OCTEANGIN 2.6mg x 20 lozenges
Leaflet: user information
Octeangin 2.6 mg lozenges
octenidine dihydrochloride
Octeangin 2.6 mg lozenges
octenidine dihydrochloride
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you need further information or advice, ask your pharmacist.
- If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
- If after 4 days you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains
- What is Octeangin lozenges and what is it used for
- What you need to know before using Octeangin lozenges
- How to use Octeangin lozenges
- Possible side effects
- How to store Octeangin lozenges
- Package contents and additional information
- What is Octeangin lozenges and what is it used for
Octeangin lozenges contain the active substance octenidine dihydrochloride. It is an antiseptic that is effective against pathogens by disrupting their cellular function.
Octeangin lozenges are used for short-term additional treatment in inflammation of the mucous membrane of the mouth and throat with typical symptoms such as pain, redness and swelling.
Octeangin Lozenges is indicated in adults and adolescents aged 12 years and older.
If after 4 days you do not feel better or your condition worsens, you should seek medical attention.
- What you need to know before using Octeangin lozenges
Do not use Octeangin lozenges
- if you are allergic to octenidine dihydrochloride or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Octeangin lozenges .
For short term use only.
Do not use this medicinal product for more than 4 days.
Children
The safety and effectiveness of Octeangin lozenges in children aged 0 to 11 years have not been established.
Other medicines and Octeangin lozenges
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No interaction studies have been conducted.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Pregnant women should consult a doctor before using Octeangin lozenges.
Breastfeeding
There is insufficient information on the excretion of octenidine hydrochloride in breast milk.
A risk to the infant cannot be completely excluded. Therefore, Octeangin lozenges 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 lozenges contain isomalt (E 953).
One lozenge contains 2.57 g of the sugar substitute isomalt, which corresponds to approximately 6 kcal (26 kJ). This should be considered in patients with diabetes mellitus. Isomalt may have a mild laxative effect.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
- How to use Octeangin lozenges
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is:
Unless otherwise prescribed, adults and adolescents 12 years of age and older should allow one lozenge to dissolve slowly in the mouth every 2-3 hours.
The maximum daily dose is 6 lozenges.
Entry path:
Allow the lozenges to dissolve slowly in the mouth (oromucosa).
Octeangin lozenges should not be used for more than 4 days without a doctor's recommendation.
Adverse reactions can be minimized by using the lowest effective dose for the shortest time necessary to control symptoms.
If you have used more than the required dose of Octeangin lozenges
In the unlikely event of an overdose, the side effects described may occur with greater intensity. In this case, please consult your doctor for symptomatic treatment.
If you forget to use Octangin lozenges
Do not take a double dose to make up for a missed lozenge.
If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.
- Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Not known (frequency cannot be estimated from the available data):
Irritation of the lining of the mouth and stomach, such as dysgeusia (taste disturbance), dry mouth, dyspepsia (indigestion), nausea and abdominal pain.
Allergic reactions.
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report side effects directly via
Medicines Executive Agency:
8 Damyan Gruev St
1303 Sofia
Tel.: +359 2 8903417
website: www.bda.bg
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
- How to store Octeangin lozenges
Keep out of the reach of children
Do not use this medicine after the expiry date which is stated on the pack and blister after EXP. The expiration date corresponds to the last day of the specified month.
Keep the blister in the carton in order to protect from light .
This medicinal product does not require special temperature storage conditions.
Do not dispose of medicines down the drain or household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
- Package contents and additional information
What does Octeangin lozenges contain?
- The active substance is octenidine dihydrochloride. One lozenge contains 2.6 mg of octenidine dihydrochloride.
- The other excipients are isomalt (E 953), tartaric acid, flavor masking bitter taste (containing propylene glycol, coffee extract and 4-(2,2,3-trimethylcyclopentyl)butanoic acid), star anise oil, peppermint oil and sucralose (E 955).
What Octeangin lozenges look like and what the package contains
Lozenges are ivory colored, round and slightly transparent.
Octeangin lozenges are available in cardboard boxes containing 12, 16, 20 or 24 lozenges, which are packed in PVC/PVDC blisters and aluminum foil.
Not all types of packaging can be put on sale.
Marketing Authorization Holder :
MCM Klosterfrau Vertriebsgesellschaft mbH
Gereonsmühlengasse 1-11
50670 Cologne
Germany
Manufacturer:
Klosterfrau Berlin GmbH
Motzener Str. 41
12277 Berlin
Germany
This medicinal product is authorized for use in the EEA Member States under the following names:
Bulgaria: Octeangin 2.6 mg lozenges
Germany, Luxembourg: Laryngomedin Octenidin Antisept
Austria: Octeangin antisept 2.6 mg Pastillen
Poland, Hungary: Octeangin
Romania: Octeangin 2.6 mg pastille
Czech Republic, Slovakia: Octenidine Klosterfrau
Date of last revision of leaflet
October/2020
