Package leaflet: Information for the user

Octenidini APC Instytut, 1 mg/mL, solution for use in the oral cavity
Octenidini dihydrochloridum
Please read the entire leaflet carefully before using this medicine, as 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 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 adverse reactions 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

What Octenidini APC Instytut is and what it is used for
Important information before using Octenidini APC Instytut
How to use Octenidini APC Instytut
Possible side effects
How to store Octenidini APC Instytut
Contents of the pack and other information

1. What Octenidini APC Instytut is and what it is used for

Octenidini APC Instytut contains the active substance octenidine dihydrochloride.
Octenidini APC Instytut has antibacterial action. It 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 Octenidini APC Instytut

When not to use Octenidini APC Instytut:

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

Warnings and precautions
Octenidini APC Instytut is intended for topical use only. This medicine must not be administered into tissues via syringe or cannula to avoid irritation of surrounding tissues, which may lead to development of oedema or tissue necrosis. In particular, the product should not be used for irrigation of periodontal pockets, root canals, or wounds following dental procedures.
Before starting treatment with Octenidini APC Instytut, consult a doctor or pharmacist.
Octenidini APC Instytut 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 with eyes. In case of contact with eyes, immediately and thoroughly rinse 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
Octenidini APC Instytut is not recommended for use in children and adolescents. The medicine has not been studied in this age group.

Octenidini APC Instytut and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Some ingredients of toothpastes may affect the efficacy of Octenidini APC Instytut. Therefore, it is best to use Octenidini APC Instytut at a different time than tooth brushing. If using Octenidini APC Instytut immediately after brushing teeth, rinse the mouth thoroughly with water first, then use Octenidini APC Instytut.
Do not use Octenidini APC Instytut 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, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Octenidini APC Instytut has no influence on the ability to drive or operate machinery.

Octenidini APC Instytut contains macrogol glycerol hydroxystearate
This may cause skin reactions.

3. How to use Octenidini APC Instytut

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine should be used twice daily (after a meal or tooth brushing).
Measure 10 mL of the medicine using the provided dosing device. When using Octenidini APC Instytut immediately after tooth brushing, thoroughly rinse the mouth with water first, then use Octenidini APC Instytut.
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 larger than recommended dose of the medicine
If a larger amount of the medicine is swallowed, gastrointestinal symptoms may occur. In such a case, contact a doctor 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 questions about 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 everyone will experience them.
The following adverse reactions have been reported after using Octenidini APC Instytut:

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

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

Common (may affect less than 1 in 10 people):
numbness sensation in the oral cavity,
deposits in the oral cavity or on the tongue,
temporary discoloration of the tongue,
tooth sensitivity.

Uncommon (may affect less than 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, please inform your doctor or pharmacist. Adverse reactions 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,
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 Octenidini APC Instytut

Keep this medicine out of sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the bottle and the cardboard
package after EXP. The expiry date refers to the last day of the stated month.
Expiry after first opening of the container:
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 package and other information

What Octenidini APC Instytut 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 glycerol hydroxystearate, sucralose, purified water, and peppermint flavour (containing propylene glycol (49%), menthol (45%), menthone (6%)).

What Octenidini APC Instytut looks like and contents of the pack
Octenidini APC Instytut is an almost clear, colourless solution for mouth rinsing with a peppermint odour.
Pack sizes available: 60 mL and 250 mL with a dispenser.
Marketing Authorisation Holder and Manufacturer
Schülke & Mayr GmbH
Robert-Koch-Strasse 2
22851 Norderstedt
Germany