Septisse

Leaflet attached to the packaging: patient information

Septisse, (0.10 g + 2.00 g)/100 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 the 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 any possible side effects not listed in the 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 Septisse and what is it used for
• 2. Important information before using Septisse
• 3. How to use Septisse
• 4. Possible side effects
• 5. How to store Septisse
• 6. Package contents and other information

1. What is Septisse and what is it used for

Septisse is a disinfecting solution containing the active substances: octenidine dihydrochloride, phenoxyethanol. Septisse 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.
Septisse is indicated for:

• disinfecting and supporting the treatment of small, superficial wounds, as well as skin disinfection before non-surgical procedures;
• repeated, short-term antiseptic treatment in the area of mucous membranes and adjacent tissues before and after diagnostic procedures in the genital and anal areas, including the vagina, vulva, and glans penis, as well as before catheterization of the urinary bladder;
• supporting antiseptic treatment in the area of closed skin covers after procedures, e.g., post-operative sutures;
• use in the genital area, e.g., in cases of vaginal inflammation, as well as on the glans penis in men;
• use in pediatrics (including umbilical cord care);
• disinfection of 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. Septisse is intended for use in adults and children of all ages.

2. Important information before using Septisse

When not to use Septisse:

• do not use Septisse for flushing the abdominal cavity (e.g., during surgery), urinary bladder, or eardrum.

Warnings and precautions

Medicine for use on the skin.

Warning! To avoid the possibility of tissue damage, local swelling, do not inject or introduce the medicine into the tissue under pressure. In each case, ensure proper drainage from the wound (e.g., drainage, suction).

Use with caution in newborns, especially premature babies. Septisse may cause severe skin changes. Excess medicine should be removed, and it should be ensured 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 Septisse in the eye. In case of contact with the eyes, they should be rinsed immediately with a large amount of water. It is not recommended to use Septisse inside the ear, and it 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 larger quantities, e.g., as a result of accidental injection. Given that octenidine dihydrochloride in Septisse is present only in a 0.1% amount, the risk of this substance is unlikely.

Septisse and other medicines

Septisse should not be used together with antiseptics based on PVP-iodine (iodine complex with povidone) on adjacent parts of the body, as this may lead to strong brown or even purple discoloration. Septisse, as a cationic medicine, may form poorly soluble residues when combined with anionic detergents or cleaning agents. Due to the possibility of interactions with anionic compounds, it is recommended to use distilled water (or water for injections) as a solvent.

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 a doctor or pharmacist before using this medicine.
Pregnancy and breastfeeding
There are no clinical trial results on the safety of using the medicine in pregnant and breastfeeding women.
Fertility
The effect of Septisse on fertility in humans has not been studied.

Driving and using machines

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

3. How to use Septisse

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
Septisse is recommended for use in an undiluted form.
Application to the skin.
Disinfection of the skin and mucous membrane
The skin and mucous membrane areas to be treated must be thoroughly moistened with a sterile swab soaked with Septisse or moistened by spraying the medicine directly onto the accessible skin and mucous membrane areas. The required exposure time should be observed - a minimum of 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 it on 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 with Septisse. Septisse should be used every time the dressing is changed. In wounds with exudate, Septisse should be used in the form of a compress, 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 with Septisse. Septisse should be used every time the dressing is changed. Septisse has disinfecting and anesthetizing effects.
Disinfection of the wound environment should be performed using sterile swabs soaked with undiluted Septisse, radiating from the center of the wound outward.
Antiseptics for vaginal mucosa
The medicine Septisse should moisten the surfaces of the vaginal mucosa, ensuring contact of the medicine with the mucosa for at least 1 minute. In numerous clinical studies, it has been shown that Septisse effectively acts bactericidally on various bacteria, including Gram-positive and Gram-negative.
Antiseptics for the glans penis in men
The medicine Septisse should moisten the surfaces of the glans penis mucosa, ensuring contact of the medicine with the mucosa for at least 1 minute.
Disinfection of the oral cavity
The oral cavity should be rinsed intensively with 20 ml of Septisse for 20 seconds.
Umbilical cord care
For umbilical cord care, a swab soaked with Septisse should be used. After 1 minute, the stump and the surrounding skin should be dried. The umbilical cord stump of the child should be kept clean and dry.

Using a larger dose of Septisse than recommended

In case of using a larger amount of Septisse than recommended or swallowing the medicine, contact a doctor immediately.

Missing a dose of Septisse

Do not use a double dose to make up for a missed dose.

Stopping the use of Septisse

In case of any further doubts related to the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
After moistening the vagina with the medicine, in rare cases, a feeling of heat or burning may occur. When rinsing the oral cavity, a bitter taste persists for about 1 hour, which is related to the action of the medicine.
Rare (occurring in 1 to 10 out of 10,000 patients):
Burning sensation, redness, itching, feeling of heat.
Very rare (occurring in less than 1 out of 10,000 patients):
Contact allergic reactions, e.g., transient redness at the application site.
Frequency not known (frequency cannot be estimated from the available data):
After flushing deep wounds with a syringe, cases of persistent swelling, redness, and tissue necrosis have been reported. In some cases, surgical intervention was necessary (see section 2).

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, inform your 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.: 22 49-21-301, fax: 22 49-21-309, e-mail: [email protected].
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 Septisse

Store the medicine out of sight and reach of children.
Do not store above 30°C.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and bottle after EXP. The expiry date stated is the last day of the given month.
Shelf-life after first opening: 2 years, but no longer than the expiry date stated on the packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Septisse contains

• The active substances of the medicine are octenidine dihydrochloride and phenoxyethanol.
• The other ingredients (excipients) are: cocamidopropyl betaine, 28-32% solution (cocamidopropyl betaine, sodium chloride, purified water), sodium gluconate, glycerol 85%, sodium hydroxide (to adjust pH), diluted hydrochloric acid (to adjust pH), purified water.

What Septisse looks like and what the pack contains

Clear, colorless solution.
HDPE bottle with a spray pump (PP/PE/stainless steel) with a PP closure, containing 30 ml of solution, placed in a cardboard box.

Marketing authorization holder and manufacturer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Date of last revision of the leaflet: