Skinsept_mucosa_500ml_82015

Skinsept™ mucosa

Preparation for disinfecting mucous membranes

Skinsept mucosa is intended for disinfecting mucous membranes and adjacent skin before surgery, gynaecological and obstetric procedures, catheterisation of the bladder and transurethral procedures. Skinsept mucosa is a combination medicine which contains active substances with proven efficacy. The active ingredients of this medicine (ethanol, hydrogen peroxide and chlorhexidine digluconate) complement one another, ensuring its broad-spectrum activity. The medicine has a bactericidal, fungicidal, protocidal and viricidal effect on Herpes simplex (herpes virus), and it inactivates HBV and HIV. Hydrogen peroxide ensures that the medicine is free from spores during its manufacture, pouring and filling. The hydrogen peroxide contained in the preparation destroys bacteria spores that may get back into the solution.

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SKINSEPT™ MUCOSA
(10.40 g + 1.67 g + 1.50 g)/100 g solution for use on mucous membranes
Ethanolum 96 per centum + Hydrogenii peroxidum 30 per centum + Chlorhexidini digluconatis solutio

Do not use Skinsept mucosa:

  • if you are hypersensitive to the active substances or to any of the excipients listed in Section 6.1. The medicine must not be used in infants and young children due to lack of data. Do not apply to large-area wounds; do not apply to eyes or ears.
  • Skinsept mucosa should not be used within the abdominal cavity (e.g. during surgery) or on nasal and bronchial mucous membranes. Do not use the medicine in the case of known allergic reactions to its ingredients.

Warnings and precautions

Do not use with agents containing anionic surfactants, which may deactivate the active substances included in the medicine. Store below 25°C.

Do not use after the expiry date. Keep out of sight and out of reach of children.


Pregnancy, breastfeeding and fertility

Accidental ingestion of the medicine poses a health risk.


Driving and operating machinery

The effect of Skinsept mucosa on your ability to drive or operate machinery is not known.


Important information about some of the ingredients of Skinsept mucosa

The medicine contains 12.4% ethanol (ethyl alcohol). In the event of accidental ingestion, this medicine may pose a health risk. This applies, among others, to people with liver disease, alcoholism, epilepsy, brain damage, and children.

Always take this medicine as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.


How to use:

Application to external mucous membranes and adjacent skin:

Unless the doctor recommends otherwise, apply the solution once, completely covering the surface to be disinfected, and leave it for 60 seconds. If HBV presence is suspected, extend the duration of the procedure, leaving the solution on the surface to be disinfected for up to 30 minutes.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Sometimes short-term redness of the skin appears, which does not pose any threat and passes by itself. Chemical burns have been reported as a result of topical use of chlorhexidine gluconate in newborns and infants. Premature babies are at particular risk owing to the immaturity of their epidermal barrier. Therefore, Skinsept mucosa may only be used in newborns and infants if there are no alternative medicines and the expected therapeutic benefits outweigh the risks. Any surplus liquid should be removed immediately.

The frequency of possible side effects listed below was determined as follows:

  • common (may affect 1 to 10 people in 100): skin irritation and contact dermatitis;
  • rare (may affect 1 to 10 people 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.

Concomitant use of agents containing anionic surfactants may result in the deactivation of chlorhexidine.


Reporting of side effects

If you experience any side effects, including any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse. Side effects may be reported directly to the Department for Monitoring Adverse Actions of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocides [Departament Monitorowania Niepożądanych Działań Produktów Leczniczych Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych], Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl

Side effects may also be reported to the marketing authorisation holder. Reporting side effects helps us gather more information on the safety of the medicine.

Store below 25°C.


Shelf life:

  • 1 year
  • 8 weeks after first opening
  • Keep out of sight and out of reach of children.

Do not use after the expiry date.

  • Do not throw away any medicines via waste water or household waste.
  • Ask your pharmacist how to dispose of medicines you no longer use.
  • These measures will help protect the environment.

What Skinsept mucosa contain

Active substance:

100 g solution contains:

  • 10.4 g ethanol (96%)
  • 1.67 g hydrogen peroxide 30
  • 1.50 g chlorhexidine digluconate solution.

The other ingredients are: lactic acid, povidone, macroglycerol hydroxystearate, fragrance (83-2890 B), sodium hydroxide 37%, purified water.

What Skinsept mucosa looks like and contents of the package

Skinsept mucosa is a clear, colourless, transparent solution with a menthol fragrance.

Packaging:

500 ml and 1,000 ml bottles.

Marketing authorisation No 13033.
This leaflet was last updated: 2018/07/20


Available packaging

Unit Wholesale Symbol
500 ml bottle 12 pcs. 3005380
1,000 ml bottle 12 pcs. 3005390

For more information about the product, please check the label.

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