Patient Information Leaflet

Octefortan, (1 mg + 20 mg)/g, cutaneous spray, solution
Octenidini dihydrochloridum + Phenoxyethanolum
Please read this 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 patient leaflet or as directed by a 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 your condition does not improve or worsens, consult your doctor.

Table of contents

What is Octefortan and what is it 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 is Octefortan and what is it used for

Octefortan is a disinfectant solution containing the active substances: octenidine dihydrochloride and phenoxyethanol. The product has bactericidal, fungicidal, and virucidal properties. The microbiological efficacy of the medicine has been extensively documented in both laboratory and clinical studies. The solution exerts its microbicidal or virucidal effect within 1 minute of application. Under laboratory conditions simulating mucosal protein load, the medicine effectively destroys microorganisms or inactivates viruses, including bacteria (including Chlamydia and Mycoplasma), fungi, yeasts, protozoa (Trichomonas), and viruses (Herpes simplex, 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, has two active centers, and acts on the surface of wounds and skin. Phenoxyethanol complements the spectrum of octenidine dihydrochloride by acting within deeper layers of the skin and mucous membranes.

Octefortan is indicated for:

disinfection and supportive treatment of minor, superficial wounds, and skin disinfection prior to non-surgical procedures;
oral cavity disinfection (e.g. aphthae, irritation caused by orthodontic appliances or dental prostheses);
disinfection of genital organs, e.g. in inflammatory conditions of the vagina, as well as on the glans penis in men;
short-term, supportive antiseptic treatment of interdigital fungal infections;
use in paediatrics (e.g. for umbilical stump care);
supportive antiseptic management of closed skin surfaces after procedures, such as postoperative 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 ingredients of this medicine (listed in section 6).
This medicine must not be used for irrigation of the abdominal cavity.

Warnings and precautions
Before starting to use Octefortan, consult your doctor or pharmacist.
This medicine is for topical use on the skin.
Warning! To avoid the risk of tissue damage and local swelling, the medicine must not be injected or
introduced into tissues under pressure. In all cases, ensure adequate drainage from body cavities (e.g. drainage, suction).
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 medicine 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 the medicine in the eyes. In case of contact with the eyes, rinse immediately with plenty 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, care should be taken to avoid significant systemic absorption, e.g. 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
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future 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.
Octefortan, being a cationic agent, may form poorly soluble residues when combined with anionic cleansing agents or detergents.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a 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 regarding use during the first trimester and as a general precaution.
Octefortan may be used during the remainder of pregnancy only if considered necessary by the physician.

Breastfeeding
There is no available data 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 ingestion by the newborn.

Driving and operating machinery
No studies have been conducted on the effects of Octefortan on the ability to drive vehicles 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 your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The medicine is recommended for use in undiluted form.
Method of administration
For topical application on the skin.
The medicine 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 of the area.

Antisepsis of superficial wounds
Spray the wound or wipe it with a sterile gauze soaked in the medicine. The medicine should always be used during each dressing change. In exuding wounds, apply the medicine as a compress, ensuring contact with the wound and maintaining moistening for at least 1 minute; extending the contact time up to 5 minutes is recommended.

Disinfection of the oral cavity
Spray onto the oral mucosa.

Antisepsis 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 shown that the medicine effectively exerts bactericidal action against various bacteria, including Gram-positive and Gram-negative species.

Antisepsis 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.

Adjunctive treatment of interdigital fungal infection
Apply the medicine by spraying onto 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
For care of the umbilical stump, use a gauze pad soaked in the medicine. After 1 minute, gently dry the stump and surrounding skin. Keep the infant’s umbilical stump clean and dry.

Postoperative suture care
Spray the wound or wipe it with a sterile gauze soaked in the medicine. The medicine should be used during every dressing change. The medicine has antiseptic and local anaesthetic effects. Disinfection of the area surrounding the wound should be performed using sterile gauzes soaked in undiluted medicine, applied 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 using a sterile gauze soaked in the medicine or by spraying the medicine directly onto accessible areas of skin and mucous membranes. Ensure even coverage of the entire treated surface. Observe the required exposure time—leave the medicine in contact 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 a larger than recommended amount of the medicine is used or if the medicine is ingested, contact a doctor immediately. If you have any further questions regarding 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 gets them.
Rarely, after moistening the vaginal mucosa, a sensation of warmth or burning may 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 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 helps to provide more information on the safety of the medicine.

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 outer 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Octefortan contains

The active substances in this medicinal product are octenidine dihydrochloride and phenoxyethanol.
1 g of cutaneous aerosol solution contains 1 mg of octenidine dihydrochloride and 20 mg of phenoxyethanol.
Other ingredients are: cocamidopropyl betaine (30% solution) consisting of dimethylammonium acetate of cocamide propyl acid, sodium chloride, water; sodium gluconate, glycerol 85%, sodium hydroxide (for pH adjustment), purified water.

What Octefortan looks like and contents of the pack
The medicinal product is a colourless, transparent solution.
30 mL solution: HDPE bottle with a spray pump made of PP/Silicone/LDPE/Stainless steel,
in a cardboard box.
50 mL solution: HDPE bottle with a spray pump made of PP/POM/Stainless steel/LDPE,
in a cardboard box.
250 mL solution: HDPE bottle with a spray pump made of PP/HDPE/LDPE/Stainless steel/Ethylene vinyl acetate/POM,
in a cardboard box.
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