Package leaflet: Information for the user

octenisept, (0.10 g + 2.00 g)/100 g, solution
Octenidinum dihydrochloridum + Phenoxyethanolum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please contact your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If your condition does not improve or worsens, consult your doctor.

Contents of the leaflet:

What octenisept is and what it is used for
Important information before use of octenisept
How to use octenisept
Possible side effects
How to store octenisept
Contents of the pack and other information

1. What octenisept is and what it is used for

Octenisept is a disinfectant solution containing the active substances: octenidine dihydrochloride, phenoxyethanol. Octenisept has bactericidal, fungicidal and virucidal properties. The microbiological efficacy of the product has been extensively documented in both laboratory and clinical studies. The solution exerts its microbicidal or virucidal effect within 1 minute of application. Even under conditions of protein load simulating mucosal secretions in laboratory settings, the product effectively destroys bacteria (including Chlamydia and Mycoplasma), fungi, yeasts, protozoa (Trichomonas), and viruses (Herpes simplex, and inactivates HBV and HIV). The antimicrobial effect persists for up to one hour, thereby ensuring safety during diagnostic, therapeutic or surgical procedures. Octenidine dihydrochloride is a cationic surfactant with two active centers, acting on the surface of skin and wounds. Phenoxyethanol complements the spectrum of octenidine dihydrochloride by acting within deeper layers of the skin and mucous membranes.

Octenisept is indicated for:

Disinfection and supportive treatment of minor, superficial wounds, and skin antisepsis prior to non-surgical procedures
Supportive antiseptic management of intact skin surfaces following procedures, e.g. post-operative suture sites
Repeated, short-term antiseptic treatment of mucous membranes and adjacent tissues before and after diagnostic procedures in the oral cavity, genital and anal areas, including vagina, vulva and glans penis, as well as prior to urinary bladder catheterization
Use in paediatrics (e.g. for umbilical stump care)
Disinfection of the oral cavity (e.g. aphthae, irritations caused by orthodontic appliances or dental prostheses)
Short-term, supportive antiseptic treatment of interdigital fungal infections
Antiseptic treatment of genital organs, e.g. in inflammatory conditions of the vagina or in conditions affecting the glans penis in males.

confidential PL S0012 p. 1
Module 1 octenisept Schülke
Octenisept is intended for use in adults and children of all ages.

2. Important information before using the medicine 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 must not be used for irrigation of the abdominal cavity.

Warnings and precautions
Before starting to use octenisept, discuss this with your doctor or pharmacist.
This medicine is for topical use on the skin only.
Caution! To avoid potential tissue damage and local swelling, the medicine must not be injected or
introduced into tissues under pressure. In all cases, adequate drainage from body cavities or wounds
(e.g. via drainage tube or suction) must be ensured.
Use with caution in newborns, especially premature infants. Octenisept may cause severe skin reactions. Excess product should be removed, and care must be taken to ensure that
the solution does not remain on the skin longer than necessary (this also applies to materials soaked with the solution that are in direct contact with the patient).
Octenisept must not be used in the eyes. If the medicine comes into contact with the eyes, rinse immediately with a large amount of water.
The use of octenisept inside the ear canal is not recommended, and the medicine must not be swallowed.
Octenidine dihydrochloride is more toxic when administered intravenously than orally; therefore, care should be taken to avoid significant absorption into the bloodstream, for example due to accidental injection. Since octenidine dihydrochloride is present in octenisept only at a concentration of 0.1%, the risk associated with this substance is unlikely.

Interaction of octenisept with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently using, has recently used, or plans to use.
Octenisept should not be used together with antiseptics based on PVP-iodine (iodine complexed with povidone) on adjacent skin areas, as this may lead to strong brown or even violet discolourations.
As a cationic agent, octenisept may form poorly soluble residues when combined with anionic soaps or detergents.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Octenisept should not be used during the first 3 months of pregnancy due to lack of clinical data regarding use during the first trimester and as a general precaution.
The medicine may be used during the remainder of pregnancy only if, in the opinion of the physician, its use is considered necessary.

Breastfeeding
There is no data available on the use of octenisept during breastfeeding. Octenisept should not be used without medical advice.
Octenisept must be removed from the breast area before breastfeeding to prevent the newborn from ingesting the medicine.

Driving and operating machinery
No studies have been conducted on the effects of octenisept on the ability to drive vehicles or operate machinery.

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 in doubt, consult your doctor or pharmacist.
Octenisept is recommended for use in its undiluted form.
Method of administration
Application to the skin
Octenisept should be applied at least once daily to the affected area by spraying, wiping with a
sterile swab, or using a compress, ensuring complete wetting of the area.

Disinfection of skin and mucous membranes
Areas of skin and mucous membranes to be treated should be thoroughly moistened using a sterile swab soaked in octenisept or by spraying the medicine directly onto accessible areas of skin and mucous membranes. The required contact time must be observed—minimum 1 minute; extending up to 5 minutes is recommended. Ensure even wetting of the entire surface. Leave in place for at least 1 minute. As supportive treatment in fungal skin infections between the toes, spray the affected areas morning and evening for a period of 14 days.

Antisepsis of superficial wounds
Spray the wound or wipe it with a sterile swab soaked in octenisept. Octenisept should always be used during each dressing change. In exuding wounds, octenisept should be applied as a moist compress, ensuring contact with the wound and maintaining wetness for at least 1 minute; extending up to 5 minutes is recommended.

Care of postoperative sutures
Spray the wound or wipe it with a sterile swab soaked in octenisept. Octenisept should always be used during each dressing change. Octenisept has antiseptic and local anesthetic effects. Disinfection around the wound should be performed using sterile swabs soaked in undiluted octenisept, wiping radially from the center of the wound outward.

Antisepsis of the vaginal mucous membrane
Moisten the surfaces of the vaginal mucous membrane with octenisept, ensuring contact with the mucous membrane for at least 1 minute. Numerous clinical studies have shown that octenisept effectively kills a wide range of bacteria, including Gram-positive and Gram-negative bacteria.

Antisepsis of the male glans penis
Moisten the mucous membrane surfaces of the glans penis with octenisept, ensuring contact with the mucous membrane for at least 1 minute.

confidential PL S0012 p. 3
Module 1 octenisept Schülke

Disinfection of the oral cavity
Rinse the mouth vigorously with 20 ml of octenisept for 20 seconds.

Care of the umbilical stump
For care of the umbilical stump, use a swab soaked in octenisept. After 1 minute, dry the stump and surrounding skin. The infant's umbilical stump should be kept clean and dry.

Use of a larger than recommended dose of octenisept
If more medicine is used than recommended or if the medicine is ingested, contact a doctor immediately.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
After moistening the vaginal mucous membrane, a sensation of warmth or burning may occur in rare cases.
When rinsing the mouth, a bitter taste may persist for about 1 hour; this is related to the action of the medicine.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: (22) 49 21 301, fax: (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 octenisept

Store below 25°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging and on the
bottle. The expiry date refers to the last day of the stated month.
Shelf-life after first opening of the bottle: 3 years.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. Such measures will help protect the
environment.

6. Contents of the pack and other information

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

What Octenisept looks like and contents of the pack
Octenisept is a clear, colourless, almost odourless liquid.
Packaging:
HDPE bottles with a spray pump made of LDPE with tamper-evident seal, or with an integrated, permanently attached pump made of HD/LD-PE/PP/EVA (cannot be unscrewed), containing 50 ml, 100 ml or 250 ml of solution.
HDPE bottles with PP closure with tamper-evident seal, containing 450 ml, 500 ml or 1000 ml of solution.
The 50 ml and 100 ml bottles are packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation 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]

For further information, please contact the local representative of the Marketing Authorisation Holder:
Schulke Polska Sp. z o.o.
Al. Jerozolimskie 132
02-305 Warsaw
Poland
Tel.: 22 11 60 700
Fax: 22 11 60 701
E-mail: [email protected]