Octenisept

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

octenisept
(0.10 g + 2.00 g)/100 g, solution for the skin
Octenidini dihydrochloridum + Phenoxyethanolum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used in accordance with the description in the patient leaflet or as directed by a doctor or pharmacist.

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult a doctor or pharmacist if you need advice or additional information.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse.
• If there is no improvement or if you feel worse, you should contact your doctor.

Table of contents of the leaflet:

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

1. What is octenisept and what is it used for

Octenisept is a disinfectant solution containing the active substances: octenidine dihydrochloride, phenoxyethanol. Octenisept has bactericidal, fungicidal, and virucidal effects. The microbiological efficacy of the medicine has been extensively documented in both laboratory and clinical studies. The efficacy of the medicine in destroying microorganisms or inactivating viruses occurs after just 1 minute of application. After additional loading with mucous membrane protein under laboratory conditions, the medicine has a destructive effect on bacteria (including Chlamydia and Mycoplasma), fungi, yeast, protozoa (Trichomonas), and viruses (Herpes simplex, inactivates HBV and HIV). The effect of the medicine lasts for an hour, thus providing safety during diagnostic, therapeutic, or surgical procedures. Octenidine dihydrochloride belongs to cationic-active compounds, has two active centers, and acts on the surface of the wound and skin. Phenoxyethanol complements the action of octenidine dihydrochloride, acting in the deeper layers of the skin and mucous membranes. Octenisept is intended for:

• disinfecting and supporting the treatment of small, superficial wounds, as well as skin disinfection before non-surgical procedures
• supporting antiseptic treatment in the area of closed skin surfaces after procedures - e.g. post-operative sutures
• repeated, short-term antiseptic treatment in the area of mucous membranes and adjacent tissues before and after diagnostic procedures in the genital and anal areas, including the vagina, vulva, and glans penis, as well as before catheterization of the urinary bladder
• in pediatrics (including umbilical cord care)
• for disinfecting the oral cavity (e.g. aphthae, irritation caused by wearing an orthodontic appliance or dental prosthesis)
• for limited-time supporting antiseptic treatment of interdigital fungal infections
• in the genital area, e.g. in cases of vaginal inflammation, as well as on the glans penis in men.

Octenisept is intended for use in adults and children of all ages.

2. Important information before using octenisept

When not to use octenisept

If the patient is allergic to octenidine dihydrochloride, phenoxyethanol, or any of the other ingredients of this medicine (listed in section 6). The medicine should not be used for flushing the abdominal cavity.

Warnings and precautions

The medicine is for use on the skin.

Warning! To avoid the possibility of tissue damage, local swelling, the medicine should not be injected or introduced into the tissue under pressure. In each case, ensure proper drainage from the wound (e.g. drainage, suction).

The medicine should be used with caution in newborns, especially premature babies. Octenisept may cause severe skin changes. Excess medicine should be removed and ensured that the solution does not remain on the skin longer than necessary (this also applies to materials soaked with the solution that come into direct contact with the patient). The medicine should not be used in the eye. If the medicine comes into contact with the eyes, they should be rinsed immediately with a large amount of water. The medicine is not recommended for use in the ear and should not be swallowed. Octenidine dihydrochloride is more toxic when used intravenously than orally, so it is necessary to avoid the medicine entering the bloodstream in larger quantities, e.g. as a result of accidental injection. Given that octenidine dihydrochloride in octenisept is present in an amount of only 0.1%, the risk of this substance is unlikely.

Other medicines and octenisept

Octenisept should not be used together with antiseptics based on PVP-iodine (iodine complex with povidone) on adjacent parts of the body, as this may lead to strong brown or even purple discoloration. As a cationic medicine, octenisept may form poorly soluble residues when combined with anionic detergents or soaps. Due to the possibility of interactions with anionic compounds, it is recommended to use distilled water (or water for injections) as a solvent.

Pregnancy, breastfeeding, and fertility

There are no clinical trial results on the safety of using the medicine in pregnant and breastfeeding women.

Driving and using machines

No studies have been conducted on the effect of octenisept on the ability to drive vehicles and operate machinery.

3. How to use octenisept

This medicine should always be taken in accordance with the description in the patient leaflet or as directed by a doctor or pharmacist. In case of doubts, you should consult a doctor or pharmacist. Octenisept is recommended for use in an undiluted form. Method of administration: application to the skin. Octenisept should be applied at least once a day to the treated area by spraying, wiping with a sterile swab, or using a dressing to ensure complete moistening. Disinfection of the skin and mucous membraneThe skin and mucous membrane areas to be treated must be thoroughly moistened with a sterile swab soaked in octenisept or moistened by spraying the medicine directly onto the accessible skin and mucous membrane areas. The required exposure time should be observed - at least 1 minute, it is recommended to extend the time to 5 minutes. Attention should be paid to uniform moistening of the entire surface. Leave for at least 1 minute. Supportively in the treatment of fungal skin infections, between the toes, the medicine should be sprayed onto the affected surfaces in the morning and evening for a period of 14 days. Antiseptics for superficial woundsThe wound should be sprayed or wiped with a sterile swab soaked in octenisept. Octenisept should always be used when changing the dressing. In wounds with exudate, octenisept should be used in the form of a dressing, ensuring contact with the wound and its moistening for at least 1 minute, it is recommended to extend the time to 5 minutes. Post-operative suture careThe wound should be sprayed or wiped with a sterile swab soaked in octenisept. Octenisept should always be used when changing the dressing. Octenisept has disinfectant and analgesic effects. Disinfection of the wound area should be performed using sterile swabs soaked in undiluted octenisept, radiating from the center of the wound outwards. Mucous membrane antiseptics of the vaginaThe surfaces of the vaginal mucous membrane should be moistened with octenisept, ensuring contact with the mucous membrane for at least 1 minute. In numerous clinical studies, it has been shown that octenisept effectively acts bactericidally on various bacteria, including Gram-positive and Gram-negative bacteria. Antiseptics of the glans penis in menThe surfaces of the glans penis mucous membrane should be moistened with octenisept, ensuring contact with the mucous membrane for at least 1 minute. Disinfection of the oral cavityThe oral cavity should be rinsed intensively with 20 ml of octenisept for 20 seconds. Umbilical cord careFor umbilical cord care, a swab soaked in octenisept should be used. After 1 minute, the stump and the surrounding skin should be dried. The umbilical cord stump in children should be kept clean and dry.

Using a larger dose of octenisept than recommended

In case of using a larger amount of the medicine than recommended or swallowing the medicine, you should immediately contact a doctor. In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although they may not occur in everyone. After moistening the vaginal mucous membrane, a feeling of heat or burning may occur in rare cases. When rinsing the oral cavity, a bitter taste persists for about 1 hour, which is related to the action of the medicine.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell 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, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store octenisept

Store in a temperature below 25°C. The medicine should be stored in a place out of sight and reach of children. Shelf life after first opening the packaging: 3 years. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What does octenisept contain

The active substances of the medicine are: octenidine dihydrochloride and phenoxyethanol. 100 g of the liquid contains 0.10 g of octenidine dihydrochloride and 2.00 g of phenoxyethanol. The other ingredients are: dimethylaminoacetic acid amidopropylcocoate, sodium D-glucuronate, glycerol 85%, sodium chloride, sodium hydroxide, purified water.

What does octenisept look like and what does the packaging contain

Octenisept is a clear, colorless, almost odorless solution for the skin. Packaging: A plastic bottle with a spray pump containing 50 ml of the solution, in a cardboard box with a leaflet attached to the packaging. A plastic bottle with a tamper-evident closure containing 250 ml of the solution. For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Austria, the country of export:

Schülke & Mayr GmbH, Seidengasse 9, A-1070 Vienna, Austria

Manufacturer:

Schülke & Mayr GmbH, D-22840 Norderstedt, Germany

Parallel importer:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź

Repackaged by:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź, CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw, SHIRAZ PRODUCTIONS Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów, CANPOLAND SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź, Marketing authorization number in Austria, the country of export: 1-20402, Parallel import authorization number: 314/22, Date of leaflet approval: 24.08.2022, [Information about the trademark]