PATIENT INFORMATION LEAFLET

Furacin 2 mg/ml Topical Solution

Nitrofural

Contents of the leaflet:

1. What Furacin topical solution is and what it is used for

2. Before using Furacin topical solution

3. How to use Furacin topical solution

4. Possible side effects

5. Storage of Furacin topical solution

6. Additional information

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

Furacin solution for skin is indicated in adults, for local application in:

Alternative treatment of second- and third-degree burns. Skin infections. Preparation of surfaces in skin grafts, where bacterial contamination may cause graft rejection or infection in the donor piece, especially in centers with a history of bacterial resistance.

No use Furacin solutionscutaneous solution

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

Be especially careful with Furacin cutaneous solution

• If you have any kidney disease, as the macroglols present as excipients may be absorbed, and their accumulation may increase the risk of adverse reactions.
• If there is overgrowth of non-sensitive bacteria to the treatment with nitrofural (another infection with worsening of the lesion or irritation in the treated area)

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

No interactions studies have been conducted.

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 (see section 3: How to use Furacin cutaneous solution).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

No adequate information is available on the use of nitrofural in pregnant women.During pregnancy, Furacinscutaneous solution should only be used if the potential benefit justifies any potential risk to the fetus.

The passage of this medication to breast milk is unknown. Therefore, a decision should be made to continue or discontinue breastfeeding or continue or discontinue treatment with Furacin, taking into account the benefits of breastfeeding for the child and the benefits of treatment with Furacinscutaneous solution for the mother.

Driving and operating machinery

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

Important information about some of the components of Furacin cutaneous solution

This medication contains macroglols (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. Inform your doctor.

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

Furacin topical solution is for topical use.

The normal dose is:

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

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

No experience in children.

Patients of advanced age, who may have a probable decline in renal function related to age, may require lower doses of nitrofural (see in the section 2, above: Use in elderly patients).

If you use more Furacin topical solution than you should

If your renal function is normal, applying the product in topical use is unlikely to cause an overdose. In case of accidental ingestion, note that nitrofural is a toxic product when ingested and 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 topical 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 Toxicological Information Service. Phone(91)5620420.

If you forgot to apply Furacinstopical solution

Do not use a double dose to compensate for the missed doses.

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

Like all medications, Furacin solution can produce adverse effects, although not all people may experience them.

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

Dermatological and Subcutaneous Tissue Disorders

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

Unknown frequency (cannot be estimated from available data): they may also appear fungal overgrowth.

Renal and Urinary Tract Disorders

Unknown frequency (cannot be estimated from available data): in patients with kidney disease, progressive renal deterioration may occur if accumulation of macrogols (excipients) occurs, such as increased urea nitrogen in the blood, anionic gap, and metabolic acidosis (see section 2, subsection: Important Information about Some Components of Furacin Solution).

If you consider that any of the adverse effects you experience are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of the reach and sight of children.

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

Do not store at a temperature above 86°F (30°C) and keep the packaging perfectly closed to protect it from direct sunlight, intense fluorescent light, and alkaline materials.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines that you do not need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help protect the environment.

Composition of Furacin Cutaneous Solution

• The active ingredient 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 Package

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

Holder of the Marketing Authorization and Responsible for Manufacturing

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 about this medication is available on the website of theSpanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.