Furagina Forte Apteo Med

Package Leaflet: Information for the User

Furagina FORTE APTEO MED, 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 directed 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 those 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, contact your doctor.

Table of Contents of the Leaflet

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

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

Furagina FORTE APTEO MED is a medicine in the form of tablets for oral administration. It contains the active substance furazidine, also known as furagin, which is a derivative of nitrofuran. Furazidine inhibits the growth of many bacteria that cause urinary tract infections.

2. Important information before taking Furagina FORTE APTEO MED

When not to take Furagina FORTE APTEO MED

• if you are allergic to furazidine or nitrofuran derivatives or to any of the other ingredients of this medicine (listed in section 6)
• in the first trimester of pregnancy
• during late pregnancy (from 38 weeks) and childbirth, due to the risk of hemolytic anemia in the newborn
• in children and adolescents under 15 years of age
• if you have peripheral neuropathy (e.g., diabetic neuropathy, a condition that can cause movement, sensory, or nervous system disorders)
• if you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (a genetic disorder that can lead to hemolysis and anemia)
• if you have renal failure (oliguria, anuria), and laboratory tests have shown a creatinine clearance of less than 60 ml/min or an elevated serum creatinine level

Warnings and precautions

Before starting treatment with Furagina FORTE APTEO MED, discuss with your doctor or pharmacist if you have:

• kidney problems
• liver problems
• nervous system disorders
• anemia
• electrolyte disturbances (changes in ion concentration in the blood), vitamin B and folic acid deficiency
• lung diseases. You should immediately stop taking Furagina FORTE APTEO MED and consult a doctor if
• you experience symptoms such as fever, chills, cough, chest pain, shortness of breath. This may be a pulmonary reaction, which can occur during treatment with nitrofuran derivatives (see also section 4)
• you experience neurological symptoms (tingling, numbness, sensation of electric currents). These may be symptoms of peripheral neuropathy, especially in diabetic patients, which in severe cases can be irreversible and life-threatening. The medicine should be stopped immediately and a doctor consulted
• you experience symptoms of liver dysfunction (jaundice, dark urine, pale stools, abdominal pain, nausea, vomiting, persistent fatigue, loss of appetite, and weight loss). Jaundice may occur during short-term use of nitrofurans (up to two weeks). Chronic hepatitis (sometimes leading to liver necrosis and reported cases of death) occurs during long-term use of nitrofurans (usually more than 6 months). If you are taking the medicine 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 glucose test results in urine. Before submitting a urine sample for such a test, inform the medical staff that you are 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 your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take

• Nitrofurans (including furazidine) should not be combined with chloramphenicol, ristomycin, levomycetin, sulfonamides (antibacterial medicines), as this may inhibit the activity of the hematopoietic system
• Furagin should not be used simultaneously with nalidixic acid and other quinolone derivatives, as antagonism (opposite action) is usually observed
• Aminoglycoside antibiotics and tetracyclines administered with furazidine enhance its antibacterial action
• Medicines that increase uric acid excretion, such as probenecid (in high doses) and sulfinpyrazone, reduce the tubular secretion of nitrofuran derivatives and may cause accumulation of furazidine in the body, increasing its toxicity and reducing the effectiveness of treatment
• Concomitant administration of alkalizing agents containing magnesium trisilicate inhibits the absorption of furazidine and reduces its antibacterial activity
• Atropine slows down the absorption of furagin, but the overall amount of absorbed active substance remains unchanged
• Antacids inhibit the absorption of furazidine
• Concomitant use of vitamin B increases the absorption of nitrofuran derivatives

Furagina FORTE APTEO MED with food, drinks, and alcohol

Furagina FORTE APTEO MED is best taken during meals containing protein, as this increases the absorption of the medicine.

Avoid consuming alcohol during treatment with furagin

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

Furagina FORTE APTEO MED should not be used during the first trimester of pregnancy or in late pregnancy (from 38 weeks) and childbirth, as furazidine may cause hemolytic anemia in the newborn.

Caution should be exercised when using the medicine during the last three months of pregnancy (III trimester)

Breastfeeding

Due to the penetration of furagin into breast milk, the medicine should not be used during breastfeeding

Fertility

In men of reproductive age - as shown by experimental studies and clinical observations of patients taking nitrofurans (as well as some antibiotics), these medicines may have an adverse effect on testicular function, as the total number of sperm and semen decreases, and changes in sperm structure and motility occur

Driving and using machines

There is no data on the effect of furagin on the ability to drive vehicles and operate machinery. However, some patients may experience dizziness, drowsiness, vision disturbances that can affect the ability to drive vehicles and operate machinery

Furagina FORTE APTEO MED contains 123 mg of lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine

3. How to take Furagina FORTE APTEO MED

Take this medicine exactly as described in the package leaflet for the patient or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The tablet can be divided into equal doses.

Oral administration. Furagina FORTE APTEO MED should be taken during meals. A diet rich in protein should be used at the same time. The medicine should be taken with a large amount of fluid.

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 taken for 7-8 days. If symptoms worsen or do not improve after 7-8 days, consult your doctor

Use in children and adolescents

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

Taking a higher dose of Furagina FORTE APTEO MED than recommended

If you have taken a higher dose of the medicine than recommended, consult your doctor or pharmacist immediately

Missing a dose of Furagina FORTE APTEO MED

If you have missed one or more doses of the medicine, continue treatment using the previously taken doses. Do not take a double dose to make up for the missed dose.

If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

If you have any further doubts about the use of this medicine, consult your doctor

4. Possible side effects

Like all medicines, Furagina FORTE APTEO MED can cause side effects, although not everybody gets them.

Among the side effects observed during clinical trials, the most common were: nausea (8%), headache (6%), and excessive gas (1.5%).

Stop taking the medicine immediately and consult a doctor or go to the nearest hospital if you experience:

• allergic reactions: rash, itching, urticaria, 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. Chronic reactions occurred in patients taking the medicine for more than 6 months. Chronic pulmonary reactions (including pulmonary fibrosis and interstitial pneumonia) may occur, especially in elderly patients. Acute hypersensitivity reactions affecting the respiratory system were characterized by fever, chills, cough, chest pain, and shortness of breath. 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. Early recognition of adverse reactions and discontinuation of the medicine are crucial. Pulmonary function impairment may be irreversible
• pseudomembranous colitis (severe small or large intestine disease characterized by diarrhea, headache, and fever)
• tingling, numbness, sensation of electric currents due to peripheral neuropathy (nerve damage), also with acute or irreversible course (the following conditions increase the risk of its occurrence: renal failure, anemia, diabetes, electrolyte disturbances, vitamin B deficiency)
• liver function disorders, symptoms of drug-induced hepatitis, cholestatic jaundice (caused by obstruction of bile flow), liver necrosis (see "Warnings and precautions" in section 2)

Additionally, the following side effects may occur

• cyanosis due to methemoglobinemia (blue discoloration of the skin with a chocolate-brown tint). In people with glucose-6-phosphate dehydrogenase deficiency, taking furagin may lead to the development of megaloblastic or hemolytic anemia
• dizziness, drowsiness, vision disturbances
• constipation, diarrhea, dyspeptic symptoms (chronic pain in the upper abdomen)
• abdominal pain, vomiting
• parotitis, pancreatitis
• alopecia, exfoliative dermatitis
• fever, chills, malaise
• infections with microorganisms resistant to nitrofuran derivatives, most often Pseudomonas or Candida

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products of 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: ndl@urpl.gov.pl

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help gather more information on the safety of the medicine

5. How to store Furagina FORTE APTEO MED

Store the medicine out of sight and reach of children.

There are no special recommendations for the storage temperature of the 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 given month.

Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment

6. Contents of the pack and other information

What Furagina FORTE APTEO MED contains

• The active substance of the medicine is furazidine, also known as furagin. One tablet contains 100 mg of furazidine (Furazidinum), previously used name: furagin
• The other ingredients are: lactose monohydrate, microcrystalline cellulose silanized with a composition of 98% microcrystalline cellulose and 2% anhydrous colloidal silica, magnesium stearate, anhydrous colloidal silica, sodium carboxymethylcellulose (type A)

What Furagina FORTE APTEO MED looks like and what the pack contains

Yellow, biconvex, round tablets with a dividing line on one side, 10 mm in diameter.

15 or 30 tablets in blisters, in a cardboard box

Marketing authorization holder

Synoptis Pharma Sp. z o.o.

ul. Krakowiaków 65

02-255 Warsaw

Manufacturer

Adamed Pharma S.A.

Pieńków

ul. M. Adamkiewicza 6A

• 05-152 Czosnów

Date of last revision of the leaflet:November 2018