaundice of the eyes, skin, and mucous membranes, dark urine, itching of the skin, 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 (sometimes leading to liver necrosis - deaths have been reported) occurs during long-term use of nitrofurans (usually more than 6 months). If the patient is taking the medicine long-term, blood tests and liver and kidney function tests may be necessary.

Effect on laboratory tests
The medicine may cause false-positive glucose test results in urine. Before submitting a urine sample for such a test, the patient should inform the medical staff that they are taking Furazek.

Children

The medicine should not be used in newborns and infants up to 3 months of age.

Furazek and other medicines

The patient should tell 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 the hematopoietic system.
• Furagin should not be used with nalidixic acid and other quinolone derivatives, as they usually exhibit antagonism (opposite effects).
• Aminoglycoside antibiotics and tetracyclines given 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 medicines containing magnesium trisilicate reduces furazidine absorption and decreases its antibacterial activity.
• Atropine slows down the absorption of furagin, but the overall amount of absorbed active substance remains unchanged.
• Antacids reduce furazidine absorption.
• Concomitant use of vitamin B increases the absorption of nitrofuran derivatives.

Furazek with food, drink, and alcohol

Furazek is best taken with meals containing protein, as it increases the absorption of the medicine.
The patient should avoid consuming alcohol during therapy with furagin.

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 should not be used during the first trimester of pregnancy or in women with a gestation period of 38 weeks or more and during childbirth, as furazidine may cause hemolytic anemia in the newborn. The patient should exercise special caution when using the medicine in the last three months of pregnancy (third trimester).
Breastfeeding
Due to the passage of furagin into human milk, the medicine should not be used during breastfeeding.
Fertility
In the case of men of reproductive age - as shown by experimental studies and clinical observations of patients taking nitrofurans (as well as some antibiotics), these medicines may have a negative effect on testicular function, as the total number of sperm and semen decreases, and the motility of sperm and changes in their structure also occur.

Driving and using machines

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

Furazek contains lactose

Each 100 mg tablet contains 123 mg of lactose monohydrate.
If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Furazek contains sodium

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

3. How to take Furazek

This medicine should always be taken as directed by the doctor. If in doubt, the patient should consult their doctor.
The tablet can be divided into equal doses.
Oral administration. Furazek should be taken with meals. The patient should also follow a protein-rich diet.
The medicine should be taken with a large amount of fluid. If the patient has missed one or more doses, they should continue treatment with the previously taken doses of the medicine.

Use in adults

On the first day of use: 400 mg per day in 4 divided doses (1 tablet every 6 hours);
in subsequent days: 300 mg per day in 3 divided doses (1 tablet every 8 hours). The treatment usually lasts 7-10 days. If necessary, the treatment can be repeated after 10-15 days.
Recurrent urinary tract infections in women
In the case of at least 3 episodes of urinary tract infection in the last 12 months, Furazek is used in a dose of 100 mg (1 tablet) at night for 6-12 months.

Use in children and adolescents

Furazek can be given to children aged 2 to 14 years. The following dosage schedule should be used.
Furazek should be used in a dose of 5-7 mg/kg body weight per day in 2 divided doses.
The medicine is used for 7-8 days. If necessary, the treatment can be repeated after 10-15 days.

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

If the child has problems swallowing tablets, the medicine can be crushed and suspended in milk.
In children under 2 years of age, the dose of the medicine should be determined by the doctor.

Taking a higher dose of Furazek than recommended

In the event of taking a higher dose of the medicine than recommended, the patient should immediately consult a doctor or pharmacist.

Missing a dose of Furazek

If the patient has missed one or more doses, they should continue treatment with the previously taken doses of the medicine. The patient should not take a double dose 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 can cause side effects, although not everybody gets them.
Among the side effects observed during clinical trials, probably related to the use of the medicine, 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 stop taking the medicine immediately and inform their doctor or go to the nearest hospital if they experience:

• allergic reactions: rash, itching, hives, anaphylactic (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 that form painful sores after rupture, often accompanied by fever, muscle and joint pain);
• acute, subacute, and chronic reactions to nitrofuran derivatives. Chronic reactions occurred in patients taking the medicine for more than 6 months. Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonia) may occur, especially in elderly patients. Acute hypersensitivity reactions affecting the respiratory system were characterized by fever, chills, cough, chest pain, shortness of breath. They 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 discontinuation of the medicine depend on the duration of treatment after the first symptoms appear. Early recognition of the side effect 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 (peripheral nerve damage), also of acute or irreversible course (the following are particularly predisposed to its occurrence: renal failure, anemia, diabetes, electrolyte disturbances, vitamin B deficiency).
• liver dysfunction, symptoms of drug-induced hepatitis, cholestatic jaundice (caused by an obstacle to bile flow), liver necrosis (symptoms see "Warnings and precautions" in section 2).

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, the use of furagin may lead to the development of megaloblastic (due to vitamin B or folic acid deficiency) or hemolytic (due to rapid red blood cell breakdown) anemia.
• dizziness, drowsiness, vision disturbances,
• constipation, diarrhea, dyspeptic symptoms (chronic pain in the upper abdomen),
• abdominal pain, vomiting,
• parotitis, pancreatitis,
• alopecia, exfoliative dermatitis,
• fever, chills, malaise,
• infections with microorganisms resistant to nitrofuran derivatives, most often bacteria of the genus Pseudomonasor fungi of the genus Candida.

In patients taking furazidine, the following have also been observed 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 this leaflet, they should tell 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
ul. Al. 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 to gather more information on the safety of the medicine.

5. How to store Furazek

The medicine should be stored out of sight and reach of children.
There are no special recommendations for the storage temperature of the medicine.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry 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 pack and other information

What Furazek contains

• The active substance of the medicine is furazidine, also known as furagin.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose silanized with a composition of 98% microcrystalline cellulose and 2% colloidal silica, magnesium stearate, colloidal silica, sodium carboxymethyl cellulose type A.

What Furazek looks like and what the pack contains

Yellow or yellow-orange tablets, round with a dividing line on one side.
30 tablets in blisters, in a cardboard box.

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

Date of last revision of the leaflet: