Dafurag

Package leaflet: Information for the patient

Dafurag, 10 mg/mL, oral suspension
Furazidinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• 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. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Dafurag is and what it is used for

Dafurag is an antibacterial medicine used in urinary tract infections. The medicine contains
the active substance – furazidin, also known as furagin, which is a nitrofuran derivative. Furazidin
inhibits the growth of bacteria causing urinary tract infections.
Dafurag is not effective against infections caused by Pseudomonas aeruginosa bacteria and is ineffective against most strains of Proteus vulgaris.
Indications
Treatment of acute and chronic uncomplicated lower urinary tract infections caused by
Escherichia coli bacteria in children and adults.

2. Important information before taking Dafurag

When not to take Dafurag

• if the patient is allergic to furazidin 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 full-term pregnancy (from week 38) and childbirth, due to the risk of hemolytic anemia (breakdown of red blood cells) in the newborn;
• in children under 3 months of age;
• if the patient has renal failure;
• if the patient has diagnosed polyneuropathy, e.g. diabetic neuropathy (nerve damage caused by elevated blood glucose levels);
• if the patient has glucose-6-phosphate dehydrogenase deficiency – the drug may cause breakdown of red blood cells (hemolysis), which in turn may lead to development of hemolytic anemia.

Warnings and precautions
Before starting treatment with Dafurag, discuss the following with your doctor or pharmacist:

• if the patient has impaired kidney or liver function, neurological disorders, anemia, electrolyte disturbances, vitamin B deficiency, folic acid deficiency, or lung diseases, or if the patient has 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, this 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. These symptoms usually resolve quickly or very quickly after discontinuation of the drug. In the case of chronic reactions, the severity and reversibility of symptoms 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 drug are crucial. Impaired lung function may be irreversible. Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonia) have occurred in patients treated with furazidin for longer than 6 months, particularly in elderly patients;
• if the medicine is used long-term – the doctor will recommend blood tests and monitor kidney and liver function.

Effect on laboratory tests
The medicine may cause false positive results in urine glucose tests. Before submitting a urine sample for such testing, inform medical personnel that you are taking Dafurag.

Children
Dafurag may be used in children over 3 months of age.

Dafurag and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Exercise particular caution when using the following medicines concomitantly:

• quinolone derivatives (e.g. nalidixic acid – an antibiotic) – furazidin may inhibit their antibacterial action;
• probenecid and sulfinpyrazone (medicines used in the treatment of gout) – may reduce the efficacy of furazidin and increase its toxicity;
• aminoglycoside and tetracycline antibiotics – when administered together with furazidin, they enhance its antibacterial effect;
• chloramphenicol and ristomycin (antibiotics) – increase the hematotoxic effects of furazidin;
• antacids containing magnesium trisilicate – reduce the absorption of furazidin, thereby weakening its antibacterial effect;
• atropine (a spasmolytic and pupil-dilating agent) – may delay absorption of furazidin, but the total amount absorbed does not change;
• vitamin B complex – increase the absorption of nitrofuran derivatives.

Dafurag with food and drink
Dafurag should preferably be taken with meals containing protein, as this enhances the absorption of furazidin.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to conceive, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Due to lack of clinical data on the harmful effects of furazidin 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, particular caution should be exercised in the third trimester of pregnancy.
The patient, in consultation with her doctor, should regularly undergo blood morphology tests (hemoglobin, iron levels, and red blood cell count – erythrocytes).
The medicine must not be used from week 38 of pregnancy or during childbirth due to the risk of hemolytic anemia (breakdown of red blood cells) in the newborn.

Breastfeeding
The medicine passes into human milk; therefore, it should not be used during breastfeeding.

Fertility
Clinical studies have shown that nitrofuran derivatives have a negative effect on testicular function. The medicine may reduce sperm motility, decrease semen secretion, and lead to pathological changes in sperm morphology.

Driving and using machines
There are no data on the effect of furazidin on the ability to drive or operate machinery.
If neurological disturbances occur, such as dizziness, drowsiness, or visual disturbances (see section 4), the patient should not drive or operate machinery.

Dafurag contains sucrose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, macrogol glycerol ricinoleate, ethanol, d-limonene, and linalool

Sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
1 mL of the medicine contains 476 mg of sucrose. This should be taken into account in patients with diabetes.

Methyl parahydroxybenzoate and propyl parahydroxybenzoate
The medicine contains 2.142 mg of methyl parahydroxybenzoate and 0.238 mg of propyl parahydroxybenzoate per 1 mL of suspension. The medicine may cause allergic reactions (possible delayed-type reactions).

Macrogol glycerol ricinoleate
The medicine contains 1.19 mg of macrogol glycerol ricinoleate per 1 mL of suspension. The medicine may cause indigestion and diarrhea.

Ethanol
This medicine contains 44 mg of alcohol (ethanol) in each 10 mL of suspension, equivalent to 0.44% (w/v). The amount of alcohol in 10 mL of this medicine is equivalent to less than 2 mL of beer or 1 mL of wine.
The small amount of alcohol in this medicine will not cause noticeable effects.

D-limonene and linalool
The medicine contains d-limonene and linalool, which may cause allergic reactions.

3. How to take Dafurag

This medicine should always be taken as directed by the physician. In case of doubt, consult your doctor.
Take the medicine orally, preferably with meals containing protein.
Before each use, shake the bottle for at least 30 seconds.
An oral syringe is provided with the package to facilitate dosing. After each use, the dosing device should be washed and dried.
Recommended dose
Adults
First day of treatment: 10 mL four times daily,
subsequent days of treatment: 10 mL three times daily.
Children over 3 months of age
5–7 mg/kg body weight per day in 2–3 divided doses.
The medicine should be used for 7–8 days. If necessary, the doctor may recommend repeating the treatment after 10–15 days.
Use in children
This medicine can be used in children over 3 months of age.
Taking more Dafurag than recommended
Due to the renal excretion of the medicine, the risk of overdose is increased in patients with impaired kidney function. Symptoms of overdose may include: headache, dizziness, allergic reactions, nausea, vomiting, anemia.
If such symptoms occur, seek medical advice immediately.
Missed dose of Dafurag
Do not take a double dose to make up for a missed dose.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should stop taking this medicine immediately and contact a doctor or go to the
nearest hospital if any of the following occur (less frequently than in 1 in 100 patients):

• 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 or pain). Swelling in the head and neck area may 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 appearing on the skin and/or mucous membranes which, when ruptured, form painful sores, often accompanied by fever, muscle pain, and joint pain);
• Acute, subacute, and chronic hypersensitivity reactions to nitrofuran derivatives affecting the respiratory system. Chronic reactions occurred in patients treated for longer than 6 months. Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonia) may occur especially in elderly patients. Acute respiratory hypersensitivity reactions presented with fever, chills, cough, chest pain, dyspnea, pleural effusion, radiological abnormalities in the lungs, and eosinophilia. These acute reactions usually resolved quickly or very quickly after discontinuation of the drug. In the case of chronic reactions, the severity of symptoms and their reversibility after stopping the drug depend on how long treatment was continued after the first adverse symptoms appeared. Prompt recognition of the adverse reaction and discontinuation of the drug are crucial. Impaired lung function may become irreversible;
• Pseudomembranous colitis (a severe disease of the large intestine characterized by diarrhea, headache, and fever);
• Itching, rash (itchy red bumps on the skin), urticaria (pinkish, itchy blisters on the skin);
• Cyanosis due to methemoglobinemia (abnormal hemoglobin pigment in red blood cells that has lost its ability to bind and transport oxygen), resulting in chocolate-brown discoloration of the skin.

In addition, the following adverse effects may occur
Common (occur in 1 to 10 out of 100 people):

• Nausea, excessive flatulence;
• Headache.

Not more frequent than in 1 in 100 patients:

• Drug-induced hepatitis symptoms, cholestatic jaundice (caused by obstruction of bile flow), liver necrosis;
• Dizziness, drowsiness;
• Visual disturbances;
• Peripheral nerve damage (including acute or irreversible forms, especially in patients with impaired kidney function, anemia, diabetes, electrolyte imbalances, or vitamin B deficiency);
• Constipation, diarrhea;
• Dyspeptic symptoms, abdominal pain, vomiting;
• Sialadenitis (inflammation of the salivary glands);
• Pancreatitis;
• Alopecia (hair loss);
• Infections caused by microorganisms resistant to furazidin;
• Fever, chills, malaise;
• Megaloblastic anemia (caused by vitamin B or folic acid deficiency) or hemolytic anemia (caused by rapid destruction of red blood cells)—may occur in individuals with glucose-6-phosphate dehydrogenase deficiency.

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 the Department of Monitoring Adverse Reactions of Medicinal Products at 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 directly to the marketing authorization holder.
Reporting adverse reactions helps to collect more information on the safety of using the medicine.

5. How to store Dafurag

Keep this medicine out of sight and reach of children.
Store below 25°C. Do not store in the refrigerator, do not freeze.
Do not use this medicine after the expiry date stated on the label and on the carton.
The expiry date refers to the last day of the stated month.
The shelf life after first opening the bottle is 3 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer require. This will help protect the environment.

6. Contents of the packaging and other information

What Dafurag contains

• The active substance is furazidin, also known as furagin. 1 mL of oral suspension contains 10 mg of furazidin.
• The other ingredients are: sucrose, glycerol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), macrogol glycerol ricinoleate, hydroxypropylcellulose, xanthan gum, natural orange flavour 72VP (orange oil, ethanol, d-limonene, linalool), purified water.

What Dafurag looks like and contents of the pack
Dafurag is a yellow oral suspension with an orange taste.
The cardboard box contains a brown glass bottle with 140 mL of suspension, closed with a white aluminium screw cap, and an oral syringe graduated in 0.1 mL increments.

Marketing Authorisation 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. Krzywa 2
95-030 Rzgów