Furedan

Patient Information Leaflet

FUREDAN 50 mg tablets

Nitrofurantoin
Read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Furedan is and what it is used for
2. What you need to know before taking Furedan
3. How to take Furedan
4. Possible side effects
5. How to store Furedan
6. Package contents and other information

1. What Furedan is and what it is used for

Furedan contains nitrofurantoin as the active substance, a synthetic antibacterial agent.
Furedan is used to treat urinary tract infections, including those of the prostate, caused by bacteria
that are sensitive to this active substance.

2. What you should know before taking Furedan

Do not take Furedan:

• if you are allergic to nitrofurantoin, to other nitrofurans (the chemical class to which nitrofurantoin belongs), or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney problems, including absence or reduced urine output;
• if you are near term pregnancy (at the end of pregnancy) (see section Pregnancy and breastfeeding);
• if you have a deficiency of the enzyme called glucose-6-phosphate dehydrogenase, due to the risk of developing low hemoglobin levels in the blood (anemia) caused by destruction of red blood cells induced by the medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Furedan.
Before using this medicine, you should undergo a test to determine whether the bacteria causing the infection are sensitive to this product, as some bacteria may be resistant.
If you need to take Furedan for prolonged periods, your doctor will monitor you closely, as neurological and lung-related side effects may occur. If you develop lung problems, altered sensation in the limbs (paresthesia), or signs of anemia due to increased destruction of red blood cells (hemolysis), you must stop treatment and consult your doctor immediately.
Consult your doctor if you have diabetes, kidney disorders, debilitating diseases, vitamin deficiencies, or electrolyte imbalances, as you may have an increased risk of developing peripheral nervous system disorders (neuropathies).
Like other antibacterial agents, Furedan may promote the development of resistant bacteria, particularly Pseudomonas, and thus may fail to eliminate all infectious germs.
Contact your doctor if you experience fatigue, yellowing of the skin or eyes (jaundice), itching, skin rashes, joint pain, abdominal discomfort, nausea, vomiting, loss of appetite, dark urine, or pale or greyish stools. These may be symptoms of liver disorders.

Children
The tablet formulation of Furedan is not indicated for use in children.

Other medicines and Furedan
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking the following medicines, as they may alter the effectiveness of nitrofurantoin:

• probenecid (a medicine used for gout and high levels of uric acid in the blood);
• antacids (used to neutralize stomach acidity);
• nalidixic acid and oxolinic acid (antibacterial drugs)

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not take Furedan during late pregnancy, as nitrofurantoin is contraindicated.
During pregnancy, you should use this medicine only if clearly necessary and under direct medical supervision.

Driving and using machines
There are no data available describing the influence of this medicine on your ability to drive vehicles or operate machinery.

Furedan contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Furedan

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The dose is 4-8 tablets daily (200-400 mg), divided into three to four single doses, taken during meals, for one week or longer if necessary, according to the doctor's judgment.
It is advisable to take the tablets for the entire duration indicated by the doctor to prevent the infection from recurring.
If you take more Furedan than you should
If you have taken more tablets than you should, or if you think a child has swallowed any tablets, contact the nearest hospital or see a doctor immediately.
Take this leaflet, any remaining tablets, and the packaging with you.
If you forget to take Furedan
Do not take a double dose to make up for the forgotten dose.
If you stop taking Furedan
Do not stop treatment prematurely; follow the instructions given by your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience any of the following side effects:

• Loss of appetite (anorexia), nausea, vomiting, diarrhoea.
• Yellowing of the skin and eyes (cholestatic jaundice; a rare event), inflammation of the liver (hepatitis due to hypersensitivity), inflammation of the liver due to activation of the immune system against liver cells, with unknown frequency.
• Inflammation of one or more peripheral nerves (peripheral neuritis), sometimes severe and irreversible, initially presenting with altered sensation in the limbs (peripheral paraesthesiae) and which may progress to affect muscles. Other nervous system reactions include: headache (cephalalgia), dizziness, involuntary eye movements (nystagmus), increased pressure inside the skull causing severe headaches (intracranial hypertension), cerebellar disturbances causing balance problems, severe inflammation of the optic nerve causing visual difficulties (retrobulbar neuritis), and episodes of intense pain localized to the eyes, lips, nose, scalp, forehead, teeth, and internal mucous membranes of the jaw and mandible (trigeminal neuralgia).
• Side effects due to drug allergy (hypersensitivity). In acute cases, these are accompanied by fever, cough, difficulty breathing (dyspnoea), chest pain, chills, increased levels of certain white blood cells (eosinophilia), and radiologically by pulmonary infiltrate with pleural reaction, the membrane covering the lungs. If undergoing long-term treatment, chronic pulmonary reactions may occur with an insidious course, showing signs of infiltration and/or pulmonary fibrosis.
• If you have a deficiency of the enzyme called glucose-6-phosphate dehydrogenase, you may experience a reduced red blood cell count due to their destruction, which can lead to decreased performance and fatigue (haemolytic anaemia); reduction or increase in certain white blood cells (granulocytopenia; eosinophilia); anaemia with large red blood cells (megaloblastic).
• Appearance of small spots on the skin (urticaria), itching, appearance of red, raised patches with blisters (erythematous-papular and vesicular eruptions); joint pain (arthralgia); asthma attacks; severe, rapidly occurring allergic reaction (anaphylaxis).
• Inflammation of the walls of small blood vessels, causing skin lesions, with unknown frequency.
• Inflammation of the renal tissue surrounding the tubules, leading to kidney impairment, with unknown frequency.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Furedan

This medicine does not require any special storage precautions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Furedan contains

• The active substance is nitrofurantoin. Each tablet contains 50 mg of nitrofurantoin.
• The other components are maize starch, lactose, polyvinylpyrrolidone, magnesium stearate, talc.

Description of the appearance of Furedan and contents of the pack
Tablets.
Pack size: 15 tablets.
Marketing Authorization Holder
SF Group S.r.l. – Via Tiburtina, 1143 – 00156 Roma
Manufacturer
Industria Farmaceutica Nova Argentia Srl - Via Giovanni Pascoli, 1 - 20064 Gorgonzola (MI)