Octenisept
Poland
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Warning! Keep this leaflet, information on the immediate packaging is in a foreign language!
octenisept
(0.10 g + 2.00 g)/100 g, cutaneous solution
Octenidini dihydrochloridum + Phenoxyethanolum
Please read the following leaflet carefully before using this medicinal product, as it contains
important information for the patient.
This medicine should always be used in accordance with the instructions provided in this patient leaflet or as directed by a physician or pharmacist.
- Keep this leaflet for future reference.
- Consult your doctor or pharmacist if you need advice or further information.
- If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
- If symptoms do not improve or worsen, consult your doctor.
Table of contents of the leaflet:
- What octenisept is and what it is used for
- Important information before using 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 this medicinal product has been extensively documented in both laboratory and clinical studies. The effectiveness of the solution in destroying microorganisms or inactivating viruses is achieved within 1 minute of application. Even under conditions of additional protein load mimicking mucosal secretions in laboratory settings, the product exerts destructive effects on bacteria (including Chlamydia and Mycoplasma), fungi, yeasts, protozoa (Trichomonas), and viruses (Herpes simplex), and inactivates HBV and HIV. The antimicrobial activity persists for up to one hour, thereby ensuring safety during diagnostic, therapeutic, or surgical procedures. Octenidine dihydrochloride belongs to cationic-active compounds and has two active centers; it acts 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-procedural suture sites
- Short-term, repeated antiseptic treatment of mucous membranes and adjacent tissues before and after diagnostic procedures involving genital organs and anus, including vagina, vulva, and glans penis, as well as prior to urinary bladder catheterization
- Use in pediatrics (including 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 mycosis
- Antiseptic management of genital organs, e.g. in inflammatory conditions of the vagina or of the glans penis in males
Octenisept is intended for use in adults and children of all ages.
2. Information before using the medicinal product Octenisept
When not to use Octenisept
Do not use Octenisept if the patient is allergic to octenidine dihydrochloride, phenoxyethanol, or any of the
other ingredients of this medicinal product (listed in section 6).
Octenisept must not be used for lavage of the abdominal cavity.
Warnings and precautions
This medicinal product is for topical use on the skin only.
Caution! To avoid the risk of tissue damage or local edema, the medicinal product must not be injected or introduced under pressure into tissues. In all cases, adequate drainage from body cavities or wounds (e.g. via drainage tubes 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 in contact with 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. In case of contact with the eyes, rinse immediately and thoroughly with large amounts of water.
Use of Octenisept inside the ear canal is not recommended, and ingestion must be avoided.
Octenidine dihydrochloride is more toxic when administered intravenously than orally; therefore, exposure to large amounts of the medicinal product entering the bloodstream, e.g. due to accidental injection, should be avoided. However, since octenidine dihydrochloride in Octenisept is present only at a concentration of 0.1%, the risk associated with this substance is unlikely.
Other medicinal products and Octenisept
Octenisept should not be used concomitantly with antiseptics based on PVP-iodine (iodine-povidone complex) on adjacent areas of the body, as this may result in strong brown or even violet discolorations.
As a cationic medicinal product, Octenisept may form poorly soluble residues when combined with anionic soaps or detergents.
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 data available on the safety of using Octenisept during pregnancy and breastfeeding.
Driving and operating machinery
No studies on the effects of Octenisept on the ability to drive vehicles or operate machinery have been conducted.
3. How to use Octenisept
This medicinal product should always be used exactly as described in the patient information leaflet or as directed by a physician or pharmacist. If in doubt, consult a physician or pharmacist.
Octenisept is intended for use undiluted.
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 gauze swab, or using a compress, ensuring complete moistening of the area.
Disinfection of skin and mucous membranes
Areas of skin and mucous membranes to be treated must be thoroughly moistened using a sterile gauze swab soaked in Octenisept or by spraying the medicinal product directly onto accessible areas of skin and mucous membranes. The required contact time must be observed—minimum 1 minute; extending the contact time up to 5 minutes is recommended. Ensure even moistening of the entire surface. Leave in place for at least 1 minute. As supportive treatment in fungal skin infections, especially between the toes, spray Octenisept onto affected areas morning and evening for 14 days.
Antiseptic treatment of superficial wounds
Spray the wound or wipe it with a sterile gauze swab soaked in Octenisept. Octenisept should always be used during every dressing change. In exuding wounds, apply Octenisept as a moist compress, ensuring contact with the wound and maintaining moistening for at least 1 minute; extending the contact time up to 5 minutes is recommended.
Postoperative suture care
Spray the wound or wipe it with a sterile gauze swab soaked in Octenisept. Octenisept should always be used during every dressing change. Octenisept has antiseptic and local anesthetic effects. The area surrounding the wound should be disinfected using sterile gauze swabs soaked in undiluted Octenisept, wiping radially from the center of the wound outward.
Antiseptic treatment of vaginal mucous membranes
Moisten the surface of the vaginal mucous membranes with Octenisept, ensuring contact between the medicinal product and the mucous membrane for at least 1 minute. Numerous clinical studies have demonstrated that Octenisept exerts effective bactericidal activity against various bacteria, including Gram-positive and Gram-negative organisms.
Antiseptic treatment of male glans penis
Moisten the mucous membrane surface of the glans penis with Octenisept, ensuring contact between the medicinal product and the mucous membrane for at least 1 minute.
Oral cavity disinfection
Rinse the mouth vigorously with 20 ml of Octenisept for 20 seconds.
Umbilical stump care
For umbilical stump care, use a gauze swab soaked in Octenisept. After 1 minute, gently dry the stump and surrounding skin. The umbilical stump of the infant should be kept clean and dry.
Use of a higher than recommended dose of Octenisept
If more Octenisept than recommended has been used or if the product has been ingested, contact a physician immediately.
If you have any further questions about the use of this medicinal product, consult your physician or pharmacist.
4. Possible adverse reactions
Like any medicine, this medicine can cause adverse reactions, although not everybody gets them.
After moistening the vaginal mucosa, a sensation of warmth or burning may rarely occur. 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 reactions occur, including any adverse reactions not listed in the leaflet, inform your doctor, pharmacist or nurse. 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 181 C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions enables continued monitoring of the safety of the medicine.
5. How to store octenisept
Store below 25°C.
The medicine should be kept out of sight and reach of children.
Shelf life after first opening the container: 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Contents of the package and other information
What Octenisept contains
The active substances in this medicine are: octenidine dihydrochloride and phenoxyethanol.
100 g of the solution contains 0.10 g of octenidine dihydrochloride and 2.00 g of phenoxyethanol.
Other components are: cocamidopropyl dimethylammonium chloride, sodium D-gluconate, glycerol 85%, sodium chloride, sodium hydroxide, purified water.
What Octenisept looks like and contents of the pack
Octenisept is a clear, colourless, almost odourless solution for topical use.
Packaging:
Plastic bottle with spray pump containing 50 ml of solution, in a cardboard box with the package leaflet.
Plastic bottle with tamper-evident closure containing 250 ml of solution.
For further information, please contact the responsible entity or the parallel importer.
Marketing Authorisation Holder in Austria, 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
Poland
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Poland
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Poland
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Poland
Austrian Marketing Authorisation Number (country of export): 1-20402
Parallel Import Authorisation Number: 314/22