Simplisept

Package Leaflet: Information for the User

Symplisept, 1 mg/g + 20 mg/g, Skin Spray, Solution

Octenidine Dihydrochloride + Phenoxyethanol

Read the Package Leaflet Carefully Before Using the Medicinal Product

This medicinal product must be used exactly as described in this package leaflet or as directed by your doctor or pharmacist.

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.
• If after 2 weeks there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet

• 1. What is Symplisept and What is it 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 Package and Other Information

1. What is Symplisept and What is it Used For

Symplisept contains the active substances octenidine dihydrochloride, which has antiseptic and disinfectant properties, and phenoxyethanol, which has bactericidal properties.
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 you are allergic to octenidine dihydrochloride, phenoxyethanol, or any of the other ingredients of this medicinal product (listed in section 6).
• This medicinal product must not be used for rinsing the abdominal cavity (during surgery), bladder, or eardrum.

Warnings and Precautions

Before using Symplisept, you should discuss it with your doctor, pharmacist, or nurse.
Do not use more of this medicinal product than necessary. Do not swallow it or allow it to enter the bloodstream, e.g., by accidental injection.
To avoid possible tissue damage, be careful when using this medicinal product and make sure it is not used under pressure or injected into tissue. For deep wounds (larger, deeper wounds with tissue loss under the skin), ensure drainage of wound contents (e.g., by drainage or a special wound treatment method called skin flap technique).
Symplisept must not be used in the eye. If it comes into contact with the eyes, rinse them immediately with plenty of water.

Children

Use with caution in newborns, especially premature babies. Symplisept may cause severe skin changes. Remove any excess medicinal product and ensure 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).
Use of Symplisept in children under 6 years of age should be limited to a few days.

Symplisept and Other Medicinal Products

Tell your doctor or pharmacist about all medicinal products you are taking or have recently taken, including those obtained without a prescription.
Do not use this medicinal product at the same time as skin disinfectants containing povidone-iodine on adjacent areas of the body, as this may lead to strong brown or purple discoloration of the skin.
Do not use Symplisept at the same time as anionic tensides (e.g., soap, detergents, or cleaning agents), as this may lead to a weakening or loss of the antimicrobial effect of the medicinal product.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicinal product.
Pregnancy
Do not use Symplisept during pregnancy.
Breastfeeding
It is unlikely that this medicinal product will pass into breast milk.
During breastfeeding, do not use Symplisept on the breast area.

Driving and Using Machines

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

3. How to Use Symplisept

Use this medicinal product exactly as described in this package leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
This medicinal product is for use on the skin only (it is intended for use on the skin only). Symplisept in the form of a spray should be used on the area of skin that requires treatment until it is completely moistened.
After application, 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 medicinal product.
To ensure the medicinal product is effective, follow these instructions carefully.
Symplisept should not be used more than 3 times a day.
Do not use this medicinal product for more than 2 weeks without consulting your 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.

Overdose

Overdose of a topically applied medicinal product is very unlikely. If you are unsure, consult your doctor or pharmacist.
In case of accidental ingestion of Symplisept, consult your doctor immediately.
If you have any further questions about the use of this medicinal product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicinal products, Symplisept can cause side effects, although not everybody gets them.
Rare (may affect up to 1 in 1,000 people):
In rare cases, burning, 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 (contact allergic reactions) may occur, e.g., transient redness of the treated skin.
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 medicinal product in premature newborns may cause a transient skin rash (erythema).
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 you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist.
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:
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 medicinal product.

5. How to Store Symplisept

Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the bottle and carton after "EXP". The expiry date refers to the last day of the month.
30 mL bottle:
Do not store above 30°C.
Shelf life after first opening: 6 months.
50 mL and 100 mL bottles:
No special storage precautions.
Shelf life after first opening: 1 year.
Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products no longer required. This will 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 skin spray, solution contains 1 mg of octenidine dihydrochloride and 20 mg of phenoxyethanol.
• The other ingredients are cocamidopropyl betaine, 38% solution (contains sodium chloride), sodium gluconate, glycerol 85%, sodium hydroxide solution 0.4% (for pH adjustment), and purified water.

What Symplisept Looks Like and Contents of the Package

Symplisept is a clear, almost odorless solution without particles or sediment, packaged in white HDPE bottles with a spray pump and a polypropylene cap.
Pack sizes are 30 mL, 50 mL, and 100 mL.
Not all pack sizes may be marketed.

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 Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Countries:

Hungary
Octizy 1 mg/g / 20 mg/g külsőleges oldatos spray
Czech Republic
Octizy
Slovakia
Octizy
Latvia
Octezy 1 mg/g / 20 mg/g uz ādas lietojams aerosols, šķīdums
Lithuania
Octezy 1 mg/g / 20 mg/g odos purškalas (tirpalas)
Fenocty 1 mg/g / 20 mg/g odos purškalas (tirpalas)
Poland
Symplisept
Bulgaria
Симплисепт 1 mg/g / 20 mg/g спрей за кожа, разтвор
Symplisept 1 mg/g / 20 mg/g cutaneous spray, solution
Romania
Octizy 1 mg/g / 20 mg/g spray cutanat, soluție
For more information about this medicinal product, contact the local representative of the marketing authorization holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00

Date of Last Revision of the Package Leaflet: