Furaginum max us pharmacia

Patient Information Leaflet

Furaginum MAX US Pharmacia, 100 mg, tablets
Furazidinum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
You should always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, 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, contact your doctor.

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

1. What this medicine is and what it is used for
Furaginum MAX US Pharmacia is a medicine in the form of tablets for oral administration. It contains furazidinum (formerly known as furagin), a nitrofuran derivative, as the active substance.
Furazidinum exerts a bacteriostatic effect, inhibiting the growth of bacteria sensitive to furazidinum that cause lower urinary tract infections.
This medicine is indicated for the treatment of acute and recurrent uncomplicated lower urinary tract infections.
If there is no improvement after 7–8 days, or if you feel worse, consult your doctor.

2. Important information before taking this medicine

Do not take this medicine if

• you are allergic to furazidinum or other nitrofuran derivatives, or to any of the other ingredients of this medicine (listed in section 6)
• during the first trimester of pregnancy
• during late pregnancy (from week 38) and childbirth, due to the risk of hemolytic anemia (anemia caused by red blood cell destruction) in the newborn
• in children and adolescents under 15 years of age
• if you have peripheral neuropathy, e.g. diabetic neuropathy (a syndrome of peripheral nerve damage, which may present with motor, sensory, or other neurological disturbances)

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• if you have glucose-6-phosphate dehydrogenase deficiency (a genetic disorder affecting an enzyme involved in red blood cell metabolism), as the medicine may cause hemolysis (red blood cell damage and anemia)
• if you have renal insufficiency (oliguria, anuria), and laboratory tests show creatinine clearance below 60 mL/min or elevated serum creatinine levels.

Warnings and precautions
Before starting treatment, consult your doctor or pharmacist if you have:

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

Immediately discontinue use and seek medical advice if

• you experience symptoms such as fever, chills, cough, chest pain, or shortness of breath. Discontinue the medicine immediately and consult your doctor. These may be pulmonary reactions, which sometimes occur during treatment with nitrofuran derivatives (see also section 4).
• you develop neurological symptoms (tingling, numbness, electric shock-like sensations). These may indicate peripheral nerve damage (peripheral neuropathy), especially in diabetic patients, which in severe cases may be irreversible and life-threatening. Discontinue the medicine immediately and consult your doctor.
• you develop symptoms of impaired liver function (yellowing of the whites of the eyes, skin, or mucous membranes, dark urine, skin 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 with long-term use of nitrofurans (usually longer than 6 months).

If you are taking this medicine long-term, regular blood tests may be necessary to monitor white blood cell count and kidney and liver function.
Effect on laboratory test results
This medicine may cause false-positive results in urine glucose tests. Inform medical personnel that you are taking this medicine before providing a urine sample for testing.
Children and adolescents
This medicine must not be used in children and adolescents under 15 years of age.
Other medicines and Furaginum MAX US Pharmacia
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

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• Nitrofurans (including furazidinum) should not be combined with chloramphenicol or ristomycin (antibacterial agents), as they may suppress hematopoietic function.
• Do not use nalidixic acid or other quinolone derivatives simultaneously with furagin, as antagonism (opposing effects) is usually observed.
• Aminoglycoside antibiotics and tetracyclines, when administered together with furazidinum, enhance its antibacterial effect.
• Drugs that increase uric acid excretion, such as probenecid (in high doses) and sulfinpyrazone, reduce tubular secretion of nitrofuran derivatives and may cause accumulation of furazidinum in the body, increasing its toxicity and reducing treatment efficacy.
• Concurrent administration of alkalizing agents containing magnesium trisilicate inhibits absorption of furazidinum and reduces its antibacterial activity.
• Atropine slows down absorption of furagin, but the total amount of absorbed active substance remains unchanged.
• Concurrent intake of B vitamins increases absorption of nitrofuran derivatives.

With food, drink and alcohol
It is best to take this medicine with meals containing protein, as this enhances drug absorption.
Avoid alcohol consumption during treatment with furagin.
Pregnancy, breastfeeding and fertility
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not use this medicine during the first trimester of pregnancy or in women during late pregnancy (from week 38) and childbirth, as furazidinum may cause hemolytic anemia in the newborn. Exercise particular caution when using during the last three months of pregnancy (third trimester).
Breastfeeding
As furagin passes into human milk, this medicine should not be used during breastfeeding.
Fertility
In men of reproductive age – see section 4.
Driving and operating machinery
There are no data on the effect of furagin on the ability to drive or operate machinery. However, some patients may experience side effects such as dizziness, drowsiness, or visual disturbances, which may affect the ability to drive or operate machinery. If any such side effects occur, the patient should not drive or operate machinery.
This medicine contains 123 mg of monohydrate lactose
If you have been previously diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".
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3. How to take this medicine

Always take this medicine exactly as described in the patient information leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The tablet may be divided into equal doses.
Oral administration. This medicine should be taken with meals.
Follow a protein-rich diet during treatment. Drink plenty of fluids when taking this medicine.

Recommended dose
Adults and adolescents over 15 years of age:
First day of treatment: 100 mg (1 tablet) 4 times daily (400 mg per day, 1 tablet every 6 hours).
Subsequent days of treatment: 100 mg (1 tablet) 3 times daily (300 mg per day, 1 tablet every 8 hours).

The usual duration of treatment is 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 medicine than recommended
If you take more than the recommended dose, seek immediate advice from your doctor or pharmacist.

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
Among the adverse effects observed during clinical trials and considered likely to be related to the use of the medicine, the most common were: nausea (8%), headache (6%), and excessive flatulence (1.5%).
The remaining adverse effects listed below occurred in no more than 1% of patients.
You should immediately stop using 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 (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 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,

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which, when ruptured, 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 the case of chronic reactions, the severity of symptoms and their reversibility after stopping the drug depend on the duration of continued treatment after the first adverse symptoms appear. 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, headache, and fever);
• tingling, numbness, and electric shock sensations due to peripheral neuropathy (damage to peripheral nerves), including acute or irreversible forms (patients particularly predisposed to this include those with renal insufficiency, anemia, diabetes, electrolyte disturbances, or vitamin B deficiency);
• liver function disorders, symptoms of drug-induced hepatitis, cholestatic jaundice (caused by obstruction of bile flow), hepatic parenchymal necrosis (see symptoms under “Warnings and precautions” in section 2);
• cyanosis due to methemoglobinemia (skin discoloration with a chocolate-brown hue). In patients with glucose-6-phosphate dehydrogenase deficiency, the use of furaginum may lead to megaloblastic anemia (caused by vitamin B12 or folic acid deficiency) or hemolytic anemia (caused by rapid destruction of red blood cells);
• pancreatitis;
• infections with microorganisms resistant to nitrofuran derivatives, most commonly Pseudomonas species or Candida species;
• fever, chills, malaise.

In addition, the following adverse effects may occur:

• dizziness, drowsiness, visual disturbances;
• constipation, diarrhea, dyspeptic symptoms (chronic epigastric pain);
• abdominal pain, vomiting;
• sialadenitis;
• alopecia, exfoliative dermatitis;
• as shown by experimental studies and clinical observations in patients using nitrofurans (as well as certain antibiotics), these drugs may adversely affect testicular function, resulting in reduced total sperm and semen volume, decreased sperm motility, and structural abnormalities in sperm.

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

5. How to store the medicine

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.
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 specified month.
Blister labelling information: EXP – expiry date, Lot – batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What the medicine contains

• The active substance is furazidin, formerly known as furagin. Each tablet contains 100 mg of furazidin (Furazidinum).
• The other ingredients are: monohydrate lactose, silicified microcrystalline cellulose composed of: 98% microcrystalline cellulose and 2% anhydrous colloidal silicon dioxide, magnesium stearate, anhydrous colloidal silicon dioxide, sodium carboxymethyl starch (type A).

What the medicine looks like and contents of the pack
Yellow, round tablets with a division 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 Authorisation Holder and Manufacturer
Marketing Authorisation 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

For further information about this medicine, please contact the representative of the Marketing Authorisation Holder:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warszawa
tel. +48 (22) 543 60 00
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