Octenisept oral mono

Package Leaflet: Information for the User

octenisept oral mono, 1 mg/mL, solution for oral use
Octenidini dihydrochloridum

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.
• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 5 days there is no improvement or you feel worse, contact a doctor.

Table of Contents of the Package Leaflet

• 1. What is octenisept oral mono and what is it used for
• 2. Important information before using octenisept oral mono
• 3. How to use octenisept oral mono
• 4. Possible side effects
• 5. How to store octenisept oral mono
• 6. Contents of the pack and other information

1. What is octenisept oral mono and what is it used for

Octenisept oral mono contains the active substance octenidine dihydrochloride.
Octenisept oral mono has antibacterial properties. The medicine is used to temporarily reduce the number of bacteria in the mouth, temporarily inhibit the formation of dental plaque, and in cases of inadequate oral hygiene (e.g., inability to brush teeth) in adults.

2. Important information before using octenisept oral mono

When not to use octenisept oral mono:

• if the patient is allergic to octenidine dihydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Octenisept oral mono is intended for topical use only. Do not administer this medicine into tissues using a syringe or cannula to avoid irritating surrounding tissues, which may cause swelling or tissue necrosis. In particular, the medicine should not be used for rinsing periodontal pockets, rinsing root canals, or rinsing wounds after dental procedures.
Before starting to use octenisept oral mono, discuss it with your doctor or pharmacist.
Octenisept oral mono is indicated only for rinsing the mouth. Do not swallow it.
Therefore, it should be used by patients who can rinse their mouths on their own.
Avoid contact with the eyes. If the medicine comes into contact with the eyes, rinse them immediately and thoroughly with water.
A temporary discoloration of the tongue may occur, which disappears after stopping the use of the medicine. Reversible discoloration of the teeth may also occur.

Children and adolescents

Octenisept oral mono is not recommended for use in children and adolescents. The medicine has not been studied in this age group.

Octenisept oral mono and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Some ingredients of toothpastes may affect the effectiveness of octenisept oral mono. Therefore, it is best to use octenisept oral mono at a different time than brushing your teeth. If you use octenisept oral mono immediately after brushing your teeth, rinse your mouth thoroughly with water, and then with octenisept oral mono.
Do not use octenisept oral mono at the same time as products containing povidone-iodine, as this may cause purple or brown spots in the mouth.

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 medicine.

Driving and using machines

Octenisept oral mono does not affect the ability to drive or use machines.

Octenisept oral mono contains macrogolglycerol hydroxystearate

This may cause skin reactions.

3. How to use octenisept oral mono

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If you are unsure, consult a doctor or pharmacist.
Use the medicine twice a day (after meals or brushing teeth).
Use 10 mL of the medicine in the attached dosing cup. If you use octenisept oral mono immediately after brushing your teeth, rinse your mouth thoroughly with water, and then with octenisept oral mono.
Rinse your mouth for 30 seconds, then spit out the solution. Do not swallow the medicine.
Do not rinse your mouth with water immediately after using the medicine.
Do not use the medicine for more than 5 days.

Using more than the recommended dose of the medicine

If you swallow more medicine than recommended, gastrointestinal symptoms may occur. In this case, contact a doctor or pharmacist.

Missing a dose of the medicine

Do not take a double dose to make up for a missed dose. Use the medicine according to the adopted dosing schedule.
If you have any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported with the use of octenisept oral mono:
Very common(may affect more than 1 in 10 people):

• taste disturbances, such as a bitter taste,
• mild, reversible tooth discoloration.

Common(may affect less than 1 in 10 people):
numbness in the mouth,
deposits in the mouth or on the tongue,
temporary tongue discoloration,
tooth sensitivity.
Uncommon(may affect less than 1 in 100 people):

• headache,
• nausea,
• tingling sensation on the tongue,
• increased salivation.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
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 octenisept oral mono

Keep the medicine out of the sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the bottle and carton after: EXP. The expiry date refers to the last day of the month.
Shelf life after first opening the package:
60 mL bottle: 2 weeks
250 mL bottle: 8 weeks
Medicines should 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 pack and other information

What octenisept oral mono contains

• The active substance is octenidine dihydrochloride. 1 mL of the solution contains 1 mg of octenidine dihydrochloride.
• The other ingredients are glycerol 85%, sodium gluconate, citric acid, disodium phosphate dihydrate (to adjust pH), macrogolglycerol hydroxystearate, sucralose, purified water, peppermint flavor (contains propylene glycol (49%), menthol (45%), mentone (6%)).

What octenisept oral mono looks like and contents of the pack

Octenisept oral mono is a nearly clear, colorless solution for mouth rinsing with a minty flavor.
Available pack sizes: 60 mL and 250 mL with a dosing cup.

Marketing authorization holder and manufacturer

Schülke & Mayr GmbH
Robert-Koch-Strasse 2
22851 Norderstedt
Germany

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

Austria – Octenimed 1 mg/ml Lösung zur Anwendung in der Mundhöhle
Czech Republic – Riduca
Germany – octenident antiseptic 1 mg/ml Lösung zur Anwendung in der Mundhöhle
Poland – octenisept oral mono
Date of last revision of the package leaflet:April 2024