Octefortan

Leaflet attached to the packaging: patient information

Octefortan, (1 mg + 20 mg)/g, skin spray, solution

Octenidine dihydrochloride + Phenoxyethanol

Read the 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, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Octefortan and what is it used for
• 2. Important information before using Octefortan
• 3. How to use Octefortan
• 4. Possible side effects
• 5. How to store Octefortan
• 6. Contents of the packaging 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 medicine has bactericidal, fungicidal, and virucidal effects.
The microbiological efficacy of the medicine has been extensively documented in both laboratory and clinical studies. The efficacy of the medicine in destroying microorganisms or inactivating viruses occurs within 1 minute of application. After additional loading with mucous membrane protein under laboratory conditions, the medicine has a destructive effect on bacteria (including Chlamydiaand Mycoplasma), fungi, yeast, protozoa (Trichomonas), and viruses (Herpes simplex, inactivates HBV and HIV). The effect of the medicine lasts for an hour, thus providing safety during diagnostic, therapeutic, or surgical procedures.
Octenidine dihydrochloride belongs to cationic-active compounds, has two active centers, and acts on the surface of the wound and skin. Phenoxyethanol complements the action of octenidine dihydrochloride, acting in the deeper layers of the skin and mucous membranes.
The medicine is indicated for:

• disinfecting and supporting the treatment of small, superficial wounds, as well as skin disinfection before non-surgical procedures,
• disinfecting the oral cavity (e.g., aphthae, irritation caused by wearing an orthodontic appliance or dental prosthesis),
• in the genital area, e.g., in cases of vaginal inflammation, as well as on the glans penis in men,
• limited-time, supportive antiseptic treatment of interdigital fungal infections,
• in pediatrics (including umbilical cord care),
• supportive antiseptic treatment of closed skin surfaces after procedures - e.g., post-operative sutures,
• repeated, short-term antiseptic treatment of mucous membranes and adjacent tissues before and after diagnostic procedures in the oral cavity, genital area, and anus, including the vagina, vulva, and glans penis, as well as before catheterization of the urinary bladder.

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

2. Important information before using Octefortan

When not to use Octefortan

• This medicine should not be used for rinsing the abdominal cavity.

Warnings and precautions

Before starting to use Octefortan, the patient should discuss it with their doctor or pharmacist.
The medicine is for use on the skin.

Warning! To avoid the possibility of tissue damage, local swelling, the medicine should not be injected or administered under pressure. In each case, proper drainage of the wound (e.g., drainage, suction) should be ensured.

The medicine should be used with caution in newborns, especially premature babies. The medicine may cause severe skin changes. Excess medicine should be removed, and it should be ensured that the medicine does not remain on the skin for longer than necessary (this also applies to materials soaked in the solution that come into direct contact with the patient).
The medicine should not be used in the eyes. If the medicine comes into contact with the eyes, they should be rinsed immediately with a large amount of water.
The medicine should not be used in the ear canal or swallowed.
Octenidine dihydrochloride is more toxic when administered intravenously than orally, so the patient should avoid getting the medicine into the bloodstream in large quantities, e.g., as a result of accidental injection. Given that octenidine dihydrochloride is present in the medicine in an amount of only 0.1%, the risk of this substance is unlikely.

Octefortan and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• This medicine should not be used together with antiseptics based on PVP-iodine (iodine complex with povidone) on adjacent areas of the body, as this may cause strong brown or even purple discoloration.
• Octefortan, as a cationic medicine, may form poorly soluble residues when combined with anionic detergents or cleaning agents.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
Octefortan should not be used during the first 3 months of pregnancy due to the lack of clinical data on the first 3 months of pregnancy and as a precautionary measure.
The medicine can be used during the remaining period of pregnancy only if, in the doctor's opinion, it is necessary.
Breastfeeding
There is no data on the use of Octefortan during breastfeeding. Octefortan should not be used without a doctor's recommendation.
Octefortan should be removed from the breast area before breastfeeding to prevent the infant from taking the medicine.

Driving and using machines

No studies have been conducted on the effect of Octefortan on the ability to drive and use machines.

3. How to use Octefortan

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The medicine is recommended for use in an undiluted form.
Method of administration
Application to the skin.
The medicine should be applied at least once a day to the treated area by spraying, wiping with a sterile swab, or using a dressing, ensuring complete moistening.
Antiseptics for superficial wounds
The wound should be sprayed or wiped with a sterile swab soaked in the medicine. The medicine should be used every time the dressing is changed. In wounds with discharge, the medicine should be applied in the form of a dressing, ensuring contact with the wound and its moistening for at least 1 minute, preferably extended to 5 minutes.
Disinfection of the oral cavity
The medicine should be sprayed onto the mucous membrane of the oral cavity.
Antiseptics for the vaginal mucosa
The surface of the vaginal mucosa should be moistened with the medicine, ensuring contact with the mucosa for at least 1 minute. Numerous clinical studies have shown that the medicine effectively acts bactericidally on various bacteria, including Gram-positive and Gram-negative bacteria.
Antiseptics for the glans penis in men
The surfaces of the glans penis mucosa should be moistened with the medicine, ensuring contact with the mucosa for at least 1 minute.
Supportive treatment of interdigital fungal infections
The medicine should be sprayed onto the affected skin surfaces in the morning and evening for 14 days. Attention should be paid to uniform moistening of the entire surface. Leave on for at least 1 minute.
Umbilical cord care
A swab soaked in the medicine should be used for umbilical cord care. After 1 minute, the stump and surrounding skin should be dried. The umbilical cord stump should be kept clean and dry.
Post-operative suture care
The wound should be sprayed or wiped with a sterile swab soaked in the medicine. The medicine should be used every time the dressing is changed. The medicine has disinfectant and anesthetic effects. Disinfection of the wound surroundings should be performed using sterile swabs soaked in undiluted medicine, radiating from the center of the wound outward.
Disinfection of the skin and mucous membranes
Areas of skin and mucous membranes to be subjected to the procedure must be thoroughly moistened with a sterile swab soaked in the medicine or moistened by spraying the medicine directly onto the accessible skin and mucous membranes. Attention should be paid to uniform coverage of the entire treated surface. The required exposure time should be observed – the medicine should be left on for at least 1 minute, preferably extended to 5 minutes.

Using a larger dose of Octefortan than recommended

In case of using a larger amount of the medicine than recommended or ingesting the medicine, the patient should immediately contact their doctor. If there are any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Octefortan can cause side effects, although not everybody gets them.
After moistening the vaginal mucosa, a feeling of heat or burning may rarely occur.
When rinsing the oral cavity, a bitter taste may persist for about 1 hour, which is related to the effect of the medicine.

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist. 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
Phone: +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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Octefortan

Store at a temperature below 25°C.
The medicine should be stored out of 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 specified month.
Shelf life after first opening the immediate packaging: until the end of the shelf life.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Octefortan contains

• The active substances of the medicine are octenidine dihydrochloride and phenoxyethanol.
• 1 g of skin spray solution contains 1 mg of octenidine dihydrochloride and 20 mg of phenoxyethanol.
• The other ingredients are: cocamidopropyl betaine (30% solution) of the composition: dimethylammonium acetic acid amidopropyl cocoate, sodium chloride, water; sodium gluconate, glycerol 85%, sodium hydroxide (to adjust pH), purified water.

What Octefortan looks like and what the packaging contains

The medicine is a colorless, 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 authorization holder and manufacturer:

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Phone: +48 (42) 22-53-100

Date of the last update of the leaflet: