Octenisept

1. What is octenisept and what is it used for

Octenisept is a disinfectant liquid 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 Chlamydium and Mycoplasma), fungi, yeast, protozoa (Trichomonas), and viruses (Herpes simplex, inactivates HBV and HIV). The effect of the medicine lasts for an hour, thus ensuring 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 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, irritation caused by wearing an orthodontic appliance or dental prosthesis)
• for limited-time 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.

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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 abdominal cavity lavage.

Warnings and precautions

Before starting to use octenisept, the doctor or pharmacist should be consulted.
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, proper drainage of the wound (e.g. drainage, suction) should be ensured.

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 should not be used inside the ear, 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. Due to the fact 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

The doctor or pharmacist should be informed about all medicines currently or recently used by the patient, as well as about medicines that the patient plans to use.
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 cause strong brown or even purple discoloration.
As a cationic medicine, octenisept may form poorly soluble residues when combined with anionic detergents or cleaning agents.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a 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 due to general precautions.
The medicine can be used during the remaining period of pregnancy only if, in the doctor's opinion, it is necessary.
Breastfeeding
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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 vehicles and operate machines.

3. How to use octenisept

This medicine should always be used exactly as described in this patient leaflet or according to the doctor's or pharmacist's instructions. In case of doubts, the doctor or pharmacist should be consulted.
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 that ensures complete moistening.
Disinfection of skin and mucous membranes
The skin and mucous membranes to be treated must be thoroughly moistened with a sterile swab soaked with octenisept or moistened by spraying the medicine directly onto the accessible skin and mucous membranes. 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 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 14 days.
Antiseptics for superficial wounds
The wound should be sprayed or wiped with a sterile swab soaked with octenisept. Octenisept should be used every time the dressing is changed. 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 with octenisept. Octenisept should be used every time the dressing is changed. Octenisept has disinfectant and anesthetic effects. Disinfection of the wound surroundings should be performed using sterile swabs soaked with undiluted octenisept, radiating from the center of the wound outwards.
Antiseptics for vaginal mucous membranes
The medicine should moisten the surfaces of the vaginal mucous membranes, 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 for the glans penis in men
The medicine should moisten the surfaces of the glans penis mucous membranes, ensuring contact with the mucous membrane for at least 1 minute.
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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 with 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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
After moistening the vaginal mucous membranes, 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 any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. 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 181C, 02-222 Warsaw, tel. (22) 49 21 301, and fax (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 allow for more information to be collected on the safety of the 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.
The medicine should not be used after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the specified month.
Shelf life after first opening the bottle: 3 years.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Package contents and other information

What octenisept contains

The active substances of the medicine are: octenidine dihydrochloride and phenoxyethanol.
100 g of liquid contains 0.10 g of octenidine dihydrochloride and 2.00 g of phenoxyethanol.
The other ingredients are: cocamidopropyl betaine - 30% or 38% solution (dimethylammonium acetate, amidopropyl cocoate), sodium chloride, sodium D-gluconate, glycerol 85%, sodium hydroxide, purified water.

What octenisept looks like and what the package contains

Octenisept is a clear, colorless, almost odorless liquid.
Packaging:
HDPE bottles with a spray pump made of LDPE with a tamper-evident closure or with an integrated pump made of HD/LD-PE/PP/EVA (cannot be removed), containing 50 ml, 100 ml, or 250 ml of liquid.
HDPE bottles with a PP closure and a tamper-evident closure, containing 450 ml, 500 ml, or 1000 ml of liquid.
The 50 ml and 100 ml bottles are placed in a carton.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Schülke & Mayr GmbH
Robert Koch Strasse 2
22851 Norderstedt
Germany
Tel.: +49 40 52100-0
Fax: + 49 40 52100-318
E-mail: [email protected]
To obtain more detailed information, the local representative of the marketing authorization holder should be contacted:
Schulke Polska Sp. z o.o.
Al. Jerozolimskie 132
02-305 Warsaw
Tel.: 22 11 60 700
Fax: 22 11 60 701
E-mail: [email protected]

Date of last revision of the leaflet: May 2023

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