Oktaseptal

Package leaflet: Information for the user

OKTASEPTAL, (0.10 g + 2.00 g)/100 g, cutaneous spray, solution
Octenidini 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 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 consult your doctor.

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 begins 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 activity of octenidine dihydrochloride by penetrating into deeper layers of the skin and mucous membranes.

Oktaseptal is indicated for:

• disinfection and supportive treatment of minor, superficial wounds, and skin disinfection prior to non-surgical procedures
• supportive antiseptic management on intact skin surfaces following procedures – e.g. post-operative sutures
• repeated, short-term 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 paediatrics (e.g. for umbilical stump care)
• oral cavity disinfection (e.g. aphthae, irritations caused by orthodontic appliances or dentures)
• short-term, supportive antiseptic treatment of interdigital fungal infections
• use on genital organs, e.g. in inflammatory conditions of the vagina, as well as on the glans penis in men.

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

2. 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 the abdominal cavity.

Warnings and precautions
Before starting to use Oktaseptal, discuss this with your doctor, pharmacist, or nurse.
This medicine is intended for 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 (using gauze).
Use with caution in newborns, especially premature infants. Oktaseptal 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).
Do not use Oktaseptal in the eyes. In case of contact with the eyes, rinse immediately with a large amount of water.
The use of Oktaseptal inside the ear canal is not recommended, and ingestion must be avoided.
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. 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
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.

• Oktaseptal should not be used together with disinfectants (antiseptics) 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. washing, cleaning, or laundry agents), 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 child, she should consult her doctor or pharmacist before using this medicine.
There are no clinical data on the safety of using this medicine in pregnant or breastfeeding women.

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

3. How to use Oktaseptal

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

Method of administration
For topical application.
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 must be thoroughly moistened with a sterile gauze pad 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, with recommended extension up to 5 minutes. The entire surface should be evenly moistened and left in contact for at least 1 minute. As supportive treatment for fungal skin infections between the toes, Oktaseptal should be sprayed on affected areas morning and evening for a period of 14 days.

• Antiseptic treatment of superficial wounds
  Spray the wound or wipe with a sterile gauze pad soaked in Oktaseptal. Oktaseptal should always be used during each dressing change. In exuding wounds, Oktaseptal should be applied as a 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
  Spray the wound or wipe with a sterile gauze pad soaked in Oktaseptal. Oktaseptal should always be used during each dressing change. The medicine has antiseptic and local anesthetic effects. The area surrounding the wound should be disinfected using sterile gauze pads soaked in undiluted Oktaseptal, applied radially from the center of the wound outward.

• Antiseptic treatment of vaginal mucous membranes
  Moisten the vaginal mucous membranes with Oktaseptal, ensuring contact with the mucous membrane for at least 1 minute. Numerous clinical studies have demonstrated that the medicine effectively exerts bactericidal action against various bacteria, including Gram-positive and Gram-negative organisms.

• Antiseptic treatment of male glans penis
  Moisten the mucous membrane of the glans penis with Oktaseptal, ensuring contact with the mucous membrane for at least 1 minute.

• Oral cavity disinfection
  Rinse the mouth thoroughly 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 infant's umbilical stump 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 dose.
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 product may cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been observed after using a medicinal product containing octenidine dihydrochloride and phenoxyethanol:

Rare (may affect less than 1 in 1,000 people):
burning sensation at the application site, erythema, itching, sensation of warmth

Very rare (may affect less than 1 in 10,000 people):
allergic contact dermatitis

Frequency not known (cannot be estimated from available data):
after irrigation of deep wounds using a syringe, cases of persistent swelling, erythema, and tissue necrosis have been reported. In some cases, surgical intervention was required (see section 2).

Rarely, after moistening of the vaginal mucosa, a sensation of warmth or burning may occur.
After rinsing the mouth, a bitter taste may persist for about 1 hour; this is related to the action of the medicinal product.

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 Reactions of Medicinal Products at 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 marketing authorization holder.
Reporting adverse reactions enables better assessment of the benefit-risk balance of the medicinal product.

5. How to store Oktaseptal

Keep the medicine out of 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 specified 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 pack and other information

What the medicine Oktaseptal contains

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

What the medicine Oktaseptal looks like and contents of the pack
The medicine Oktaseptal is a clear, colourless and almost odourless liquid.
Packaging consists of:
PE bottles with LDPE/PP atomiser, containing 30 ml, 50 ml, 60 ml or 250 ml of the medicine, placed
in a cardboard box with a package leaflet.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Pharmaceutical Plants "UNIA" Labour Cooperative
Chłodna Street 56/60, 00-872 Warsaw
Tel.: 22 620 90 81 ext. 190, Fax: 22 654 92 40
E-mail: [email protected]
The package leaflet content for Oktaseptal is available in the Audio Leaflet system via a nationwide, toll-free telephone number: 800 706 848.