Octefortan

Package Leaflet: Information for the Patient

Octefortan, (1 mg + 20 mg)/g, Skin Solution

Octenidine Dihydrochloride + Phenoxyethanol

Read the Package Leaflet Carefully Before Using the Medicinal Product

This medicinal product must always be used exactly as described in this package leaflet for the patient or as directed by your doctor or pharmacist.

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, including any not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, you should contact your doctor.

Table of Contents of the Package 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 Package 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 medicinal product has bactericidal, fungicidal, and virucidal effects. The microbiological efficacy of the medicinal product has been extensively documented in both laboratory and clinical studies. The efficacy of the medicinal product in destroying microorganisms or inactivating viruses occurs within 1 minute of application. After additional protein loading of the mucous membrane under laboratory conditions, the medicinal product has a destructive effect on bacteria (including Chlamydia and Mycoplasma), fungi, yeasts, protozoa (Trichomonas), and viruses (Herpes simplex, inactivates HBV and HIV). The effect of the medicinal product lasts for 1 hour, thus providing safety during diagnostic, therapeutic, or surgical procedures. Octenidine dihydrochloride belongs to the group of 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 medicinal product is indicated for:

• disinfection and supportive treatment of small, superficial wounds, as well as skin disinfection before non-surgical procedures,
• disinfection of the oral cavity (e.g., aphthous ulcers, irritation caused by wearing orthodontic appliances or dental prostheses),
• 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 medicinal product is intended for use in adults and children of all ages.

2. Important Information Before Using Octefortan

When Not to Use Octefortan

• This medicinal product must not be used for flushing the abdominal cavity.

Warnings and Precautions

Before starting to use Octefortan, discuss it with your doctor or pharmacist. The medicinal product is for use on the skin.

Warning! To Avoid the Risk of Tissue Damage, Local Swelling, the Medicinal Product Must Not be Injected or Introduced into the Tissue Under Pressure. In All Cases, Ensure Proper Drainage of the Wound (e.g., Drainage, Suction).

Use with caution in newborns, especially premature infants. The medicinal product may cause severe skin changes. Remove any excess medicinal product and ensure that the solution does not remain on the skin longer than necessary (this also applies to materials soaked with the solution that come into direct contact with the patient). Do not use the medicinal product in the eyes. If the medicinal product comes into contact with the eyes, rinse them immediately with a large amount of water. Do not use the medicinal product in the ear canal or swallow it. Octenidine dihydrochloride is more toxic when used intravenously than orally, so avoid introducing the medicinal product into the bloodstream in large quantities, e.g., as a result of accidental injection. Given that octenidine dihydrochloride is present in the medicinal product in an amount of only 0.1%, the risk of this substance is unlikely.

Octefortan and Other Medicinal Products

Tell your doctor or pharmacist about all medicinal products you are taking or have recently taken, as well as any medicinal products you plan to take.

• This medicinal product must not be used together with antiseptics based on PVP-iodine (iodine complex with povidone) on adjacent areas of the body, as this may lead to strong brown or even purple discoloration.
• As a cationic medicinal product, Octefortan may form poorly soluble residues when combined with anionic detergents or soaps.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicinal product. Pregnancy The use of Octefortan is not recommended 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 medicinal product can be used during the remaining period of pregnancy only if, in the doctor's opinion, it is necessary. Breastfeeding There are no data on the use of Octefortan during breastfeeding. Octefortan must 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 medicinal product.

Driving and Using Machines

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

3. How to Use Octefortan

This medicinal product must always be used exactly as described in this package leaflet for the patient or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. The medicinal product is recommended for use in an undiluted form. Method of Administration Topical application. The medicinal product should be applied at least once a day to the treated area by moistening, wiping with a sterile swab, or using a dressing, ensuring complete moistening. Superficial Wound AntisepsisThe wound should be wiped with a sterile swab soaked in the medicinal product. The medicinal product should be used every time the dressing is changed. The medicinal product should be used whenever the dressing is changed. Oral Cavity DisinfectionThe oral cavity should be rinsed intensively with 20 mL of the medicinal product for 20 seconds. Vaginal Mucosa AntisepsisThe surface of the vaginal mucosa should be moistened with the medicinal product, ensuring contact between the medicinal product and the mucosa for at least 1 minute. In numerous clinical studies, it has been shown that the medicinal product effectively acts bactericidally against various bacteria, including Gram-positive and Gram-negative bacteria. Glans Penis Antisepsis in MenThe surfaces of the glans penis mucosa should be moistened with the medicinal product, ensuring contact between the medicinal product and the mucosa for at least 1 minute. Supportive Treatment of Interdigital Fungal InfectionsThe medicinal product should be applied to 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 CareA swab soaked in the medicinal product should be used for umbilical cord care. After 1 minute, dry the stump and the surrounding skin. Keep the umbilical cord stump of the child clean and dry. Post-Operative Suture CareThe wound should be wiped with a sterile swab soaked in the medicinal product. The medicinal product should be used every time the dressing is changed. The medicinal product has a disinfectant and anesthetic effect. Disinfection of the wound surroundings should be performed using sterile swabs soaked in undiluted medicinal product, radiating from the center of the wound outward. Disinfection of Skin and Mucous MembranesThe skin and mucous membrane areas to be subjected to the procedure must be thoroughly moistened with a sterile swab soaked in the medicinal product. Attention should be paid to uniform coverage of the entire treated surface. The required exposure time should be observed - the medicinal product should be left on for at least 1 minute, and it is recommended to extend the exposure time to 5 minutes.

Use of a Larger Than Recommended Dose of Octefortan

In case of use of a quantity of the medicinal product larger than recommended or ingestion of the medicinal product, contact your doctor immediately. If you have any further doubts related to the use of this medicinal product, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medicinal products, 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 persists for about 1 hour, which is related to the effect of the medicinal product.

Reporting Side Effects

If you experience any side effects, including any not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to Store Octefortan

Store below 25°C. Keep the medicinal product out of the sight and reach of children. Do not use this medicinal product 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 of the immediate packaging: until the end of the shelf-life. Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Octefortan Contains

• The active substances of the medicinal product are octenidine dihydrochloride and phenoxyethanol.
• 1 g of the skin 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 (for pH adjustment), purified water.

What Octefortan Looks Like and What the Package Contains

The medicinal product is a colorless, transparent solution. HDPE bottle with a dropper made of LDPE and a cap made of LDPE/HDPE, containing 20 mL of the solution, in a cardboard box. HDPE bottle with a cap made of HDPE, containing 500 mL or 1000 mL of the solution. 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, Tel.: +48 (42) 22-53-100

Date of the Last Update of the Package Leaflet: