Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Dentinox N
15% + 0.34% + 0.32%, gel for application on gums
Chamomillae tinctura + Lidocaini hydrochloridum + Macrogoli aether laurilicus
Please read the entire leaflet carefully before using this 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
physician or pharmacist.

Keep this leaflet for future reference.
If you need advice or further information, please consult your pharmacist.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 7 days, or if symptoms worsen, consult a doctor.

Table of Contents:

What Dentinox N is and what it is used for
Important information before using Dentinox N
How to use Dentinox N
Possible side effects
How to store Dentinox N
Contents of the pack and other information

1. What Dentinox N is and what it is used for

A traditional medicine used to relieve discomfort associated with painful teething in infants (irritated gums and pain).
The effectiveness of this medicine for the mentioned indications is based solely on long-standing use and experience.
If there is no improvement after 7 days, or if the patient feels worse, consult a doctor.

2. Important information before using Dentinox N

When not to use Dentinox N:

if the patient is allergic (hypersensitive) to the active substances or to any of the other ingredients of this medicine (listed in section 6); intolerance to chamomile or other plants from the Asteraceae family. Hypersensitivity reactions to chamomile (e.g. contact dermatitis) are very rare. Cross-reactivity may occur in individuals allergic to plants from the Asteraceae family (e.g. ragweed);
intolerance to lidocaine or similar local anesthetics (amide-type);
fructose intolerance.

Warnings and precautions
Before starting to use Dentinox N, consult a doctor or pharmacist.
Avoid contact with the eyes. In case of accidental contact with eyes, rinse thoroughly with water or physiological saline.
If increased redness or swelling of the gums occurs, or if hypersensitivity reactions develop on the skin or mucous membranes, contact a doctor. The same applies in case secondary symptoms occur.
Exercise caution in patients with congenital or acquired methemoglobinemia or in patients with glucose-6-phosphate dehydrogenase deficiency due to increased risk of drug-induced methemoglobinemia.

Children
Dentinox N should not be used in infants under 3 months of age.
Dentinox N should not be used in infants under 12 months of age who are concurrently being treated with medicinal products that induce methemoglobinemia.

Dentinox N and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Do not use together with other local anesthetics.

Use of Dentinox N with food and drink
Dentinox N should be used after meals.

Pregnancy, breastfeeding, and effects on fertility
This medicine is intended for children. However, in case of use by an adult, there are no data available on the safety of use during pregnancy or breastfeeding. Therefore, use of Dentinox N during pregnancy and breastfeeding is not recommended.

Driving and operating machinery
This medicine is intended for children. There are no data available on the effect on the ability to drive or operate machinery.

Dentinox N contains propylene glycol and non-crystallizing liquid sorbitol
Due to the presence of propylene glycol, local irritation of the oral mucosa may occur after application of Dentinox N.
The product contains non-crystallizing liquid sorbitol and therefore should not be used by patients with rare hereditary fructose intolerance. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor.
10 g of gel contains: 1 g of non-crystallizing liquid sorbitol (equivalent to 0.25 g of fructose), i.e. less than 0.1 bread unit.
Calorific value: 2.6 kcal/g of sorbitol.
The product contains small amounts of ethanol (alcohol), less than 100 mg per dose.

3. How to use Dentinox N

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Apply the gel briefly when acute teething symptoms occur. Apply a small amount of gel (about the size of a pea) onto the gums using a clean finger or cotton swab, and gently massage in.
When applying the gel with a finger, hands should be thoroughly washed before and after use.
This procedure should be repeated 2–3 times daily, especially after eating or after performing oral hygiene procedures before going to bed.

Duration of use
Dentinox N should be used only when necessary.
The Dentinox N gingival gel may be used throughout the entire period of eruption of primary teeth. The same applies to the eruption of molars.
Please also pay attention to the information provided in the section "What Dentinox N is and what it is used for".

Use of more than the recommended dose of Dentinox N
The risk of adverse effects increases.
In such a case, discontinue use of Dentinox N and consult a doctor. If too much gel has been applied, remove the excess.

Missed application of Dentinox N
Do not apply a double amount to make up for a missed application. Do not apply more gel than recommended in section 3.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everybody experiences them.
Skin and mucous membrane hypersensitivity reactions may occur, particularly related to the presence of lidocaine. Hypersensitivity may manifest, for example, as burning or redness.
In case of skin or mucous membrane hypersensitivity reactions, discontinue use of the medicine and consult a doctor.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in the 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, Tel.: (22) 49 21 301, Fax: (22) 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables better assessment of the safety of the medicine.
Adverse reactions can also be reported to the marketing authorization holder or the parallel importer.

5. How to store Dentinox N

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Store below 25°C. Keep the tube tightly closed.
The shelf life after first opening the tube is 1 year.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Dentinox N contains
10 g of gel contains:
Active substances:
Chamomillae tinctura (chamomile tincture) (1:4-4.5) 1500 mg
Extraction solvent: ethanol 70% (V/V)
Lidocaini hydrochloridum (lidocaine hydrochloride) 34 mg
Macrogoli aether laurilicus (macrogol lauryl ether) 32 mg
Ethanol content in the product up to 9.5%.
Excipients:
carbomer, levomenthol, disodium edetate, sodium hydroxide 10%, polysorbate 20, propylene glycol,
sodium saccharin, liquid non-crystallizing sorbitol, purified water, xylitol.

What Dentinox N looks like and contents of the pack
Dentinox N is a gel intended for local application to the gums. Due to the presence of the herbal active ingredient (Chamomillae tinctura), Dentinox N gel has a light brown colour.
The package contains an aluminium tube with a HDPE cap, filled with 10 g of gel, packed together with the patient leaflet in a cardboard box.

For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.

Marketing Authorisation Holder in Bulgaria, country of export:
Dentinox Gesellschaft
für pharmazeutische Präparate
Lenk & Schuppan KG
Nunsdorfer Ring 19
D-12277 Berlin
Germany

Manufacturer:
Dentinox Gesellschaft
für pharmazeutische Präparate
Lenk & Schuppan KG
Nunsdorfer Ring 19
D-12277 Berlin
Germany

Parallel importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warszawa
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa Synoptis Industrial Sp. z o.o.
ul. Działkowa 56 ul. Forteczna 35/37
02-234 Warszawa 87-100 Toruń
Poland

Marketing Authorisation Number in Bulgaria, country of export: 9600261
Parallel import authorisation number: 53/23