Actisept Med

Package Leaflet: Information for the Patient

ACTISEPT MED (0.10 g + 2.00 g)/100 g, skin spray, solution
Octenidine dihydrochloride + Phenoxyethanol

Read the package 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 package leaflet for the patient or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 the medicine and what is it used for
• 2. Important information before using the medicine
• 3. How to use the medicine
• 4. Possible side effects
• 5. How to store the medicine
• 6. Contents of the pack and other information

1. What is ACTISEPT MED and what is it used for

The medicine is a disinfecting solution containing two active substances: octenidine dihydrochloride and phenoxyethanol.
The medicine has bactericidal, fungicidal, and virucidal effects.
The microbiological efficacy of octenidine and phenoxyethanol 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 protein loading of the mucous membrane under laboratory conditions, the medicine has a destructive effect on bacteria (including Chlamydia and Mycoplasma), fungi, yeast, protozoa (Trichomonas), and viruses (Herpes simplex, inactivates HBV and HIV). This effect lasts for an hour, thus ensuring 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 medicine is indicated for:

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

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 flushing the abdominal cavity.

Warnings and precautions

Before starting to use the medicine, the patient should discuss it with their doctor or pharmacist.
The medicine is intended for use on the skin.
Warning! To avoid the possibility of tissue damage, local swelling, the medicine must not be injected or introduced into the tissue under pressure. In each case, ensure adequate drainage from the wound (e.g., drainage, suction).
The medicine should be used with caution in newborns, especially premature babies, as it may cause severe skin changes. Excess medicine should be removed and ensured that the solution does not remain on the skin longer than necessary (this also applies to materials soaked with the solution in direct contact with the patient).
The medicine should not be used in the eye. In case of contact with the eyes, they should be rinsed immediately with a large amount of water.
The medicine is not recommended for use in the ear and should not be swallowed.
Octenidine dihydrochloride is more toxic when used intravenously than orally, so it is necessary to avoid the medicine entering the bloodstream in large quantities, e.g., as a result of accidental injection. Given that octenidine dihydrochloride is present in the medicine only in a concentration of 0.1%, the risk of this substance is unlikely.

Interactions with other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently using or have recently used, as well as any medicines they plan to use.
The medicine should not be used together with antiseptics based on PVP-iodine (iodine complex with povidone) on adjacent parts of the body, as this may cause strong brown or even purple discoloration.
as a cationic medicine, it may form poorly soluble residues when combined with anionic detergents or surfactants.

Pregnancy, breastfeeding, and fertility

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
The medicine 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 are no data on the use of the medicine during breastfeeding. The medicine should not be used without a doctor's recommendation.
The medicine 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 the medicine on the ability to drive and use machines.

3. How to use the medicine

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of 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
should be applied at least once a day to the treated area by spraying, wiping with a sterile swab, or using a dressing to ensure complete moistening.
Disinfection of skin and mucous membrane
The skin and mucous membrane areas 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 membrane areas. The required exposure time should be observed - at least 1 minute, and it is recommended to extend the time to 5 minutes. Attention should be paid to uniform moistening of the entire surface. Leave for at least 1 minute. Supportively in the treatment of fungal skin infections, between the toes, the medicine should be sprayed onto the affected surfaces in the morning and evening for a period of 14 days.
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 exudate, the medicine should be used in the form of a dressing, ensuring contact with the wound and its moistening for at least 1 minute, and it is recommended to extend the time to 5 minutes.
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 a disinfecting and anesthetizing effect. Disinfection of the wound area should be performed using sterile swabs soaked in undiluted medicine, radiating from the center of the wound outward.
Mucous membrane antiseptics of the vagina
The medicine should be used to moisten the surfaces of the vaginal mucous membrane, ensuring contact between the medicine and the mucous membrane for at least 1 minute. In numerous clinical studies, it has been shown that the medicine effectively acts bactericidally against various bacteria, including Gram-positive and Gram-negative bacteria.
Antiseptics of the glans penis in men
The medicine should be used to moisten the surfaces of the glans penis mucous membrane, ensuring contact between the medicine and the mucous membrane for at least 1 minute.
Disinfection of the oral cavity
The medicine should be sprayed onto the mucous membrane of the oral cavity.
Umbilical cord care
A swab soaked in the medicine should be used for umbilical cord care. After 1 minute, the stump and the surrounding skin should be dried. The umbilical cord stump in children should be kept clean and dry.

Using more than the recommended dose of the medicine

In case of using a larger amount of the medicine than recommended or swallowing the medicine, the patient should immediately contact their doctor.
In case of 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, this medicine can cause side effects, although not everybody gets them.
After moistening the vaginal mucous membrane, in rare cases, a feeling of heat or burning may be felt. After rinsing the oral cavity, a bitter taste may persist for about 1 hour, which is related to the action of the medicine.

Reporting side effects

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

5. How to store the medicine

The medicine should be stored out of sight and reach of children.
Store in the original packaging, at a temperature below 25°C.
Shelf life after first opening of 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 month stated.
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 pack and other information

What the medicine contains

• The active substances of the medicine are: octenidine dihydrochloride and phenoxyethanol. 100 g of solution contains 0.10 g of octenidine dihydrochloride and 2.00 g of phenoxyethanol.
• The other ingredients (excipients) are: glycerol 85%, sodium gluconate, cocamidopropyl betaine - 30% solution (dimethylaminoacetic acid amidopropyl cocoate, sodium chloride), sodium hydroxide (to adjust pH), purified water.

What the medicine looks like and what the pack contains

The medicine is a clear, colorless solution.
The packaging of the medicine consists of 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 authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Medicine information

tel.: (22) 742 00 22
e-mail: [email protected]

Date of last revision of the leaflet: