Iruxol Neo ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Iruxol Neo ointment

Read the entire leaflet carefully before you start using this medicine

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you; do not give it to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet

1. What Iruxol Neo is and what it is used for
2. Before you use Iruxol Neo
3. How to use Iruxol Neo
4. Possible side effects
5. How to store Iruxol Neo
6. Further information

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

The active ingredients are proteolytic enzymes acting on components of skin ulcers and wounds, and an aminoglycoside-type antibiotic. It is indicated in adults for the debridement (cleaning and removal) of necrotic (dead) tissue in small-sized cutaneous ulcers of various origins, and for reducing the amount of surface bacteria.

2. Before using Iruxol Neo

Do not use Iruxol Neo

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

Special precautions with Iruxol Neo

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

• If you notice an infection in the lesion or possible superinfections caused by resistant microorganisms, consult your doctor, who will prescribe the appropriate treatment. Some antibiotics should not be used together with this medicine on the same area (see section Use with other medicines).

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

• Avoid contact of the ointment with 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 infection spreading.

• This medicine should not be used in children, as its safety and efficacy have not been established in this population.

Use with other medicines

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

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

• The following products should not be used together with Iruxol Neo, as 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. mercuric chloride).

• Other enzymatic preparations.

• The following products may be used together with Iruxol Neo:

• Antibiotics such as neomycin, bacitracin, polymyxin B and framycetin.

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 specifically advises you to do so after evaluating the benefits against the potential risks.

Driving and operating machinery

No effects of Iruxol Neo on driving or operating machinery have been reported.

3. How to use Iruxol Neo

Follow exactly the administration instructions for Iruxol Neo provided by your doctor. If you have any doubts, consult your doctor or pharmacist.

For topical use only.

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

Adults

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

Strict aseptic (cleanliness) conditions must be maintained. Before each application, the lesion should be gently cleaned with gauze soaked in physiological saline or another cleansing solution compatible with the ointment, in order to remove necrotic tissue.

In general, this medicine should not be used for longer than one week unless your doctor decides to extend the treatment. If no reduction in necrotic (dead) tissue is observed after 14 days from the start of treatment, you must inform your doctor, who will discontinue the treatment and replace it with another.

Use in children

The safety and efficacy of Iruxol Neo in children have not been established; therefore, 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, over large areas of eroded skin (e.g., ulcers), or for prolonged periods, neomycin may be absorbed in sufficient amounts to cause adverse effects such as hearing loss, kidney damage, and muscle relaxation (neuromuscular blockade). Rarely, severe cases of dermatitis have occurred with local use of neomycin, one of the active ingredients in this medicine. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Iruxol Neo

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

If you stop using Iruxol Neo

Do not stop treatment earlier than indicated by your doctor, otherwise the desired results may not be achieved.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Iruxol Neo can cause adverse effects, although not everyone will experience them.

The assessment of adverse 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 every 100 people.

Adverse effects such as pain, stinging, irritation, inflammation, or redness of the skin have been observed, which usually do not require discontinuation of treatment.

Hypersensitivity reactions to neomycin are common, especially if used for prolonged periods, including: inflammation, burning, rash, hives (urticaria); anaphylactic reactions (exaggerated allergic reaction) may rarely occur.

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

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not store above 25°C.

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

6. Additional Information

Composition of Iruxol Neo ointment

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

Appearance of the product and contents of the container

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

Marketing Authorization Holder

Smith & Nephew GmbH

Friesenweg 30, 22763 Hamburg, Germany.

Manufacturer

Nordmark Pharma GmbH

Pinnauallee 4, 25436 Uetersen, Germany.

You can request further information about this medicinal product 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 leaflet was approved in April 2018.

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.es/