Patient Information Leaflet

IROXOL MONO 1.2 IU/g, ointment
Collagenasum
Please read all of this leaflet carefully before using this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

What IROXOL MONO is and what it is used for
What you need to know before using IROXOL MONO
How to use IROXOL MONO
Possible side effects
How to store IROXOL MONO
Contents of the pack and other information

1. What IROXOL MONO is and what it is used for

IROXOL MONO contains the active substance collagenase – clostridiopeptidase A and accompanying proteases. Collagenase is a proteolytic enzyme that breaks down collagen fibers. The collagenase and other proteases contained in the medicine remove all proteinaceous components from the wound, thereby accelerating the wound debridement process.

Indications
Enzymatic debridement of wounds (ulcers and limited-area burns) with necrotic tissue.

2. Important information before using the medicine IRUXOL MONO

When not to use IRUXOL MONO

if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
for extensive burns.

Warnings and precautions
In case of burns, the ointment should be applied to no more than 10% of the body surface area, following prior consultation with a specialist in burn treatment.
Contact of the medicine with eyes and mucous membranes should be avoided.
In diabetic patients, dry eschar should be moistened with caution to avoid development of moist eschar.
If necrotic tissue debridement does not occur within 14 days, the patient should contact a physician to consider changing the treatment approach.

IRUXOL MONO and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient intends to use.
Do not use IRUXOL MONO simultaneously with antiseptics, detergents containing heavy metals, or soap, as they may reduce the activity of collagenase.
Do not use other topical medicines during treatment with IRUXOL MONO, especially antibiotics such as tyrothricin, gramicidin, and tetracyclines, as they may affect collagenase activity.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
IRUXOL MONO may be used during the first trimester of pregnancy only if, in the opinion of the physician, it is absolutely necessary.

Driving and operating machinery
IRUXOL MONO does not impair the ability to drive or operate machinery.

3. How to use IRUXOL MONO

This medicine should always be used exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
This medicine is intended for topical application to the skin.
To achieve the best wound healing results with IRUXOL MONO, adequate moisture at the wound
site should be maintained.
Dry wounds should be moistened with physiological saline (0.9% sodium chloride solution) or
another tissue-tolerated solution.
Dry wounds covered with hard eschar should first be softened using a moistening dressing.
If wounds are infected, the physician will administer an appropriate antibiotic (e.g. chloramphenicol,
neomycin, framycetin, bacitracin, gentamicin, polymyxin B, macrolides - e.g. erythromycin,
clindamycin - mupirocin, sulfadiazine, fusidic acid-sodium salt or clotrimazole).
Apply a 2 mm layer of the medicine onto a dressing or directly onto the appropriately prepared
(see above) moistened wound surface once daily. Ensure access to the wound surface.
Do not apply excessive amounts of the medicine to the wound, as this does not accelerate wound
healing.
To avoid irritation, the wound edges and surrounding healthy skin should be protected from
contact with the medicine.
The dressing should be changed once daily.
In cases of circulatory disorders, ischemic ulcers in diabetes or neurogenic ulcers, the physician
will initiate appropriate causal treatment. The efficacy of IRUXOL MONO has not been demonstrated
in the treatment of venous leg ulcers.
If you feel the effect is too strong or too weak, consult your doctor.
Taking more IRUXOL MONO than recommended
In case of ingestion, remove the medicine from the gastrointestinal tract (e.g. by inducing vomiting,
gastric lavage).
Missing a dose of IRUXOL MONO
Do not use a double dose to make up for a missed application of the ointment.
If several doses have been missed, inform your treating physician and follow their instructions.
Stopping treatment with IRUXOL MONO
Treatment with IRUXOL MONO may only be discontinued on the advice of a physician.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
IRUXOL MONO is generally well tolerated.
Local reactions such as pain, itching, burning sensation, and redness may occur. In case of
severe reactions, treatment should be discontinued and a doctor should be consulted.
Other adverse reactions may occur in some individuals during treatment with IRUXOL MONO.
If any other adverse effects not listed in this leaflet occur, inform your doctor.
Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C,
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store IRUXOL MONO
Keep the medicine out of sight and reach of children.
Store below 25°C in a dry place.
Do not use this medicine after the expiry date stated on the carton and tube. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What IRUXOL MONO contains

The active substances are collagenase N (0.52 mg - 3.75 mg), with clostridiopeptidase A activity of not less than 1.2 units, and not less than 0.24 units of accompanying proteases.
The other ingredients are: liquid paraffin, white soft paraffin.

What IRUXOL MONO looks like and contents of the pack
Tube in a cardboard box. IRUXOL MONO is available in pack sizes containing 20 g or 30 g of ointment.
Marketing Authorisation Holder
Smith & Nephew GmbH
Friesenweg 30
22763 Hamburg
Germany
Manufacturer
Nordmark Pharma GmbH
Pinnauallee 4
D-25436 Uetersen
Germany
For further information, please contact the local representative of the Marketing Authorisation Holder:
Smith & Nephew Sp. z o.o.
Osmańska Street 12
02-823 Warsaw
Poland
Tel. 22 360 41 20
Fax. 22 360 41 21