Furaginum Adamed

Package Leaflet: Information for the Patient

FURAGINUM ADAMED, 50 mg, tablets

Furazidinum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and is intended for your use only. Do not give it to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Furaginum Adamed and what is it used for

The active substance of Furaginum Adamed is furazidine, also known as furagin, an antibacterial medicine used in urinary tract infections. Most bacteria that cause urinary tract infections are sensitive to the action of furazidine. Furaginum Adamed is not effective in infections caused by Pseudomonas aeruginosa.
Indications:
Treatment of acute and chronic uncomplicated lower urinary tract infections caused by Escherichia coli.

2. Important information before taking Furaginum Adamed

When not to take Furaginum Adamed:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6) or to nitrofuran derivatives,
• if you are in the first trimester of pregnancy (first 3 months of pregnancy),
• in case of severe renal impairment (oliguria, anuria),
• in case of diagnosed polyneuropathy, e.g. diabetic (nerve damage, e.g. due to elevated blood glucose levels),
• in case of glucose-6-phosphate dehydrogenase deficiency, as the medicine may cause hemolysis (red blood cell damage and anemia).

Warnings and precautions

Before starting treatment with Furaginum Adamed, discuss it with your doctor or pharmacist.
During treatment with the medicine, be cautious:

• in patients with renal impairment, anemia, vitamin B and folic acid deficiency, and lung diseases, as the medicine may cause red blood cell destruction (erythrocytes),
• in diabetic patients, as nitrofuran derivatives may cause symptoms of polyneuropathy (nerve damage),
• in men of reproductive age, as clinical studies have shown that nitrofuran derivatives have a negative effect on testicular function. They may cause decreased sperm motility, decreased sperm secretion, and abnormalities in sperm structure. During long-term use of the preparation, the doctor will recommend blood tests and determination of biochemical parameters of kidney and liver function.

Children and adolescents

Furaginum Adamed can be used in children over 2 years of age.
In children under 2 years of age, the dose should be determined directly by the doctor.

Furaginum Adamed and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

• Furazidine is an antagonist of nalidixic acid, inhibiting its bacteriostatic action.
• Medicines that increase the excretion of uric acid in the urine, such as probenecid (in high doses) and sulfinpyrazone, reduce the tubular secretion of furazidine and may cause its accumulation in the body, increasing its toxicity and reducing its concentration in the urine below the minimum bacteriostatic concentration, and consequently reducing its therapeutic effectiveness.
• Aminoglycoside antibiotics and tetracyclines given with furazidine enhance its antibacterial action.
• Chloramphenicol and ristomycin increase the hemotoxic effect.
• Taking furazidine with antacids containing magnesium trisilicate reduces its absorption.
• Atropine delays the absorption of furazidine, but the total amount of absorbed substance does not change.
• Taking vitamins of group B increases the absorption of furazidine.

Effect on laboratory tests:
During the administration of medicines from the same group (nitrofuran derivatives), false-positive results of glucose tests in the urine were observed.

Furaginum Adamed with food, drinks, and alcohol

Furaginum Adamed is best taken during meals containing protein.
Avoid consuming alcohol while taking 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 effect of furazidine on the fetus, the medicine should not be used in 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 monitor the hemoglobin and iron levels and the number of erythrocytes in the blood (perform blood morphology tests).

Driving and using machines

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

Furaginum Adamed contains 13.75 mg of sucrose.

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

3. How to take Furaginum Adamed

Always take this medicine exactly as your doctor has told you.
In case of doubts, consult a doctor or pharmacist.
The medicine is best taken orally during meals, especially those containing protein, as it increases the absorption of furazidine.
Recommended dose:
Adults:
First day of treatment: 100 mg (2 tablets) 4 times a day (maximum 8 tablets per day); subsequent days 100 mg (2 tablets) 3 times a day (6 tablets per day).
In case of recurrent urinary tract infections in women (at least 3 episodes of urinary tract infection in the last 12 months): 100 mg (2 tablets) at night for 6-12 months.

Use in children and adolescents

Children from 2 to 14 years of age:
5 mg/kg body weight per day to 7 mg/kg body weight per day in 2 or 3 divided doses (the tablet can be crushed and mixed with milk).
In children under 2 years of age, the dose should be determined directly by the doctor.
The medicine is taken for 7 to 8 days. If necessary, the treatment can be repeated after 10-15 days.

Overdose of Furaginum Adamed

The medicine is slightly toxic. Since furazidine is excreted from the body by the kidneys, in patients with impaired renal function, symptoms of overdose may occur, such as: headaches, dizziness, allergic reactions, nausea, anemia.

Missed dose of Furaginum Adamed

If you miss a dose, continue treatment with the previously taken doses of the medicine.
Do not take a double dose to make up for the missed dose.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Furaginum Adamed can cause side effects, although not everybody gets them.
Most patients tolerate furazidine well.
Among the side effects observed during clinical trials, probably related to the use of the medicine, the most common were: nausea (8%), headaches (6%), and excessive gas (1.5%). The following side effects occurred in no more than 1% of patients:

• cyanosis due to methemoglobinemia (blue discoloration of the skin with a chocolate-brown tint). In people with glucose-6-phosphate dehydrogenase deficiency, taking furazidine may lead to the development of megaloblastic (due to vitamin B or folic acid deficiency) or hemolytic anemia (due to rapid destruction of red blood cells);
• itching, urticaria, anaphylaxis (immediate allergic reaction);
• angioedema, rash;
• acute, subacute, and chronic reactions to nitrofuran derivatives. Chronic reactions occurred in patients taking the medicine for more than 6 months. Acute allergic reactions affecting the respiratory system manifested as fever, chills, cough, chest pain, and pleural effusion. They usually resolved quickly or very quickly after discontinuation of the medicine.
• dizziness, drowsiness, vision disturbances;
• peripheral neuropathy (damage to peripheral nerves), also with acute or irreversible course (the following conditions predispose to its occurrence: renal impairment, anemia, diabetes, electrolyte disturbances, vitamin B deficiency);
• constipation, diarrhea, dyspeptic symptoms (chronic pain in the upper abdomen);
• abdominal pain, vomiting;
• salivary gland inflammation, pancreatitis, pseudomembranous colitis;
• symptoms of drug-induced hepatitis;
• cholestatic jaundice (caused by an obstacle to bile flow);
• liver necrosis;
• alopecia, exfoliative dermatitis;
• erythema multiforme, Stevens-Johnson syndrome (vesicular rash);
• fever, chills, malaise;
• infections with microorganisms resistant to nitrofuran derivatives, most often Pseudomonas or Candida.

In addition, in patients taking furazidine, the following have been observed with an unknown frequency:

• muscle cramps, muscle pain.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.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 the medicine.

5. How to store Furaginum Adamed

Store in a dry place.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack after: EXP. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. 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 Furaginum Adamed contains

• The active substance of the medicine is furazidine, also known as furagin. Each tablet contains 50 mg of the active substance.
• The other ingredients are: corn starch, sucrose, colloidal silicon dioxide, stearic acid.

What Furaginum Adamed looks like and what the pack contains

Furaginum Adamed 50 mg tablets are yellow-orange. One side of the tablet has a dividing line, the other side is smooth. The tablet can be divided into equal doses.
Furaginum Adamed tablets are available in cardboard boxes containing 30 tablets.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Date of last revision of the leaflet:

• 03.2023