Linoseptic
Poland
Table of Contents
 | Linoseptic Spray - EN 1.3.1 Summary of Product Characteristics, Labelling and Package Leaflet Package Leaflet | Page 1 15/01/2021 |
Package leaflet: Information for the user
Linoseptic, 1 mg/g + 20 mg/g, cutaneous aerosol, solution
Octenidinum dihydrochloridum + Phenoxyethanolum
Please read all of this leaflet carefully before using this medicine because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.
- Keep this leaflet, so that it can be read again if necessary.
- If advice or further information is needed, consult the pharmacist.
- If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.
- If there is no improvement after 2 weeks or if the patient feels worse, contact the 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 repeated, short-term, supportive antiseptic treatment of minor
superficial wounds in patients of all age groups.
2. Information before using Linoseptic
When not to use Linoseptic:
- if the patient is allergic to oxytetracycline hydrochloride, phenoxyethanol, or any of the other ingredients of this medicine (listed in section 6).
- This medicine must not be used as a method of gastric content cleansing (i.e. during surgery [intraoperatively]) or of the urinary bladder or tympanic membrane.
Warnings and precautions
Before starting treatment with Linoseptic, discuss this with your doctor or pharmacist.
Avoid contact between Linoseptic and anionic surfactants (e.g. soap, detergents).
Do not swallow the medicinal product or allow it to enter the bloodstream, e.g. through accidental injection.
To avoid possible tissue damage, exercise caution during application of the medicine to ensure that the product is not applied under pressure or injected into tissues.
 | Linoseptic Spray - EN 1.3.1 Summary of Product Characteristics, Labelling and Package Leaflet Package Leaflet | Page 2 15/01/2021 |
In the case of wound cavities (larger, deeper wounds where part of the skin is missing), ensure
that the medicinal product is removed from the wound (e.g., via a drain or suction).
Do not use Linoseptic in the eye. If contact occurs, immediately rinse the eyes thoroughly
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 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 Linoseptic in children should be limited to a few days.
Linoseptic and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as over-the-counter medicines.
Do not use this medicine together with antiseptic disinfectants based on PVP-
iodine to cover skin areas, as this may cause severe brown or violet skin discoloration.
Pregnancy and breastfeeding
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
Linoseptic should not be used 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 a negligible effect on the ability to drive and
operate machinery.
3. How to use Linoseptic
This medicine should always be used exactly as described in the patient leaflet or as directed by a physician or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicinal product is intended for topical application to the skin. The product should be applied precisely to the area intended for treatment, until the wound is completely moistened.
Wait at least 1 or 2 minutes before taking further actions, such as applying a dressing, allowing the wound to slightly dry.
To ensure effective treatment, it is essential to follow these instructions carefully.
Do not use this medicine for longer than 2 weeks without consulting a doctor.
Use in children
 | Linoseptic Spray - EN 1.3.1 Summary of Product Characteristics, Labelling and Package Leaflet Package Leaflet | Page 3 15/01/2021 |
Due to the topical use, the Linoseptic medicinal product is used in the same way in adults and
children. In children under 6 years of age, the duration of use should be limited to a few days.
Use of a higher than recommended dose of Linoseptic
In the case of topical medicinal products, 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 application of Linoseptic
Do not use a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicinal product, consult your doctor or
pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Rare (may occur in not 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 such as temporary redness of the treated skin are possible.
When used for mouth rinsing, Linoseptic may cause a temporary bitter taste.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in the leaflet, inform your doctor or pharmacist.
Adverse effects 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; tel.: + 48 22 49 21 301; fax: + 48 22 49 21 309; e-mail: [email protected] .
Adverse effects can also be reported to the marketing authorization holder.
By reporting adverse effects, additional information on the safety of the medicine can be collected.
5. How to store Linoseptic medicine
Keep the medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the bottle and carton following:
"EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicinal product.
100 ml bottle:
Shelf-life after first opening of the bottle container: 1 year.
 | Linoseptic Spray - EN 1.3.1 Summary of Product Characteristics, Labelling and Package Leaflet Package Leaflet | Page 4 15/01/2021 |
Bottle 30 ml and 50 ml:
Shelf life after first opening of the bottle packaging: 6 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.
6. Contents of the package and other information
What Linoseptic contains
- The active substances in the medicine are octenidine dihydrochloride and phenoxyethanol. 1 g of cutaneous aerosol solution contains 1 mg of octenidine dihydrochloride and 20 mg of phenoxyethanol.
- The other ingredients are: cocamidopropyl betaine, 38 % activity (containing sodium chloride), sodium gluconate, glycerol 85 %, sodium hydroxide 0.4 % solution, purified water.
What Linoseptic looks like and contents of the pack
Linoseptic product is a clear, colourless cutaneous aerosol solution, available in white high-density polyethylene (HDPE) bottles equipped with a spray pump and a polycarbonate (PP) cap, packed in a cardboard box.
Pack sizes are 30, 50 and 100 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Dr. August Wolff GmbH & Co. KG Arzneimittel
Sudbrackstrasse 56
33611 Bielefeld
GERMANY
tel.: +49 521 8808-05
fax: +49 521 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 + 20 mg/g Wound Spray for topical use, solution |
| Czech Republic: | Linoseptic |
| Estonia: | Linoseptic |
| Germany: | Linola sept Wound Spray with Octenidine and Phenoxyethanol 1 mg/g + 20 mg/g, spray for topical use, solution |
| Hungary: | Linoseptic 1 mg/g + 20 mg/g Cutaneous solution spray |
| Latvia: | Linoseptic 1 mg/20 mg/g Cutaneous aerosol, solution |
| Lithuania: | Linoseptic 1 mg/20 mg/g Cutaneous spray (solution) |
| Poland: | Linoseptic |