Patient Information Leaflet

Furagina FORTE APTEO MED, 100 mg, tablets
Furazidinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7–8 days, or if you feel worse, you should contact your doctor.

Contents of the leaflet

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

1. What Furagina FORTE APTEO MED is and what it is used for

Furagina FORTE APTEO MED is a medicine presented in the form of oral tablets. It contains as the active substance furazidin, also known as furagin, which is a nitrofuran derivative. Furazidin inhibits the growth of many bacteria causing urinary tract infections.
Furagina FORTE APTEO MED is indicated for the treatment of lower urinary tract infections.

2. Important information before taking Furagina FORTE APTEO MED

When not to take Furagina FORTE APTEO MED

if the patient is allergic to furazidin or nitrofuran derivatives, or to any of the other ingredients of this medicine (listed in section 6)
during the first trimester of pregnancy
in full-term pregnancy (from week 38) and during delivery, due to the risk of haemolytic anaemia (anaemia associated with the breakdown of red blood cells) in the newborn
in children and adolescents under 15 years of age
if the patient has peripheral neuropathy, e.g. diabetic neuropathy (a condition involving damage to the peripheral nerves, which may be characterized by motor, sensory or other neurological disturbances)
if the patient has glucose-6-phosphate dehydrogenase deficiency (a genetic disorder involving deficiency of an enzyme involved in red blood cell metabolism), as the medicine may cause haemolysis (destruction of red blood cells and anaemia)
if the patient has renal failure (oliguria, anuria), and laboratory tests show creatinine clearance below 60 ml/min or elevated serum creatinine levels

Warnings and precautions
Before starting treatment with Furagina FORTE APTEO MED, consult a doctor or pharmacist if the patient has:

impaired kidney function,
impaired liver function,
nervous system disorders,
anaemia,
electrolyte imbalances (changes in blood ion concentrations), deficiency of B vitamins or folic acid,
lung diseases.

Immediately discontinue use of Furagina FORTE APTEO MED and seek medical advice if:

the patient develops symptoms such as fever, chills, cough, chest pain, or shortness of breath. These may be pulmonary reactions, which may occasionally occur during treatment with nitrofuran derivatives (see also section 4).
the patient develops neurological symptoms (tingling, numbness, sensation of electric currents). These may indicate peripheral nerve damage (peripheral neuropathy), especially in diabetic patients, which in severe cases may be irreversible and life-threatening. The medicine should be immediately discontinued and medical advice sought.
the patient develops symptoms of impaired liver function (yellowing of the whites of the eyes, skin or mucous membranes, dark urine, itching, pale stools, abdominal pain, nausea, vomiting, persistent fatigue, loss of appetite, weight loss). Jaundice may occur during short-term use of nitrofurans (within two weeks). Chronic hepatitis (sometimes leading to liver necrosis – fatal cases have been reported) may occur during prolonged treatment with nitrofurans (usually after more than 6 months). If the medicine is used long-term, blood tests may be necessary to monitor white blood cell count and 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 the patient is taking Furagina FORTE APTEO MED.

Children and adolescents
Furagina FORTE APTEO MED should not be used in children and adolescents under 15 years of age.

Furagina FORTE APTEO MED and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Nitrofurans (including furazidin) should not be combined with chloramphenicol, ristomycin, chloramphenicol, or sulfonamides (antibacterial agents), as this may suppress haematopoietic function.
Concomitant use of nalidixic acid and other quinolone derivatives with furazidin should be avoided, as antagonism (opposing effects) is usually observed.
Aminoglycoside antibiotics and tetracyclines, when administered together with furazidin, enhance its antibacterial effect.
Drugs that increase uric acid excretion, such as probenecid (at high doses) and sulfinpyrazone, reduce tubular secretion of nitrofuran derivatives and may cause accumulation of furazidin in the body, increasing its toxicity and reducing treatment efficacy.
Concurrent administration of alkalizing agents containing magnesium trisilicate inhibits absorption of furazidin and reduces its antibacterial activity.
Atropine slows down absorption of furazidin, although the total amount of absorbed active substance remains unchanged.
Medicines that neutralize gastric acid inhibit absorption of furazidin.
Concurrent intake of B vitamins increases absorption of nitrofuran derivatives.

Furagina FORTE APTEO MED, food, drink and alcohol
Furagina FORTE APTEO MED should preferably be taken with meals containing protein, as this enhances absorption of the medicine.
Alcohol consumption should be avoided during treatment with furazidin.

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

Pregnancy
Furagina FORTE APTEO MED should not be used during the first trimester of pregnancy or in women during full-term pregnancy (from week 38) and during delivery, as furazidin may cause haemolytic anaemia in the newborn. Particular caution is advised during the last three months of pregnancy (third trimester).

Breastfeeding
Due to passage of furazidin into breast milk, the medicine should not be used during breastfeeding.

Fertility
In men of reproductive age – experimental studies and clinical observations in patients treated with nitrofurans (as well as certain other antibiotics) have shown that these medicines may adversely affect testicular function, leading to reduced total sperm and semen volume, decreased sperm motility, and structural changes in sperm.

Driving and operating machinery
There is no data on the effect of furazidin on the ability to drive or operate machinery. However, in some patients, dizziness, drowsiness or visual disturbances may occur, which could affect the ability to drive or operate machinery.

Furagina FORTE APTEO MED contains 123 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 Furagina FORTE APTEO MED
This medicine should always be taken exactly as described in the patient information leaflet or as directed by the doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
The tablet may be divided into equal doses.
Oral administration. Furagina FORTE APTEO MED should be taken with meals. At the same time, a protein-rich diet should be followed. The medicine should be taken with plenty of fluids.

Recommended dose
Adults and adolescents over 15 years of age
First day of treatment: 400 mg per day in 4 divided doses (1 tablet every 6 hours);
subsequent days of treatment: 300 mg per day in 3 divided doses (1 tablet every 8 hours).
The medicine is usually administered for 7–8 days. If symptoms worsen or do not improve after 7–8 days, consult a doctor.

Use in children and adolescents
The medicine should not be used in children and adolescents under 15 years of age.

Taking more than the recommended dose of Furagina FORTE APTEO MED
In case of overdose, seek immediate medical advice from a doctor or pharmacist.

Missed dose of Furagina FORTE APTEO MED
If one or more doses have been missed, continue treatment with the previously prescribed doses. Do not take a double dose to make up for a missed dose.

If the effect of the medicine seems too strong or too weak, consult a doctor.
In case of any further doubts regarding the use of this medicine, consult a doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.
The most commonly observed adverse reactions during clinical trials, considered to be probably related
to the use of this medicine, were: nausea (8%), headache (6%), and excessive flatulence (1.5%).
The remaining adverse reactions listed below occurred in no more than 1% of patients.
You should immediately stop using this medicine and contact your doctor or go to
the nearest hospital if any of the following occur:

allergic reactions: rash, itching, urticaria, anaphylactic reactions (sudden local or systemic allergic reactions, including life-threatening anaphylactic shock), angioedema (a severe allergic reaction – sudden swelling of the face, limbs or joints without itching or pain). Swelling in the head and neck area may cause difficulties in swallowing and breathing;
severe skin reactions (exfoliative dermatitis, erythema multiforme – red-blue skin lesions and (or) mucosal lesions, 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; fever, muscle and joint pain often occur simultaneously);
acute, subacute and chronic hypersensitivity reactions to nitrofuran derivatives. 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, and pleural effusion. These reactions most often resolved quickly or very quickly after discontinuation of the medicine. In cases 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 reactions and prompt discontinuation of the medicine are crucial. Impaired lung function may be irreversible;
pseudomembranous colitis (a serious disease of the small or large intestine characterized by diarrhoea, headache and fever);
tingling, numbness, sensation of electric shocks due to peripheral neuropathy (damage to peripheral nerves), including acute or irreversible forms (patients predisposed to this include those with renal failure, anaemia, diabetes, electrolyte disturbances, or vitamin B deficiency);
liver function disorders, symptoms of drug-induced hepatitis, cholestatic jaundice (caused by obstruction of bile flow), hepatic parenchymal necrosis (see symptoms under “Warnings and precautions” in section 2).

Additionally, the following adverse reactions may occur:

cyanosis due to methemoglobinemia (skin discoloration with a chocolate-brown hue). In patients with glucose-6-phosphate dehydrogenase deficiency, the use of furazidin may lead to megaloblastic anaemia (caused by vitamin B or folic acid deficiency) or hemolytic anaemia (caused by rapid destruction of red blood cells);
dizziness, drowsiness, visual disturbances;
constipation, diarrhoea, dyspeptic symptoms (chronic epigastric pain);
abdominal pain, vomiting;
sialadenitis, pancreatitis;
alopecia, exfoliative dermatitis;
fever, chills, malaise;
infections with microorganisms resistant to nitrofuran derivatives, most commonly Pseudomonas species or Candida species.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, you should inform your doctor, pharmacist, or nurse. Adverse reactions
can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 4921 301
Fax: +48 22 4921 309
e-mail: [email protected]
Adverse reactions can also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Furagina FORTE APTEO MED

Keep the medicine out of the sight and reach of children.
There are no special storage temperature requirements for this medicine.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Furagina FORTE APTEO MED contains

The active substance is furazidin, also known as furagine. Each tablet contains 100 mg of furazidin (Furazidinum); former name: furagine.
Other ingredients are: lactose monohydrate, microcrystalline cellulose with silica composed of: microcrystalline cellulose 98% and colloidal anhydrous silica 2%, magnesium stearate, colloidal anhydrous silica, sodium carboxymethyl starch (type A).

What Furagina FORTE APTEO MED looks like and contents of the pack
Yellow, biconvex, round tablets, 10 mm in diameter, with a score line on one side.
15 or 30 tablets in blister packs, packed in a cardboard box.
Marketing Authorization Holder
Synoptis Pharma Sp. z o.o.
Krakowiaków Street 65
02-255 Warsaw
Manufacturer
Adamed Pharma S.A.
Pieńków
M. Adamkiewicza Street 6A
05-152 Czosnów