Dentinox N

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Dentinox N

15% + 0.34% + 0.32%, gel for application to the gums
Chamomillae tinctura+ Lidocaini hydrochloridum+ Macrogoli aether laurilicus

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 7 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Dentinox N and what is it used for
• 2. Important information before using Dentinox N
• 3. How to use Dentinox N
• 4. Possible side effects
• 5. How to store Dentinox N
• 6. Contents of the packaging and other information

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

Dentinox N is a traditionally used medicine for relieving discomfort associated with teething in infants (gum irritation and pain).
The efficacy of the medicine is based solely on long-term use and experience.
If there is no improvement after 7 days or the patient feels worse, they should consult their 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 any of the other ingredients of this medicine (listed in section 6); intolerance to chamomile or other plants of the Asteraceaefamily. Hypersensitivity reactions to chamomile (e.g., contact dermatitis) are very rare. Cross-reactions may occur in people allergic to plants of the Asteraceaefamily (e.g., wormwood);
• intolerance to lidocaine or similar local anesthetics (amidotype);
• intolerance to fructose.

Warnings and precautions

Before using Dentinox N, you should discuss it with your doctor or pharmacist.
Avoid contact with the eyes. If the medicine accidentally comes into contact with the eyes, they should be rinsed with plenty of water or physiological saline.
If severe redness or swelling of the gums occurs, or if there is a hypersensitivity reaction on the skin or mucous membranes, you should consult your doctor. The same applies to the occurrence of secondary accompanying symptoms.
Caution should be exercised in patients with congenital or acquired methemoglobinemia or in patients with glucose-6-phosphate dehydrogenase deficiency, due to the increased risk of toxic 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 being treated with methemoglobinemia-inducing agents.

Dentinox N and other medicines

You should tell 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 take.
Do not use with other local anesthetics.

Using Dentinox N with food and drink

Dentinox N should be used after eating.

Pregnancy, breastfeeding, and fertility

The medicine is intended for children, but in the case of its use by an adult, there is a lack of data on the safety of use during pregnancy and breastfeeding, so it is not recommended to use the medicine during pregnancy and breastfeeding.

Driving and using machines

The medicine is intended for children. There is a lack of data on the effect on the ability to drive and use machines.

Dentinox N contains propylene glycol and liquid sorbitol, non-crystallizing

Due to the presence of propylene glycol, local irritation may occur when Dentinox N is applied to the mucous membranes of the mouth.
The medicine contains liquid sorbitol, non-crystallizing, so it should not be used by patients with rare hereditary fructose intolerance. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor.
10 g of gel contains: 1 g of liquid sorbitol, non-crystallizing (which corresponds to 0.25 g of fructose), i.e., less than 0.1 bread units.
Caloric value: 2.6 kcal/g of sorbitol.
The medicine 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 the patient leaflet or as directed by a doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
The medicine should be used for a short period when acute symptoms of teething occur, applying a small amount of gel (the size of a pea) to the gums with a clean finger or cotton swab and gently massaging it in.
If applying the gel with your finger, you should wash your hands thoroughly before and after using the gel.
This procedure should be repeated 2-3 times a day, especially after eating or after oral hygiene procedures before bedtime.
Duration of administration
Dentinox N should only be used when necessary.
Dentinox N gel can be used throughout the period of teething. The same applies to the eruption of molars.
You should also pay attention to the information contained in the section "What is Dentinox N and what is it used for".

Using a higher dose of Dentinox N than recommended

The possibility of side effects increases.
In such a case, you should stop using Dentinox N and consult your doctor. If too much gel is applied, the excess should be removed.

Missing a dose of Dentinox N

You should not use a double dose to make up for a missed dose. You should not apply more gel than recommended in section 3.

4. Possible side effects

Like all medicines, Dentinox N can cause side effects, although not everybody gets them.
There may be skin and mucous membrane hypersensitivity reactions, particularly related to the presence of lidocaine. Hypersensitivity may manifest as, for example, burning or redness.
In the event of a hypersensitivity reaction on the skin or mucous membrane, you should stop using the medicine and consult your doctor.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
By reporting side effects, you can help gather more information on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder or parallel importer.

5. How to store Dentinox N

The medicine should be stored out of 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 month stated.
Store at a temperature below 25°C. Store the tube tightly closed.
Shelf life after first opening the tube - 1 year.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Dentinox N contains

10 g of gel contains:
active substances:
Chamomillae tinctura(chamomile extract) (1:4-4.5)
1500 mg
ethanol 70% (V/V) extractant
Lidocaini hydrochloridum(lidocaine hydrochloride)
34 mg
Macrogoli aether laurilicus(macrogol lauryl ether)
32 mg
Maximum ethanol content in the product: 9.5%.
excipients:
carbomer, levomenthol, disodium edetate, sodium hydroxide 10%, polysorbate 20, propylene glycol, sodium saccharin, liquid sorbitol, non-crystallizing, purified water, xylitol.

What Dentinox N looks like and what the packaging contains

Dentinox N is a gel for local application to the gums. Due to the presence of a herbal active substance (Chamomillae tinctura), Dentinox N gel has a light brown color.
The packaging contains an aluminum tube with an HDPE cap, containing 10 g of gel, packaged together with the patient leaflet in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Bulgaria, the 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 Warsaw

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35/37
87-100 Toruń
Marketing authorization number in Bulgaria, the country of export: 9600261

Parallel import authorization number: 53/23 Date of approval of the leaflet: 21.03.2023

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