Maxiseptic

Package Leaflet: Information for the User

Maxiseptic, 1 mg/ml + 20 mg/ml, Solution for the Skin

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 package leaflet, you may need to read it again.
• If you need advice or additional information, ask your pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 14 days there is no improvement or the patient feels worse, contact a doctor.

Table of Contents of the Package Leaflet

• 1. What is Maxiseptic and what is it used for
• 2. Important information before using Maxiseptic
• 3. How to use Maxiseptic
• 4. Possible side effects
• 5. How to store Maxiseptic
• 6. Contents of the pack and other information

1. What is Maxiseptic and what is it used for

Maxiseptic is an antiseptic medicine used on the skin or wounds to destroy microorganisms and infectious agents and prevent infections. Maxiseptic contains two active substances: octenidine dihydrochloride and phenoxyethanol, which act antibacterially and antifungally.

Maxiseptic is intended for use in adults and children of all ages for:

• repeated, short-term antiseptic treatment in the area of mucous membranes and adjacent tissues before diagnostic procedures in the genital and anal areas, including the vagina, vulva, and glans penis, as well as before catheterization of the urinary bladder
• antiseptic treatment of small, superficial wounds and skin disinfection before non-surgical procedures
• limited-time supporting antiseptic treatment of interdigital fungal infections.

If after 14 days there is no improvement or the patient feels worse, contact a doctor.

2. Important information before using Maxiseptic

When not to use Maxiseptic:

• for rinsing the abdominal cavity (e.g. during surgery), urinary bladder, or the interior of the ear (eardrum in the middle ear, which vibrates in response to sound waves).

Warnings and precautions

Before starting to use Maxiseptic, discuss it with your doctor, pharmacist, or nurse.

Maxiseptic is intended for external use only.

Do not swallow Maxiseptic or allow it to enter the bloodstream, e.g. as a result of accidental injection.

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 4).

To avoid tissue damage, the medicine must not be administered by syringe into deep tissues. Maxiseptic is intended for external use only (using a swab).

Use with caution in newborns, especially premature babies. Maxiseptic may cause severe skin changes.

Remove excess medicine and make sure 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 Maxiseptic in the eye. In case of contact with the eyes, rinse them immediately with a large amount of water.

In the case of interdigital fungal infections, Maxiseptic is used only for limited-time supporting antiseptic treatment.

Avoid contact of the medicine with anionic surfactants, such as detergents and cleaning agents.

Due to the risk of interaction with anionic compounds, it is recommended to use distilled water (or water for injections) as a solvent.

Children and adolescents

Maxiseptic is intended for use in children of all ages.

Maxiseptic with other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about medicines you plan to take.

Do not mix Maxiseptic with other substances, in particular, do not use it in combination with antiseptic agents based on PVP-iodine on adjacent skin areas, as intense discoloration with a brown to purple color may occur in the border area.

Maxiseptic with food, drinks, and alcohol

Maxiseptic is intended for external use only.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

As a precaution, it is best to avoid using Maxiseptic during pregnancy.

Do not use Maxiseptic unless your doctor decides otherwise.

Breastfeeding

As a precaution, it is best to avoid using Maxiseptic during breastfeeding.

Do not use Maxiseptic unless your doctor decides otherwise.

Do not use Maxiseptic on the breast area in breastfeeding women.

Fertility

The effect of Maxiseptic on fertility in humans has not been studied.

Driving and using machines

Maxiseptic has no effect on the ability to drive and use machines.

3. How to use Maxiseptic

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.

In case of doubt, ask your doctor, pharmacist, or nurse.

Method of administration

Application to the skin.

Maxiseptic is intended for use on the skin surface and must not be administered, for example by syringe, into deep tissue layers.

Maxiseptic is intended for use on the skin or small, superficial wounds.

Maxiseptic is recommended for use undiluted.

Adults

Apply Maxiseptic once a day to the treated area, ensuring complete wetting.

Unless otherwise directed, gently rub the treated area with at least two swabs soaked with Maxiseptic, one after the other, to ensure complete wetting.

Before covering the wound with a dressing, plaster, or putting on clothes, wait at least one or two minutes until Maxiseptic is completely dry.

In the case of limited-time supporting antiseptic treatment of interdigital fungal infections, apply the medicine to the affected areas in the morning and evening.

To achieve the desired treatment effect, follow the instructions below carefully.

Do not use Maxiseptic for more than 2 weeks without medical supervision.

Use in children and adolescents

The dosage of Maxiseptic is the same for adults and children.

Using more than the recommended dose of Maxiseptic

Overdose of Maxiseptic after local application is very unlikely.

In case of doubt, ask your doctor, pharmacist, or nurse.

In case of swallowing Maxiseptic, contact a doctor immediately.

Missing a dose of Maxiseptic

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

Stopping use of Maxiseptic

In case of further doubts about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Maxiseptic can cause side effects, although not everybody gets them.

After using the medicine containing octenidine dihydrochloride and phenoxyethanol, the following side effects have been observed:

Rare side effects (may affect up to 1 in 100 people):

Burning sensation, redness, itching, feeling of heat.

Very rare side effects (may affect up to 1 in 10,000 people):

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 side effects not listed in this package leaflet, tell your doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department for 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

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 medicine.

5. How to store Maxiseptic

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton.

The expiry date refers to the last day of that month.

There are no special precautions for storage.

After first opening the bottle, Maxiseptic is suitable for use for 1 year, provided the expiry date has not been exceeded.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required.

This will help protect the environment.

6. Contents of the pack and other information

What Maxiseptic contains

• The active substances are octenidine dihydrochloride and phenoxyethanol.

1 ml of solution for the skin contains 1 mg of octenidine dihydrochloride and 20 mg of phenoxyethanol.

• The other ingredients are sodium gluconate, glycerol, cocamidopropyl betaine CAB 30-LQ-(MH), purified water, and hydrochloric acid, 10% solution (to adjust pH 5.0-6.5).

What Maxiseptic looks like and contents of the pack

Maxiseptic is a clear, colorless solution with a characteristic odor.

The medicine is available in HDPE bottles containing 250 ml, 500 ml, or 1000 ml of solution, with a PP cap and a guarantee ring, placed in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder

Bausch Health Ireland Limited

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Tel. +48 17 865 51 00

Manufacturer

ICN Polfa Rzeszów S.A.

ul. Przemysłowa 2

35-105 Rzeszów

Poland

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland:

Maxiseptic

Date of last revision of the package leaflet:April 2025