Package leaflet: Information for the patient

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

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

Table of contents of the leaflet:

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 herbal medicinal product used to relieve discomfort associated with teething in infants (gum irritation and pain).
The efficacy of this product for the mentioned indications is based exclusively on long-standing use and experience.
If there is no improvement after 7 days, or if you feel worse, you should 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 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-reaction may occur in individuals allergic to plants from the Asteraceae family (e.g. ragweed).
intolerance to lidocaine or similar local anaesthetics (amide-type);
fructose intolerance

Warnings and precautions
Before starting treatment with Dentinox N, consult a doctor or pharmacist.
Avoid contact with 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 on the skin or mucous membranes develop, contact a doctor. The same applies in case of secondary accompanying symptoms.
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 simultaneously being treated with medications that induce methemoglobinemia.

Dentinox N and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Do not use together with other local anaesthetic agents.

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

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

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

Dentinox N contains propylene glycol and sorbitol
Due to the presence of propylene glycol, local irritation of the oral mucosa may occur after application of Dentinox N.
The medicine contains sorbitol and therefore should not be used by patients with rare hereditary fructose intolerance. If a patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor.
10 g of gel contains: 1 g sorbitol (equivalent to 0.25 g fructose), i.e. less than 0.1 bread unit.
Calorific value: 2.6 kcal/g sorbitol
The medicine contains a small amount 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 in doubt, consult a doctor or pharmacist.
Apply the gel for a short period only, 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 sleep.

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 of gel 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 can cause adverse reactions, although not everybody will experience 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, use of the medicine should be discontinued and medical advice should be sought.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform a doctor or pharmacist. 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.: + 48 22 49 21 301, fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions enables better assessment of the medicine's safety profile.

5. How to store Dentinox N

Keep the medicine 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 stated month.
Store below 25 °C. Keep the tube tightly closed.
Shelf life after first opening: one 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 packaging 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:
sorbitol liquid, non-crystallizing, xylitol, propylene glycol, carbomer 934 P, polysorbate 20, disodium
edetate, sodium hydroxide 10%, sodium saccharin, levomenthol, purified water.

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 color.
The pack contains an aluminum tube with an internal lacquer coating, a membrane, and an HDPE cap, containing 10 g of gel, packaged together with a patient leaflet in a cardboard box.

For further information, please contact the responsible party or the parallel importer.

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

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

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation number in Bulgaria, country of export: 9600261
Parallel Import Licence number: 43/19