Dafurag Max

Package Leaflet: Information for the Patient

Dafurag max, 100 mg, tablets

Furazidinum

Read the package leaflet carefully before taking the medicine, as it contains

important information for the patient.

• This medicine should always be taken exactly as described in the package leaflet for the patient or as advised by a doctor or pharmacist.
• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including any not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If after 7-8 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

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

1. What is Dafurag max and what is it used for

Dafurag max is an antibacterial medicine containing the active substance – furazidine, also known as furagin, which is a derivative of nitrofuran. Furazidine inhibits the growth of bacteria that cause urinary tract infections.
The indication for the use of Dafurag max is lower urinary tract infection.
If after 7-8 days there is no improvement or you feel worse, you should contact your doctor.

2. Important information before taking Dafurag max

When not to take Dafurag max:

• if you are allergic to furazidine or any of the other ingredients of this medicine (listed in section 6) or to nitrofuran derivatives;
• during the first three months of pregnancy;
• during late pregnancy (from the 38th week) and childbirth, due to the risk of hemolytic anemia in the newborn (anemia related to the breakdown of red blood cells);
• in children and adolescents under 15 years of age;
• if you have severe kidney failure (oliguria, anuria);
• if you have diagnosed polyneuropathy, e.g. diabetic (nerve damage caused by high blood sugar levels);
• if you have a deficiency of glucose-6-phosphate dehydrogenase - the medicine may cause red blood cell breakdown (hemolysis), which in turn can cause the development of hemolytic anemia (anemia caused by excessive breakdown of red blood cells).

Warnings and precautions

Before starting to take Dafurag max, you should discuss it with your doctor or pharmacist.

• If you have kidney, liver, or nervous system disorders, anemia, electrolyte disturbances, vitamin B deficiency, folic acid deficiency, or lung disease;
• if you have diabetes, as furazidine may cause nerve damage. Peripheral nerve damage has been observed in patients treated with nitrofuran derivatives. This condition can be irreversible and life-threatening in severe cases. Therefore, Dafurag max should be discontinued if symptoms from the nervous system occur (tingling, numbness, sensation of electric currents);
• if you have a 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. These symptoms usually resolve quickly or very quickly after discontinuation of the medicine. In the case of chronic reactions, 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. The key issue is the earliest possible recognition of the adverse reaction and discontinuation of the medicine. Pulmonary function impairment may be irreversible. Chronic reactions occurred in patients taking furazidine for more than 6 months. Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonia) may occur, especially in elderly patients;
• if the medicine is used for a long time - blood tests may be necessary to monitor the white blood cell count and kidney and liver function. Effect on laboratory tests The medicine may cause false-positive glucose test results in urine. Before submitting a urine sample for such a test, you should inform the medical staff that you are taking Dafurag max.

Children and adolescents

Dafurag max should not be used in children and adolescents under 15 years of age.

Dafurag max and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take.
Be particularly careful when taking the following medicines:

• quinolone derivatives (e.g. nalidixic acid - an antibiotic) - furazidine may inhibit their antibacterial activity;
• probenecid and sulfinpyrazone (medicines used to treat gout) - may weaken the effect of furazidine and increase its toxicity;
• aminoglycoside and tetracycline antibiotics - when given with furazidine, they enhance its antibacterial activity;
• chloramphenicol and ristomycin (antibiotics) - increase the toxic effect of furazidine;
• antacids containing magnesium trisilicate, as they reduce the absorption of furazidine, which weakens its antibacterial activity;
• atropine (a spasmolytic and mydriatic agent) - may delay the absorption of furazidine, but the overall amount of absorbed substance does not change;
• vitamin B - increases the absorption of nitrofuran derivatives.

Dafurag max with food and drink

Dafurag max is best taken during meals containing protein, as it increases the absorption of the medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Due to the lack of clinical data on the harmful effects of furazidine on the embryo or fetus, the medicine should not be used during the first trimester of pregnancy.
Due to the risk of causing hemolytic anemia in the fetus, special caution should be exercised in women in the third trimester of pregnancy.
The patient, in agreement with the attending physician, should regularly perform blood morphology tests (hemoglobin concentration, iron, and red blood cell count - erythrocytes).
Breastfeeding
The medicine passes into breast milk, so it should not be used during breastfeeding.
Fertility
Clinical studies have shown that nitrofuran derivatives have a negative effect on testicular function.
They can cause a decrease in sperm motility, reduce sperm secretion, and lead to pathological changes in sperm morphology.

Driving and using machines

There is no data on the effect of furazidine on the ability to drive and use machines.
If you experience dizziness, drowsiness, and vision disturbances, do not drive or operate machines.

Dafurag max contains lactose

Each Dafurag max tablet contains 118 mg of lactose monohydrate. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Dafurag max

This medicine should always be taken exactly as described in the package leaflet for the patient or as advised by a doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Take the medicine orally, preferably during meals containing protein.

Recommended dose

Adults and adolescents over 15 years of age
First day of treatment: 1 tablet 4 times a day;
subsequent days of treatment: 1 tablet 3 times a day.
The medicine is used for 7-8 days. If symptoms worsen or do not improve after 7-8 days, you should contact your doctor.

Use in children and adolescents

Dafurag max should not be used in children and adolescents under 15 years of age.

Taking a higher dose of Dafurag max than recommended

Due to the excretion of the medicine from the body by the kidneys, the risk of overdose is increased in patients with impaired kidney function. Symptoms such as headache, dizziness, allergic reactions, nausea, anemia may occur. If such symptoms occur, you should immediately contact your doctor.

Missing a dose of Dafurag max

Do not take a double dose to make up for a missed dose.

Stopping treatment with Dafurag max

Stopping treatment with Dafurag max during the course of treatment may result in failure to cure the lower urinary tract infection.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

You should stop taking this medicine and inform your doctor or go to the

nearest hospital immediately if you experience:(less common, may affect up to 1 in 100 people)

• anaphylactic reactions (sudden local or systemic allergic reactions, 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 can cause difficulty swallowing and breathing.
• severe skin reactions (exfoliative dermatitis, erythema multiforme - red-purple spots on the skin and/or mucous membranes, sometimes with blisters, fever, and joint pain, Stevens-Johnson syndrome - blisters on the skin and/or mucous membranes that form painful sores after rupture, often accompanied by fever, muscle and joint pain);
• acute, subacute, and chronic reactions to nitrofuran derivatives related to the respiratory system. Chronic reactions occurred in patients taking the medicine for more than 6 months. Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonia) may occur, especially in elderly patients. Acute reactions to the respiratory system were 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. They usually resolved quickly or very quickly after discontinuation of the medicine. In the case of chronic reactions, 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. The key issue is the earliest possible recognition of the adverse reaction and discontinuation of the medicine. Pulmonary function impairment may be irreversible.
• pseudomembranous colitis (severe disease of the small or large intestine, manifested by diarrhea, headache, and fever);
• itching, rash (itchy, red bumps on the skin), urticaria (light red, itchy blisters on the skin);

Additionally, the following side effects may occur

Common(affects 1 to 10 users in 100):

• nausea, excessive gas;
• headache.

Less common (may affect up to 1 in 100 people)

• symptoms of drug-induced hepatitis, cholestatic jaundice (caused by an obstacle to bile flow), liver necrosis;
• dizziness, drowsiness;
• vision disturbances;
• peripheral nerve damage (also with acute or irreversible course, especially in patients with impaired kidney function, anemia, diabetes, electrolyte disturbances, or vitamin B deficiency);
• acute, subacute, and chronic reactions to nitrofuran derivatives related to the respiratory system. Chronic reactions occurred in patients taking the medicine for more than 6 months.
• vomiting,
• constipation, diarrhea;
• symptoms of indigestion, abdominal pain;
• salivary gland inflammation;
• pancreatitis;
• hair loss;
• infections with microorganisms resistant to furazidine;
• fever;
• chills;
• malaise;
• blue-gray skin discoloration;
• megaloblastic anemia (resulting from a deficiency of vitamin B or folic acid) or hemolytic anemia (caused by rapid breakdown of red blood cells) - may occur in people with a deficiency of glucose-6-phosphate dehydrogenase.

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance 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
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dafurag max

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the blister pack after: EXP and carton after: Expiry Date (EXP). The expiry date stated on the packaging refers to the last day of the given month.
The word Lot on the blister pack means batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Dafurag max contains

• The active substance of the medicine is furazidine, also known as furagin. 1 tablet contains 100 mg of furazidine.
• The other ingredients are: mannitol; lactose monohydrate; talc; colloidal silica anhydrous; sodium carboxymethylcellulose (type A); magnesium stearate.

What Dafurag max looks like and contents of the pack

The medicine is in the form of an oval, biconvex tablet, yellow in color.
The tablets are packaged in blisters and a cardboard box.
The pack contains 15 or 30 tablets.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów
Date of last revision of the leaflet:22.06.2020