Octeangin

Leaflet attached to the packaging: patient information

Octeangin

2.6 mg, hard tablets

Octenidinum dihydrochloridum

Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one person. It should not be passed on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Octeangin and what is it used for

Octeangin contains the active substance octenidine dihydrochloride. This is an antiseptic substance that effectively combats pathogenic microorganisms by destroying their cell function. Octeangin is used for short-term supplementary treatment of inflammation of the mucous membrane of the mouth and throat with typical symptoms such as pain, redness, and swelling. Octeangin is indicated for use in adults and adolescents from 12 years of age. If there is no improvement after 4 days or if the patient feels worse, they should consult a doctor.

2. Important information before using Octeangin

When not to use Octeangin

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

Warnings and precautions

Before starting to use Octeangin, the patient should discuss it with their doctor or pharmacist. For short-term use only. This medicine should not be used for more than 4 days.

Children

The safety and efficacy of Octeangin in children from 0 to 11 years of age have not been established.

Octeangin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to use. No interaction studies have been conducted.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. Pregnancy Women who are pregnant should consult their doctor before using Octeangin. Breastfeeding There is insufficient information on the passage of octenidine dihydrochloride into human milk. It cannot be entirely ruled out that there is a risk to the breastfed child. Therefore, Octeangin should not be used during breastfeeding. Fertility No studies have been conducted.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines. Octeangin contains isomalt (E 953). One hard tablet contains 2.57 g of isomalt (sugar substitute), which corresponds to approximately 6 kcal (26 kJ). This should be taken into account in patients with diabetes. Isomalt may have a mild laxative effect. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.

3. How to use Octeangin

This medicine should always be used in accordance with the recommendations of the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. The recommended dose is: Adults and adolescents from 12 years of age should use one hard tablet every 2-3 hours, unless otherwise advised. The maximum dose is 6 hard tablets per day. Route of administration: The tablet should be sucked actively and continuously, moving it around the mouth until it is completely dissolved. This medicine should not be used for more than 4 days. Side effects can be reduced by using the smallest effective dose for the shortest period necessary to alleviate the symptoms.

Using a higher dose of Octeangin than recommended

In the unlikely event of an overdose, the described side effects may worsen. In such a case, the patient should consult their doctor to start symptomatic treatment.

Missing a dose of Octeangin

The patient should not take a double dose to make up for a missed hard tablet. In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Frequency not known (frequency cannot be estimated from the available data):

• Irritation of the mucous membrane of the mouth and stomach, such as taste disorders, dry mouth, indigestion, nausea, or abdominal pain.
• Discoloration of the tongue.
• Allergic reactions.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181 C, 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, it is possible to gather more information on the safety of the medicine.

5. How to store Octeangin

The medicine should be stored out of sight and reach of children. This medicine should not be used after the expiry date stated on the carton and blister after: EXP. The expiry date refers to the last day of the month stated. The blister should be stored in the outer packaging to protect it from light .There are no special instructions for storing the medicine at a certain temperature. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Octeangin contains

• The active substance is octenidine dihydrochloride. One hard tablet contains 2.6 mg of octenidine dihydrochloride.
• The other ingredients are: isomalt (E 953), tartaric acid, flavor (contains propylene glycol, coffee extract, and 4-(2,2,3-trimethylcyclopentyl)butyric acid), star anise essential oil, peppermint essential oil, sucralose (E 955).

What Octeangin looks like and what the packaging contains

The hard tablets are cream-white, round, and slightly transparent. Octeangin is available in cardboard boxes containing 12, 16, 20, or 24 hard tablets, which are packaged in PVC/PVDC/Aluminum blisters. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

M.C.M. Klosterfrau Healthcare Sp. z o.o. ul. Hrubieszowska 2 01-209 Warsaw tel. +48 22 231 8287

Manufacturer

Klosterfrau Berlin GmbH Motzener Strasse 41 Marienfelde 12277 Berlin Germany

This medicinal product is authorized for marketing in the Member States of the European

Economic Area under the following names:

Germany, Luxembourg: Laryngomedin Octenidin Antisept Austria: Octeangin antisept 2.6 mg Pastillen Bulgaria, Hungary, Poland, Romania: Octeangin Czech Republic, Slovakia: Octenidine Klosterfrau Date of last revision of the leaflet:July 2024