Actisept med
Poland
Table of Contents
Package leaflet: Information for the patient
ACTISEPT MED (0.10 g + 2.00 g)/100 g, cutaneous aerosol, solution
Octenidini dihydrochloridum + Phenoxyethanolum
Please read the entire 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
advised by the doctor, pharmacist, or nurse.
- Keep this leaflet for future reference.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
- If there is no improvement or if you feel worse, contact your doctor.
Table of contents of the leaflet
- What the medicine is and what it is used for
- Important information before using the medicine
- How to use the medicine
- Possible side effects
- How to store the medicine
- Contents of the package and other information
1. What ACTISEPT MED is and what it is used for
The medicine is a disinfectant solution containing two active substances:
octenidine dihydrochloride and phenoxyethanol.
The medicine acts bactericidal, fungicidal, and virucidal.
The microbiological efficacy of octenidine and phenoxyethanol has been widely documented
in both laboratory and clinical studies. The medicine's effectiveness in destroying
microorganisms or inactivating viruses occurs within 1 minute of application. Even under
additional protein load from mucous membranes under laboratory conditions, the medicine
exerts destructive effects on bacteria (including Chlamydia and Mycoplasma), fungi, yeasts,
protozoa (Trichomonas), and viruses (Herpes simplex, inactivates HBV and HIV). This effect
persists for one hour, thus 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 action 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 disinfection prior to non-surgical procedures;
- supportive antiseptic management on intact 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 in the oral cavity, genital organs, and anus, including the vagina, vulva, and glans penis, as well as prior to urinary bladder catheterization;
- use in paediatrics (including umbilical stump care);
- disinfection of the oral cavity (e.g., aphthae, irritations caused by orthodontic appliances or dental prostheses);
- short-term, supportive antiseptic treatment of interdigital fungal infections;
- use in genital organs, e.g., in inflammatory conditions of the vagina, as well as on the glans penis in males.
The medicine is intended for use in adults and children of all ages.
2. Important information before using the medicine
When not to use the medicine:
- if the patient is allergic to octenidine dihydrochloride, phenoxyethanol, or any of the other ingredients of this medicine (listed in section 6);
- do not use the medicine for peritoneal lavage.
Warnings and precautions
Before starting treatment, discuss with your doctor or pharmacist.
The medicine is intended for topical use on the skin.
Caution! To avoid the risk of tissue damage or local edema, 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 preterm infants. It may cause severe skin reactions. Excess medicine should be removed, and care must be taken to ensure 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).
The medicine must not be used in the eyes. In case of contact with the eyes, rinse immediately with a large amount of water.
Use inside the ear canal is not recommended, and the medicine should not be swallowed.
Octenidine dihydrochloride is more toxic when administered intravenously than orally; therefore, avoid significant systemic absorption, e.g., due to accidental injection. Since octenidine dihydrochloride is present in the medicine at a concentration of only 0.1%, the risk associated with this substance is unlikely.
Other medicines
Inform your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
The medicine should not be used concurrently 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 violet discolorations.
As a cationic agent, it may form poorly soluble residues when combined with anionic cleansing agents or detergents.
Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
The medicine should not be used during the first 3 months of pregnancy due to lack of clinical data for this period and as a general precaution.
The medicine may be used during the remainder of pregnancy only if, in the opinion of the doctor, it is necessary.
Breastfeeding
There are no data on the use of the medicine during breastfeeding. The medicine should not be used without medical advice.
The medicine should be removed from the breast area before breastfeeding to prevent the newborn from ingesting it.
Driving and operating machinery
No studies have been conducted on the effects of the medicine on the ability to drive vehicles or operate machinery.
3. How to use the medicine
This medicine should always be used exactly as described in this patient information leaflet or as directed by a physician or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine is recommended for use in its undiluted form.
Method of administration
Topical application
Apply 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.
Disinfection of skin and mucous membranes
Skin and mucous membrane areas to be treated should be thoroughly moistened using a sterile gauze soaked in the medicine or by spraying the medicine directly onto accessible skin and mucous membrane areas. Ensure the required contact time—minimum 1 minute, preferably extended to 5 minutes. Make sure the entire surface is evenly moistened. Leave in place for at least 1 minute. As supportive treatment in skin fungal infections, especially between the toes, spray the medicine onto affected areas morning and evening for 14 days.
Antiseptic treatment of superficial wounds
Spray the wound or wipe it with a sterile gauze soaked in the medicine. The medicine should always be used when changing the dressing. In exuding wounds, apply the medicine as a compress, ensuring contact with the wound and maintaining moistening for at least 1 minute, preferably extended to 5 minutes.
Postoperative suture care
Spray the wound or wipe it with a sterile gauze soaked in the medicine. The medicine should always be used when changing the dressing. The medicine acts as a disinfectant and local anesthetic. Disinfection around the wound should be performed using sterile gauzes soaked in undiluted medicine, applied radially from the center of the wound outward.
Antiseptic treatment of vaginal mucous membrane
Moisten the vaginal mucous membrane surfaces with the medicine, ensuring contact between the medicine and mucous membrane 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 bacteria.
Antiseptic treatment of male glans penis
Moisten the mucous membrane surfaces of the glans penis with the medicine, ensuring contact between the medicine and mucous membrane for at least 1 minute.
Oral cavity disinfection
Spray the medicine onto the oral mucous membrane.
Umbilical stump care
For umbilical stump care, 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.
Use of a higher than recommended dose of the medicine
If more medicine has been used than recommended or if the medicine has been ingested, contact a doctor immediately.
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 medicine can cause adverse reactions, although not everybody will experience them.
After moistening the vaginal mucosa, a sensation of warmth or burning may rarely be felt.
After 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 symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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
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 the medicine
Keep the medicine out of sight and reach of children.
Store in the original packaging, at a temperature below 25 °C.
Shelf life after first opening the immediate packaging: 12 months.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of down the drain or in household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.
6. Contents of the pack and other information
What the medicinal product contains
- The active substances are: octenidine dihydrochloride and phenoxyethanol. 100 g of solution contains 0.10 g of octenidine dihydrochloride and 2.00 g of phenoxyethanol.
- Other components (excipients) are: glycerol 85%, sodium gluconate, cocamidopropyl betaine – 30% solution (dimethylammonium acetate of amidopropyl coco acid amide, sodium chloride), sodium hydroxide (for pH adjustment), purified water.
What the medicinal product looks like and contents of the pack
The medicinal product is a clear, colourless solution.
The container is an HDPE bottle with a PP/PE spray pump, containing 50 mL of solution, in a cardboard box, or an HDPE bottle with a PP/PE spray pump, containing 250 mL of solution.
Marketing Authorisation Holder and Manufacturer
„PRZEDSIĘBIORSTWO PRODUKCZENIA FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Product Information
tel.: (22) 742 00 22
e-mail: [email protected]