Linoseptic
Poland
Table of Contents
 | Linoseptic Gel - EN 1.3.1 Summary of Product Characteristics, Labelling and Package Leaflet Package Leaflet | Page 1 22/06/2022 |
Package leaflet: Information for the user
Linoseptic, 1 mg/g + 10 mg/g, gel
Octenidinum 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 possible adverse reactions 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 Linoseptic is and what it is used for
- Important information before using Linoseptic
- How to use Linoseptic
- Possible side effects
- How to store Linoseptic
- Contents of the pack and other information
1. What Linoseptic is and what it is used for
Linoseptic contains the active substances: octenidine dihydrochloride, an antiseptic and disinfectant agent, and phenoxyethanol, a bactericidal agent.
It is applied to the skin for the short-term, repeated, supportive antiseptic treatment of minor superficial wounds in patients of all age groups.
2. Important information before using Linoseptic
When not to use Linoseptic:
- if the patient is allergic to oxychloride octenidine, phenoxyethanol, or any of the other ingredients of this medicine (listed in section 6).
- This medicine must not be used in the stomach (i.e. during surgery [intraoperatively]), urinary bladder, or eardrum.
Warnings and precautions
Before starting treatment with Linoseptic, discuss it with your doctor or pharmacist.
Avoid contact between Linoseptic and anionic surfactants (e.g. soap, detergents).
Do not swallow the medicinal product and avoid its entry into the bloodstream, i.e. through accidental injection.
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To avoid possible tissue damage, care should be taken during application of the medicine to ensure that the product is not applied under pressure or injected into tissues.
For cavity wounds (larger, deeper wounds where part of the skin is missing), ensure that the medicinal product has been completely removed from the wound surface (e.g., by using a drain or suction device).
Do not apply Linoseptic to the eyes. In case of contact with eyes, rinse immediately with a large amount of water.
Children
Use with caution in newborns, especially premature infants. Linoseptic may cause severe skin reactions. Excess medication should be removed, and it should be ensured that the gel does not remain on the skin longer than necessary (this also applies to materials impregnated with the gel that are in direct contact with the patient).
The use of Linoseptic in children should be limited to a few days.
Linoseptic and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, including those obtained without a prescription.
Do not use this medicine together with antiseptic disinfectants based on PVP-iodine for sealing skin areas, as this may cause serious brown or purple skin discoloration.
Pregnancy and breastfeeding
If the patient is pregnant, 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
Do not use Linoseptic during pregnancy.
Breastfeeding
It is unlikely that this medicine passes into breast milk.
Linoseptic should not be applied to the breast area of breastfeeding women.
Driving and operating machinery
Linoseptic has no effect or has negligible effect on the ability to drive vehicles and operate machinery.
Linoseptic contains butylhydroxytoluene and alcohol (ethanol)
Butylhydroxytoluene may cause local skin reactions (e.g., contact dermatitis) or irritation of the eyes and mucous membranes.
This medicine contains 93.8 mg of alcohol (ethanol) per 1 g of gel. It may cause a burning sensation on damaged skin.
3. How to use Linoseptic
This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The medicinal product is intended for topical application only. The medicine should be applied exactly to the affected
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the area to be treated until the wound is completely covered.
Wait at least 1 or 2 minutes before taking any further actions, such as applying a dressing.
For the medicine to work effectively, it is essential to follow these instructions precisely.
Do not use this medicine for longer than 2 weeks without consulting a doctor.
Use in children
Due to its topical use, Linoseptic should be used in the same way in both adults and children. In children under 6 years of age, the duration of use should be limited to a few days.
Use of more than the recommended dose of Linoseptic
With topical medicines, overdose is very unlikely. However, if the patient is concerned, they should consult a doctor or pharmacist.
In case of accidental ingestion of Linoseptic, seek medical advice immediately.
Missed dose of Linoseptic
Do not apply a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Rare (may occur in no more than 1 in 1,000 people):
In rare cases, burning, redness, itching, and a sensation of warmth at the application site may occur.
Very rare (may occur in less than 1 in 10,000 people):
Contact allergic reactions are possible, such as temporary redness of treated skin.
When used for mouth rinsing, Linoseptic may cause a temporary bitter taste.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring 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 responsible entity.
Reporting adverse reactions enables further collection of information on the safety of using the medicine.
5. How to store Linoseptic
Keep this medicine out of sight and reach of children.
 | Linoseptic Gel - EN 1.3.1 Summary of Product Characteristics, Labelling and Package Leaflet Package Leaflet | Page 4 22/06/2022 |
Do not use this medicine after the expiry date stated on the tube and the carton after "EXP".
The expiry date refers to the last day of the stated month.
No special storage instructions for the medicinal product.
After first opening: Do not store above 25°C.
Period of use after first opening of the tube: 1 year.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.
6. Contents of the pack and other information
What Linoseptic contains
- The active substances in Linoseptic are octenidine dihydrochloride and phenoxyethanol. 1 g of gel contains 1 mg of octenidine hydrochloride and 10 mg of phenoxyethanol.
- The other ingredients are: ethanol 96%, glycerol 85%, poloxamer 407 [containing butylhydroxytoluene (E321)] and purified water.
What Linoseptic looks like and contents of the pack
Linoseptic is a clear, transparent and homogeneous gel, available in transparent tubes made of high-density polyethylene (HDPE) and low-density polyethylene (LDPE), with transparent caps made of polypropylene (PP).
Pack size: 30 g.
Marketing Authorisation Holder and Manufacturer
Dr. August Wolff GmbH & Co. KG Arzneimittel
Sudbrackstr. 56
33611 Bielefeld
Germany
Tel.: +49 (0)521 8808-05
Fax: +49 (0)521 8808-334
E-mail: [email protected]
This medicinal product is authorised in the European Economic Area countries under the following names:
| Austria: | Linola sept 1 mg/g + 10 mg/g Wound Gel |
| Czech Republic: | Linoseptic |
| Estonia: | Linoseptic |
| Germany: | Linola sept Wound Gel with Octenidine and Phenoxyethanol 1 mg/g + 10 mg/g Gel |
| Hungary: | Linoseptic 1 mg/g + 10 mg/g Gel |
| Lithuania: | Linoseptic 1 mg/10 mg/g Gel |
| Latvia: | Linoseptic 1 mg/10 mg/g Gel |
| Poland: | Linoseptic |
 | Linoseptic Gel - EN 1.3.1 Summary of Product Characteristics, Labelling and Package Leaflet Package Leaflet | Page 5 22/06/2022 |