IRUXOL MONO OINTMENT

Introduction

Package Leaflet: Information for the User

Iruxol Mono Ointment

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Contents of the Package Leaflet

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

1. What is Iruxol Mono Ointment and what is it used for

The active ingredients are proteolytic enzymes, which act on components of skin ulcers. It is used for the debridement (cleaning and removal) of necrotic (dead) tissue in skin ulcers.

2. Before using Iruxol Mono Ointment

Do not use Iruxol Mono Ointment

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

Take special care with Iruxol Mono Ointment

-If you have an infection in the ulcer, you should consult your doctor, who will apply the appropriate treatment, preferably orally. 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, it may eliminate the effect of this medicine (see section Use of other medicines).

-In case you are weakened, caution is required and you should consult your doctor due to the risk of infection spread.

-If after 14 days from the start of treatment, there is no reduction in dead tissue, you should consult your doctor, who will interrupt the treatment and replace it with another.

Use of other medicines

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

The following products should not be used together with Iruxol Mono Ointment 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 and those containing heavy metals (e.g., mercurochrome).

-Other enzymatic preparations.

The following products can be used together with Iruxol Mono Ointment:

• Antibiotics such as neomycin-bacitracin-polymyxin B and framicetin.

-Sterile saline solution.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

There is not enough data on the use of this medicine in pregnant or breastfeeding women. As a precaution, do not use Iruxol Mono Ointment during pregnancy and breastfeeding, unless your doctor considers it clearly necessary considering the potential risks versus benefits.

Driving and using machines

The use of Iruxol Mono does not have any effect on driving or using machines.

3. How to use Iruxol Mono Ointment

Follow exactly the administration instructions of Iruxol Mono Ointment indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Topical use. To pierce the sealed tube, press using the reverse of the cap.

The normal dose is:

Adults

Apply a layer of ointment approximately 2 mm thick once a day, directly on the area to be treated, slightly moistened, for example with physiological serum. It can also be applied on a sterile gauze or dressing that is placed on the ulcer. Sometimes it may be necessary to apply the ointment twice a day.

Strict aseptic (clean) conditions 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 dead tissue (see section Use of other medicines).

If there is no reduction in dead tissue after 14 days from the start of treatment, you should inform your doctor, who will interrupt the treatment and replace it with another debridement method.

Use in children: The safety and efficacy of Iruxol Mono Ointment in children have not been established, so it should not be used in them.

If you use more Iruxol Mono Ointment than you should

Due to the characteristics of this medicine, intended for topical use, it is not expected to produce an overdose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist 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 Mono Ointment

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 usual schedule.

If you interrupt the treatment with Iruxol Mono Ointment

Do not interrupt the treatment until your doctor indicates it, or otherwise, the desired results will not be obtained.

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

4. Possible side effects

Like all medicines, Iruxol Mono Ointment can cause side effects, although not everybody gets them.

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

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 leaflet, inform your doctor or pharmacist.

Reporting of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Iruxol Mono Ointment

Keep out of the reach and sight of children.

Do not store above 25°C.

Do not use Iruxol Mono Ointment after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Further information

Composition of Iruxol Mono Ointment

• The active ingredients are Clostridiopeptidase A (Collagenase) and other proteolytic enzymes.

1 g of ointment contains 1.2 UI of Clostridiopeptidase A (Collagenase) and 0.24 UI of other proteolytic enzymes.

• The other ingredients are liquid paraffin and solid paraffin.

Appearance and packaging of the product

Iruxol Mono is presented as an ointment. The ointment is colorless or slightly brown. Each package contains 15 or 30 g of ointment in an aluminum tube.

Marketing authorization holder and manufacturer

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

Phone: +34 93 373 7301

Fax: +34 93 373 7453

This 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/