Uro furaginum max

Patient Information Leaflet: Information for the User

uroFuraginum Max, 100 mg, tablets
Furazidinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor
or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7–8 days, or if you feel worse, you should contact your doctor.

Table of Contents

1. What uroFuraginum Max is and what it is used for
2. What you need to know 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 uroFuraginum Max is and what it is used for

uroFuraginum Max is a medicine in tablet form for oral administration. It contains the active substance
furazidin, also known as furagin, which is a nitrofuran derivative. Furazidin inhibits the growth of many bacteria
causing urinary tract infections.
uroFuraginum Max is indicated for the treatment of lower urinary tract infections.

2. Important information before taking uroFuraginum Max

When not to take uroFuraginum Max

• if the patient is allergic to nitrofurantoin or other 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 caused by red blood cell breakdown) in the newborn
• in children and adolescents under 15 years of age
• if the patient has peripheral neuropathy, e.g. diabetic neuropathy (a condition involving damage to peripheral nerves, which may manifest as motor, sensory or other nervous system disorders)
• 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 uroFuraginum Max, 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), vitamin B complex deficiency or folic acid deficiency,
• lung diseases.

Immediately discontinue use of uroFuraginum Max and seek medical advice if:

• the patient develops symptoms such as fever, chills, cough, chest pain, or shortness of breath. These may be pulmonary reactions, which sometimes occur during treatment with nitrofuran derivatives (see also section 4).
• the patient develops neurological symptoms (tingling, numbness, sensation of electric currents). These may indicate peripheral nerve damage (peripheral neuropathy), particularly in diabetic patients, which in severe cases may be irreversible and life-threatening. The drug should be immediately discontinued and medical advice sought.
• the patient develops symptoms of impaired liver function (jaundice of the eyes, skin and mucous membranes, dark urine, itching, pale stools, abdominal pain, nausea, vomiting, persistent fatigue, loss of appetite and weight loss). Jaundice may occur even during short-term use of nitrofurans (within two weeks). Chronic hepatitis (sometimes leading to liver necrosis – fatal cases have been reported) may occur during prolonged use of nitrofurans (usually longer than 6 months). If the patient is on long-term treatment, periodic blood tests may be necessary to monitor white blood cell count and kidney and liver function.

Effect on laboratory tests
The drug may cause falsely positive results in urine glucose tests. Before submitting a urine sample for testing, inform medical personnel that the patient is 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
Inform the doctor or pharmacist about all medicines currently used, recently taken, or planned for use.

• Nitrofurans (including nitrofurantoin) should not be combined with chloramphenicol, ristomycin, chloramphenicol, or sulfonamides (antibacterial agents), as this may suppress hematopoietic function.
• Nalidixic acid and other quinolone derivatives should not be used concomitantly with nitrofurantoin, as antagonism (opposing action) is usually observed.
• Aminoglycoside antibiotics and tetracyclines, when administered together with nitrofurantoin, enhance its antibacterial effect.
• Drugs increasing uric acid excretion, such as probenecid (in high doses) and sulfinpyrazone, reduce tubular secretion of nitrofuran derivatives and may cause accumulation of nitrofurantoin in the body, increasing its toxicity and reducing treatment efficacy.
• Concurrent administration of alkalizing agents containing magnesium trisilicate inhibits absorption of nitrofurantoin and reduces its antibacterial activity.
• Atropine delays absorption of nitrofurantoin, although the total amount of active substance absorbed remains unchanged.
• Drugs that neutralize gastric acid inhibit absorption of nitrofurantoin.
• Concurrent intake of vitamin B complex increases absorption of nitrofuran derivatives.

uroFuraginum Max, food, drink and alcohol
uroFuraginum Max should preferably be taken with protein-containing meals, as this enhances drug absorption.
Alcohol consumption should be avoided during treatment with nitrofurantoin.

Pregnancy, breastfeeding and fertility

If the patient is pregnant, 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
uroFuraginum Max should not be used during the first trimester of pregnancy or in women with full-term pregnancy (from week 38) and during childbirth, as nitrofurantoin 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 nitrofurantoin into human milk, the drug should not be used during breastfeeding.

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

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

uroFuraginum Max contains lactose
Each 100 mg tablet contains 123 mg of monohydrate lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.

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

3. How to take uroFuraginum Max

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The tablet may be divided into equal doses.
Oral administration. uroFuraginum Max should be taken during meals. At the same time, maintain a protein-rich diet. The medicine should be taken with plenty of fluids.

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 used for 7–8 days. If symptoms worsen or do not improve after 7–8 days, consult your doctor.

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

If you take more uroFuraginum Max than recommended
If you take more than the recommended dose, seek immediate advice from your doctor or pharmacist.

If you miss a dose of uroFuraginum Max
If you miss one or more doses, continue treatment with your previously prescribed doses. Do not take a double dose to make up for a missed dose.

If you feel the effect of the medicine is too strong or too weak, consult your doctor.
If you have any further doubts regarding the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Among adverse events observed during clinical trials and considered likely related to the use of this medicine, the most common were: nausea (8%), headache (6%), and excessive flatulence (1.5%).
Other adverse reactions listed below occurred in no more than 1% of patients.

Immediately discontinue use of this medicine and contact a 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 (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-blue skin lesions and/or mucous membranes, sometimes with blisters, fever and joint pain), Stevens-Johnson syndrome—blisters on the skin and/or mucous membranes which rupture and form painful sores, often accompanied by fever, muscle pain 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 drug. In cases of chronic reactions, the severity of symptoms and their reversibility after stopping the drug depend on how long treatment was continued after the first adverse symptoms appeared. Early recognition of adverse effects and prompt discontinuation of the drug are crucial. Impairment of lung function may be irreversible;
• Pseudomembranous colitis (a severe disease of the small or large intestine characterized by diarrhea, abdominal pain and fever);
• Tingling, numbness, sensation of electric shocks due to peripheral neuropathy (damage to peripheral nerves), which may have acute or irreversible course (patients particularly predisposed include those with renal impairment, anemia, diabetes, electrolyte disturbances, or vitamin B deficiency);
• Liver function disorders, drug-induced hepatitis, cholestatic jaundice (caused by obstruction of bile flow), hepatocellular necrosis (see symptoms under "Warnings and precautions" in section 2).

Additionally, the following adverse reactions may occur:

• Cyanosis due to methemoglobinemia (skin discoloration with chocolate-brown hue). In patients with glucose-6-phosphate dehydrogenase deficiency, the use of furagin may lead to megaloblastic anemia (caused by vitamin B or folic acid deficiency) or hemolytic anemia (caused by rapid destruction of red blood cells);
• Dizziness, drowsiness, visual disturbances;
• Constipation, diarrhea, dyspeptic symptoms (chronic epigastric pain);
• Abdominal pain, vomiting;
• Sialadenitis (inflammation of salivary glands), pancreatitis;
• Alopecia, exfoliative dermatitis;
• Fever, chills, malaise;
• Infections with microorganisms resistant to nitrofuran derivatives, most commonly Pseudomonas species or Candida species.

In patients treated with furazidin, the following adverse reactions have also been observed, with unknown frequency:

• Muscle cramps, muscle pain.

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

5. How to store uroFuraginum Max

Keep this medicine out of sight and reach of children.
There are no special requirements regarding 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 following 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 packaging and other information

What uroFuraginum Max contains

• The active substance is furazidinum, also known as furagine. The other ingredients are: lactose monohydrate, silicified microcrystalline cellulose composed of: microcrystalline cellulose 98% and colloidal anhydrous silica 2%, magnesium stearate, colloidal anhydrous silica, sodium carboxymethyl starch type A.

What uroFuraginum Max looks like and contents of the pack
Yellow or yellow-orange, round tablets, with a division line on one side.
Available in blister packs of 15 or 30 tablets, packed in a cardboard box.
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