DORITRI FOREST FRUIT FLAVOR

Package leaflet: Information for the patient

DoriTri forest fruit flavour, 0.5 mg + 1.0 mg + 1.5 mg, lozenges
tyrothricin + benzalkonium chloride + benzocaine
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 2 days or if your condition worsens, contact your doctor.

Leaflet contents

1. What DoriTri forest fruit flavour lozenges are and what they are used for
2. Important information before taking DoriTri forest fruit flavour lozenges
3. How to take DoriTri forest fruit flavour lozenges
4. Possible side effects
5. How to store DoriTri forest fruit flavour lozenges
6. Contents of the pack and other information

1. What DoriTri forest fruit flavour lozenges are and what they are used for

DoriTri forest fruit flavour lozenges contain benzocaine, a local anaesthetic, and tyrothricin and benzalkonium chloride as antibacterial agents. They are used in the treatment of oral and throat conditions.
DoriTri forest fruit flavour lozenges are intended for local, short-term adjunctive treatment of mild to moderate inflammatory conditions of the throat and oral cavity, such as:

• sore throat with pain and swallowing difficulties
• inflammatory conditions of the oral mucosa and gums.

In case of severe throat infection or sore throat accompanied by fever, headache, nausea or vomiting, consult a doctor before use.
DoriTri forest fruit flavour lozenges are indicated for use in adults and adolescents aged 12 years and older.

2. Important information before taking DoriTri forest fruit flavour lozenges

Do not take DoriTri forest fruit flavour lozenges:

• if you are allergic to tyrothricin, benzalkonium chloride, benzocaine or any of the other ingredients of this medicine (listed in section 6), particularly if you have a sensitivity to para-compounds or to quaternary ammonium salts.
• for application on large open wounds in the mouth or throat.
• in children under 2 years of age.

Warnings and precautions

Before taking DoriTri forest fruit flavour lozenges, discuss with your doctor or pharmacist.
In case of purulent tonsillitis with fever, your doctor will decide whether DoriTri forest fruit flavour lozenges should be used in addition to primary treatment, e.g. antibiotics.
Do not take DoriTri forest fruit flavour lozenges if you have open wounds in the mouth or throat.
If you have a severe throat infection or sore throat with high fever, headache, nausea or vomiting, consult your doctor before taking DoriTri forest fruit flavour lozenges. If these symptoms occur during treatment, discontinue use and contact your doctor.
Patients with a tendency to skin hypersensitivity reactions (allergic contact dermatitis) should avoid using DoriTri forest fruit flavour lozenges due to the risk of hypersensitivity reactions.

Children

The safety and efficacy of DoriTri forest fruit flavour lozenges have not been established in children under 12 years of age. Therefore, dosing recommendations are not available for children aged 6 to 11 years. DoriTri forest fruit flavour lozenges should not be used in children under 6 years of age, as controlled sucking cannot be guaranteed. DoriTri forest fruit flavour lozenges are contraindicated in children under 2 years of age.

DoriTri forest fruit flavour lozenges and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
No interactions with other medicines have been reported with correct use.
The effect of benzalkonium chloride may be reduced when used concurrently with anionic surfactants, such as toothpaste.
Medicines that cause methaemoglobinaemia (e.g. local anaesthetics, dapsone) may increase the risk of methaemoglobinaemia.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Although there is currently no evidence that DoriTri forest fruit flavour lozenges are harmful to the foetus, as a precaution, they should not be used during pregnancy or breastfeeding.

Driving and operating machinery

DoriTri forest fruit flavour lozenges have no effect or negligible effect on the ability to drive and operate machinery.

DoriTri forest fruit flavour lozenges contain 860.7 mg of sorbitol

Sorbitol is a source of fructose. If you or your child has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the body cannot break down fructose, consult your doctor before taking this medicine or giving it to your child. Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.

DoriTri forest fruit flavour lozenges contain 11.2 mg of sucrose from the excipient - sucrose stearate

If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

DoriTri forest fruit flavour lozenges contain 1 mg of sodium from excipients: sodium saccharin and sodium carmellose.

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

DoriTri forest fruit flavour lozenges contain 0.27 mg of cochineal red, Ponceau 4R (E124) from the flavour.

Cochineal red, Ponceau 4R, may cause allergic reactions.

3. How to take DoriTri forest fruit flavour lozenges

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Dosage

The recommended dose for adults and adolescents aged 12 years and older is 1–2 lozenges to be slowly dissolved in the mouth several times daily, every 2–3 hours.

Do not exceed the maximum daily dose of 8 lozenges.

Continue treatment for one day after symptoms have resolved.

Due to insufficient experience in children under 12 years of age, no dosing recommendations can be given for children aged 6 to 11 years.

Administration method

Place the lozenge(s) in the mouth and allow them to dissolve slowly. Do not chew or swallow the lozenge whole.

Do not use DoriTri forest fruit flavour lozenges before or after tooth brushing, as toothpaste may reduce the effectiveness of the lozenges.

Taking more than the recommended dose of DoriTri forest fruit flavour lozenges

When used correctly, poisoning with DoriTri forest fruit flavour lozenges is excluded, and no cases have been reported to date.
However, ingestion of a large number of lozenges may cause gastrointestinal symptoms and increased methaemoglobin formation (especially in children). Possible symptoms include shortness of breath and bluish discoloration of lips and fingers. Contact your doctor if significant overdose is suspected, particularly in children.
Recommended measures include administration of large amounts of water and activated charcoal tablets, as well as appropriate treatment by a doctor for methaemoglobinaemia.

Missed dose of DoriTri forest fruit flavour lozenges

Do not take a double dose to make up for a missed dose.
Take 1 lozenge as soon as you remember and continue with the usual dosing schedule.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Possible adverse reactions:
Rare (may occur in less than 1 out of 1,000 people):

• Skin hypersensitivity reactions, especially to esters of para-aminobenzoic acid (benzocaine). In sensitive patients, sensitization to para-group compounds (e.g. penicillins, sulfonamides, sunscreens, p-aminosalicylic acid) may be induced.
• Altered taste perception or tongue numbness.
• Application of tyrothricin on open wounds or abrasions may cause bleeding.

Very rare (may occur in less than 1 out of 10,000 people):

• Local application of benzocaine, especially in children and on large wound surfaces, has led to increased blood methemoglobin levels. Possible symptoms include shortness of breath and bluish discoloration of lips and fingers.
• Laxative effect due to sorbitol content, especially at high doses.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 181C
02-222 Warsaw
Phone: +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 helps provide more information on the safety of using this medicine.

5. How to store DoriTri smak owoców leśnych, effervescent tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after:
"EXP". The expiry date refers to the last day of the stated month.
Storage conditions:
Do not store above 25°C.

6. Contents of the pack and other information

What DoriTri smak owoców leśnych, pastilles contains:

• Active substances: Each pastille contains: Tyrothricin 0.5 mg Benzalkonium chloride solution 1.0 mg Benzocaine 1.5 mg
• Other ingredients: Sorbitol (E 420), talc, stearic acid saccharide type III, sodium saccharin, red fruit flavour (Cochineal Red, Ponceau 4R (E 124), triacetin (E 1518), maltodextrin (corn), arabic gum / acacia gum (E 414), ascorbic acid (E 300) and sodium sulphate (E 514)), povidone K 25,
  sodium carmellose

What DoriTri smak owoców leśnych, pastilles look like and contents of the pack
Pink, round, flat-faced pastilles with bevelled edges and a smooth surface, approximately 16 mm in diameter.
Pack contains 20 or 40 pastilles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Medice Pharma GmbH & Co. KG
Kuhloweg 37
58638 Iserlohn
Germany
Telephone: +49 2371 937-111
Fax: +49 2371 937-329
Email: [email protected]

Manufacturer
Medice Arzneimittel Pütter GmbH & Co. KG
Kuhloweg 37
58638 Iserlohn
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
Bulgaria Доритрицин Горски плодове
Croatia Doritri s okusom šumskog voća 1,0 mg/1,5 mg/0,5 mg pastille
Czech Republic Doritri Lesní ovoce
Estonia Doritri Wild berry
Latvia Doritri Wild berry 1 mg/1,5 mg/0,5 mg presētas sūkājamās tabletes
Lithuania Doritri Wild berry
Poland DoriTri smak owoców leśnych
Portugal Doritri Frutos Vermelhos pastilhas
Romania Dorithricin fructe de padure 0,5 mg/1,0 mg/1,5 mg comprimate de supt
Slovenia Doritri z okusom gozdnih sadežev 1,0 mg/1,5 mg/0,5 mg stisnjene pastile