Furaginum sema

Patient Information Leaflet

FURAGINUM SEMA, 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 taken exactly as described in this patient leaflet or as
instructed by the 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 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.

Contents of the leaflet:

1. What the medicine is and what it is used for
2. What you need to know 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 the medicine is and what it is used for

This medicine contains the active substance furazidinum, also known as furagin, a nitrofuran derivative which inhibits the growth of bacteria causing urinary tract infections. This medicine is not effective against infections caused by Pseudomonas aeruginosa bacteria and against most strains of Proteus species.
The indication for use of this medicine is:

• lower urinary tract infection.

2. Important information before using F S 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,
• in the term pregnancy (from week 38) and during delivery, due to the risk of haemolytic anaemia (anaemia 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 been diagnosed with polyneuropathy (a disorder of the nervous system), e.g. in the course of 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 a doctor or pharmacist if the patient has:

• impaired kidney function,
• impaired liver function,
• nervous system disorders,
• anaemia,
• electrolyte imbalances,
• deficiency of B-group vitamins and folic acid,
• lung diseases,
• diabetes, as furazidin may cause nerve damage. Peripheral nerve damage has been observed in patients treated with nitrofuran derivatives. This disorder, in severe cases, may be irreversible and life-threatening. 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. If such symptoms occur, the medicine should be discontinued immediately – symptoms usually resolve quickly or very quickly after discontinuation. In the case of chronic reactions, the severity of symptoms and their reversibility 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 pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonitis) have occurred in patients treated with furazidin for longer than 6 months, particularly in elderly patients.

If the medicine is used long-term, blood tests and assessments of kidney and liver function may be necessary.
See also section 4 regarding when to discontinue the medicine and consult a doctor.

Medicines and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
Particular 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 reducing its urinary concentration, thereby potentially reducing its efficacy,
• antacids containing magnesium trisilicate – reduce the absorption of furazidin,
• atropine – delays the absorption of furazidin, although the total amount absorbed remains unchanged,
• B-group vitamins – increase the absorption of furazidin.

Effect on laboratory tests
During treatment with furazidin, 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 protein-containing meals, which enhances drug absorption.
Alcohol consumption should be avoided during treatment.

Pregnancy, breastfeeding, and effect on 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
The medicine must not be used during the first three months of pregnancy (first trimester) or in women at term (from week 38) and during delivery. Particular caution is required during use in the last three months of pregnancy (third trimester). Furazidin may cause haemolytic anaemia in the newborn.

Breastfeeding
The medicine should not be used during breastfeeding. Furazidin passes into human milk and may harm the breastfed infant.

Fertility
Nitrofuran derivatives may negatively affect testicular function, reduce sperm motility and cause adverse changes in sperm morphology, as well as reduce semen secretion.

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 impair such abilities (dizziness, drowsiness, visual disturbances). If such adverse effects occur, the patient should not drive or operate machinery.

The medicine 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 take 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.
The medicine should be taken orally during meals containing protein, as protein increases drug absorption. The line (score) on the tablet is not intended for dividing the tablet into equal doses.
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.

Taking more than the recommended dose
If more than the recommended dose is taken, the following symptoms may occur: headache, dizziness, allergic reactions, nausea, vomiting, anaemia. If such symptoms occur, seek immediate medical attention at the nearest hospital emergency department, as specialist treatment may be required (including gastric lavage and intravenous fluids, and in severe cases, haemodialysis).
Since the medicine is eliminated from the body 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 a missed dose.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.
If you have any further doubts about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You must stop taking this medicine immediately and contact your doctor or go to the nearest hospital if you experience:

• itching, urticaria, anaphylactic reactions (sudden local or systemic allergic reactions), angioedema (a severe allergic reaction – sudden swelling of the face, which may make breathing difficult, swelling of limbs or joints), rash;
• hypersensitivity reactions affecting the respiratory system (see also "Warnings and precautions" in section 2);
• acute reactions – characterized by fever, chills, cough, chest pain, dyspnoea, pleural effusion, changes in lung radiological imaging, and increased count of a specific type of white blood cells; these usually resolve quickly or very quickly after discontinuation of the medicine;
• chronic reactions – including pulmonary fibrosis and diffuse interstitial pneumonia; the severity of symptoms and their reversibility after stopping the medicine depend on how long treatment was continued after the first adverse symptoms appeared;
• severe skin reactions: exfoliative dermatitis, erythema multiforme (red-purple skin spots and (or) mucosal lesions), Stevens-Johnson syndrome (bullous erythema multiforme; blisters on the skin and (or) mucous membranes which, when ruptured, form painful wounds, often accompanied by fever, muscle and joint pain);
• pseudomembranous colitis (a severe disease of the large intestine characterized by diarrhoea, headache, and fever);
• tingling, numbness, sensation of electric shocks due to peripheral neuropathy (peripheral nerve damage, which may be acute or irreversible, especially in patients with renal impairment, anaemia, diabetes, electrolyte disturbances, or vitamin B deficiency);
• drug-induced hepatitis, cholestatic jaundice (caused by obstruction of bile flow), characterized by yellowing of the sclera, skin and mucous membranes, dark urine, skin itching, pale stools, abdominal pain, nausea, vomiting, persistent fatigue, loss of appetite and weight loss), hepatic parenchymal necrosis;
• fever, chills, malaise, infections with microorganisms resistant to nitrofurantoin. The above adverse reactions occur in no more than 1 in 100 patients.

In addition, the following adverse reactions may occur
Adverse reactions occurring frequently (in 1 to 10 out of 100 patients):

• nausea, excessive flatulence;
• headache.

Adverse reactions occurring less frequently (no more than 1 in 100 patients):

• cyanosis, megaloblastic anaemia (anaemia due to vitamin B or folic acid deficiency) or haemolytic anaemia;
• dizziness, somnolence, visual disturbances;
• constipation, diarrhoea, dyspeptic symptoms (e.g. postprandial fullness, bloating), abdominal pain, vomiting, sialadenitis, pancreatitis;
• alopecia.

In patients taking nitrofurantoin, the following have also been observed with unknown frequency:

• muscle cramps, muscle pain.

Nitrofuran derivatives may negatively affect testicular function (see "Fertility" in section 2).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, you should 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
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 reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine

Keep the medicine out of the 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:
Expiry date (EXP). The expiry date refers to the last day of the specified month.
Lot is the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine contains

• The active substance is furazidin (Furazidinum), also known as furagin. One tablet contains 50 mg of furazidin.
• 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 line engraved on one side.
The line (engraving) does not serve for dividing the tablet into equal doses.
Cartons containing 30 tablets in blisters.
Marketing Authorisation Holder
Laboratoria Gemini Sp. z o.o.
Al. Grunwaldzka 411
80-309 Gdańsk
e-mail: [email protected]
Manufacturer
Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice