Maxiseptic

Package Leaflet: Information for the User

Maxiseptic, 1 mg/ml + 20 mg/ml, 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 the doctor, pharmacist, or nurse.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this package leaflet, the doctor, pharmacist, or nurse should be informed. See section 4.
• If there is no improvement after 14 days or the patient feels worse, the doctor should be consulted.

Package Leaflet Contents

• 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. Package contents and other information

1. What is Maxiseptic and what is it used for

Maxiseptic is an antiseptic agent 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 have antibacterial and antifungal effects. 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 there is no improvement after 14 days or the patient feels worse, the doctor should be consulted.

2. Important information before using Maxiseptic

When not to use Maxiseptic:

• if the patient is allergic to octenidine dihydrochloride, phenoxyethanol, or any of the other ingredients of this medicine (listed in section 6)
• for rinsing the abdominal cavity (e.g., during surgery), urinary bladder, or eardrum (the membrane in the middle ear that vibrates in response to sound waves).

Warnings and precautions

Before starting to use Maxiseptic, the doctor, pharmacist, or nurse should be consulted. Maxiseptic is intended for external use only. Maxiseptic should not be swallowed or allowed 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 should not be administered by syringe into deep tissues. Maxiseptic is intended for external use only (spraying or applying the medicine with a sprayed swab).

Caution should be exercised when using Maxiseptic in newborns, especially premature infants. Maxiseptic may cause severe skin changes. Excess medicine should be removed, and care should be taken to ensure that the solution does not remain on the skin longer than necessary (this also applies to materials saturated with the solution that come into direct contact with the patient). Maxiseptic should not be used in the eye. If the medicine comes into contact with the eyes, they should be rinsed immediately with a large amount of water. In the case of interdigital fungal infections, Maxiseptic is used only for limited-time supporting antiseptic treatment. For interdigital fungal infections, the doctor or pharmacist should be consulted. To achieve the desired treatment result, the following instructions should be strictly followed. Maxiseptic should not be used for more than 2 weeks without medical supervision.

Maxiseptic and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. Maxiseptic should not be mixed with other substances, in particular, it should not be used in combination with antiseptic agents based on PVP-iodine on adjacent skin areas, as an intense brown to purple discoloration may occur in the border area. Contact with anionic surfactants, such as detergents and cleaning agents, should be avoided. Due to the possibility of interactions with anionic compounds, the use of distilled water (or water for injections) as a solvent is recommended.

Maxiseptic with food, drink, and alcohol

Maxiseptic is intended for external use only.

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 As a precaution, it is best to avoid using Maxiseptic during pregnancy. Do not use Maxiseptic unless the doctor decides otherwise. Breastfeeding As a precaution, it is best to avoid using Maxiseptic during breastfeeding. Do not use Maxiseptic unless the doctor decides otherwise. Maxiseptic should not be used on the breast area of breastfeeding mothers. Fertility The effect of Maxiseptic on human fertility 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 the doctor, pharmacist, or nurse. If in doubt, the doctor, pharmacist, or nurse should be consulted. Method of administration Application to the skin. Maxiseptic is intended for use on the skin surface and should not be administered, e.g., by syringe, into deep tissue layers. Maxiseptic is intended for use on the skin or small, superficial wounds. Maxiseptic is recommended for use undiluted. Unless otherwise directed, the medicine should be applied gently once a day by spraying onto the treated, easily accessible areas, ensuring they are completely moistened. Alternatively, the medicine can be applied by spraying onto a swab and then gently wiping the treated area with at least two swabs saturated with Maxiseptic to ensure complete moistening. Application using swabs is the preferred method. Before covering the wound with a dressing, plaster, or clothing, wait at least one or two minutes for Maxiseptic to dry completely. In the case of limited-time supporting antiseptic treatment of interdigital fungal infections, the medicine should be applied to the affected areas in the morning and evening. To achieve the desired treatment result, the following instructions should be strictly followed. Maxiseptic should not be used 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. If in doubt, the doctor, pharmacist, or nurse should be consulted. If Maxiseptic is swallowed, the doctor should be contacted immediately.

Missing a dose of Maxiseptic

A double dose should not be used to make up for a missed dose.

Stopping use of Maxiseptic

If there are any further doubts about using this medicine, the doctor, pharmacist, or nurse should be consulted.

4. Possible side effects

Like all medicines, this medicine 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 1000 people):

Burning sensation, redness, itching, feeling of warmth.

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 any side effects occur, including any possible side effects not listed in this package leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, 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, more information can be gathered on the safety of the medicine.

5. How to store Maxiseptic

The medicine should be stored out of the sight and reach of children. This medicine should not be used after the expiry date stated on the carton. The expiry date refers to the last day of the month stated. There are no special precautions for storage of the medicinal product. Shelf-life after first opening: 1 year. Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Maxiseptic contains

• The active substances of Maxiseptic are octenidine dihydrochloride and phenoxyethanol. 1 ml of skin spray solution 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 a 50 ml or 250 ml solution in an HDPE bottle with an HDPE and PP dosing pump, 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

Manufacturer

ICN Polfa Rzeszów S.A. ul. Przemysłowa 2 35-959 Rzeszów Poland

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

Poland: Maxiseptic Lithuania: Duoseptic 1 mg/20 mg/ml odos purškalas (tirpalas) /m Bulgaria: ОКТЕНИДИН 1 mg/ml + 20 mg/ml спрей за кожа, разтвор

Date of last revision of the package leaflet: