Label: information for the user

Iruxol Mono ointment

Read this label carefully before starting to use the medication.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your pharmacist.
• This medication has been prescribed for 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 adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this label, inform your doctor or pharmacist.

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

2. Before using Iruxol Mono ointment

3. How to use Iruxol Mono ointment

4. Possible adverse effects

5. Storage of Iruxol Mono ointment

6. Additional information

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

Do not use Iruxol Mono ointment

-If you are allergic (hypersensitive) to the active principles or to any of the other components of this medication.

Be especially careful with Iruxol Mono ointment

-If you have an infection in the ulcer, consult your doctor, who will apply the appropriate treatment, preferably orally. There are antibiotics that cannot be used with this medication in the same area (see sectionUse of other medications).

-If you use it with some soaps or antiseptics, it may eliminate the effect of this medication (see sectionUse of other medications).

-In case you are weakened, caution is required and you should consult your doctor for the risk of extending an infection.

-If, after 14 days since the start of treatment, the dead tissue has not decreased, consult your doctor, who will interrupt the treatment and replace it with another.

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.

The following products should not be used together with Iruxol Mono ointment because they may reduce or suppress its activity:

-Topical antibiotics such as tetroxine, gramicidin, and tetracyclines.

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

-Other enzymatic preparations.

Yes, the following products can be used together with Iruxol Mono ointment:

-Antibiotics such as neomycin-bacitracin-polymyxin B and framycetin.

-Sterile saline solution.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

There are not enough data on the use of this medication in pregnant women or those planning to become pregnant. As a precaution, do not use Iruxol Mono ointment during pregnancy and breastfeeding, unless your doctor considers it clearly necessary, considering the potential risks against the benefits.

Driving and operating machines

The use of Iruxol Mono has no effect on driving or operating machines.

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

Cutaneous 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 affected area lightly moistened, for example with physiological serum. It can also be applied on a sterile gauze or dressing placed over the ulcer. In some cases, it may be necessary to apply the ointment twice a day.

Strict aseptic conditions must be maintained. Before each application, the wound should be gently cleaned with a gauze soaked in physiological serum or another compatible cleaning solution to remove necrotic tissue (see sectionUse of other medications).

If no reduction of necrotic tissue is observed after 14 days from the start of treatment, inform your doctor, who will interrupt and replace with another debridement method.

Use in childrenThis product has not been established for safety and efficacy in children, so it should not be used in them.

If you use more Iruxol Mono ointment than you should

Due to the characteristics of this medication, intended for cutaneous use, it is not expected that an overdose will occur.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or go to a medical center, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Iruxol Mono ointment

Do not use more ointment to compensate for the missed doses. If you forgot a dose, apply it as soon as possible and continue with your regular schedule.

If you interrupt treatment with Iruxol Mono ointment

Do not interrupt treatment until your doctor tells you to do so, or otherwise the desired results will not be obtained.

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

Like all medications, Iruxol Mono ointment may produce adverse effects, although not everyone will experience them.

Observed adverse effects include pain, itching, irritation, inflammation, or redness of the skin, which usually do not require discontinuation of treatment.

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

Reporting 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 can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

Do not store at a temperature above 25°C.

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Iruxol Mono Ointment

• The active principles are Clostridiopeptidasa A (Collagenase) and other proteolytic enzymes.

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

• The other components are liquid paraffin and solid paraffin.

Appearance of the product and contents of the package

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

Holder of the marketing authorization and responsible 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 medication 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.

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