Octenisept

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging 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 exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• 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 within 1 minute of application. After additional loading with mucous membrane protein under laboratory conditions, the medicine has a destructive effect on bacteria (including Chlamydiumand Mycoplasma), fungi, yeast, protozoa (Trichomonas), and viruses (including Herpes simplex, inactivates HBV and HIV). The effect of the medicine lasts for one hour, thus ensuring safety during diagnostic, therapeutic, or surgical procedures.
Octenidine dihydrochloride belongs to the group of 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 oral cavity, genital organs, and anus, 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, irritations caused by wearing orthodontic appliances or dental prostheses)
• for limited-time supporting antiseptic treatment of interdigital fungal infections
• in the area of genital organs, e.g., in inflammatory conditions of the vagina, as well as in the area of 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).
Octenisept should not be used for flushing the abdominal cavity.

Warnings and precautions

Before starting to use Octenisept, you should discuss it with your doctor or pharmacist.
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 administered under pressure. In each case, ensure proper drainage from the wound (e.g., drainage, suction).

Caution should be exercised when using Octenisept in newborns, especially premature infants. Octenisept may cause severe skin changes. Excess medicine should be removed, and it should be 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).
Octenisept should not be used in the eyes. If the medicine comes into contact with the eyes, they should be rinsed immediately with a large amount of water.
Octenisept is not recommended for use in the ear canal, and it should not be swallowed.
Octenidine dihydrochloride is more toxic when administered intravenously than orally; therefore, it should be avoided that the medicine enters the bloodstream in larger quantities, e.g., as a result of accidental injection. Given that octenidine dihydrochloride is present in Octenisept only in a concentration of 0.1%, the risk of this substance is unlikely.

Octenisept and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
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.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
Octenisept should not be used during the first 3 months of pregnancy due to the lack of clinical data on the first 3 months of pregnancy and as a precautionary measure.
The medicine can be used during the remaining period of pregnancy only if, in the doctor's opinion, it is necessary.
Breastfeeding
There are no data on the use of Octenisept during breastfeeding. Octenisept should not be used without a doctor's recommendation.
Octenisept should be removed from the breast area before breastfeeding to prevent the infant from taking the medicine.

Driving and using machines

No studies have been conducted on the effect of Octenisept on the ability to drive and use machines.

3. How to use Octenisept

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
Octenisept is recommended for use undiluted.
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 membrane
The 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, and it is recommended to extend the time to 5 minutes. Attention should be paid to uniform moistening of the entire surface. Leave it on for at least 1 minute. To support 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 wounds
The 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 discharge, Octenisept should be used in the form of a dressing, ensuring contact with the wound and its moistening for at least 1 minute, and it is recommended to extend the time to 5 minutes.
Post-operative suture care
The wound should be sprayed or wiped with a sterile swab soaked in Octenisept. Octenisept should always be used when changing the dressing. Octenisept has disinfecting and anesthetizing effects. Disinfection of the wound surroundings should be performed using sterile swabs soaked in undiluted Octenisept, radiating from the center of the wound outward.
Antiseptics for the vaginal mucosa
The vaginal mucosa surfaces should be moistened with Octenisept, ensuring contact between the medicine and the mucosa for at least 1 minute. In numerous clinical studies, it has been shown that Octenisept effectively acts bactericidally against various bacteria, including Gram-positive and Gram-negative bacteria.
Antiseptics for the glans penis in men
The glans penis mucosa surfaces should be moistened with Octenisept, ensuring contact between the medicine and the mucosa for at least 1 minute.
Disinfection of the oral cavity
The oral cavity should be rinsed intensively with 20 ml of Octenisept for 20 seconds.
Umbilical cord care
A swab soaked in Octenisept should be used for umbilical cord care. 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

If you use a larger amount of the medicine than recommended or swallow it, you should immediately contact your doctor.
If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
After moistening the vaginal mucosa, 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 effect 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 or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 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 provide more information on the safety of this medicine.

5. How to store Octenisept

Store at a temperature below 25°C.
The medicine should be stored in a place that is out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Shelf life after first opening the bottle: 3 years.
Medicines should not be disposed of via wastewater or household waste. 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 Octenisept contains

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

What Octenisept looks like and what the packaging contains

Octenisept is a clear, colorless, almost odorless solution.
Packaging:
A plastic bottle with a spray pump, containing 50 ml of the solution, in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or the 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Austrian marketing authorization number, the country of export:1-20402

Parallel import authorization number: 154/23

Date of leaflet approval: 31.07.2023

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