Furaginum Max Us Pharmacia

Package Leaflet: Information for the Patient

Furaginum MAX US Pharmacia, 100 mg, Tablets

Furazidinum

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

This medicine should always be taken exactly as described in this patient leaflet or as advised 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, contact a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform 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 the medicine is and what it is used for

2. Important information before taking the medicine

3. How to take the medicine

4. Possible side effects

5. How to store the medicine

6. Contents of the pack and other information

1. What the medicine is and what it is used for

is a medicine in the form of tablets for oral administration. It contains as an active substance furazidine, formerly known as furagin, which is a nitrofuran derivative. Furazidine, acting bacteriostatically, inhibits the growth of furazidine-sensitive bacteria that cause lower urinary tract infections. The indication for the use of the medicine is the treatment of acute and recurrent uncomplicated lower urinary tract infections. If after 7-8 days there is no improvement or the patient feels worse, they should contact their doctor.

2. Important information before taking the medicine

When not to take the medicine

• 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 motor, sensory, or other nervous system disorders)

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• if the patient has a deficiency of the enzyme glucose-6-phosphate dehydrogenase (a condition 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 the medicine, the patient should discuss it with their doctor or pharmacist if they have:

• renal impairment,
• liver dysfunction,
• nervous system disorders,
• anemia,
• electrolyte disturbances (changes in ion concentration in the blood), vitamin B and folic acid deficiency,
• pulmonary diseases.

The patient should stop taking the medicine immediately and seek medical advice if:

• they experience symptoms such as fever, chills, cough, chest pain, shortness of breath, and the medicine should be discontinued and the doctor consulted. These may be pulmonary reactions, which can occur during treatment with nitrofuran derivatives (see also section 4)
• 4).
• they experience neurological symptoms (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 discontinued and the doctor consulted.
• they experience symptoms of liver dysfunction (jaundice of the eyes, skin, and mucous membranes, dark urine, itching of the skin, 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 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 the medicine.

Children and adolescents

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

Medicine interactions

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.

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• Nitrofurans (including furazidine) should not be combined with chloramphenicol, ristomycin (antibacterial medicines), as this may inhibit bone marrow function.
• Furagin should not be used with nalidixic acid and other quinolone derivatives, as antagonism (opposite effects) is usually observed.
• 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 treatment efficacy.
• Concomitant administration of alkalizing medicines 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.
• Concomitant intake of vitamin B increases the absorption of nitrofuran derivatives.

with food, drink, and alcohol
The medicine is best taken during meals containing protein, as this increases its absorption. 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
The medicine 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 (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 - see section 4.

Driving and using machines

There is no data on the effect of furagin on the ability to drive and use machines. However, some patients may experience side effects such as dizziness, drowsiness, vision disturbances, which may affect the ability to drive and use machines. If any of these side effects occur, the patient should not drive or operate machines.

The medicine 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.

The medicine contains sodium

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

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist. The tablet can be divided into equal doses. Oral administration. The medicine should be taken during meals. A protein-rich diet should be followed. 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: 100 mg (1 tablet) 4 times a day (400 mg per day, 1 tablet every 6 hours); subsequent days of treatment: 100 mg (1 tablet) 3 times a day (300 mg per day, 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.

Overdose

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

Missed dose

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. If the patient has any further doubts about taking this medicine, they 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 the medicine immediately 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 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);

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which after rupture form painful sores, 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 interstitial pneumonia) may occur, especially in elderly patients. Acute allergic reactions affecting the respiratory system were characterized by fever, chills, cough, chest pain, and pleural effusion. 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 (severe small or large intestine disease characterized by diarrhea, headache, and fever);
• tingling, numbness, sensation of electric currents due to peripheral neuropathy (peripheral nerve damage), also with acute or irreversible course (the following conditions predispose to its occurrence: renal failure, anemia, diabetes, electrolyte disturbances, vitamin B deficiency);
• liver function disorders, symptoms of drug-induced hepatitis, cholestatic jaundice (caused by bile flow obstruction), liver necrosis (symptoms see "Warnings and precautions" in section 2;
• 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 anemia (caused by vitamin B12 or folic acid deficiency) or hemolytic anemia (caused by rapid red blood cell breakdown);
• pancreatitis;
• infections with microorganisms resistant to nitrofuran derivatives, most often Pseudomonas or Candida;
• fever, chills, malaise.

The following side effects may also occur

• dizziness, drowsiness, vision disturbances;
• constipation, diarrhea, dyspeptic symptoms (chronic upper abdominal pain);
• abdominal pain, vomiting;
• salivary gland inflammation;
• hair loss, exfoliative dermatitis;
• 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 the overall sperm count and sperm motility decrease, and changes in sperm morphology occur.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist, or nurse. 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:
Aleje 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.
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Reporting side effects will help gather more information on the safety of the medicine.

5. How to store the medicine

The medicine should be stored out of sight and reach of children. There are no special storage temperature recommendations for the medicine. The medicine should be stored in its original packaging to protect it from light. The medicine should not be used after the expiration date stated on the carton after: EXP. The expiration date refers to the last day of the given month. The blister packaging is labeled with: EXP - expiration date, Lot - batch number. 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 the medicine contains

• The active substance of the medicine is furazidine, formerly known as furagin. One tablet contains 100 mg of furazidine (Furazidinum).
• The other ingredients are: lactose monohydrate, microcrystalline cellulose silicified with a composition of 98% microcrystalline cellulose and 2% colloidal silica, magnesium stearate, colloidal silica, sodium carboxymethylcellulose (type A).

What the medicine looks like and contents of the pack

Yellow, round tablets with a dividing line on one side, 10 mm in diameter. The tablet can be divided into equal doses. Aluminum/PVC blisters in a cardboard box. 15 tablets. 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

US Pharmacia Sp. z o.o.
ul. Ziębicka 40,
50-507 Wrocław

Manufacturer

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
To obtain more detailed information about this medicine, the patient should contact the representative of the marketing authorization holder:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
phone +48 (22) 543 60 00
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Date of last revision of the leaflet:

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