Patient Information Leaflet

Dafurag max, 100 mg, tablets
Furazidinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

This medicine should always be taken exactly as described in this patient information leaflet or as directed by the doctor or pharmacist.
Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7–8 days, or if your condition worsens, consult your doctor.

Contents of the leaflet

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

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

Dafurag max is an antibacterial medicine containing the active substance furazidinum, also known as furagin, which is a nitrofuran derivative. Furazidinum inhibits the growth of bacteria causing urinary tract infections.
Dafurag max is indicated for the treatment of lower urinary tract infections.
If there is no improvement after 7–8 days, or if your condition worsens, consult your doctor.

2. Important information before taking Dafurag max

When not to take Dafurag max:

if the patient is allergic to nitrofurantoin 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 during childbirth, due to the risk of haemolytic anaemia in the newborn (anaemia associated with the breakdown of red blood cells);
in children and adolescents under 15 years of age;
if the patient has severe renal impairment (oliguria, anuria);
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 medicine may cause breakdown of red blood cells (haemolysis), which in turn may lead to development of haemolytic anaemia (anaemia caused by excessive breakdown of red blood cells).

Warnings and precautions
Before starting treatment with Dafurag max, discuss this with your doctor or pharmacist.

If the patient has impaired kidney or liver function, neurological disorders, anaemia, electrolyte disturbances, deficiency of B-complex vitamins, folic acid deficiency, or lung diseases;
if the patient has diabetes, as nitrofurantoin 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, Dafurag max should be discontinued if neurological symptoms occur (tingling, numbness, sensation of electric shocks);
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 medicine. In case of chronic reactions, the severity of symptoms and their reversibility 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 medicine are crucial. Impaired lung function may become irreversible. Chronic reactions have been reported in patients treated with nitrofurantoin for longer than 6 months. Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonia) may occur especially in elderly patients;
if the medicine is used long-term – blood tests may then be necessary to monitor white blood cell count as well as 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 testing, inform medical personnel 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
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for use.
Exercise particular caution when using the following medicines concomitantly:

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

Dafurag max with food and drink
Dafurag max should preferably be taken with protein-rich meals, as this enhances absorption of the medicine.

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

Pregnancy
Due to lack of clinical data on harmful effects of nitrofurantoin on the embryo or foetus, the medicine should not be used during the first trimester of pregnancy.
Due to the risk of causing haemolytic anaemia in the foetus, particular caution should be exercised in women during the third trimester of pregnancy.
The patient, in consultation with her attending physician, should regularly undergo blood morphology tests (haemoglobin concentration, iron levels, and red blood cell count – erythrocytes).

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

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

Driving and operating machinery
There is no data available on the effect of nitrofurantoin on the ability to drive or operate machinery.
If dizziness, drowsiness, or visual disturbances occur, do not drive or operate machinery.

Dafurag max contains lactose
Each Dafurag max tablet contains 118 mg of monohydrate lactose. 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 take Dafurag max

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Take the medicine orally, preferably with meals containing protein.
Recommended dose
Adults and adolescents over 15 years of age
First day of treatment: 1 tablet four times daily;
subsequent days of treatment: 1 tablet three times daily.
The medicine should be taken for 7–8 days. If symptoms worsen or do not improve after 7–8 days, consult your doctor.
Use in children and adolescents
Dafurag max must not be used in children and adolescents under 15 years of age.
Taking more than the recommended dose of Dafurag max
Due to the excretion of the medicine via the kidneys, the risk of overdose is increased in patients with impaired renal function. Symptoms may include: headache, dizziness, allergic reactions, nausea, anemia. If such symptoms occur, consult your doctor immediately.
Missed dose of Dafurag max
Do not take a double dose to make up for a missed dose.
Stopping treatment with Dafurag max
Interrupting treatment with Dafurag max during therapy may result in failure to cure the lower urinary tract infection.
If you have any further questions about 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 experiences them.
You should stop taking this medicine immediately and contact a doctor or go to the
nearest hospital if any of the following occur: (occurring in no more than 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 in 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 – occurrence of blisters on the skin and/or mucous membranes which, when ruptured, form painful sores, often accompanied by fever, muscle 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 were manifested by fever, chills, cough, chest pain, dyspnea, pleural effusion, radiological changes in the lungs and eosinophilia. These 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. Impairment of lung function may be irreversible.
pseudomembranous colitis (a severe disease of the small or large intestine characterized by diarrhea, headache and fever);
itching, rash (itchy red bumps on the skin), urticaria (pinkish, itchy wheals on the skin);

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

nausea, excessive flatulence;
headache.

Not more frequently than in 1 in 100 patients:

drug-induced hepatitis symptoms, cholestatic jaundice (caused by obstruction of bile flow), liver necrosis;
dizziness, somnolence;
visual disturbances;
peripheral nerve damage (including acute or irreversible forms, especially in patients with impaired renal function, anemia, diabetes, electrolyte imbalances or vitamin B deficiency);
acute, subacute and chronic hypersensitivity reactions to nitrofuran derivatives affecting the respiratory system. Chronic reactions occurred in patients treated for longer than 6 months.
vomiting;
constipation, diarrhea;
dyspeptic symptoms, abdominal pain;
sialadenitis;
pancreatitis;
alopecia;
infections with microorganisms resistant to furazidin;
fever;
chills;
malaise;
blue-brownish discoloration of the skin;
megaloblastic anemia (due to 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 those not listed
in this leaflet, you should inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Dafurag max

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

6. Contents of the pack and other information

What Dafurag max contains

The active substance is furazidin, also known as furagin. One tablet contains 100 mg of furazidin.
The other ingredients are: mannitol; lactose monohydrate; talc; colloidal anhydrous silica; sodium carboxymethyl starch (type A); magnesium stearate.

What Dafurag max looks like and contents of the pack
Dafurag max is a yellow, elongated, oval, biconvex tablet.
The tablets are packed in blisters and cardboard boxes.
The pack contains 15 or 30 tablets.
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. Szkolna 31
95-054 Ksawerów