Furaginum Teva

Leaflet attached to the packaging: patient information

Furaginum Teva, 50 mg, tablets

(Furazidine)

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms 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. Package contents 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, also known as furagin, as an active substance, which has antibacterial properties.
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 colibacteria.

2. Important information before taking Furaginum Teva

When not to take Furaginum Teva:

• if the patient is allergic to the active substance, 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 nervous system disorders);
• 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) due to the risk of hemolysis in the case of oral administration of the medicine;
• if the patient has severe renal failure (oliguria, anuria) and/or kidney tissue infection;
• in newborns, infants, and children under 2 years of age.

Warnings and precautions

If the patient has the following circumstances, caution should be exercised when taking Furaginum Teva.

• If the patient experiences headaches, tinnitus, and nausea during treatment. To prevent these unpleasant sensations, the doctor may recommend taking an antihistamine.
• If nerve inflammation occurs during treatment. The doctor should prescribe vitamins from group B (niacinamide and thiamine). Such complications occurred during the use of Furaginum Teva for more than 2 weeks.
• If the patient has severe kidney function disorders (glomerular filtration rate below 30 ml/min).
• Nitrofuran drugs have an adverse effect on testicular function - the total number of sperm and ejaculate volume decrease, as well as sperm motility and changes in their structure.
• Alcohol should be avoided during treatment with furazidine. Concurrent use of furazidine with ethanol may cause a disulfiram-like effect. The following clinical symptoms may then occur: a feeling of heat, abdominal pain, nausea, vomiting, and tachycardia.

Furaginum Teva and other medicines

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

• Ristomycin, levomycetin, sulfonamides. They should not be taken concurrently with Furaginum Teva due to the risk of vascular system depression (reduced functional ability of the vascular system).
• Nalidixic acid. It should not be taken concurrently with Furaginum Teva due to their antagonism (opposite action).
• Other medicines used to treat urinary tract infections. Their effect is weaker when taken with Furaginum Teva.
• Concurrent use of vitamin B or increased salt intake enhances the absorption of the active substance of Furaginum Teva.
• Atropine slows down the absorption of furazidine, but the total amount of absorbed active substance remains unchanged.
• Antacids inhibit the absorption of furazidine.

Furaginum Teva with food and drink

The medicine should be taken during meals. A high-protein diet should be taken at the same time. The medicine should be taken with a large amount of liquid.
Alcohol should be avoided during treatment with Furaginum Teva.

Pregnancy and breastfeeding

Pregnancy
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor before taking this medicine.
Furaginum Teva should not be taken during the first trimester of pregnancy.
Breastfeeding
Before taking any medicine, the patient should consult a doctor or pharmacist.
Furaginum Teva can be taken during breastfeeding only if, in the doctor's opinion, the benefit to the mother outweighs the risk to the breastfed child. In such a case, the patient should consider stopping breastfeeding for some time.

Driving and operating machines

Furazidine does not affect the ability to drive vehicles and operate machines. However, some patients may experience side effects that can affect the ability to drive vehicles and operate machines (dizziness, drowsiness, vision disorders, see also section 4).

Furaginum Teva contains lactose monohydrate and sucrose

1 tablet contains 18.80 mg of lactose monohydrate and 10.00 mg of 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 as directed by the doctor. In case of doubts, the patient should consult a doctor or pharmacist.
Oral administration.
Furaginum Teva should be taken during meals. A high-protein diet should be taken at the same time. The medicine should be taken with a large amount of liquid.
Adults
On the first day of treatment: 400 mg per day in 4 divided doses (2 tablets every 6 hours);
in subsequent days: 300 mg per day in 3 divided doses (2 tablets every 8 hours). The treatment usually lasts 7-10 days. If necessary, the treatment can be repeated after 10-15 days.
Recurrent urinary tract infections in women
If a urinary tract infection has occurred at least 3 times in the last 12 months, Furaginum Teva is taken in a dose of 100 mg at night for 6-12 months.
Children
Furaginum Teva can be given to children aged 2-14 years. The following dosage regimen should be used.
Furaginum Teva should be taken in a dose of 5-7 mg/kg body weight per day in 2 divided doses. The medicine is taken for 7-8 days. If necessary, the treatment can be repeated after 10-15 days.

Care should be taken when giving the medicine to small children due to the risk of choking.

If the child has problems swallowing tablets, the medicine can be crushed and suspended in milk.

Use of a higher dose of Furaginum Teva than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult a doctor or pharmacist. There are no data on cases of Furaginum Teva poisoning. Toxicity symptoms may occur in patients with impaired renal excretory function (see section 4).
Procedure
If poisoning occurs during oral administration of the medicine, the patient should drink large amounts of liquid. To alleviate acute symptoms, antihistamines are used.

Missing a dose of Furaginum Teva

If one or more doses of the medicine are missed, the treatment should be continued with the previously taken doses. A double dose should not be taken to make up for the missed dose.
In case of any doubts related to the use of this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Furaginum Teva can cause side effects, although not everybody gets them.
If the following serious side effects occur, the patient should stop taking the medicine and immediately consult a doctor.
Side effects that occur rarely (in 1 to 10 out of 10,000 patients)

• anaphylactic reactions (life-threatening local or systemic allergic reactions), angioedema (a skin and subcutaneous tissue disease characterized by the formation of limited edema);
• severe skin reactions (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome - a blistering multiforme erythema);
• symptoms of drug-induced hepatitis, cholestatic jaundice (caused by an obstacle to bile flow) manifested by nausea, vomiting, loss of appetite, general malaise, fever, itching, and yellowing of the skin and eyes, pale stools, dark urine, liver necrosis (usually during long-term use).

Side effects that occur with an unknown frequency (cannot be determined based on available data):

• itching, urticaria, rash;
• hypersensitivity:
• asthmatic reaction (shortness of breath) in patients with asthma; hypersensitivity reactions affecting the respiratory system, including:
• acute reactions - manifested by fever, chills, cough, chest pain, shortness of breath, effusion into the pleural cavity, changes in the radiological image of the lungs, and eosinophilia - usually quickly resolving 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 appear; after detecting a side effect, the medicine should be discontinued immediately; lung function impairment may be irreversible;
• methemoglobinemia-induced cyanosis; in patients with glucose-6-phosphate dehydrogenase deficiency, the use of furazidine may lead to the development of megaloblastic or hemolytic anemia.
• headache, dizziness, drowsiness, vision disorders, peripheral nerve damage manifested by a sensation of tingling and pricking in the limbs (also of acute or irreversible course, especially in patients with renal function disorders, anemia, diabetes, electrolyte disturbances, or vitamin B deficiency);
• infections with microorganisms resistant to furazidine, fever, chills, malaise;
• pancreatitis

Other side effects:
Side effects that occur frequently (in 1 to 10 out of 100 patients):

• excessive gas;

Side effects that occur with an unknown frequency (cannot be determined based on available data):

• nausea, vomiting, constipation, diarrhea, symptoms of indigestion, abdominal pain, loss of appetite, salivary gland inflammation;
• hair loss (transient).

To prevent side effects, it is recommended to take the medicine with a large amount of liquid and concurrently take vitamins from group B and antihistamines.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Furaginum Teva

Store in a temperature below 25°C.
Store in the original packaging to protect from light.
The medicine should be stored out of sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging. The expiry date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Furaginum Teva contains

• The active substance of the medicine is furazidine, also known as furagin. 1 tablet contains 50 mg of furazidine.
• Other ingredients of the medicine are: lactose monohydrate, potato starch, sucrose, stearic acid, polysorbate 80.

What Furaginum Teva looks like and what the package contains

Yellow or orange-yellow tablets, round, with a uniform surface.
The package contains 30 tablets in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
Phone: (22) 345 93 00

Manufacturer

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Krakow
Date of leaflet approval:April 2022