Octenisept oral mono

Package leaflet: Information for the user

octenisept oral mono, 1 mg/mL, solution for oral use
Octenidini dihydrochloridum
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 contact your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 5 days, or if you feel worse, consult your doctor.

Contents of the leaflet

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

Octenisept oral mono contains the active substance octenidine dihydrochloride.
Octenisept oral mono has antibacterial action. The medicine is used to temporarily reduce the number of bacteria in the oral cavity, to temporarily inhibit dental plaque formation, and in cases of inadequate oral hygiene (e.g. when tooth brushing is not possible) in adults.

2. Important information before using the medicinal product 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 medicinal product (listed in section 6).

Warnings and precautions
Octenisept oral mono is intended for topical use only. This medicinal product must not be administered deep into tissues via syringe or cannula, as this may cause irritation of surrounding tissues, potentially leading to oedema or tissue necrosis. In particular, the product must not be used for irrigation of periodontal pockets, root canals, or wounds following dental procedures.
Before starting treatment with Octenisept oral mono, consult your doctor or pharmacist.
Octenisept oral mono is indicated solely for mouth rinsing. It must not be swallowed. Therefore, it should only be used by patients who are able to rinse their mouth independently.
Avoid contact of the product with the eyes. In case of accidental contact with eyes, rinse immediately and thoroughly with water.
Temporary discolouration of the tongue may occur, which disappears after discontinuation of the product. Reversible discolouration of teeth may also occur.

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

Octenisept oral mono and other medicinal products
Inform your doctor or pharmacist about all medicinal products currently used, recently used, or planned for use.
Some ingredients of toothpastes may affect the efficacy of Octenisept oral mono. Therefore, it is best to use Octenisept oral mono at a different time than tooth brushing. If using Octenisept oral mono immediately after brushing teeth, rinse the mouth thoroughly with water first, then use Octenisept oral mono.
Do not use Octenisept oral mono simultaneously with products containing povidone-iodine, as this may cause violet or brown stains in the oral cavity.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicinal product.

Driving and operating machinery
Octenisept oral mono has no influence on the ability to drive or operate machinery.

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 patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a physician or pharmacist.
The medicine should be used twice daily (after a meal or tooth brushing).
Use 10 mL of the medicine with the dosing cap provided. When using octenisept oral mono
immediately after tooth brushing, rinse the mouth thoroughly with water first, then use the
medicine octenisept oral mono.
Rinse the mouth for 30 seconds, then spit out the solution. Do not swallow the medicine.
Do not rinse the mouth with water immediately after using the medicine.
Do not use the medicine for longer than 5 days.
Use of a higher than recommended dose of the medicine
Gastrointestinal symptoms may occur if a larger amount of the medicine is swallowed. In such
a case, contact a physician or pharmacist.
Missed dose
Do not use a double dose to make up for a missed dose. Continue using the medicine according
to the prescribed dosing schedule.
If you have any further doubts regarding the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been reported after using octenisept oral mono:

Very common (may affect more than 1 in 10 people):

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

Common (may affect up to 1 in 10 people):

• oral numbness,
• deposits in the oral cavity or on the tongue,
• temporary discoloration of the tongue,
• tooth sensitivity.

Uncommon (may affect up to 1 in 100 people):

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Octenisept oral mono

Keep this medicine out of the sight and reach of children.
No special storage conditions apply for this medicine.
Do not use this medicine after the expiry date stated on the bottle and the outer carton after: EXP. The expiry date refers to the last day of the stated month.
Expiry date after first opening the container:
60 mL bottle: 2 weeks
250 mL bottle: 8 weeks
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 solution contains 1 mg of octenidine dihydrochloride.
• The other ingredients are glycerol 85%, sodium gluconate, citric acid, disodium phosphate dihydrate (for pH adjustment), macrogol stearoyl monoglycerol, sucralose, purified water, peppermint flavour (containing propylene glycol (49%), menthol (45%), menthone (6%)).

What octenisept oral mono looks like and contents of the pack
Octenisept oral mono is a nearly clear, colourless solution for rinsing the oral cavity with a mint aroma.
Available pack sizes: 60 mL and 250 mL with a dispenser.

Marketing Authorisation Holder and Manufacturer
Schülke & Mayr GmbH
Robert-Koch-Strasse 2
22851 Norderstedt
Germany

This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Austria – Octenimed 1 mg/ml solution for use in the oral cavity
Czech Republic – Riduca
Germany – octenident antiseptic 1 mg/ml solution for use in the oral cavity
Poland – octenisept oral mono