Skinsept Mucosa

Package Leaflet: Information for the User

Skinsept Mucosa (10.40 g + 1.67g + 1.50 g) / 100 g, Solution for Mucous Membranes
Ethanolum 96 per centum + Hydrogenii peroxidum 30 per centum + Chlorhexidini digluconatis solutio

Read the Package Leaflet Carefully Before Using the Medicinal Product

This medicinal product should always be used exactly as described in the package leaflet for the patient or as directed by the doctor, pharmacist, or nurse.
Keep this package leaflet, you may need to read it again.

• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including any not listed in this package leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if you feel worse, consult a doctor.

Table of Contents of the Package Leaflet:

• 1. What is Skinsept Mucosa and What is it Used For
• 2. Important Information Before Using Skinsept Mucosa
• 3. How to Use Skinsept Mucosa
• 4. Possible Side Effects
• 5. How to Store Skinsept Mucosa
• 6. Contents of the Package and Other Information

1. What is Skinsept Mucosa and What is it Used For

Skinsept Mucosa is intended for the disinfection of mucous membranes and adjacent skin before operations, gynecological and obstetric procedures, catheterization of the urinary bladder, and transurethral procedures.
Skinsept Mucosa is a combination medicinal product containing active substances with proven efficacy. The active substances in this medicinal product - ethanol, hydrogen peroxide, and chlorhexidine digluconate - complement each other in their range of action, ensuring a broad spectrum of activity. The medicinal product has bactericidal, fungicidal, protozoicidal, and virucidal effects, including against Herpes simplex(herpes virus), and inactivates HBV and HIV viruses.
Hydrogen peroxide ensures that the medicinal product is free from spores during production, filling, and packaging. The hydrogen peroxide contained in the medicinal product destroys bacterial spores that may re-enter the solution.

2. Important Information Before Using Skinsept Mucosa

When Not to Use Skinsept Mucosa

• if the patient has been diagnosed with hypersensitivity to the active substances or to any of the excipients listed in section 6.1. The medicinal product should not be used in infants and young children due to the lack of data. Do not use on large wounds; do not use in the eyes or ears. Skinsept Mucosa should not be used in the abdominal cavity (e.g., during surgery) or on the mucous membranes of the nose and bronchi. The medicinal product should not be used in case of known allergic reactions to its components.

Warnings and Precautions

Avoid contact between Skinsept Mucosa and the eyes, due to the risk of vision damage.
In case of contact with the eyes, rinse them immediately and thoroughly with water. If irritation, redness, or eye pain occurs, or if vision disturbances appear, consult a doctor immediately.
After using medicinal products containing chlorhexidine digluconate, severe cases of permanent corneal damage (eye surface damage) have been reported in patients under general anesthesia (deep, painless sleep) during surgical procedures on the head, face, and neck, which may require corneal transplantation.
Do not use with products containing anionic surfactants, which may cause deactivation of the active substances of the medicinal product.

Pregnancy, Breast-feeding, and Fertility

Accidental ingestion of the medicinal product poses a risk to health.

Driving and Using Machines

The effect of Skinsept Mucosa on the ability to drive and use machines is not known.

Important Information About Some Ingredients of Skinsept Mucosa

The medicinal product contains 12.4% ethanol (ethyl alcohol).
In case of accidental ingestion, the medicinal product may pose a risk to health, particularly for individuals with liver disease, alcohol dependence, epilepsy, brain damage, and children.

Skinsept Mucosa Contains Fragrances and Macrogolglycerol Hydroxystearate

The fragrances contained in this medicinal product, i.e., benzyl alcohol, cinnamaldehyde, citral, eugenol, geraniol, D-limonene, linalol, may cause allergic reactions.
For further information, see section 6.
Macrogolglycerol hydroxystearate may cause skin reactions.

3. How to Use Skinsept Mucosa

This medicinal product should always be used exactly as directed by the doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
Method of administration:
Apply to external mucous membranes and adjacent skin.
Unless otherwise directed by the doctor, apply the solution once, completely covering the disinfected surface, and leave it on for 60 seconds. In case of suspected HBV virus presence, extend the exposure time, leaving the solution on the disinfected surface for up to 30 minutes.

4. Possible Side Effects

Like all medicinal products, Skinsept Mucosa can cause side effects, although not everybody gets them.
Sometimes, temporary skin redness may occur, which does not pose any risk and disappears on its own.
Chemical burns have been reported due to the local use of chlorhexidine digluconate in newborns and infants. Premature babies are particularly at risk due to the immaturity of the skin barrier. Therefore, Skinsept Mucosa should only be used in newborns and infants when there are no alternative medicinal products available, and the expected therapeutic benefits outweigh the risks. It is recommended to remove any excess liquid immediately.
The frequency of possible side effects listed below is defined as follows:

• often: (may occur in 1 to 10 users in 100); skin irritation and contact dermatitis;
• rarely: (may occur in 1 to 10 users in 10,000); urticaria and allergic reactions, including anaphylactic shock;
• unknown: (frequency cannot be estimated from the available data); chemical burns in newborns and infants.
• unknown: corneal damage (eye surface damage) and permanent eye damage, including permanent vision impairment (after accidental exposure of the eye during surgical procedures on the head, face, and neck) in patients under general anesthesia (deep, painless sleep) - after using medicinal products containing chlorhexidine digluconate.

Concomitant use of products containing anionic surfactants may cause deactivation of chlorhexidine.

Reporting Side Effects

If you experience any side effects, including any not listed in this package leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Aleje Jerozolimskie 181C
02-222 Warsaw
tel.: +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.
Reporting side effects will help to gather more information on the safety of the medicinal product.

5. How to Store Skinsept Mucosa

Store at a temperature below 25°C.

Shelf Life:

18 months
8 weeks after the first opening of the immediate packaging.
Keep the medicinal product out of the sight and reach of children.

Do Not Use After the Expiry Date.

Medicinal products should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicinal products that are no longer needed.
This will help protect the environment.

6. Contents of the Package and Other Information

What Skinsept Mucosa Contains

Active substance: 100 g of solution contains: 10.4 g of ethanol 96%, 1.67 g of hydrogen peroxide 30%, 1.50 g of chlorhexidine digluconate solution.
Other ingredients are: lactic acid, povidone, macrogolglycerol hydroxystearate, fragrance MANE 260229 (benzyl alcohol, cinnamaldehyde, anethole, citral, eugenol, geraniol, propylene glycol, D-limonene, linalol, menthol, peppermint essential oil, sage essential oil, orange essential oil), sodium hydroxide 37%, purified water.

What Skinsept Mucosa Looks Like and What the Package Contains

Skinsept Mucosa is a clear, colorless, transparent solution with a menthol scent.
Packaging: bottles of 500 ml and 1000 ml.

Marketing Authorization Holder

Ecolab Sp. z o.o.
ul. Opolska 114
31-323 Kraków
Poland
+48 12 2616100

Manufacturer

Ecolab Deutschland GmbH
Reisholzer Werftstrasse 38-42
D-40589 Düsseldorf
Germany

Date of the Last Update of the Package Leaflet: