Iruxol Mono

Package Leaflet: Information for the User

IROXOL MONO 1.2 j/g, ointment

Collagenase

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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 side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is IRUXOL MONO and what is it used for
• 2. Important information before using IRUXOL MONO
• 3. How to use IRUXOL MONO
• 4. Possible side effects
• 5. How to store IRUXOL MONO
• 6. Contents of the pack and other information

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

IRUXOL MONO contains the active substance collagenase - clostridiopeptidase A and accompanying proteases. Collagenase is a proteolytic enzyme that causes the breakdown of collagen fibers.
The collagenase and other proteases in the medicine remove all protein elements from the wound, resulting in the acceleration of the wound cleaning process.
Indications
Enzymatic cleaning of wounds (ulcers and burns of limited surface area) from necrotic tissues.

2. Important information before using IRUXOL MONO

When not to use IRUXOL MONO

• on extensive burns.

Warnings and precautions

In the case of burns, the ointment should be applied to no more than 10% of the body surface area after prior consultation with a burn treatment specialist.
Contact with the eyes and mucous membranes should be avoided.
In patients with diabetes, dry gangrene should be moistened with caution to avoid the development of wet gangrene.
If the reduction of necrotic tissue does not occur within 14 days, you should contact your doctor to change the treatment method.

IRUXOL MONO and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Do not use IRUXOL MONO at the same time as disinfecting medicines, detergents containing heavy metals, and soap, as they weaken the activity of collagenase.
Do not use other local medicines, especially antibiotics such as tyrothricin, gramicidin, and tetracycline, during treatment with IRUXOL MONO, as they may affect the activity of collagenase.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
IRUXOL MONO may be used in the first trimester of pregnancy only if, in the doctor's opinion, it is absolutely necessary.

Driving and using machines

While using IRUXOL MONO, you can drive and operate machinery.

3. How to use IRUXOL MONO

This medicine should always be used according to the doctor's recommendations. If you are unsure, consult your doctor or pharmacist.
The medicine is intended for local use on the skin.
To achieve the best wound healing results with IRUXOL MONO, ensure adequate moisture in the wound area.
Dry wounds should be moistened with a physiological saline solution (0.9% sodium chloride solution) or another well-tolerated solution.
Dry and hard scab-covered wounds should first be softened using a moistening dressing.
If the wounds are infected, the doctor will apply an appropriate antibiotic (such as 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 to the dressing or directly to the properly prepared (see above) moistened wound surface once a day. Ensure access to the wound surface is maintained.
Do not apply an excessive amount of medicine to the wound, as it does not accelerate the wound healing process.
To avoid irritation, the wound edges and healthy skin should be protected from the action of the medicine.
The dressing should be changed once a day.
In the case of circulatory disorders, ulcers of ischemic origin in diabetes, or neurologic origin, the doctor will apply appropriate causal treatment. It has not been shown that IRUXOL MONO is effective in the treatment of ulcers in the course of venous disease of the lower limbs.
If you feel that the action is too strong or too weak, consult your doctor.

Overdose of IRUXOL MONO

In case of ingestion, remove the medicine from the gastrointestinal tract (e.g., through vomiting, stomach lavage) .

Missed application of IRUXOL MONO

Do not apply a double dose to make up for a missed application of the ointment.
If you have missed several doses, inform your attending doctor and follow their recommendations.

Discontinuation of IRUXOL MONO

Treatment with IRUXOL MONO may only be discontinued on the doctor's instructions.

4. Possible side effects

Like all medicines, IRUXOL MONO can cause side effects, although not everybody gets them.
IRUXOL MONO is usually well tolerated.
Local reactions, such as pain, itching, burning, and redness, may occur. If reactions are severe, discontinue use and consult your doctor.
Some people using IRUXOL MONO may experience other side effects. If you experience other side effects not listed in this leaflet, inform your doctor.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store IRUXOL MONO

Keep the medicine out of the sight and reach of children.
Store in a temperature 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 month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will 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 j, and not less than 0.24 j of accompanying proteases.
• The other ingredients are: liquid paraffin, white vaseline

What IRUXOL MONO looks like and contents of the pack

Tube in a carton box. IRUXOL MONO is available in packs containing 20 or 30 g of ointment.

Marketing Authorization Holder

Smith & Nephew GmbH
Friesenweg 30
22763 Hamburg
Germany

Manufacturer

Nordmark Pharma GmbH
Pinnauallee 4
D-25436 Uetersen
Germany
To obtain more detailed information, please contact the local representative of the marketing authorization holder:
Smith & Nephew Sp. z o.o.
ul. Osmańska 12
02-823 Warsaw
Phone: 22 360 41 20
Fax: 22 360 41 21

Date of last revision of the leaflet: