Doritri miemta

Package Leaflet: Information for the Patient

DoriTri mint, 0.5 mg + 1.0 mg + 1.5 mg, lozenges
tyrothricin + benzalkonium chloride + benzocaine

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• The package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 2 days, they should contact their doctor.

Table of Contents of the Package Leaflet

• 1. What is DoriTri mint lozenges and what is it used for
• 2. Important information before taking DoriTri mint lozenges
• 3. How to take DoriTri mint lozenges
• 4. Possible side effects
• 5. How to store DoriTri mint lozenges
• 6. Package contents and other information

1. What is DoriTri mint lozenges and what is it used for

DoriTri mint lozenges contain the local anesthetic benzocaine and tyrothricin and benzalkonium chloride as antibacterial agents. They are used to treat diseases of the mouth and throat.

Indications

Supportive treatment of mild to moderate inflammatory conditions of the throat and mouth, such as

• pharyngitis with sore throat and difficulty swallowing
• inflammatory conditions of the oral mucosa and gums.

In the case of severe throat infection or sore throat with fever, headache, nausea, or vomiting, medical advice should be sought before use.
DoriTri mint is indicated for use in adults and adolescents aged 12 years and older.
If there is no improvement or the patient feels worse after 2 days, they should contact their doctor.

2. Important information before taking DoriTri mint lozenges

When not to take DoriTri mint lozenges

• if the patient is allergic to tyrothricin, benzalkonium chloride, benzocaine, or any of the other ingredients of this medicine (listed in section 6), especially allergy to para-group compounds or quaternary ammonium salts.
• on larger open wounds in the mouth and throat.
• in children under 2 years of age

Warnings and precautions

Before taking DoriTri mint lozenges, the patient should discuss this with their doctor or pharmacist.
In the case of purulent tonsillitis with fever, the doctor will decide whether DoriTri mint lozenges should be used in addition to basic treatment, e.g., antibiotics.
DoriTri mint lozenges should not be taken if the patient has open wounds in the mouth or throat.
If the patient has a severe throat infection or sore throat with high fever, headache, nausea, or vomiting, they should consult their doctor before taking DoriTri mint lozenges. If these symptoms occur during treatment with DoriTri mint lozenges, treatment should be discontinued and the doctor consulted.
Patients with a tendency to skin hypersensitivity reactions (allergic contact dermatitis) should avoid using DoriTri mint lozenges due to the possibility of hypersensitivity reactions.

Children

The safety and efficacy of DoriTri mint lozenges in children under 12 years of age have not been established. Therefore, there are no dosage recommendations for children aged 6 to 11 years. DoriTri mint lozenges should not be used in children under 6 years of age, as controlled sucking cannot be guaranteed. DoriTri mint is contraindicated in children under 2 years of age.

DoriTri mint lozenges 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 take.
No interactions with other medicines have been reported to date after proper use.
The effect of benzalkonium chloride may be weakened in the case of concurrent use of anionic surfactants, such as toothpaste.

Pregnancy and breastfeeding

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.
Although there is no evidence to date that DoriTri mint lozenges have a harmful effect on the fetus, as a precautionary measure, they should not be used during pregnancy or breastfeeding.

Driving and using machines

DoriTri mint lozenges have no influence or insignificant influence on the ability to drive and use machines.

DoriTri mint lozenges contain 870.7 mg of sorbitol

Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to some sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, they should consult their doctor before taking the medicine or giving it to their child.

DoriTri mint lozenges contain 11.2 mg of sucrose from the excipient saccharose stearylate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

DoriTri mint lozenges contain 1 mg of sodium from the excipients saccharin sodium and sodium carmellose

The medicine contains less than 1 mmol (23 mg) of sodium per lozenge, which means the medicine is considered "sodium-free".

3. How to take DoriTri mint lozenges

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Dosage

The recommended dose for adults and children aged 12 years and older is 1-2 lozenges to be slowly dissolved in the mouth several times a day, every 2-3 hours.
The daily dose should not exceed 8 lozenges.
Treatment should be continued for another day after symptoms have resolved.
Since there is insufficient experience with the use of DoriTri mint lozenges in children under 12 years of age, no recommendation can be made for use in children aged 6 to 11 years.

Method of administration

Place the lozenge (lozenges) in the mouth and wait for it to dissolve slowly.

Overdose of DoriTri mint lozenges

In the case of proper use, poisoning with DoriTri mint lozenges can be ruled out, and no cases have been reported to date.
After taking a large number of lozenges, gastrointestinal symptoms and increased production of methemoglobin (especially in children) may occur. Possible symptoms include shortness of breath and cyanosis of the lips and fingers. The patient should consult their doctor in case of suspected significant overdose, especially in children.
Recommended measures include administering large amounts of water and activated charcoal and appropriate measures taken by the doctor to treat methemoglobinemia.

Missed dose of DoriTri mint lozenges

A double dose should not be taken to make up for a missed dose.
The patient should take 1 DoriTri mint lozenge immediately and continue with the usual dose according to the dosage instructions.

4. Possible side effects

Like all medicines, DoriTri mint lozenges can cause side effects, although not everybody gets them.

Possible side effects:

Rare (may affect up to 1 in 1,000 people):

• Skin hypersensitivity reactions, especially to esters of p-aminobenzoic acid (benzocaine). In sensitive patients, allergy to para-group compounds (e.g., penicillins, sulfonamides, sunscreens, p-aminosalicylic acid) may be triggered.
• In sensitive patients, hypersensitivity reactions (including respiratory disorders) to peppermint oil may occur.
• Altered taste perception or numbness of the tongue.
• Using tyrothricin on open wounds or abrasions may cause bleeding.

Very rare (may affect up to 1 in 10,000 people):

• Local use of benzocaine, especially in children and on larger wound surfaces, has led to increased methemoglobin levels in the blood. Possible symptoms include shortness of breath and cyanosis of the lips and fingers.
• Laxative effect due to the content of sorbitol, especially in high doses.

Reporting side effects

If side effects occur, including any side effects not listed in this package leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02-222 Warsaw
Phone: +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, more information can be collected on the safety of the medicine.

5. How to store DoriTri mint lozenges

The medicine should be stored out of sight and reach of children.
The 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.

Storage conditions:

Do not store above 25°C.

6. Package contents and other information

What DoriTri mint lozenges contain:

• Active substances are: Each lozenge contains: Tyrothricin 0.5 mg Benzalkonium chloride solution 1.0 mg Benzocaine 1.5 mg
• Other ingredients are: Sorbitol (E 420), talc, saccharose stearylate type III, saccharin sodium, peppermint oil with reduced menthol content, povidone K 25, sodium carmellose

What DoriTri mint lozenges look like and what the package contains

White, round lozenges with a diameter of about 16 mm
The package contains 20 or 40 lozenges.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Medice Pharma GmbH & Co. KG
Kuhloweg 37
58638 Iserlohn
Germany
Phone: +49 2371 937-111
Fax: +49 2371 937-329
Email: info@medice-pharma.de

Manufacturer

Medice Arzneimittel Pütter GmbH & Co. KG
Kuhloweg 37
58638 Iserlohn
Germany
Phone: +49 2371/937-0
Fax: +49 2371/937-106
Email: info@medice.de
www.medice.de

Date of last revision of the package leaflet: 02/2023