Package leaflet: information for the patient

Octefortan, (1 mg + 20 mg)/g, solution for skin application
Octenidini dihydrochloridum + Phenoxyethanolum
Please read this leaflet carefully before using the medicine, as 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 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 or if you feel worse, consult your doctor.

Table of contents of the leaflet

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

1. What Octefortan is and what it is used for

Octefortan is a disinfectant solution containing the active substances: octenidine dihydrochloride and phenoxyethanol. The product has bactericidal, fungicidal, and virucidal activity. The microbiological efficacy of the medicine has been widely documented in both laboratory and clinical studies. The effectiveness of the solution in destroying microorganisms or inactivating viruses occurs within 1 minute after application. Even under additional protein load simulating mucosal conditions in laboratory settings, the medicine exerts destructive effects on bacteria (including Chlamydium and Mycoplasma), fungi, yeasts, protozoa (Trichomonas), and viruses (Herpes simplex, and inactivates HBV and HIV). The effect of the medicine lasts for one hour, thereby ensuring safety during diagnostic, therapeutic, or surgical procedures. Octenidine dihydrochloride belongs to cationic surfactant compounds, has two active centers, and acts on the surface of wounds and skin. Phenoxyethanol complements the spectrum of activity of octenidine dihydrochloride by acting in deeper layers of the skin and mucous membranes.

The medicine is indicated for:

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

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

2. Important information before using Octefortan

When not to use Octefortan

if the patient is allergic to octenidine dihydrochloride, phenoxyethanol, or any of the other components of this medicine (listed in section 6).
This medicine must not be used for irrigating the abdominal cavity.

Warnings and precautions
Before starting to use Octefortan, discuss it with your doctor or pharmacist.
This is a medicine for topical use on the skin.
Caution! To avoid the risk of tissue damage or local swelling, the medicine must not be injected or
introduced into tissues under pressure. In all cases, adequate drainage from wound cavities (e.g. via drain or suction) must be ensured.
Use with caution in newborns, especially premature infants. The medicine may cause severe skin reactions. Excess medicine 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).
Do not use the medicine in the eyes. If contact occurs, rinse immediately with large amounts of water.
Do not use the medicine inside the ear or allow it to be swallowed.
Octenidine dihydrochloride is more toxic when administered intravenously than orally; therefore, avoid significant amounts of the medicine entering the bloodstream, for example due to accidental injection. However, since octenidine dihydrochloride is present in the medicine only at a concentration of 0.1%, the risk associated with this substance is unlikely.

Octefortan and other medicines
Tell your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.

This medicine should not be used together with antiseptics based on PVP-iodine (iodine complexed with povidone) on adjacent areas of the body, as this may lead to strong brown or even violet discolorations.
As a cationic agent, Octefortan may form poorly soluble residues when combined with anionic detergents or cleansing agents.

Pregnancy and breastfeeding
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.

Pregnancy
Octefortan should not be used during the first three months of pregnancy due to lack of clinical data for this period and as a general precaution.
Octefortan may be used during the remainder of pregnancy only if, in the opinion of the doctor, it is necessary.

Breastfeeding
There are no data available on the use of Octefortan during breastfeeding. Octefortan should not be used without medical advice.
Octefortan must be removed from the breast area before breastfeeding to prevent the newborn from being exposed to the medicine.

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

3. How to use Octefortan

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.
The medicine is recommended for use in undiluted form.
Method of administration
Topical application.
The medicine should be applied at least once daily to the affected area by moistening, wiping with a sterile gauze, or using a compress, ensuring complete wetting.

Antiseptic treatment of superficial wounds
Wipe the wound with a sterile gauze soaked in the medicine. The medicine should always be used with each dressing change. In exuding wounds, apply the medicine 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.

Disinfection of the oral cavity
Rinse the mouth vigorously with 20 mL of the medicine for 20 seconds.

Antiseptic treatment of the vaginal mucosa
Moisten the surface of the vaginal mucosa with the medicine, ensuring contact between the medicine and the mucosa for at least 1 minute. Numerous clinical studies have demonstrated that the medicine exerts effective bactericidal action against various bacteria, including Gram-positive and Gram-negative species.

Antiseptic treatment of the male glans penis
Moisten the mucosal surface of the glans penis with the medicine, ensuring contact with the mucosa for at least 1 minute.

Supportive treatment in interdigital fungal infections
Apply the medicine to the affected skin areas morning and evening for a period of 14 days. Ensure even moistening of the entire surface. Leave in place for at least 1 minute.

Care of the umbilical stump
Use a gauze pad soaked in the medicine for umbilical stump care. After 1 minute, dry the stump and surrounding skin. Keep the infant's umbilical stump clean and dry.

Care of postoperative wounds
Wipe the wound with a sterile gauze soaked in the medicine. Always use the medicine with each dressing change. The medicine has antiseptic and local anesthetic effects. Disinfect the area surrounding the wound using sterile gauzes soaked in undiluted medicine, wiping radially from the center of the wound outward.

Disinfection of skin and mucous membranes
Skin and mucous membrane areas intended for medical procedures must be thoroughly moistened with a sterile gauze soaked in the medicine. Ensure even coverage of the entire treated surface. Observe the required exposure time—leave the medicine on the surface for at least 1 minute; extending the exposure time up to 5 minutes is recommended.

Use of a higher than recommended dose of Octefortan
If more medicine is used than recommended or if the medicine is ingested, contact a doctor immediately. If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody experiences them.
After moistening the vaginal mucous membrane, 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 this leaflet, inform a 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: +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 medicine’s safety.

5. How to store Octefortan

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label.
The expiry date refers to the last day of the stated month.
Shelf-life after first opening of the immediate packaging: until the end of the expiry period.
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 packaging and other information

What Octefortan contains

The active substances in Octefortan are octenidine dihydrochloride and phenoxyethanol.
1 g of the skin solution contains 1 mg of octenidine dihydrochloride and 20 mg of phenoxyethanol.
Other components are: cocamidopropyl betaine (30% solution) with composition: dimethylammonium acetate of amidopropyl coco acid amide, sodium chloride, water; sodium gluconate, glycerol 85%, sodium hydroxide (for pH adjustment), purified water.

What Octefortan looks like and contents of the pack
Octefortan is a colourless, clear solution.
HDPE bottle with LDPE dropper and LDPE cap, containing 20 mL of solution,
packaged in a cardboard box.
HDPE bottle with HDPE cap, containing 500 mL or 1000 mL of solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel. + 48 (42) 22-53-100