Noruxol

Package leaflet: Information for the patient

NORUXOL Ointment

Clostridiopeptidase A 1.2 units and protease 0.24 units
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 14 days.

Contents of this leaflet:

1. What NORUXOL is and what it is used for
2. What you need to know before using NORUXOL
3. How to use NORUXOL
4. Possible side effects
5. How to store NORUXOL
6. Contents of the pack and other information

1. What NORUXOL is and what it is used for

Noruxol ointment contains collagenase N, composed of clostridiopeptidase A (collagenase enzyme) and associated proteases.
These enzymes are used for the treatment of wounds because they are able to remove (debride) dry or moist crusts and eschars (necrotic, fibrinous tissue) commonly present on wounds, leg ulcers, pressure ulcers, diabetic ulcers, and burns.
By removing crusts and eschars, Noruxol accelerates wound healing and the healing process.
Consult your doctor if you do not feel better or if you feel worse after 14 days.

2. What you need to know before using NORUXOL

Do not use Noruxol

• if you are allergic to clostridiopeptidase, protease, proteolytic enzymes, or to any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions
Talk to your doctor or pharmacist before using Noruxol if:

• you have been told you have an infection in the wound
• you are diabetic and have been told you have a wound or dry gangrene; in this case, moisten the wound before applying Noruxol, taking care not to make it excessively wet
• you have a severe burn; in this case, Noruxol must be used only on the advice of and under the supervision of a specialist doctor.

The use, especially if prolonged, of topical products (on the skin) may cause sensitization reactions; if this occurs, stop treatment and consult your doctor or pharmacist.
Avoid contact with eyes and mucous membranes. Do not ingest.
Other medicines and Noruxol
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, and/or other local treatments, e.g. dressings.
Noruxol ointment must not be used if you are applying other products to the wound that could interfere with this medicine by inhibiting its enzymatic activity, such as:

• antiseptics
• heavy metals
• detergents
• soaps
• topical antibiotics (tyrothricin, gramicidin, and tetracyclines)

Products containing silver and silver sulfadiazine may instead be used together with Noruxol.
Noruxol with food, drinks and alcohol
There are no known effects of food, drinks or alcohol on the use of Noruxol.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
As a precautionary measure, avoid the use of Noruxol during the first three months of pregnancy unless otherwise advised by your doctor.
Driving and using machines
It is unlikely that Noruxol will affect your ability to drive or use machinery.

3. How to use NORUXOL

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply this medicine only to the skin. Avoid contact with the eyes and mouth (mucous membranes).
To ensure the treatment's effectiveness, apply Noruxol to a moist wound.

• If the wound is dry or becomes dry, moisten it with physiological saline solution (0.9% NaCl) or other solutions (e.g. glucose) before applying the ointment.
• Dry, hard crusts can be softened by applying a dressing, gauze, or moist bandage.

Apply a thin layer of Noruxol (approximately 2 mm) directly to the wound or onto a dressing to be placed on the wound.
Ensure that the ointment is in close contact with the wound and cover it with a dressing.
Apply the ointment once daily, unless otherwise instructed by your doctor. However, it may be applied twice daily if a stronger wound cleansing effect is required. Before reapplying the product, make sure to remove any dead tissue (necrotic) that has detached.
If you do not observe improvement after 14 days of treatment, consult your doctor or pharmacist.
If you use more NORUXOL than you should
Applying more Noruxol to the wound than recommended is not dangerous; however, keep in mind that using a larger amount than recommended does not increase its effectiveness.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
When using Noruxol, you may experience the following side effects:

• local pain at the wound site
• local skin reactions such as itching, burning, erythema

If reactions are severe, discontinuation of therapy should be considered.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NORUXOL

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the carton and tube after "Exp.". The expiry date refers to the last day of that month.
Once the tube has been opened, the product is no longer considered sterile. Any remaining contents should therefore not be used, but properly discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What NORUXOL contains

• The active substance is collagenase N*, an enzyme mixture composed of clostridiopeptidase and associated proteases. Each gram of ointment contains 0.52 - 3.75 mg of collagenase N*, containing not less than 1.2 Units of clostridiopeptidase A and not less than 0.24 Units of associated proteases.
• The other components are liquid paraffin and white soft paraffin.

*The active substance, collagenase N, is a lyophilized purified ultrafiltrate from a culture of Clostridium
histolyticum. The active substance consists of the collagenolytic enzyme clostridiopeptidase A (EC 3.4.24.3) and
other proteases.
Description of the appearance of NORUXOL and package contents
NORUXOL is a transparent or slightly brownish ointment, available in an aluminium tube containing 30 g.
Marketing Authorization Holder
Smith & Nephew S.r.l.
Viale T. Edison, 110
20099 Sesto San Giovanni (MI)
Italy
Manufacturer
Nordmark Pharma GmbH
Pinnauallee 4
D-25436 Uetersen
Germany