FURACIN 2 mg/ml CUTANEOUS SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Furacin 2 mg/ml cutaneous solution

Nitrofural

Contents of the pack:

1. What Furacin cutaneous solution is and what it is used for
2. Before you use 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 is Furacin cutaneous solution and what is it used for

Nitrofural, the active substance of the medicine, is a nitrofurane derivative with antiseptic and disinfectant activity, with antibacterial action against most pathogenic germs that normally cause skin infections.

Furacin cutaneous solution is indicated in adults for local application in:

Alternative treatment of second and third degree burns. Skin infections. Preparation of skin surfaces for skin grafts, where bacterial contamination can cause graft rejection or infection in the donor piece, especially 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 any of the other components of Furacin cutaneous solution.

Take special care with Furacin cutaneous solution

• If you have any kidney disease, as the macrogoles present as excipients may be absorbed and accumulate, increasing the risk of adverse reactions.
• If there is an overgrowth of germs not sensitive to treatment with nitrofural (another infection with worsening of the lesion or irritation in the treated area)

Use of other medicines

Tell 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 performed.

Use in children

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

Use in elderly patients

Elderly patients, who are likely to have a greater deterioration of renal function due to age, may require lower doses of nitrofural (see section 2: Use in elderly patients).

Pregnancy and lactation

Consult your doctor or pharmacist before using any medicine.

There is no adequate information on the use of nitrofural in pregnant women. During pregnancy, Furacin cutaneous solution should only be used if the possible benefit justifies any potential risk to the fetus.

It is not known whether this medicine passes into breast milk. Therefore, a decision must be made to either continue/discontinue breastfeeding or continue/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 and use machines.

Important information about some of the components of Furacin cutaneous solution

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

3. How to use Furacin cutaneous solution

Follow exactly the administration instructions of Furacin cutaneous solution indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Furacin cutaneous solution is for cutaneous use.

The normal dose is:

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

If the symptoms worsen or do not improve after 3 days of treatment with Furacin cutaneous solution, you should discontinue treatment and consult your doctor.

There is no experience in children.

Elderly patients, who are likely to have a greater deterioration of renal function due to age, may require lower doses of nitrofural (see section 2: Use in elderly patients).

If you use more Furacin cutaneous solution than you should

If your kidney function is normal, applying the product for cutaneous use is unlikely to cause an overdose. In case of accidental ingestion, take into account that nitrofural is a toxic product when ingested and the adverse effects affect the nerves, and in patients with glucose-6-phosphate dehydrogenase deficiency, hemolysis (release of hemoglobin contained in red blood cells) may occur.

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

If you forget to apply Furacin cutaneous solution

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

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

4. Possible side effects

Like all medicines, Furacin cutaneous solution can cause side effects, although not everybody gets them.

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

Disorders of the skin and subcutaneous tissue

Frequent: 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 the available data): mycoses due to overgrowth of fungi may also appear.

Renal and urinary disorders

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

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. Storage of Furacin cutaneous solution

Keep out of the reach and sight of children.

Do not use Furacin cutaneous solution after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Further information

Composition of Furacin cutaneous solution

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

Appearance of the product and contents of the container

Furacin cutaneous solution is presented in the form of a solution for cutaneous use in a 100 ml topaz-colored plastic bottle with a stopper.

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 updated information on this medicineis available on the website of theSpanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.