Octenidini apc pharmlog

Package leaflet: Information for the user

Octenidini APC Pharmlog, 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, as you may need to read it again.
• If you need advice or further information, please consult 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 Octenidini APC Pharmlog is and what it is used for
2. Important information before using Octenidini APC Pharmlog
3. How to use Octenidini APC Pharmlog
4. Possible side effects
5. How to store Octenidini APC Pharmlog
6. Contents of the pack and other information

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

Octenidini APC Pharmlog contains the active substance octenidine dihydrochloride.
Octenidini APC Pharmlog has antibacterial action. This 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 Octenidini APC Pharmlog

When not to use Octenidini APC Pharmlog:

• 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 Pharmlog is intended for topical use only. This medicine must not be injected into tissues using a 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 to use Octenidini APC Pharmlog, consult your doctor or pharmacist.
Octenidini APC Pharmlog is indicated solely for rinsing the mouth. 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 medicine with eyes. If contact occurs, immediately and thoroughly rinse eyes with water.
Transient discolouration of the tongue may occur, which disappears after discontinuation of the medicine. Reversible discolouration of teeth may also occur.

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

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

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.

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

Octenidini APC Pharmlog contains macrogolglycerol hydroxystearate
This may cause skin reactions.

3. How to use Octenidini APC Pharmlog

This medicine should always be used exactly as described in this patient 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 Pharmlog immediately after tooth brushing, rinse the mouth thoroughly with water first, then with Octenidini APC Pharmlog.
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
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 doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this product may cause adverse effects, although not everyone experiences them.
The following adverse effects have been reported after using Octenidini APC Pharmlog:

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):
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 up to 1 in 100 people):

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this 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,
Website: https://smz.ezdrowie.gov.pl.
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Octenidini APC Pharmlog

Keep this medicine out of sight and reach of children.
There are no special storage requirements for this medicine.
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 specified month.
Expiry after first opening of the container:
60 mL bottle: 2 weeks
250 mL bottle: 8 weeks
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

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

What Octenidini APC Pharmlog looks like and contents of the pack
Octenidini APC Pharmlog is a nearly clear, colourless solution for mouthwash with a peppermint odour.
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