Simplisept

Package Leaflet: Information for the User

Symplisept, 1 mg/g + 10 mg/g, Gel

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 or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement after 2 weeks or the patient feels worse, a doctor should be consulted.

Package Leaflet Contents

• 1. What Symplisept is and what it is used for
• 2. Important information before using Symplisept
• 3. How to use Symplisept
• 4. Possible side effects
• 5. How to store Symplisept
• 6. 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 acts as a bactericide.
Symplisept is used on the skin for the repeated, short-term supportive antiseptic treatment of small, superficial wounds in patients of all age groups.

2. Important information before using Symplisept

When not to use Symplisept:

• If the patient is allergic to octenidine dihydrochloride, phenoxyethanol, or any of the other ingredients of this medicine (listed in section 6).
• The medicine should not be used for rinsing the abdominal cavity (during surgery), the urinary bladder, or the eardrum.

Warnings and precautions

Before starting to use Symplisept, the doctor, pharmacist, or nurse should be consulted.
This medicine should not be used in larger quantities than necessary, it should not be swallowed, or allowed to enter the bloodstream, e.g., as a result of accidental injection.
To prevent possible tissue damage, caution should be exercised when using this medicine, and it should be ensured that the medicine is not used under pressure or injected into tissue.
In the case of deep wounds (larger, deeper wounds with tissue loss under the skin), it should be ensured that the wound contents drain (e.g., through drainage or a special wound treatment method called skin flap technique).
Symplisept should not be used in the eye. In case of eye contact, they should be rinsed immediately with a large amount of water.

Children

Caution should be exercised when using Symplisept in newborns, especially premature infants. Symplisept 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).
The use of Symplisept in children under 6 years of age should be limited to a few days.

Symplisept and other medicines

The doctor or pharmacist should be informed about all medicines that the patient is currently taking or has recently taken, including those available without a prescription.
This medicine should not be used at the same time as skin disinfectants based on
povidone-iodineon adjacent areas of the body, as this may lead to strong brown or purple discoloration of the skin.
Symplisept should not be used at the same time as anionic tensides (e.g., soap, detergents, or cleaning agents), as this leads to a weakening or loss of the antimicrobial effect of the medicine.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Symplisept should not be used during pregnancy.
Breastfeeding
It is very unlikely that this medicine will pass into breast milk.
During breastfeeding, Symplisept gel should not be applied to the breast area.

Driving and using machines

Symplisept has no influence or negligible influence on the ability to drive and use machines.

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 burning sensation on damaged skin.
Butylhydroxytoluene may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.

3. How to use Symplisept

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.
The medicine should be used on the skin (it is intended for use on the skin only). Symplisept gel should be applied in a thin layer to the skin area to be treated until it is completely covered.
After applying the gel, wait at least 1 to 2 minutes before proceeding, e.g., applying a dressing. This time is necessary to achieve the desired effect of the medicine.
To ensure the effectiveness of the medicine, these instructions should be followed carefully.
Symplisept should not be used more than 3 times a day.
The medicine should not be used for more than 2 weeks without consulting a doctor.

Use in children and adolescents

In relation to topical use, 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 of a topically used medicine is very unlikely. In case of doubt, a doctor or pharmacist should be consulted.
In case of accidental ingestion of Symplisept, a doctor should be consulted immediately.
In case of any further doubts about the use of this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare (may affect up to 1 in 1000 people):
In rare cases, burning, redness, itching, and a feeling of warmth may occur at the site of application.
Very rare (may affect up to 1 in 10,000 people):
Local skin irritation (reactions caused by contact allergy), e.g., transient redness of the treated skin, is possible.
If Symplisept comes into contact with the mouth, it may cause a transient bitter taste in the mouth.

Additional side effects in children and adolescents

Use of this medicine in premature newborns may cause a transient skin rash (erythema reaction).
The frequency, type, and severity of side effects in children and adolescents are considered to be the same as in adults.

Reporting side effects

If side effects occur, including those not listed in this package leaflet, the doctor or pharmacist should be informed.
Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Symplisept

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the tube and carton after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storage.
After first opening the tube:do not store above 25°C.
Shelf life after first opening the tube: 1 year.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be consulted on how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack 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.
• The other ingredients are ethanol 96%, glycerol 85%, poloxamer 407 (containing butylhydroxytoluene (E321)), and purified water.

What Symplisept looks like and contents of the pack

Symplisept is a colorless, transparent, homogeneous gel that becomes more fluid at low temperatures (below 15°C) and more viscous at higher temperatures. It is available in transparent tubes made of HD- and LD-polyethylene, closed with a transparent polypropylene cap.
Pack size: 30 g.

Marketing authorization holder and manufacturer

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

Countries:

Hungary
Octizy 1 mg/g / 10 mg/g gel
Czech Republic
Octizy
Slovakia
Octizy
Latvia
Octezy 1 mg/g / 10 mg/g gels
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
To obtain more detailed information on this medicine, the local representative of the marketing authorization holder should be contacted:
EGIS Polska Sp. z o.o.
Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00

Date of last revision of the package leaflet