Laryngomedin

Package leaflet: information for the patient

Laryngomedin
2.6 mg, hard pastilles
Octenidini dihydrochloridum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Laryngomedin is and what it is used for
2. Important information before using Laryngomedin
3. How to use Laryngomedin
4. Possible adverse reactions
5. How to store Laryngomedin
6. Contents of the pack and other information

1. What Laryngomedin is and what it is used for

Laryngomedin contains the active substance octenidine dihydrochloride. This is an antiseptic substance which effectively combats pathogenic microorganisms by disrupting their cellular function.
Laryngomedin is used for short-term supplementary treatment of inflammation of the mucous membranes of the mouth and throat 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, or if the patient feels worse, medical advice should be sought.

2. Important information before using Laryngomedin

When not to use Laryngomedin
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 Laryngomedin, 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 Laryngomedin in children aged 0 to 11 years have not been established.
Laryngomedin and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.
No studies on interactions have been conducted.
Pregnancy, breastfeeding and effects on fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Pregnancy
Pregnant women should consult their doctor before using Laryngomedin.
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, Laryngomedin 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.
Laryngomedin contains isomalt (E 953).
One hard tablet 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 consult a doctor before taking this medicine.

3. How to use Laryngomedin

This medicine should always be used according to the instructions given by your doctor or pharmacist. If you have any doubts,
you should consult your 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.
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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 Laryngomedin for longer than 4 days.
The risk of adverse effects can be reduced by using the lowest effective dose for the shortest period necessary to relieve symptoms.
Use of a higher than recommended dose of Laryngomedin
In the unlikely event of an overdose, the adverse effects described may become more pronounced. In such a case, consult a doctor for initiation of symptomatic treatment.
Missed dose of Laryngomedin
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 your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everybody experiences them.
Frequency unknown (frequency cannot be estimated from the available data):

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a 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 to the marketing authorization holder.
Reporting adverse reactions allows more information to be gathered on the safety of the medicine.

5. How to store Laryngomedin

Keep the medicine out of the 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.
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No special temperature storage instructions apply.
Medicines should not be disposed of via wastewater 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 Laryngomedin contains

• The active substance is octenidine dihydrochloride. Each hard tablet 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 Laryngomedin looks like and contents of the pack
The hard tablets are creamy-white, round, and slightly transparent.
Laryngomedin is available in cardboard boxes containing 12, 16, 20 or 24 hard tablets, 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.: 22 231 8287

Manufacturer
Klosterfrau Berlin GmbH
Motzener Strasse 41
Marienfelde
12277 Berlin
Germany