Octenidini Apc Institut

Package Leaflet: Information for the User

Octenidini APC Institute, 1 mg/mL, Oral Solution

Octenidini dihydrochloride

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 any 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 Octenidini APC Institute and what is it used for
• 2. Important information before using Octenidini APC Institute
• 3. How to use Octenidini APC Institute
• 4. Possible side effects
• 5. How to store Octenidini APC Institute
• 6. Contents of the pack and other information

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

Octenidini APC Institute contains the active substance octenidine dihydrochloride.
Octenidini APC Institute acts against bacteria. 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 Octenidini APC Institute

When not to use Octenidini APC Institute:

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

Warnings and precautions

Octenidini APC Institute is intended for surface 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 Octenidini APC Institute, discuss it with your doctor or pharmacist.
Octenidini APC Institute is intended for rinsing the mouth only. Do not swallow it.
Therefore, it should be used by patients who can rinse their mouth on their own.
Avoid contact of the medicine 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

Octenidini APC Institute is not recommended for use in children and adolescents. The medicine has not been studied in this age group.

Octenidini APC Institute and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Some ingredients in toothpastes may affect the effectiveness of Octenidini APC Institute.
Therefore, it is best to use Octenidini APC Institute at a different time than brushing your teeth. If you use Octenidini APC Institute immediately after brushing your teeth, rinse your mouth thoroughly with water and then with the medicine.
Do not use Octenidini APC Institute 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, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Octenidini APC Institute does not affect the ability to drive or use machines.

Octenidini APC Institute contains macrogolglycerol hydroxystearate

This may cause skin reactions.

3. How to use Octenidini APC Institute

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 your doctor or pharmacist.
Use the medicine twice a day (after meals or brushing teeth).
Measure 10 mL of the medicine using the enclosed dosing cup. If you use Octenidini APC Institute immediately after brushing your teeth, rinse your mouth thoroughly with water and then with the medicine.
Rinse your mouth for 30 seconds and 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 your 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 recommended dosing schedule.
If you have any further questions about using this medicine, consult your 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 Octenidini APC Institute:
Very common(may affect more than 1 in 10 people):

• taste disorders, 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 any not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department for 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Octenidini APC Institute

Keep the medicine out of the sight and reach of children.
No special precautions for storage are necessary.
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 Octenidini APC Institute 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 (to adjust pH), macrogolglycerol hydroxystearate, sucralose, purified water, peppermint flavor (contains propylene glycol (49%), menthol (45%), mentone (6%)).

What Octenidini APC Institute looks like and contents of the pack

Octenidini APC Institute is a nearly clear, colorless oral solution 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

Date of last revision of the package leaflet: