Doritri smak ovocuv leshnih

Package Leaflet: Information for the Patient

DoriTri fruit flavor, 0.5 mg + 1.0 mg + 1.5 mg, sucking tablets
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.

• This 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 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 Leaflet

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

1. What is DoriTri fruit flavor sucking tablets and what is it used for

Indications
DoriTri fruit flavor sucking tablets 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 high fever, headache, nausea, or vomiting, a doctor should be consulted before use.
DoriTri fruit flavor is indicated for use in adults and adolescents over 12 years of age.
If there is no improvement or the patient feels worse after 2 days, they should contact their doctor.

2. Important information before taking DoriTri fruit flavor sucking tablets

When not to take DoriTri fruit flavor sucking tablets

• 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 allergy to 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 fruit flavor sucking tablets, the patient should discuss this with their doctor or pharmacist.
In the case of purulent tonsillitis with fever, the doctor will decide whether to use DoriTri fruit flavor sucking tablets in addition to basic treatment, e.g., antibiotics.
DoriTri fruit flavor sucking tablets 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 fruit flavor sucking tablets. If these symptoms occur during treatment with DoriTri fruit flavor sucking tablets, treatment should be discontinued and a doctor consulted.
Patients with a tendency to skin hypersensitivity reactions (allergic contact dermatitis) should avoid using DoriTri fruit flavor sucking tablets due to the possibility of hypersensitivity reactions.

Children

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

DoriTri fruit flavor sucking tablets and other medicines

The patient should inform 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 reduced 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 fruit flavor sucking tablets 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 fruit flavor sucking tablets have no influence or insignificant influence on the ability to drive and use machines.

DoriTri fruit flavor sucking tablets contain 860.7 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 fruit flavor sucking tablets contain 11.2 mg of sucrose from the excipient sucrose stearyl ester

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

DoriTri fruit flavor sucking tablets contain 1 mg of sodium from the excipients sodium saccharin and sodium carmellose

The medicine contains less than 1 mmol (23 mg) of sodium per sucking tablet, i.e., the medicine is considered "sodium-free).

3. How to take DoriTri fruit flavor sucking tablets

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.

Dosage

The recommended dose for adults and children over 12 years of age is 1-2 sucking tablets to be slowly dissolved in the mouth several times a day, every 2-3 hours.
The daily dose should not exceed 8 sucking tablets.
Treatment should be continued for another day after the symptoms have disappeared.
Since there is not enough experience with the use of DoriTri fruit flavor sucking tablets in children under 12 years of age, no dosage recommendation can be made for children between 6 and 11 years of age.

Method of administration

Place the sucking tablet (tablets) in the mouth and wait for it to dissolve slowly.

Overdose of DoriTri fruit flavor sucking tablets

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

Missed dose of DoriTri fruit flavor sucking tablets

A double dose should not be taken to make up for a missed dose.
1 DoriTri fruit flavor sucking tablet should be taken immediately and the usual dose continued according to the dosage instructions.

4. Possible side effects

Like all medicines, this medicine 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.
• Altered taste perception or tongue numbness.
• 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 leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store DoriTri fruit flavor sucking tablets

The medicine should be stored out of sight and reach of children.
This 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 fruit flavor sucking tablets contain:

• The active substances are: Each sucking tablet contains: Tyrothricin 0.5 mg Benzalkonium chloride solution 1.0 mg Benzocaine 1.5 mg
• The other ingredients are: Sorbitol (E 420), talc, sucrose stearyl ester type III, sodium saccharin, red fruit flavor, povidone K 25, sodium carmellose

What DoriTri fruit flavor sucking tablets look like and what the package contains

White, round sucking tablets with a diameter of approximately 16 mm
The package contains 20 or 40 sucking tablets.
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: [email protected]

Manufacturer

Medice Arzneimittel Pütter GmbH & Co. KG
Kuhloweg 37
58638 Iserlohn
Germany
Phone: +49(0)2371/937-0
Fax: +49(0)2371/937-106
Email: [email protected]
www.medice.de

Date of last revision of the leaflet: 02/2023