PATIENT INFORMATION LEAFLET

Furacin 2 mg/g ointment

Nitrofural

Contents of the leaflet:

1. What Furacin ointment is and what it is used for

2. Before using Furacin ointment

3. How to use Furacin ointment

4. Possible side effects

5. Storage of Furacin ointment

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 ointment is indicated for 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.

Do not use Furacin ointment p omada

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

Be especially careful with Furacin ointment

• 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, including those purchased without a prescription.

No interactions have been studied.

Use in children

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

Use in elderly patients

Older 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 ointment).

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, Furacin ointment should only be used if the potential benefit justifies any potential risk to the fetus.

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

Driving and operating machinery

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

Important information about some of the components of Furacin ointment

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 ointment as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Furacin ointment is for topical use.

The normal dose is:

Adults: Apply directly to the wound or extend previously on 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 ointment, discontinue treatment and consult your doctor.

No experience in children.

Patients of advanced age, having probably a 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 ointment than you should

If your renal function is normal, applying the product for 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 appear.

If you have used more Furacin ointment 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 Furacin ointment

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, Furacinpomada can produce adverse effects, although not all people will 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): fungal overgrowth may also occur.

Renal and urinary 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 blood urea nitrogen, anionic gap, and metabolic acidosis (see section 2, the subsection: Important information about some of the components of Furacin pomada).

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

Keep out of reach and sight of children.

Do not use Furacin ointment 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 30°C and keep the packaging perfectly closed to protect it from direct sunlight, intense fluorescent light, and alkaline materials.

Medicines should not be thrown into the drains or trash. Deposit the packaging and medicines that you do not need at the SIGRE point of the pharmacy. In case of 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 Ointment

• The active ingredient is Nitrofural. Each gram of ointment contains 2 mg of Nitrofural.
• The other components (excipients) are: macrogol 300, macrogol 1500, macrogol 4000, and purified water.

Appearance of the Product and Contents of the Container

Furacin ointment is presented in the form of ointment in a 30 g and 100 g tube; and in a 500 g plastic jar (clinical packaging).

Holder of the Marketing Authorization and Responsible for Manufacturing

SEID, S.A.

Carretera de Sabadell a Granollers Km, 15

08185 - LLÍÇÀ DE VALL (BARCELONA)

This leaflet was approved in March 2007.

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.