Oktaseptal

Package leaflet: Information for the user

OKTASEPTAL, (0.10 g + 2.00 g)/100 g, cutaneous solution
Octenidini dihydrochloridum + Phenoxyethanolum
Please read this leaflet carefully before using this 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 a
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your doctor or pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after several days of use, or if you feel worse, you should contact your doctor.

Table of contents of the leaflet

1. What Oktaseptal is and what it is 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 Oktaseptal is and what it is used for

Oktaseptal contains two active substances: octenidine dihydrochloride and phenoxyethanol.
The medicine has bactericidal, fungicidal and virucidal properties.
The effect of Oktaseptal occurs within 1 minute after application and lasts approximately
for one hour.
Octenidine dihydrochloride acts on the surface of wounds and skin. Phenoxyethanol complements the spectrum of octenidine dihydrochloride by penetrating into deeper layers of the skin and mucous membranes.
Oktaseptal is intended for:

• disinfection and supportive treatment of minor superficial wounds, and skin disinfection prior to non-surgical procedures
• supportive antiseptic management on intact skin surfaces after procedures – e.g. post-procedural sutures
• repeated, short-term antiseptic treatment on mucous membranes and adjacent tissues before and after diagnostic procedures in the genital and anal areas, including vagina, vulva and glans penis, as well as prior to urinary bladder catheterization
• use in paediatrics (including care of the umbilical stump)
• oral cavity disinfection (e.g. aphthae, irritation caused by orthodontic appliances or dental prostheses)
• short-term, supportive antiseptic treatment of interdigital tinea
• use in the genital organs, e.g. in inflammatory conditions of the vagina, as well as on the glans penis in males

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 washing out the abdominal cavity.

Warnings and precautions
Before starting to use Oktaseptal, discuss this with your doctor, pharmacist, or nurse.
This medicine is intended for topical use on the skin.
Warning
To avoid tissue damage, the product must not be administered via syringe into deep tissues. Oktaseptal is intended exclusively for external use (applied with a gauze pad).
Use with caution in newborns, especially premature infants. Oktaseptal may cause severe skin reactions.
Excess product should be removed, and it must be ensured 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).
Do not use Oktaseptal in the eyes. In case of contact with the eyes, rinse immediately with plenty of water.
The use of Oktaseptal inside the ear is not recommended, and ingestion must be avoided.
Octenidine dihydrochloride is more toxic when administered intravenously than orally; therefore, it is important to avoid significant absorption into the bloodstream, e.g., due to accidental injection. However, since octenidine dihydrochloride in Oktaseptal is present only at a concentration of 0.1%, the risk associated with this substance is unlikely.

Oktaseptal and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient intends to use.

• Oktaseptal should not be used together with antiseptic agents containing PVP-iodine (iodine complexed with povidone) on adjacent areas of the body, as this may cause intense brown or violet skin discoloration.
• Avoid contact between Oktaseptal and soap or detergents (e.g., laundry, cleaning, or 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 the solvent.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
There are no clinical data available on the safety of using Oktaseptal in pregnant or breastfeeding women.

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

3. How to use Oktaseptal

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Method of administration
For topical application on the skin.

The medicine should be used undiluted.
Oktaseptal should be applied at least once daily to the affected area by spraying, wiping with a sterile gauze, or using a compress, ensuring complete moistening.

• Disinfection of skin and mucous membranes
  Areas of skin and mucous membranes to be treated should be thoroughly moistened with a sterile gauze soaked in Oktaseptal 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 the time up to 5 minutes is recommended. The entire surface should be evenly moistened and left for at least 1 minute. For supportive treatment of fungal skin infections, particularly between the toes, Oktaseptal should be applied to affected areas morning and evening for 14 days.

• Antiseptic treatment of superficial wounds
  The wound should be sprayed or wiped with a sterile gauze soaked in Oktaseptal. Oktaseptal should always be used during each dressing change. In exuding wounds, Oktaseptal should be applied as a moist compress, ensuring contact with the wound and maintaining moisture for at least 1 minute; extending the contact time up to 5 minutes is recommended.

• Postoperative suture care
  The wound should be sprayed or wiped with a sterile gauze soaked in Oktaseptal. Oktaseptal should be used during every dressing change. The medicine acts as both an antiseptic and a local anesthetic. The area surrounding the wound should be disinfected using sterile gauzes soaked in undiluted Oktaseptal, wiping radially from the center of the wound outward.

• Antiseptic treatment of vaginal mucous membranes
  The vaginal mucous membranes should be moistened with Oktaseptal, ensuring contact with the mucosa for at least 1 minute. Numerous clinical studies have demonstrated that the medicine effectively exerts bactericidal activity against various bacteria, including Gram-positive and Gram-negative species.

• Antiseptic treatment of male glans penis
  The mucous membrane of the male glans penis should be moistened with Oktaseptal, ensuring contact with the mucosa for at least 1 minute.

• Oral cavity disinfection
  The oral cavity should be vigorously rinsed with 20 mL of Oktaseptal for 20 seconds.

• Umbilical stump care
  For umbilical stump care, use a gauze pad soaked in Oktaseptal. 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 Oktaseptal
If more Oktaseptal than recommended has been used or if the medicine has been accidentally ingested, contact a doctor immediately.

Missed dose of Oktaseptal
Do not use a double dose to make up for a missed application.

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.
The following adverse reactions have been observed after administration of a medicinal product containing octenidine dihydrochloride and phenoxyethanol:
Rare (may affect fewer than 1 in 1,000 people):
sensation of burning at the site of application, erythema, itching, feeling of warmth
Very rare (may affect fewer than 1 in 10,000 people):
allergic contact dermatitis
Frequency not known (frequency cannot be estimated from the available data):
after rinsing deep wounds using a syringe, cases of persistent swelling, erythema and tissue necrosis have been reported. In some cases, surgical intervention was necessary (see section 2).
After moistening the vaginal mucosa, a sensation of warmth or burning may rarely occur.
After mouth rinsing, a bitter taste may persist for approximately 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 this 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 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions enables better assessment of the safety of the medicine.

5. How to store the medicine Oktaseptal

Keep this medicine out of the sight and reach of children.
Store below 25°C. Keep in the original packaging.
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 must 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 packaging and other information

What the medicine Oktaseptal contains

• The active substances in the medicine are octenidine dihydrochloride and phenoxyethanol.
• 100 g of the skin solution contains 0.10 g of octenidine dihydrochloride and 2.00 g of phenoxyethanol.
• Other ingredients are: glycerol 85%, sodium D-gluconate, cocamidopropyl betaine 30%, sodium hydroxide, purified water.

What Oktaseptal looks like and contents of the pack
Oktaseptal is a clear, colourless, almost odourless solution for the skin.
The medicine is packed in:
A PE bottle with a PP screw cap, with a tamper-evident seal and child-resistant closure, and a PE sealing wad.
1 bottle contains 1000 mL of solution.

Marketing Authorisation 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 package leaflet of Oktaseptal is available in the Audio Leaflet system via a nationwide, toll-free telephone number: 800 706 848.