Octenigin

Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Octeangin
2.6 mg, hard pastilles
Octenidini dihydrochloridum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

1. What Octeangin is and what it is used for
2. What you should know before using Octeangin
3. How to use Octeangin
4. Possible side effects
5. How to store Octeangin
6. 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 functions.
Octeangin is used for short-term adjunctive treatment of inflammation of the oral and pharyngeal mucosa associated with typical symptoms such as pain, redness, and swelling.
Octeangin 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 it with your doctor or pharmacist.
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 baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Pregnant women should consult their doctor before using Octeangin.

Breastfeeding
There is insufficient information regarding the passage of octenidine dihydrochloride into human breast milk.
The 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 have been conducted on the influence on the ability to drive and operate machinery.

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

3. How to use Octeangin

This medicine should always be used as recommended 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, unless
otherwise advised.
Maximum dose is 6 hard lozenges per day.
Route of administration:
The lozenge should be actively and continuously sucked, moving it around the oral cavity 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 described adverse effects may become more severe.
In such a case, consult a doctor for symptomatic treatment.
Missed dose of Octeangin
Do not take 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Frequency unknown (frequency cannot be determined from available data):

• Irritation of the oral and gastric mucosa, such as taste disturbances, dry mouth, indigestion, nausea, or abdominal pain.
• Discoloration of the tongue.
• Allergic reactions.

Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Octeangin

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special temperature storage conditions are required. Store in the original packaging to protect from light.
Medicines must not be disposed of via the sewage system 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 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, flavouring ( Masking Flavour PHL-121355 ) (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 boxes containing 12, 16, 20 or 24 hard pastilles,
packaged in PVC-PVDC/Al blisters.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, country of export:
M.C.M. Klosterfrau Vertriebsgesellschaft mbH
Gereonsmühlengasse 1-11, 50670 Cologne, Germany
Manufacturer:
Klosterfrau Berlin GmbH
Motzener Strasse 41, Marienfelde, 12277 Berlin, Germany
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing authorisation number in Romania, country of export: 14990/2023/01
14990/2023/02
14990/2023/03
14990/2023/04
Parallel import authorisation number: 278/25
This medicinal product is authorised for sale in the European Economic Area under the following trade names:
Germany, Luxembourg: Laryngomedin Octenidin Antisept
Austria: Octeangin antisept 2.6 mg Pastillen
Bulgaria, Hungary, Poland, Romania: Octeangin
Czech Republic, Slovakia: Octenidine Klosterfrau