Package leaflet: Information for the user

Furaginum Teva, 100 mg, tablets
Furazidinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

What Furaginum Teva is and what it is used for
What you need to know before taking Furaginum Teva
How to take Furaginum Teva
Possible side effects
How to store Furaginum Teva
Contents of the pack and other information

1. What Furaginum Teva is and what it is used for

Furaginum Teva is available as tablets for oral administration. It contains as the active substance furazidin, also known as furagin. Furazidin is a nitrofuran derivative which inhibits the growth of bacteria causing urinary tract infections.

Furaginum Teva is indicated for:

Treatment of uncomplicated lower urinary tract infections, including recurrent urinary tract infections in women caused by Escherichia coli microorganisms.

2. Important information before using Furaginum Teva

When not to use Furaginum Teva:

if the patient is allergic to furazidin, nitrofuran derivatives, or any of the other ingredients of this medicine (listed in section 6)
if the patient has peripheral neuropathy (a syndrome of peripheral nerve damage, which may be characterized by motor, sensory, or other neurological disturbances), e.g. in diabetic patients
if the patient has glucose-6-phosphate dehydrogenase deficiency (a condition associated with genetically determined deficiency of an enzyme involved in metabolism in red blood cells)
if the patient has renal insufficiency (in laboratory tests, creatinine clearance below 60 ml/min or elevated serum creatinine levels)
in newborns and infants up to 3 months of age
during the first three months of pregnancy (first trimester)
during term pregnancy (from week 38) and during labour, due to the risk of haemolytic anaemia (anaemia associated with destruction of red blood cells) in the newborn.

Warnings and precautions
If any of the circumstances described below apply to the patient (see also section 4), the use of Furaginum Teva should be discussed with a doctor.

If the patient has diabetes, renal or liver dysfunction, neurological disorders, electrolyte imbalances (changes in blood ion concentrations), anaemia, deficiency of B-group vitamins and folic acid, or lung diseases, special caution is required during treatment, as there is an increased risk of developing peripheral neuropathy (peripheral nerve damage). This disorder may, in severe cases, be irreversible and life-threatening. For this reason, Furaginum Teva 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 drug should be discontinued immediately. Chronic pulmonary reactions have been reported in patients treated with furazidin for longer than 6 months. Chronic pulmonary reactions may particularly occur in elderly patients.
If the drug is used long-term, blood tests may be necessary to monitor white blood cell count and kidney and liver function.
Alcohol consumption should be avoided during treatment with furazidin (see separate section below).

Rarely, liver function disorders may occur (jaundice of the sclera, skin and mucous membranes, skin itching, pale stools, dark urine, abdominal pain, vomiting, nausea, loss of appetite, persistent fatigue and weight loss), including cholestatic jaundice (caused by obstruction of bile flow) and chronic hepatitis. If liver function disorders are detected, treatment with furazidin should be discontinued immediately.
Children
Furaginum Teva should not be used in newborns and infants up to 3 months of age.
Furaginum Teva and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to use.
Special caution is required when using the following medicines concomitantly:

ristomycin, chloramphenicol, sulfonamides, chloramphenicol (antibacterial chemotherapeutic agents) – increase the toxic effect of furazidin on the haematopoietic system;
quinolone derivatives, e.g. nalidixic acid, norfloxacin, oxolinic acid (antibacterial agents) – furazidin may inhibit their antibacterial activity;
probenecid and sulfinpyrazone (drugs increasing urinary excretion of uric acid) – may reduce furazidin excretion and lead to its accumulation in the body, increasing its toxicity and decreasing its concentration in urine, which may reduce its efficacy;
drugs that are carbonic anhydrase inhibitors (sulfonamides) and drugs that increase urine pH (alkalinizing agents) – may reduce the antibacterial activity of nitrofurans;
vitamin B – increases the absorption of nitrofuran derivatives;
atropine (a spasmolytic and pupil-dilating agent) – may delay the absorption of furazidin, although the total amount absorbed does not change;
antacids containing magnesium trisilicate – reduce the absorption of furazidin and may decrease its antibacterial effect.

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.
Furaginum Teva with food or alcohol
See section 3.
Alcohol consumption should be avoided during treatment with Furaginum Teva due to the risk of a disulfiram-like reaction, with symptoms such as flushing, abdominal pain, nausea, vomiting, and tachycardia.
Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or 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
Furaginum Teva should not be used during the first three months of pregnancy (first trimester) or in women with term pregnancy (from week 38) and during labour.
Special caution is required during use in the last three months of pregnancy (third trimester), as furazidin may cause haemolytic anaemia in the newborn (anaemia associated with red blood cell destruction).
Breastfeeding
Furaginum Teva should not be used during breastfeeding. Furazidin passes into breast milk and may harm the breastfed infant.
Effect on fertility
Nitrofuran derivatives may adversely affect testicular function, slightly or moderately reducing the total sperm count in semen.
Driving and operating machinery
There are no data on the effect of furazidin on the ability to drive or operate machinery. However, in some patients, adverse effects may occur that could affect the ability to drive or operate machinery (headache, dizziness, drowsiness, visual disturbances; see also section 4).
Furaginum Teva contains monohydrate lactose and 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 Furaginum Teva
This medicine should always be taken according to the doctor's instructions. In case of doubt, consult the doctor.
Use in adults
Day 1: 1 tablet (100 mg) 4 times daily.
Subsequent days: 1 tablet (100 mg) 3 times daily.
Treatment usually lasts 7–10 days. If necessary, treatment may be repeated after 10–15 days.
Recurrent urinary tract infections in women
If at least 3 episodes of urinary tract infection have occurred in the past 12 months, Furaginum Teva should be used at a dose of 100 mg (1 tablet) at bedtime for a period of 6–12 months.
Use in children and adolescents
Furaginum Teva may be administered to children aged 2 to 14 years. The following dosing schedule should be applied.
Furaginum Teva should be administered at a dose of 5–7 mg/kilogram body weight per day, divided into 2 doses. The treatment lasts 7–8 days. If necessary, treatment may be repeated after 10–15 days.
For children under 2 years of age, the dose should be determined by a doctor (see "When not to use Furaginum Teva" in section 2).
Caution should be exercised when administering the medicine to young children due to the risk of choking (see below).
Method of administration
The medicine is taken orally. If a child has difficulty swallowing tablets, the tablet may be crushed and suspended in milk. The score line on the tablet is intended only to facilitate breaking the tablet for easier swallowing, not for dividing it into equal doses. Furaginum Teva should be taken during meals. A protein-rich diet should be followed simultaneously. The medicine should be taken with a large amount of fluid.
If one or several doses have been missed, treatment should be continued with the previously prescribed doses.
Overdose of Furaginum Teva
If an overdose is taken, symptoms such as nausea, vomiting, headache, dizziness, allergic reactions, and anaemia may occur. If any disturbing symptoms occur, seek immediate medical advice from a doctor, pharmacist, or the nearest hospital emergency department, as specialist treatment may be necessary. Gastric lavage and administration of large amounts of fluids to enhance urinary excretion of the drug are recommended. Blood morphology, liver function laboratory tests, and pulmonary function monitoring are advised. In severe cases, haemodialysis should be performed.
Due to renal excretion of the drug, the risk of overdose is increased in patients with impaired renal function.
Missed dose of Furaginum Teva
If one or several doses have been missed, treatment should be continued with the previously prescribed doses. Do not take a double dose to make up for a missed dose.
Discontinuation of Furaginum Teva
Discontinuing Furaginum Teva during treatment may result in failure to cure lower urinary tract infection.
If you have any further questions 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.
You must immediately stop taking this medicine and contact a doctor or go to the
nearest hospital if the following occur:
(rare: may affect 1 in 1,000 patients):

allergic reactions: rash, itching, urticaria, anaphylactic reactions (sudden local or systemic allergic reactions with symptoms such as:
swelling of the face, lips, tongue or throat
difficulty breathing or swallowing
hives, itching

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 in swallowing and breathing;

severe skin reactions (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome - bullous erythema multiforme);
drug-induced hepatitis symptoms (yellowing of the whites of the eyes, skin and mucous membranes, skin itching, pale stools, dark urine, abdominal pain, vomiting, nausea, loss of appetite, persistent fatigue and weight loss), cholestatic jaundice (caused by obstruction of bile flow), liver necrosis (usually during prolonged use); (frequency unknown):
asthmatic reactions (shortness of breath) in patients with asthma; hypersensitivity reactions affecting the respiratory system, including:
acute reactions - manifested, among others, by fever, chills, cough, chest pain, shortness of breath - usually resolve quickly after discontinuation of the drug
chronic reactions - including lung changes (e.g. pulmonary fibrosis, pneumonia) - severity of symptoms and reversibility after discontinuation of the drug depend on the duration of treatment after the onset of first adverse symptoms; upon detection of an adverse reaction, immediate discontinuation of the drug is necessary; lung function impairment may be irreversible
cyanosis due to methemoglobinemia, which may additionally manifest as fatigue, shortness of breath, headache and dizziness, increased heart rate, drowsiness and coma;
pseudomembranous colitis (a severe disease of the small or large intestine manifested by diarrhea, headache and fever);
peripheral nerve damage (also acute or irreversible), especially in patients with impaired kidney function, anemia, diabetes, electrolyte disturbances or vitamin B deficiency.

Other adverse reactions of Furaginum Teva may include:
Common (may affect up to 1 in 10 people):

nausea, excessive flatulence;
headache.

Frequency unknown (frequency cannot be determined from available data):

dizziness, drowsiness, visual disturbances;
vomiting, constipation, diarrhea, dyspeptic symptoms, abdominal pain, sialadenitis, pancreatitis;
alopecia (transient);
infections with microorganisms resistant to furazidin, fever, chills, malaise;
in patients with glucose-6-phosphate dehydrogenase deficiency, the use of furazidin may lead to megaloblastic anemia (due to vitamin B or folic acid deficiency) or hemolytic anemia (caused by rapid breakdown of red blood cells), with symptoms such as: easy fatigue, general weakness, concentration problems, headache and dizziness, feeling of shortness of breath.

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:
Department of Monitoring of Adverse Drug Reactions
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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Furaginum Teva

Keep this medicine out of the sight and reach of children.
No special storage instructions apply for this medicine.
Do not use this medicine after the expiry date stated on the packaging after: 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 you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Furaginum Teva contains

The active substance is furazidin. Each tablet contains 100 mg of furazidin, also known as furagin.
The other ingredients are: monohydrate lactose, potato starch, sucrose, Polysorbate 80, stearic acid.

What Furaginum Teva looks like and contents of the pack
Furaginum Teva is a yellow or yellow-orange, oval, biconvex tablet with a uniform surface, 3.6 – 4.4 mm thick, 9.3 – 9.7 mm long, with a line on one side. The line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and does not indicate division into equal doses.
The cardboard box contains 15, 25 or 30 tablets in blisters and the patient leaflet.

Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
Emilii Plater 53
00-113 Warsaw
tel.: (22) 345 93 00

Manufacturer
Teva Operations Poland Sp. z o.o.
Mogilska 80
31-546 Kraków