Furaginum Teva

Leaflet attached to the packaging: information for the user

Furaginum Teva, 100 mg, tablets

Furazidine

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Furaginum Teva and what is it used for
• 2. Important information before taking Furaginum Teva
• 3. How to take Furaginum Teva
• 4. Possible side effects
• 5. How to store Furaginum Teva
• 6. Contents of the packaging and other information

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

Furaginum Teva is available in the form of tablets for oral administration. It contains furazidine as the active substance, also known as furagin. Furazidine is a nitrofuran derivative that inhibits the growth of bacteria that cause urinary tract infections.

• The indication for the use of Furaginum Teva is:
• treatment of uncomplicated lower urinary tract infections, including recurrent urinary tract infections in women caused by Escherichia coli bacteria.

2. Important information before taking Furaginum Teva

When not to take Furaginum Teva:

• if the patient is allergic to furazidine, nitrofuran derivatives, or any of the other ingredients of this medicine (listed in section 6)
• if the patient has polyneuropathy (a syndrome of peripheral nerve damage, which may be characterized by motor, sensory, or other neurological disorders), e.g. in diabetics
• if the patient has a deficiency of the enzyme glucose-6-phosphate dehydrogenase (a disease associated with a genetically determined enzyme deficiency involved in red blood cell metabolism)
• if the patient has renal failure (creatinine clearance below 60 ml/min or elevated creatinine levels in serum)
• in newborns and infants under 3 months of age
• during the first three months of pregnancy (first trimester)
• during the period of carried pregnancy (from 38 weeks) and childbirth, due to the risk of hemolytic anemia in the newborn.

Warnings and precautions

If the patient is affected by the circumstances described below (see also section 4), the use of Furaginum Teva should be discussed with the doctor.

• If the patient has diabetes, renal dysfunction, liver dysfunction, neurological disorders, electrolyte disturbances, anemia, vitamin B and folic acid deficiency, or lung disease, caution should be exercised when using the medicine, as there is an increased risk of peripheral polyneuropathy (peripheral nerve damage). This disorder can be irreversible and life-threatening in severe cases. Therefore, Furaginum Teva should be discontinued if neurological symptoms occur (tingling, numbness, sensation of electric currents).
• If the patient experiences fever, chills, cough, chest pain, 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. Chronic reactions occurred in patients taking furazidine for more than 6 months. Chronic pulmonary reactions may occur, especially in elderly patients.
• If the medicine is used for a long time, it may be necessary to perform blood tests to control the white blood cell count and renal and liver function.
• Alcohol should be avoided during treatment with furazidine (see separate section below).

Rarely, liver function disorders may occur (jaundice of the eyes, skin, and mucous membranes, itching of the skin, discoloration of stools, dark urine, abdominal pain, vomiting, nausea, loss of appetite, constant fatigue, and weight loss), including cholestatic jaundice (caused by an obstacle to bile flow) and chronic hepatitis. If liver function disorders are detected, treatment with furazidine should be discontinued immediately.

Children

Furaginum Teva should not be used in newborns and infants under 3 months of age.

Furaginum Teva and other medicines

The patient should tell the doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• streptomycin, levomycetin, sulfonamides, chloramphenicol (antibacterial chemotherapeutics) - increase the toxic effect of furazidine on the hematopoietic system;
• quinolone derivatives, e.g. nalidixic acid, norfloxacin, oxolinic acid (antibacterial agents) - furazidine may inhibit their antibacterial activity;
• probenecid and sulfinpyrazone (medicines that increase the excretion of uric acid in the urine) - may reduce the excretion of furazidine and cause its accumulation in the body, increasing its toxicity and reducing its concentration in the urine, which may lead to a decrease in its effectiveness;
• medicines that are carbonic anhydrase inhibitors (sulfonamides) and medicines that increase the pH of urine (alkalizing) - may reduce the antibacterial activity of nitrofurans;
• vitamin B - increases the absorption of nitrofuran derivatives;
• atropine (a medicine that relaxes and dilates the pupils) - may delay the absorption of furazidine, but the overall amount of absorbed substance does not change;
• antacids containing magnesium trisilicate reduce the absorption of furazidine - may reduce the antibacterial activity of furazidine.

Effect on laboratory tests

During the administration of furazidine, the results of glucose tests in urine using Benedict's and Fehling's solutions may be falsely positive. The results of glucose tests in urine performed using enzymatic methods are usually correct.

Furaginum Teva with food or alcohol

See section 3.

Alcohol should be avoided during treatment with Furaginum Teva due to the possibility of a disulfiram-like effect with symptoms such as a feeling of heat, abdominal pain, nausea, vomiting, and tachycardia.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects that they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.

Pregnancy

Furaginum Teva should not be used during the first three months of pregnancy (first trimester) or in carried pregnancy (from 38 weeks) and childbirth.

Care should be taken when using the medicine during the last three months of pregnancy (third trimester), as furazidine may cause hemolytic anemia in the newborn.

Breastfeeding

Furaginum Teva should not be used during breastfeeding. Furazidine passes into breast milk and may harm the breastfed child.

Fertility

Nitrofuran derivatives may have an adverse effect on testicular function, slightly or moderately reducing the total number of sperm in the semen.

Driving and operating machines

There is no data on the effect of furazidine on the ability to drive vehicles and operate machines.

However, some patients may experience side effects that may affect the ability to drive vehicles and operate machines (headache, dizziness, drowsiness, vision disturbances; see also section 4).

Furaginum Teva contains lactose monohydrate and sucrose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.

3. How to take Furaginum Teva

This medicine should always be taken according to the doctor's instructions. In case of doubts, the doctor should be consulted.

Use in adults

First day: 1 tablet (100 mg) 4 times a day.

Subsequent days: 1 tablet (100 mg) 3 times a day.

Treatment usually lasts 7-10 days. If necessary, treatment can be repeated after 10-15 days.

Recurrent urinary tract infections in women

In case of at least 3 episodes of urinary tract infection in the last 12 months, Furaginum Teva is used in a dose of 100 mg (1 tablet) at night for 6-12 months.

Use in children and adolescents

Furaginum Teva can be given to children aged 2 to 14 years. The following dosing schedule should be used.

Furaginum Teva should be used in a dose of 5-7 mg/kg body weight per day in 2 divided doses. The medicine is used for 7-8 days. If necessary, treatment can be repeated after 10-15 days.

In children under 2 years of age, the dose of the medicine should be determined by the doctor (see "When not to take Furaginum Teva" in section 2).

Care should be taken when administering the medicine to small children due to the risk of choking (see below).

Method of administration

The medicine is used orally. If the child has problems swallowing tablets, the medicine can be crushed and suspended in milk. The line on the tablet only facilitates its crushing, for easier swallowing, and not division into equal doses. Furaginum Teva should be taken during meals. A high-protein diet should be used at the same time. The medicine should be taken with a large amount of fluids.

If one or more doses of the medicine are missed, treatment should be continued using the previously taken doses.

Taking a higher dose of Furaginum Teva than recommended

In case of taking a higher dose of the medicine than recommended, nausea, vomiting, headache, dizziness, allergic reactions, or anemia may occur. If any worrying symptoms occur, the doctor, pharmacist, or emergency department of the nearest hospital should be consulted immediately, as specialized treatment may be necessary. Gastric lavage and administration of a large amount of fluids are recommended to increase the excretion of the medicine in the urine. Blood morphology tests, liver function tests, and monitoring of lung function are recommended. In severe cases, hemodialysis should be performed.

Due to the excretion of the medicine from the body through the kidneys, the risk of overdose is increased in patients with impaired renal function.

Missing a dose of Furaginum Teva

If one or more doses of the medicine are missed, treatment should be continued using the previously taken doses. A double dose should not be taken to make up for the missed dose.

Stopping the use of Furaginum Teva

Stopping the use of Furaginum Teva during treatment may result in incomplete cure of the lower urinary tract infection.

In case of any further doubts related to the use of this medicine, the doctor should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The use of this medicine should be stopped immediately and the doctor or the nearest hospital should be notified 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
• urticaria, itching

including life-threatening anaphylactic shock), angioedema (severe allergic reaction - sudden swelling of the face, limbs, or joints without itching and pain). Swelling in the head and neck area may cause difficulty swallowing and breathing;

• severe skin reactions (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome - blistering multiforme erythema);
• symptoms of drug-induced hepatitis (jaundice of the eyes, skin, and mucous membranes, itching of the skin, discoloration of stools, dark urine, abdominal pain, vomiting, nausea, loss of appetite, constant fatigue, and weight loss), cholestatic jaundice (caused by an obstacle to bile flow), liver necrosis (usually during long-term use); (frequency not known):
• asthmatic reactions (shortness of breath) in patients with asthma; reactions of hypersensitivity concerning the respiratory system, including:
• acute reactions - manifested by fever, chills, cough, chest pain, shortness of breath - usually quickly resolve after discontinuation of the medicine
• chronic reactions - including changes in the lungs (e.g. pulmonary fibrosis, pneumonia) - the severity of symptoms and their reversibility after discontinuation of the medicine depend on the duration of treatment after the first symptoms of adverse reactions appear; after detecting an adverse reaction, the medicine should be discontinued immediately; impairment of lung function may be irreversible
• methemoglobinemia, which can also manifest as fatigue, shortness of breath, headache, dizziness, rapid heart rate, drowsiness, and coma;
• pseudomembranous colitis (severe disease of the small or large intestine manifested by diarrhea, headache, and fever);
• peripheral nerve damage (also with acute or irreversible course, especially in patients with impaired renal function, anemia, diabetes, electrolyte disturbances, or vitamin B deficiency).

Other side effects of Furaginum Teva may include:

Common (may affect 1 in 10 patients):

• nausea, excessive gas;
• headache.

Frequency not known (frequency cannot be estimated from the available data):

• dizziness, drowsiness, vision disturbances;
• vomiting, constipation, diarrhea, symptoms of indigestion, abdominal pain, salivary gland inflammation, pancreatitis;
• hair loss (temporary);
• infections with microorganisms resistant to furazidine, fever, chills, malaise;
• in people with glucose-6-phosphate dehydrogenase deficiency, the use of furazidine may lead to the development of megaloblastic or hemolytic anemia (due to a deficiency of vitamin B or folic acid) with symptoms such as: easy fatigue, general weakness, concentration problems, headache, and dizziness.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to: Department for Monitoring of Adverse Reactions to Medicinal Products

Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Jerozolimskie Avenue 181C

02-222 Warsaw

Tel.: +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.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Furaginum Teva

The medicine should be stored in a place invisible and inaccessible to children.

There are no special recommendations for storing the medicine.

The medicine should not be used after the expiry date stated on the packaging after: EXP.

The expiry date means the last day of the given month.

Medicines should not be disposed of via wastewater or household waste containers. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Furaginum Teva contains

• The active substance of the medicine is furazidine. 1 tablet contains 100 mg of furazidine, also known as furagin.
• The other ingredients are: lactose monohydrate, potato starch, sucrose, Polysorbate 80, stearic acid.

What Furaginum Teva looks like and what the packaging contains

Furaginum Teva is a yellow or yellow-orange, oval, biconvex tablet with a smooth surface, 3.6-4.4 mm thick, 9.3-9.7 mm long, with a line on one side. The line on the tablet only facilitates its crushing, for easier swallowing, and not division into equal doses.

The cardboard box contains 15, 25, or 30 tablets in blisters and a patient leaflet.

Marketing authorization 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 Krakow

Date of last update of the leaflet:March 2022