urofuraginum Max

Package Leaflet: Information for the User

uroFuraginum Max, 100 mg, tablets
Furazidine

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

This medicine should always be taken exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 7-8 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

1. What is uroFuraginum Max and what is it used for

uroFuraginum Max is a medicine in the form of tablets for oral administration. It contains the active substance furazidine, also known as furagin, which is a derivative of nitrofuran. Furazidine inhibits the growth of many bacteria that cause urinary tract infections.

2. Important information before taking uroFuraginum Max

When not to take uroFuraginum Max

• 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 late pregnancy (from the 38th week) and childbirth, due to the risk of hemolytic anemia in the newborn
• in children and adolescents under 15 years of age
• if the patient has peripheral neuropathy (e.g., diabetic neuropathy, a condition characterized by nerve damage that can cause movement, sensory, or other nervous system disorders)
• if the patient has a deficiency of the enzyme glucose-6-phosphate dehydrogenase (a genetic disorder that can lead to hemolysis and anemia), as the medicine may cause hemolysis
• 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 uroFuraginum Max, the patient should discuss it with their doctor or pharmacist if they have:

• kidney problems
• liver problems
• nervous system disorders
• anemia
• electrolyte disturbances (changes in ion concentration in the blood), vitamin B and folic acid deficiencies
• lung diseases. The patient should stop taking uroFuraginum Max and consult a doctor 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)
• 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, and the patient should consult a doctor
• they experience symptoms of liver dysfunction (jaundice, dark urine, pale stools, abdominal pain, nausea, vomiting, persistent fatigue, loss of appetite, and weight loss). Jaundice can occur during short-term use of nitrofurans (up to two weeks). Chronic hepatitis (sometimes leading to liver necrosis - reported cases of death) occurs during long-term use of nitrofurans (usually more than 6 months). If the patient is taking the medicine long-term, blood tests may be necessary to monitor white blood cell count and kidney and liver function

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 uroFuraginum Max.

Children and adolescents

uroFuraginum Max should not be used in children and adolescents under 15 years of age.

uroFuraginum Max 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.

• Nitrofurans (including furazidine) should not be combined with chloramphenicol, ristomycin, levomycetin, sulfonamides (antibacterial medicines), as they may inhibit the activity of 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 administered with furazidine enhance its antibacterial effect
• Medicines that increase uric acid excretion, such as probenecid (in high doses) and sulfinpyrazone, reduce the tubular secretion 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 reduces furazidine absorption and decreases its antibacterial activity
• Atropine slows down furagin absorption, but the overall amount of absorbed active substance remains unchanged
• Antacids inhibit furazidine absorption
• Concomitant use of vitamin B increases the absorption of nitrofuran derivatives

uroFuraginum Max with food, drink, and alcohol
uroFuraginum Max is best taken during meals containing protein, as it increases the absorption of the medicine.
The patient should avoid consuming alcohol during treatment 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
uroFuraginum Max 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. Particular caution should be exercised during the last three months of pregnancy (III 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 an adverse effect on testicular function, as they reduce the overall number of sperm and semen, as well as the motility of sperm and changes in their structure.

Driving and using machines

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

uroFuraginum Max 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 consult their doctor before taking the medicine.

uroFuraginum Max contains sodium

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

3. How to take uroFuraginum Max

This medicine should always be taken exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The tablet can be divided into equal doses.
Oral administration. uroFuraginum Max should be taken during meals. The patient should also follow a protein-rich diet. The medicine should be taken with a large amount of fluid.
Recommended dose
Adults and adolescents over 15 years of age
First day of treatment: 400 mg per day in 4 divided doses (1 tablet every 6 hours);
subsequent days of treatment: 300 mg per day in 3 divided doses (1 tablet every 8 hours).
The medicine is usually taken for 7-8 days. If symptoms worsen or do not improve after 7-8 days, the patient should consult their doctor.

Use in children and adolescents

The medicine should not be used in children and adolescents under 15 years of age.

Taking a higher dose of uroFuraginum Max than recommended

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

Missing a dose of uroFuraginum Max

If the patient misses one or more doses, they should continue treatment with the previously taken doses. They 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, this medicine 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 less than 1% of patients.

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

• allergic reactions: rash, itching, urticaria, 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 can 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, and 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 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 increase the risk of its occurrence: renal failure, anemia, diabetes, electrolyte disturbances, vitamin B deficiency)
• liver function disorders, 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, taking furagin may lead to the development of megaloblastic or hemolytic anemia
• dizziness, drowsiness, vision disturbances
• constipation, diarrhea, dyspeptic symptoms (chronic abdominal pain)
• abdominal pain, vomiting
• parotitis, pancreatitis
• alopecia, exfoliative dermatitis
• fever, chills, malaise
• infections with microorganisms resistant to nitrofuran derivatives, most often Pseudomonas or Candida

In patients taking furazidine, the following side effects 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 Drug Safety Monitoring 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 uroFuraginum Max

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 uroFuraginum Max 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 silicon dioxide, magnesium stearate, colloidal silicon dioxide, sodium carboxymethylcellulose type A

What uroFuraginum Max looks like and contents of the pack

Yellow or yellow-orange tablets, round with a dividing line on one side.
15 or 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: