IRUXOL NEO OINTMENT

Introduction

Package Leaflet: Information for the User

Iruxol Neo Ointment

Read the entire package leaflet carefully before starting to use the medicine

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the Package Leaflet

1. What is Iruxol Neo and what is it used for
2. Before using Iruxol Neo
3. How to use Iruxol Neo
4. Possible side effects
5. Storage of Iruxol Neo
6. Additional information

1. What is Iruxol Neo and what is it used for

The active ingredients are proteolytic enzymes that act on components of ulcers and skin wounds, and an aminoglycoside antibiotic. It is indicated in adults for the debridement (cleaning and removal) of necrotic tissue in small skin ulcers of various origins and reduction of the number of superficial bacteria.

2. Before using Iruxol Neo

Do not use Iruxol Neo

-If you are allergic (hypersensitive) to the active ingredients, to other aminoglycoside antibiotics, or to any of the other components of this medicine.

Be careful with Iruxol Neo

-Iruxol Neo should not be used on large areas, as neomycin could be absorbed through the skin and have adverse effects on other parts of the body. This is more likely if you have kidney disease or are being treated with an aminoglycoside antibiotic orally or by another route (e.g., amikacin, tobramycin, or gentamicin).

-If you notice that you have an infection in the lesion or that superinfections by resistant microorganisms may have occurred, consult your doctor, who will apply the appropriate treatment. There are antibiotics that cannot be used with this medicine in the same area (see section Use of other medicines).

-If you use some soaps or antiseptics with the ointment, they may eliminate the effect of this medicine (see section Use of other medicines).

-You should avoid contact between the ointment and the eyes or mucous membranes (e.g., the genital area).

-If you are weakened, caution is required, and you should consult your doctor due to the risk of spreading an infection.

-In children, this medicine should not be used, as its safety and efficacy have not been established in them.

Use of other medicines

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

• Aminoglycoside antibiotics (e.g., amikacin, tobramycin, or gentamicin): if you are being treated with an antibiotic of this type, orally or by another route, it may increase the risk of adverse reactions in other areas of the body.

-The following products should not be used in conjunction with Iruxol Neo because they may reduce or suppress its activity:

-Locally applied antibiotics such as tyrothricin, gramicidin, and tetracyclines

-Detergents, soaps, acidic solutions, or antiseptics such as hexachlorophene or those containing heavy metals (e.g., mercurochrome).

-Other enzymatic preparations.

-However, the following products can be used in conjunction with Iruxol Neo: - Antibiotics such as neomycin, bacitracin, polymyxin B, and framicetin.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

To avoid any risk to the child, you should not use Iruxol Neo if you are pregnant or breastfeeding, unless your doctor indicates it, weighing the benefits against the possible risks.

Driving and using machines

No effects of Iruxol Neo on driving or using machines have been described.

3. How to use Iruxol Neo

Follow your doctor's instructions for administering Iruxol Neo exactly. Consult your doctor or pharmacist if you have doubts.

Topical use.

To pierce the sealed tube, press using the back of the cap. The normal dose is:

Adults

Apply a layer of ointment approximately 2 mm thick, once a day, directly to the area to be treated, lightly moistened with hydrogel or physiological serum. It can also be applied to a sterile gauze or dressing placed over the wound. Occasionally, it may be necessary to apply the ointment twice a day.

Strict aseptic conditions (cleanliness) must be maintained. Before each application, the lesion should be gently cleaned with a gauze impregnated with physiological serum or another cleaning solution compatible with the ointment to remove necrotic tissue.

In general, the medicine should not be used for more than one week, unless the doctor decides to extend it longer. If a reduction in necrotic tissue is not observed after 14 days from the start of treatment, you should inform your doctor, who will interrupt and replace it with another.

Use in children

The safety and efficacy of Iruxol Neo have not been established in children, so it should not be used in this age group.

If you use more Iruxol Neo than you should

If you use more Iruxol Neo than recommended, on large areas of eroded skin (e.g., in ulcers) or for prolonged periods, neomycin could be absorbed in sufficient quantities to produce adverse effects such as hearing loss, kidney damage, and muscle relaxation (neuromuscular blockade). Rarely, severe cases of dermatitis have occurred due to the local use of neomycin, one of the active ingredients of this medicine. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Iruxol Neo

Do not use more ointment to make up for forgotten doses. If you have forgotten a dose, apply it as soon as possible and continue with your regular schedule.

If you interrupt treatment with Iruxol Neo

Do not interrupt treatment before your doctor indicates it, or the desired results will not be achieved.

If you have any other doubts about using this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Iruxol Neo can cause side effects, although not everyone gets them.

The assessment of side effects is based on the following frequencies:

Very common: may affect more than 1 in 10 people.

Common: may affect between 1 and 10 in 100 people.

Side effects such as pain, itching, irritation, inflammation, or redness of the skin have been observed, which usually do not require interruption of treatment.

Frequent hypersensitivity reactions to neomycin have been observed, especially if used for prolonged periods, including: inflammation, burning, rash, appearance of hives (urticaria); rarely, anaphylactic reactions (exaggerated allergic reaction) may occur.

For the case of excessive use of the medicine, see section If you use more Iruxol Neo than you should.

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Iruxol Neo

Keep out of the reach and sight of children.

Do not use Iruxol Neo 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 25°C.

Medicines should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Additional information

Composition of Iruxol Neo ointment

• The active ingredients are: Clostridiopeptidase A (Collagenase) 0.6 UI/g and Neomycin (as sulfate) 3.5 mg/g.
• The other components are: liquid paraffin and white vaseline.

Appearance of the product and packaging contents

Iruxol Neo is presented as a white or slightly brown ointment. Each package contains 15 or 30 g of ointment in an aluminum tube.

Marketing authorization holder

Smith & Nephew GmbH

Friesenweg 30, 22763 Hamburg, Germany.

Manufacturer

Nordmark Pharma GmbH

Pinnauallee 4, 25436 Uetersen, Germany.

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Local representative

Smith & Nephew, S.A.U

Fructuós Gelabert, 2-4

08970 Sant Joan Despí Barcelona, Spain

Tel: +34 93 373 7301

Fax: +34 93 373 7453

This package leaflet was approved in April 2018.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/