Maxiseptic
Poland
Table of Contents
Package leaflet: Information for the user
Maxiseptic, 1 mg/ml + 20 mg/ml, cutaneous spray, solution
Octenidinum dihydrochloridum + Phenoxyethanolum
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor, pharmacist, or nurse.
- Keep this leaflet as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
- If there is no improvement or if you feel worse after 14 days, consult your doctor.
Contents of the leaflet
- What Maxiseptic is and what it is used for
- Important information before using Maxiseptic
- How to use Maxiseptic
- Possible side effects
- How to store Maxiseptic
- Contents of the pack and other information
1. What Maxiseptic is and what it is used for
Maxiseptic is an antiseptic medicine used on the skin or wounds to destroy microorganisms and infectious agents, and to 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 of mucous membranes and adjacent tissues prior to diagnostic procedures involving the genital organs and anus, including the vagina, vulva, and glans penis, as well as prior to urinary bladder catheterization
- antiseptic treatment of minor, superficial wounds and skin disinfection before non-surgical procedures
- short-term, supportive antiseptic treatment of interdigital tinea (athlete's foot).
If there is no improvement or if you feel worse after 14 days, consult your doctor.
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 irrigation of the abdominal cavity (e.g. during surgery), urinary bladder, or tympanic membrane (the membrane in the middle ear that 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.
Maxiseptic must not be swallowed or allowed to enter the bloodstream, e.g. due to accidental injection.
Cases of persistent swelling, redness, and tissue necrosis have been reported after irrigating deep wounds with a syringe (see section 4).
To avoid tissue damage, do not administer Maxiseptic with a syringe into deep tissues. Maxiseptic is intended for external use only (spraying or application using a gauze pad soaked with the solution).
Use with caution in newborns, especially premature infants. Maxiseptic may cause severe skin reactions. Excess product 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 impregnated with the solution that are in direct contact with the patient).
Do not use Maxiseptic in the eyes. If contact occurs, rinse immediately with large amounts of water.
In interdigital mycosis (fungal infection of the skin between fingers and toes), Maxiseptic should be used only for limited-time supportive antiseptic treatment. In case of interdigital mycosis, consult a doctor or pharmacist. To achieve optimal treatment results, strictly follow the instructions provided by your doctor or pharmacist.
Maxiseptic and other medicines
Inform your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
Maxiseptic must not be mixed with other substances. In particular, do not use it in combination with antiseptic agents based on PVP-iodine (povidone-iodine) on adjacent skin areas, as intense discoloration ranging from brown to violet may occur at the boundary area.
Avoid contact with anionic surfactants, such as detergents and cleaning agents. 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, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
As a precautionary measure, it is best to avoid using Maxiseptic during pregnancy. Do not use Maxiseptic unless otherwise directed by a doctor.
Breastfeeding
As a precautionary measure, it is best to avoid using Maxiseptic during breastfeeding. Do not use Maxiseptic unless otherwise directed by a doctor. Maxiseptic should not be applied to the breast area in breastfeeding women.
Fertility
The effect of Maxiseptic on fertility in humans has not been studied.
Driving and operating machinery
Maxiseptic has no influence on the ability to drive and operate machinery.
3. How to use Maxiseptic
This medicine should always be used exactly as described in this patient information leaflet, or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
Method of administration
Topical application.
Maxiseptic is intended for use on the skin surface and must not be administered, for example by injection, into deep tissue layers.
Maxiseptic is intended for use on the skin surface or on small, superficial wounds.
Maxiseptic is recommended for use in its undiluted form.
Unless otherwise advised, apply Maxiseptic gently once daily by spraying directly onto the affected, easily accessible areas, ensuring complete wetting of the area. Alternatively, Maxiseptic can be sprayed onto a gauze pad and the affected area gently wiped, using at least two gauze pads soaked with Maxiseptic, to ensure complete wetting. Application using gauze pads is the preferred method.
After application, wait at least one or two minutes for Maxiseptic to dry completely before covering the wound with a dressing, plaster, or clothing.
For short-term supportive antiseptic treatment of interdigital fungal infection (tinea), apply the medicine to the affected areas in the morning and evening.
To achieve the desired therapeutic effect, strictly follow the instructions above.
Do not use Maxiseptic for longer than 2 weeks without medical supervision.
Use in children and adolescents
The dosage of Maxiseptic is the same for adults and children.
Use of more than the recommended dose of Maxiseptic
Overdose with Maxiseptic after topical application is very unlikely. If in doubt, consult a doctor, pharmacist, or nurse.
If Maxiseptic is swallowed, seek immediate medical advice from a doctor.
Missed dose of Maxiseptic
Do not apply a double dose to make up for a missed dose.
Stopping Maxiseptic
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been observed after using a medicine containing octenidine dihydrochloride and phenoxyethanol:
Uncommon adverse reactions (may affect up to 1 in 1000 people):
Burning sensation, redness, itching, feeling of warmth.
Very rare adverse reactions (may affect up to 1 in 10,000 people):
Allergic contact reactions, e.g. transient redness at the site of application.
Frequency not known (frequency cannot be estimated from the available data):
Cases of persistent swelling, erythema, and tissue necrosis have been reported after irrigation of deep wounds using a syringe (see section 2).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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
Phone: +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 provide more information on the safety of the medicine.
5. How to store Maxiseptic
Keep this medicine out of 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 the stated month.
No special storage instructions apply.
After first use, Maxiseptic can be used for a period of 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 in use. This will help protect the environment.
6. Contents of the pack and other information
What Maxiseptic contains
- The active substances in this medicine are octenidine dihydrochloride and phenoxyethanol. 1 ml of cutaneous aerosol solution contains 1 mg of octenidine dihydrochloride and 20 mg of phenoxyethanol.
- The other components are sodium gluconate, glycerol, cocamidopropyl betaine CAB 30-LQ-(MH), purified water and hydrochloric acid, 10% solution (for adjusting pH to 5.0–6.5).
What Maxiseptic looks like and contents of the pack
Maxiseptic is a clear, colourless solution with a characteristic odour.
The medicine is available in HDPE bottles containing 50 ml or 250 ml of solution, with an HDPE and PP dosing pump, packed in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation 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.
Przemysłowa 2 Street
35-105 Rzeszów
Poland
This medicinal product is authorised in the European Economic Area countries
under the following names:
Poland: Maxiseptic
Lithuania: Duoseptic 1 mg/20 mg/ml odos purškalas (tirpalas) /m
Bulgaria: ОКТЕКЕЪР 1 mg/ml + 20 mg/ml спрей за кожа, разтвор