Patient Information Leaflet

Octeangin
2.6 mg, hard pastilles
Octenidinum dihydrochloridum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
If the patient experiences any adverse reactions, including those not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Table of Contents

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

1. What Octeangin is and what it is used for

Octeangin contains the active substance octenidine dihydrochloride. This is an antiseptic agent
that effectively combats pathogenic microorganisms by disrupting their cellular function.
Octeangin is used for short-term supplementary treatment of inflammation of the mucous membranes of the
oral cavity and throat, associated with typical symptoms such as pain, redness, and swelling.
This medicine is indicated for use in adults and adolescents aged 12 years and older.
If there is no improvement after 4 days of treatment, or if symptoms worsen, consult a doctor.

2. 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, discuss this with your doctor or pharmacist.
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For short-term use only.
Do not use this medicine for longer than 4 days.

Children
The safety and efficacy of Octeangin in children aged 0 to 11 years have not yet been established.

Octeangin and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
No studies on interactions have been conducted.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Women who are pregnant should consult their doctor before using Octeangin.

Breastfeeding
There is insufficient information regarding the passage of octenidine dihydrochloride into human milk.
A risk to the breastfed infant cannot be completely ruled out. Therefore, Octeangin should not be used during breastfeeding.

Fertility
No studies have been conducted.

Driving and operating machinery
No studies on the influence on the ability to drive and operate machinery have been conducted.

Octeangin contains isomalt (E 953).
One hard lozenge contains 2.57 g of isomalt (a sugar substitute), providing 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, the patient should consult a doctor before taking this medicine.

3. How to use Octeangin

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Recommended dose:
Adults and adolescents aged 12 years and older should take one hard lozenge every 2–3 hours.
The maximum dose is 6 hard lozenges per day.
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Route of administration:
The lozenge should be actively and continuously sucked, moving it around the mouth until it dissolves completely.
Do not use Octeangin for longer than 4 days.
Adverse effects can be minimized by using the lowest effective dose for the shortest period necessary to relieve symptoms.
Use of a higher than recommended dose of Octeangin
In the unlikely event of overdose, the adverse effects described may become more severe. In such a case, consult a doctor to initiate symptomatic treatment.
Missed dose of Octeangin
Do not use a double dose to make up for a missed hard lozenge.
If you have any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Common (may affect up to 1 in 10 people):

taste disturbance (dysgeusia).

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

abdominal pain, diarrhoea, nausea, dry mouth, vomiting, indigestion, epigastric discomfort.

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

irritation of the oral and gastric mucosa,
tongue discoloration,
allergic reactions.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, 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 181 C, 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 directly to the Marketing Authorisation Holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Octeangin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister marked EXP.
The expiry date refers to the last day of the stated month.
Store the blister in the outer packaging to protect it from light.
There are no special requirements regarding the storage temperature of this medicine.
Medicines should not be disposed of via wastewater 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 Octeangin contains

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

What Octeangin looks like and contents of the pack
The hard pastilles are creamy white, round and slightly translucent.
Octeangin is available in cardboard cartons containing 12, 16, 20 or 24 hard pastilles,
which are packed in PVC/PVDC/Aluminium blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:
Germany, Luxembourg: Laryngomedin Octenidin Antisept
Austria: Octeangin antisept 2.6 mg Pastillen
Belgium, Bulgaria, Hungary, Poland, Romania: Octeangin
Czech Republic, Estonia, Latvia, Lithuania, Slovakia: Octenidine Klosterfrau
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Croatia: Oktenidindiklorid Klosterfrau
Slovenia: Oktenidin Klosterfrau
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