Package leaflet: Information for the user

Symplisept, 1 mg/g + 10 mg/g, gel
Octenidini dihydrochloridum + Phenoxyethanolum
Please read all of this leaflet carefully before using this medicine, because 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 or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 2 weeks, or if you feel worse, you should contact your doctor.

Contents of the leaflet

What Symplisept is and what it is used for
Important information before using Symplisept
How to use Symplisept
Possible side effects
How to store Symplisept
Contents of the pack and other information

1. What Symplisept is and what it is used for
Symplisept contains the active substances: octenidine dihydrochloride, which acts as an antiseptic and disinfectant, and phenoxyethanol, which has bactericidal properties.
Symplisept is applied to the skin for repeated, short-term supportive antiseptic treatment of minor, superficial wounds in patients of all age groups.

2. Important information before using Symplisept

When not to use Symplisept:

If you are allergic to octenidine dihydrochloride, phenoxyethanol, or any of the other ingredients of this medicine (listed in section 6).
This medicine must not be used to irrigate the abdominal cavity (during surgery), the urinary bladder, or the tympanic membrane.

Warnings and precautions
Before starting to use Symplisept, discuss it with your doctor, pharmacist, or nurse.
Do not use larger amounts of this medicine than necessary. Do not swallow it, and avoid its entry into the bloodstream, for example, due to accidental injection.
To prevent possible tissue damage, exercise caution when using this medicine and ensure that the medicine is not applied under pressure or injected into tissue.
In the case of deep wounds (larger, deeper wounds with loss of subcutaneous tissue), ensure proper wound drainage (e.g., via drainage or a special wound treatment method known as skin grafting technique).
Do not apply Symplisept gel to the eyes. If contact with the eyes occurs, rinse immediately with a large amount of water.
Children
Use with caution in newborns, especially premature infants. Symplisept may cause severe skin reactions. Excess product should be removed, and care must 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).
The use of Symplisept in children under 6 years of age should be limited to a few days.
Symplisept and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those available without a prescription.
Do not use this medicine simultaneously with skin disinfectants based on povidone-iodine on adjacent areas of the body, as this may lead to strong brown or violet skin discoloration.
Do not use Symplisept together with anionic surfactants (e.g., soap, detergents, or cleaning agents), as this may weaken or eliminate the antimicrobial effect of the medicine.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use Symplisept during pregnancy.
Breastfeeding
It is very unlikely that this medicine passes into breast milk.
During breastfeeding, do not apply Symplisept gel to the breast area.
Driving and operating machinery
Symplisept has no effect or negligible effect on the ability to drive and operate machinery.
Symplisept contains alcohol (ethanol) and butylhydroxytoluene
This medicine contains 95.2 mg of alcohol (ethanol) in each 1 g of gel. The medicine may cause a stinging sensation on damaged skin.
Butylhydroxytoluene may cause local skin reactions (e.g., contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Symplisept

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine is for topical use (it is intended for external use only). Symplisept in gel form should be applied in a thin layer to the area of skin requiring treatment, until the area is completely covered.
After applying the gel, wait at least 1 to 2 minutes before proceeding further, for example, applying a dressing. This time is necessary to achieve the desired effect of the medicine.
To ensure effectiveness, these instructions must be carefully followed.
Symplisept should be used no more than 3 times daily.
Do not use this medicine for longer than 2 weeks without consulting a doctor.

Use in children and adolescents
Due to the topical application, Symplisept should be used in the same way in adults, adolescents, and children. In children under 6 years of age, Symplisept should be used for only a few days.

Use of a higher than recommended dose of the medicine
Overdose with a topically applied medicine is very unlikely. If in doubt, consult a doctor or pharmacist.
In case of accidental ingestion of Symplisept, seek medical advice immediately.
If you have any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Rare (may affect up to 1 in 1,000 people):
In rare cases, a burning sensation, redness, itching, and a feeling of warmth may occur at the application site.
Very rare (may affect up to 1 in 10,000 people):
Local skin irritation (reactions due to contact allergy) is possible, for example, transient redness of the treated skin.
If Symplisept enters the oral cavity, it may cause a transient bitter taste in the mouth.
Additional adverse reactions in children and adolescents
Use of this medicine in premature newborns may cause transient skin rash (erythematous reaction).
The frequency, type, and severity of adverse reactions in children and adolescents are considered to be the same as in adults.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Symplisept

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the tube and the outer carton following "EXP". The expiry date refers to the last day of the specified month.
No special storage conditions apply.
After first opening the tube: do not store above 25°C.
Period of use after first opening the tube: 1 year.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the package and other information

What Symplisept contains

The active substances are octenidine dihydrochloride and phenoxyethanol. 1 g of gel contains 1 mg of octenidine dihydrochloride and 10 mg of phenoxyethanol.
Other ingredients are: ethanol 96%, glycerol 85%, poloxamer 407 (containing butylhydroxytoluene (E321)) and purified water.

What Symplisept gel looks like and contents of the pack
Symplisept is a colourless, transparent, homogeneous gel which becomes more fluid at lower
temperatures (below 15°C) and more sticky at higher temperatures. It is available in
transparent tubes made of HD- and LD-polyethylene, closed with a transparent cap made of polypropylene.
Pack size: 30 g.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Egis Pharmaceuticals PLC
Kereszturi ut 30-38
1106 Budapest
Hungary

Manufacturer:
Dr. August Wolff GmbH & Co KG Arzneimittel
Sudbrackstraße 56
33611 Bielefeld
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
Hungary Octizy 1 mg/g / 10 mg/g gel
Czech Republic Octizy
Slovakia Octizy
Latvia Octezy 1 mg/g / 10 mg/g gel
Lithuania Fenocyty Plus 1 mg/g / 10 mg/g gelis
Octezy Plus 1 mg/g / 10 mg/g gelis
Poland Symplisept
Bulgaria Симплисепт 1 mg/g / 10 mg/g гел
Symplisept 1 mg/g + 10 mg/g gel
Romania Octizy 1 mg/10 mg/g gel

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Tel.: +48 22 417 92 00