Oktaseptal

Package Leaflet: Information for the User

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

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, consult a doctor or pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after a few days of use, no improvement occurs or you feel worse, you should contact a doctor.

Table of Contents of the Package Leaflet

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

1. What is Oktaseptal and what is it used for

Oktaseptal contains two active substances: octenidine dihydrochloride and phenoxyethanol.
The medicine has bactericidal, fungicidal, and virucidal effects.
The effect of Oktaseptal occurs after 1 minute of application and lasts for about an hour.
Octenidine dihydrochloride acts on the surface of the wound and skin. Phenoxyethanol complements the action of octenidine dihydrochloride by penetrating deeper into the skin and mucous membranes.
Oktaseptal 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)
• disinfecting the oral cavity (e.g. aphthae, irritation caused by wearing orthodontic appliances or dental prostheses)
• limited-time, supportive 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.

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

2. Important information before using Oktaseptal

When not to use Oktaseptal

• if the patient is allergic to octenidine dihydrochloride, phenoxyethanol, or any of the other ingredients of this medicine (listed in section 6);
• for flushing the abdominal cavity.

Warnings and precautions

Before starting to use Oktaseptal, you should discuss it with your doctor, pharmacist, or nurse.
The medicine is intended for use on the skin.

Caution

To avoid tissue damage, the medicine should not be administered using a syringe into deep tissues. Oktaseptal is intended for external use only (using a swab).

It should be used with caution in newborns, especially premature babies. Oktaseptal 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).
Oktaseptal should not be used in the eye. In case of contact with the eyes, they should be rinsed immediately with a large amount of water.
Oktaseptal should not be used inside the ear and should not be swallowed.
Octenidine dihydrochloride is more toxic when used intravenously than orally, so it should be avoided to get the medicine into the bloodstream in larger quantities, e.g. as a result of accidental injection. Given that octenidine dihydrochloride in Oktaseptal is present only in a quantity of 0.1%, the risk of this substance is unlikely.

Oktaseptal and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

• Oktaseptal should not be used together with disinfecting agents (antiseptics) containing PVP iodine (iodine complex with povidone) on adjacent body parts, as this may cause intense brown or purple discoloration of the skin.
• Oktaseptal should not come into contact with soap and detergents (e.g. washing, cleaning, washing agents - so-called anionic surfactants), as insoluble residues may form.
• 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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
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 Oktaseptal on the ability to drive and use machines.

3. How to use Oktaseptal

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
Method of administration
Application to the skin.
The medicine should be used undiluted.
Oktaseptal 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 subjected to the procedure must be thoroughly moistened with a sterile swab soaked with Oktaseptal 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. The entire surface should be evenly moistened and left for at least 1 minute. Supportively in the treatment of fungal skin infections, between the toes, Oktaseptal should be used on 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 with Oktaseptal. Oktaseptal should be used every time the dressing is changed. In wounds with discharge, Oktaseptal 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 care

The wound should be sprayed or wiped with a sterile swab soaked with Oktaseptal. Oktaseptal should be used every time the dressing is changed. The medicine has a disinfecting and anesthetizing effect. Disinfection of the wound area should be performed using sterile swabs soaked with undiluted Oktaseptal and rinsed radially from the center to the outside of the wound.

• Antiseptics for the vaginal mucosa

Oktaseptal should be used to moisten the surfaces of the vaginal mucosa, ensuring contact with the mucosa for at least 1 minute. In numerous clinical trials, it has been shown that the medicine effectively acts bactericidally on various bacteria, including Gram-positive and Gram-negative bacteria.

• Antiseptics for the glans penis in men

Oktaseptal should be used to moisten the surfaces of the glans penis mucosa, ensuring contact with the mucosa for at least 1 minute.

• Disinfection of the oral cavity

The oral cavity should be rinsed intensively with 20 mL of Oktaseptal for 20 seconds.

• Umbilical cord care

For umbilical cord care, a swab soaked with Oktaseptal 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 more than the recommended dose of Oktaseptal

In case of using a larger dose of Oktaseptal than recommended or swallowing the medicine, you should immediately contact a doctor.

Missing a dose of Oktaseptal

A double dose should not be used to make up for a missed dose.
In case of any further doubts related to the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Oktaseptal can cause side effects, although not everybody gets them.
After using the medicine containing octenidine dihydrochloride and phenoxyethanol, the following side effects have been observed:
Rare (may affect up to 1 in 1,000 people):
burning sensation at the application site, redness, itching, feeling of warmth
Very rare (may affect up to 1 in 10,000 people):
allergic contact dermatitis
Frequency not known (frequency cannot be estimated from the available data):
after flushing deep wounds with a syringe, cases of persistent swelling, redness, and tissue necrosis have been reported. In some cases, surgical intervention was necessary (see section 2).
After moistening the vaginal mucosa, a feeling of warmth or burning may rarely occur.
After 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 those not listed in this package leaflet, 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 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Oktaseptal

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Store in the original package.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Oktaseptal 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: glycerol 85%, sodium D-glucuronate, cocamidopropyl betaine 30%, sodium hydroxide, purified water.

What Oktaseptal looks like and contents of the pack

Oktaseptal is a clear, colorless, almost odorless solution for the skin.
The packaging of the medicine is:
A PE bottle with a PP cap with a security ring and a child-resistant closure, with a PE sealing plug.
1 bottle contains 1000 mL of the solution.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne „UNIA” Spółdzielnia Pracy
ul. Chłodna 56/60, 00-872 Warsaw
tel.: 22 620 90 81 ext. 190, fax: 22 654 92 40
e-mail: [email protected]
The content of the Oktaseptal package leaflet is available in the Ulotka Audio system under the national, free phone number: 800 706 848.

Date of last revision of the package leaflet: