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

Read the leaflet carefully 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.

• The 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 possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. 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. Package contents 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 pain (gum irritation and painful symptoms). The effectiveness of the product for these indications 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 starting to use Dentinox N, the patient should discuss it with their doctor or pharmacist. The patient should avoid eye contact. If the medicine accidentally comes into contact with the eyes, they should be rinsed thoroughly with water or physiological saline. If stronger redness or swelling of the gums occurs, or if there is a hypersensitivity reaction on the skin or mucous membranes, the patient should contact their doctor. The same applies to the occurrence of secondary accompanying symptoms. The patient should exercise caution if they have congenital or acquired methemoglobinemia or a deficiency of glucose-6-phosphate dehydrogenase, 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient should not use Dentinox N 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 there is a lack of data on the safety of its use during pregnancy and breastfeeding. Therefore, 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 its effect on the ability to drive and use machines.

Dentinox N contains propylene glycol and sorbitol

Due to the presence of propylene glycol, local irritation of the oral mucosa may occur after applying Dentinox N. The medicine contains sorbitol, 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 sorbitol (equivalent to 0.25 g of fructose), i.e., less than 0.1 bread units. Caloric value: 2.6 kcal/g 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. In case of doubt, the patient should consult their 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 a cotton swab and gently rubbing it in. If the gel is applied with a finger, the hands should be washed thoroughly before and after use. This procedure should be repeated 2-3 times a day, especially after eating or after oral hygiene procedures before bedtime. The duration of treatment should be as short as possible. Dentinox N gel for gums can be used throughout the teething period. The same applies to the eruption of molars. The patient 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 risk of side effects increases. In such a case, the patient should stop using Dentinox N and consult their doctor. If too much gel is applied, the excess should be removed.

Missing a dose of Dentinox N

The patient should not use a double dose to make up for a missed dose. The patient 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. Skin and mucous membrane hypersensitivity reactions may occur, particularly due to the presence of lidocaine. Hypersensitivity may manifest as burning or redness. If a hypersensitivity reaction occurs on the skin or mucous membranes, the patient should stop using the medicine and consult their doctor.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. 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.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Dentinox N

The medicine should be stored out of sight and reach of children. The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. The medicine should be stored at a temperature below 25°C. The tube should be kept tightly closed. The shelf life after first opening: 1 year. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Dentinox N contains

10 g of gel contains: active substances: Chamomillae tinctura(chamomile tincture) (1:4-4.5) 1500 mg, ethanol 70% (V/V) extract, Lidocaini hydrochloridum(lidocaine hydrochloride) 34 mg, Macrogoli aether laurilicus(macrogol lauryl ether) 32 mg, maximum ethanol content in the product 9.5%, excipients: liquid sorbitol, 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 what the package 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 package contains an aluminum tube with an inner lacquer coating, a membrane, and an HDPE screw cap containing 10 g of gel, packaged with a patient leaflet in a cardboard box. For more detailed information, the patient 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, 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

Repackaged by:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź, Marketing authorization number in Bulgaria, the country of export: 9600261, Parallel import authorization number: 43/19

Date of leaflet approval: 25.01.2024

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