Furagina apteo med

Package leaflet: information for the user

FURAGINA APTEO MED, 50 mg, tablets
Furazidinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used as described in this patient leaflet or as directed by the
physician 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 adverse reactions, including any possible adverse reactions 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.

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
The medicine contains furazidin as the active substance. Furazidin is a nitrofuran derivative which inhibits the growth of bacteria sensitive to furazidin causing lower urinary tract infections.
The indication for use of the medicine is:

• lower urinary tract infection.

2. Important information before taking the medicine

When not to use the medicine

• If the patient is allergic to furazidin, other nitrofuran derivatives, or to any of the other ingredients of this medicine (listed in section 6).
• During the first trimester of pregnancy.
• During term pregnancy (from week 38) and during delivery, due to the risk of hemolytic anemia (anemia associated with the breakdown of red blood cells) in the newborn.
• In children and adolescents.
• If the patient has renal insufficiency, and laboratory tests have shown creatinine clearance below 60 ml/min or elevated serum creatinine levels.
• If the patient has diagnosed polyneuropathy (a nervous system disorder), e.g. in diabetes.
• If the patient has glucose-6-phosphate dehydrogenase deficiency (an enzyme involved in metabolic processes in red blood cells).

Warnings and precautions
Before starting to take this medicine, discuss with your doctor or pharmacist:

• If the patient has impaired kidney or liver function, nervous system disorders, anemia, electrolyte disturbances, deficiency of B vitamins or folic acid, or lung diseases.
• If the patient has diabetes, because furazidin may cause nerve damage. Peripheral nerve damage has been observed in patients treated with nitrofuran derivatives. This disorder may be irreversible and life-threatening in severe cases. Therefore, the medicine should be discontinued if neurological symptoms occur (tingling, numbness, sensation of electric currents).
• If the patient develops fever, chills, cough, chest pain, or shortness of breath. These may be symptoms of acute pulmonary reactions, which are sometimes observed in patients treated with nitrofuran derivatives (see section 4). If such symptoms occur, the medicine should be discontinued immediately – symptoms usually resolve quickly or very quickly after discontinuation. In chronic reactions, the severity and reversibility of symptoms after stopping the medicine depend on how long treatment was continued after the first adverse symptoms appeared. Early recognition of adverse effects and prompt discontinuation of the medicine are crucial. Impaired lung function may be irreversible. Chronic reactions have been reported in patients taking furazidin for longer than 6 months. Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonia) may occur especially in elderly patients.
• If the medicine is used long-term. In such cases, blood tests may be necessary to monitor white blood cell count, and kidney and liver function.

Children and adolescents
This medicine should not be used in children and adolescents.
Other medicines and this medicine
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Special caution is required when using the following medicines concomitantly:

• Nalidixic acid (an antibiotic) – furazidin inhibits its bacteriostatic effect.
• Aminoglycosides and tetracyclines (antibiotics) – enhance the antibacterial effect of furazidin.
• Chloramphenicol and ristomycin (antibiotics) – increase the toxic effect of furazidin on blood cells.
• Probenecid (in high doses) and sulfinpyrazone (medicines increasing urinary excretion of uric acid) – reduce the excretion of furazidin and may cause its accumulation in the body, increasing its toxicity and decreasing its concentration in urine, thereby reducing its effectiveness.
• Antacids containing magnesium trisilicate – reduce the absorption of furazidin.
• Atropine – delays the absorption of furazidin, but the total amount absorbed does not change.
• B vitamins – increase the absorption of furazidin.

Effect on laboratory tests
During furazidin administration, urine glucose tests using Benedict's or Fehling's solutions may yield false positive results. Urine glucose tests performed by enzymatic methods are usually accurate.
With food, drink and alcohol
The medicine should be taken orally during meals containing protein, which enhances the absorption of the medicine.
Alcohol consumption should be avoided during treatment with this medicine.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
This medicine should not be used during the first three months of pregnancy (first trimester) or in women with term pregnancy and during delivery. Special caution is required during use in the last three months of pregnancy (third trimester). Furazidin may cause hemolytic anemia in the newborn.
Breastfeeding
This medicine should not be used during breastfeeding. Furazidin passes into human milk and may harm the breastfed infant.
Driving and operating machinery
There is no data on the effect of furazidin on the ability to drive or operate machinery.
However, some patients may experience adverse effects that could affect their ability to drive (dizziness, drowsiness, visual disturbances).
If the patient experiences these adverse effects, he or she should not drive or operate machinery.
This medicine contains sucrose
One tablet contains 13.75 mg of sucrose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use the medicine

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
Adults
First day of treatment: 100 mg (2 tablets) 4 times daily; subsequent days: 100 mg (2 tablets) 3 times daily.
Method of administration
The medicine should be taken orally during meals containing protein, as protein increases the absorption of the medicine.
The medicine should be used for 7–8 days. If symptoms worsen or do not improve after 7–8 days, consult a doctor.
Use in children and adolescents
This medicine should not be used in children and adolescents.
Use of a higher than recommended dose of the medicine
If a higher than recommended dose of the medicine is taken, the following symptoms may occur: headache, dizziness, allergic reactions, nausea, vomiting, anemia. If such symptoms occur, seek immediate medical attention at the nearest hospital emergency department, as specialist treatment may be necessary (including gastric lavage and intravenous fluids, and in severe cases, hemodialysis).
Due to the excretion of the medicine via the kidneys, the risk of overdose is increased in patients with impaired kidney function.
Missed dose
If a dose is missed, continue treatment with the previously prescribed doses. Do not take a double dose to make up for the missed dose.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
Stopping the medicine
If you have any further doubts regarding the use of this medicine, consult your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should immediately stop taking this medicine and contact your doctor or go to the
nearest hospital if any of the following adverse effects occur,
which are rare (may affect up to 1 in 1,000 people):

• cyanosis, megaloblastic anaemia (anaemia due to vitamin B or folic acid deficiency), or haemolytic anaemia;
• tingling, numbness, sensation of electric shocks due to peripheral neuropathy (damage to peripheral nerves), including acute or irreversible forms (patients particularly predisposed to this include those with renal failure, anaemia, diabetes, electrolyte disturbances, vitamin B deficiency);
• 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 symptoms most often 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 treatment 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 diarrhoea, headache, and fever);
• severe skin reactions (exfoliative dermatitis, erythema multiforme - red-blue skin patches and/or mucosal lesions, sometimes with blisters, fever, and joint pain, Stevens-Johnson syndrome - skin and/or mucosal blisters which, when ruptured, form painful ulcers, often accompanied by fever, muscle and joint pain);
• itching, urticaria, anaphylactic reactions (sudden local or systemic allergic reactions), angioedema (a skin and subcutaneous tissue disorder characterized by localized swelling), rash;
• symptoms of drug-induced hepatitis, cholestatic jaundice (caused by obstruction of bile flow), hepatic parenchymal necrosis (symptoms see section 2, "Warnings and precautions").

In addition, the following adverse effects may occur:
Common (may affect up to 1 in 10 people):

• nausea, excessive flatulence;
• headache.

Rare (may affect up to 1 in 1,000 people):

• dizziness, drowsiness, visual disturbances;
• fever, chills, malaise;
• infections with microorganisms resistant to nitrofuran derivatives, most commonly Pseudomonas species or Candida species;
• alopecia;
• constipation, diarrhoea, dyspeptic symptoms (e.g. postprandial fullness, bloating), abdominal pain, vomiting, sialadenitis, pancreatitis.

Nitrofuran derivatives may negatively affect testicular function, reduce sperm motility, decrease semen secretion, and lead to adverse changes in sperm morphology.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, 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
Phone: +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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine

Keep the medicine out of sight and reach of children.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the blister and carton following: EXP.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the package and other information

What the medicine contains

• The active substance is furazidinum. Each tablet contains 50 mg of furazidinum.
• The other ingredients are: maize starch, sucrose, colloidal anhydrous silica, stearic acid.

What the medicine looks like and contents of the pack
Uncoated tablets, biconvex, yellow-orange in colour, with a score line on one side.
The line (score) is not intended for dividing the tablet into equal doses.
Cardboard boxes containing 30 tablets in blisters.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Synoptis Pharma Sp. z o.o.
Tel: +48 22 32 16 240

Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice