FURACIN 2 MG/ML CUTANEOUS SOLUTION

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Furacin 2 mg/ml cutaneous solution

Nitrofural

Package leaflet contents:

1. What Furacin cutaneous solution is and what it is used for
2. Before using Furacin cutaneous solution
3. How to use Furacin cutaneous solution
4. Possible side effects
5. Storage of Furacin cutaneous solution
6. Further information

1. What Furacín Cutaneous Solution is and what it is used for

Nitrofural, the active substance of the medicine, is a nitrofuran derivative with antiseptic and disinfectant activity, exerting antibacterial action against most pathogenic microorganisms that commonly cause infections on the skin surface.

Furacín Cutaneous Solution is indicated in adults for local application in:

Alternative treatment of second- and third-degree burns. Skin infections. Preparation of surfaces for skin grafts, where bacterial contamination may lead to graft rejection or infection at the donor site, particularly in centers with a history of bacterial resistance.

2. Before using Furacin cutaneous solution

Do not use Furacin cutaneous solution

• If you are allergic (hypersensitive) to the active substance or to any of the other components of Furacin cutaneous solution.

Take special care with Furacin cutaneous solution

• If you have any kidney disease, since macrogols present as excipients could be absorbed, and their accumulation may increase the risk of adverse reactions.
• If overgrowth of germs not sensitive to nitrofurazone treatment occurs (another infection with worsening of the lesion or irritation in the treated area).

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

No interaction studies have been conducted.

Use in children

The safety and efficacy of nitrofurazone in children have not been established (see section 3: How to use Furacin cutaneous solution).

Use in elderly patients

Elderly patients, who likely have a greater age-related decline in renal function, may require lower doses (see section 3: How to use Furacin cutaneous solution).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

There is insufficient information regarding the use of nitrofurazone in pregnant women. Furacin cutaneous solution should be used during pregnancy only if the potential benefit justifies any potential risk to the fetus.

It is unknown whether this medicine passes into breast milk. Therefore, a decision must be made whether to discontinue breastfeeding or to discontinue treatment with Furacin, taking into account the benefit of breastfeeding for the child and the benefit of treatment with Furacin cutaneous solution for the mother.

Driving and using machines

It is very unlikely that Furacin cutaneous solution will affect your ability to drive or operate machinery.

Important information about some of the components of Furacin cutaneous solution

This medicine contains macrogols (polyethylene glycols) as excipients; if you have any kidney disease, you should exercise caution, as they may be absorbed and accumulate, increasing the risk of adverse effects on the kidneys, such as progressive deterioration. You must inform your doctor.

3. How to use Furacín topical solution

Follow exactly the instructions for use of Furacín topical solution provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

Furacín topical solution is for topical use only.

The usual dose is:

Adults: Apply directly to the lesion or first impregnate a sterile gauze and then cover the lesion; apply once daily or every few days, depending on the dressing technique.

If symptoms worsen or do not improve after 3 days of treatment with Furacín topical solution, you must discontinue treatment and consult your doctor.

There is no experience in children.

Elderly patients, who may have age-related impaired renal function, may require lower doses of nitrofural (see section 2 above: Use in elderly patients).

If you use more Furacín topical solution than you should

If your renal function is normal, overdose is unlikely when the product is used topically. In case of accidental ingestion, note that nitrofural is a toxic substance when ingested, and adverse effects may affect the nerves; in patients with glucose-6-phosphate dehydrogenase deficiency, hemolysis (release of hemoglobin from red blood cells) may occur.

If you have used more Furacín topical solution than you should, or in case of accidental ingestion, consult your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service. Telephone (91)5620420.

If you forget to apply Furacin solution

Do not use a double dose to make up for missed doses.

If you forget a dose, apply it as soon as possible and continue with your regular dosing schedule.

4. Possible adverse effects

Like all medicines, Furacin topical solution may cause adverse effects, although not everyone experiences them.

The adverse effects observed are described below according to their frequency of occurrence.

Disorders of the skin and subcutaneous tissue

Common: at least 1 in 100 patients may experience allergic reactions, such as contact dermatitis (redness, itching, rash, swelling, etc.).

Frequency not known (cannot be estimated from available data): fungal superinfections (mycosis) may also occur.

Renal and urinary disorders

Frequency not known (cannot be estimated from available data): in patients with renal disease, symptoms of progressive renal impairment may occur if macrogols (excipients) accumulate, such as increased blood urea nitrogen, anion gap, and metabolic acidosis (see section 2, the subsection: Important information about some of the components of Furacin topical solution).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Furacín Topical Solution Storage

Keep out of the reach and sight of children.

Do not use Furacin topical solution after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C. Keep the container tightly closed to protect it from direct sunlight, intense fluorescent light, and alkaline materials.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This helps protect the environment.

6. Additional Information

Composition of Furacin Cutaneous Solution

• The active substance is Nitrofural. Each millilitre of solution contains 2 mg of Nitrofural.
• The other components (excipients) are: macrogol 300, macrogol 1500 and purified water.

Appearance of the medicinal product and content of the container

Furacin cutaneous solution is supplied as a cutaneous solution in a 100 ml amber-coloured plastic bottle with closure.

Marketing Authorization Holder and Manufacturer

SEID, S.A.

Carretera de Sabadell a Granollers, Km 15

08185 - LLIÇÀ DE VALL (BARCELONA)

This leaflet was approved in March 2007.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.