Skinsept mucosa

Package leaflet: Information for the user

Skinsept Mucosa (10.40 g + 1.67 g + 1.50 g) / 100 g, solution for mucous membranes
Ethanolum 96 per centum + Hydrogenii peroxidum 30 per centum + Chlorhexidini digluconatis solutio
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the
physician, pharmacist, or nurse.
Keep this leaflet, as you may need to read it again.

• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your physician, pharmacist, or nurse. See section 4.
• If your condition does not improve or worsens, contact your physician.

Contents of the leaflet:

1. What Skinsept Mucosa is and what it is 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 pack and other information

1. What Skinsept Mucosa is and what it is used for

Skinsept Mucosa is intended for disinfection of mucous membranes and adjacent skin prior to surgical procedures, gynecological and obstetric interventions, urinary bladder catheterization, and transurethral procedures.
Skinsept Mucosa is a combination medicine containing active substances with proven efficacy. The active substances contained in this medicine—ethanol, hydrogen peroxide, and chlorhexidine digluconate—complement each other's spectrum of activity, providing broad antimicrobial action. The medicine has bactericidal, fungicidal, protozoacidal, and virucidal effects against Herpes simplex (herpes simplex virus), and inactivates HBV and HIV viruses.
Hydrogen peroxide ensures that the product remains free from bacterial spores during manufacturing, transfer, and filling processes. The hydrogen peroxide contained in the medicine destroys bacterial spores that might re-enter the solution.

2. Important information before using Skinsept Mucosa

When not to use Skinsept Mucosa

• if the patient has known hypersensitivity to the active substances or to any of the excipients listed in section 6.1. The product must not be used in infants and young children due to lack of data. Do not apply to large wounds; do not use in eyes or ears. Skinsept Mucosa should not be used within the abdominal cavity (e.g. intraoperatively) or on nasal or bronchial mucous membranes. The product should not be used in cases of known allergic reactions to its components.

Warnings and precautions
Avoid contact of Skinsept Mucosa with the eyes due to the risk of visual damage.
In case of eye contact, immediately and thoroughly rinse eyes with water. If eye irritation, redness or pain occurs, or if vision disturbances develop, contact a physician immediately.
Following accidental contact with eyes during surgical procedures, severe cases of permanent corneal damage (surface eye damage) have been reported in patients under general anaesthesia (in deep, painless sleep) after use of products containing chlorhexidine digluconate, which may necessitate corneal transplantation.
Do not use together with products containing anionic surfactants, as they may cause deactivation of the active substances in the medicinal product.
Pregnancy, breastfeeding and fertility
Accidental ingestion poses a health hazard.
Driving and operating machinery
The effect of Skinsept Mucosa on the ability to drive and operate machinery is unknown.
Important information about certain excipients in Skinsept Mucosa
The product contains 12.4% ethanol (ethyl alcohol).
Accidental ingestion may pose a health hazard, particularly in individuals with liver disease, alcoholism, epilepsy, brain damage, and in children.
Skinsept Mucosa contains fragrances and macrogolglycerol hydroxystearate
The fragrances contained in this medicinal product, namely: benzyl alcohol, cinnamaldehyde, citral, eugenol, geraniol, D-limonene, linalool, may cause allergic reactions.
Additional information – see section 6.
Macrogolglycerol hydroxystearate may cause skin reactions.

3. How to use Skinsept Mucosa

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
Method of use:
Application to external mucous membranes and adjacent skin
Unless otherwise directed by a physician, apply the solution once, completely covering the
surface to be disinfected, and leave it in place for 60 seconds. In case of suspected presence
of HBV virus, prolong the contact time by leaving the solution on the surface to be disinfected
for up to 30 minutes.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Transient redness of the skin may occasionally occur, which is not dangerous and resolves spontaneously.
Chemical burns have been reported following topical application of chlorhexidine gluconate in newborns and infants. Premature infants are particularly at risk due to the immaturity of the skin barrier. Therefore, Skinsept Mucosa should be used in newborns and infants only when no alternative medicine is available and when the expected therapeutic benefit outweighs the risk. It is recommended to promptly remove any excess fluid.
The frequency of the possible adverse reactions listed below is defined as follows:

• Common (may occur in 1 to 10 out of 100 people): skin irritation and contact dermatitis;
• Rare (may occur in 1 to 10 out of 10,000 people): urticaria and allergic reactions, including anaphylactic shock;
• Unknown frequency (cannot be estimated from available data): chemical burns in newborns and infants.
• Unknown frequency: corneal damage (damage to the surface of the eye) and permanent eye damage, including permanent visual impairment (following accidental eye exposure during surgical procedures on the head, face, and neck) in patients under general anaesthesia (deep, painless sleep) after administration of medicinal products containing chlorhexidine digluconate.

Concurrent use of products containing anionic surfactants may result in deactivation of chlorhexidine.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. 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 Skinsept Mucosa

Store below 25°C.
Shelf life:
18 months
8 weeks after first opening of the immediate packaging
Keep out of sight and reach of children.
Do not use after the expiry date.
Medicines must not be disposed of in wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use.
This will help protect the environment.

6. Contents of the packaging and other information

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

What Skinsept Mucosa looks like and contents of the pack
Skinsept Mucosa is a clear, colourless, transparent solution with a menthol odour.
Packaging: bottles of 500 ml and 1000 ml.

Marketing Authorisation Holder
Ecolab Sp. z o.o.
Opolska Street 114
31-323 Kraków
Poland
+48 12 2616100

Manufacturer
Ecolab Deutschland GmbH
Ecolab-Allee 1
D-40789 Monheim am Rhein,
Germany