Product description

Package leaflet: information for the patient
Note: Keep the leaflet. Information on the immediate packaging in a foreign language.

DENTINOX N (Денmuноkс)
15% + 0.34% + 0.32%, gel for use on gums
Chamomillae tinctura + Lidocaini hydrochloridum + Macrogoli aether laurilicum

Parallel imported drug.
Dentinox N and Денноkс are different trade names of the same drug written in Polish and Bulgarian.
Read this leaflet carefully before you start taking this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.
Please keep this leaflet. You may need to read it again.
If you need advice or further information, please contact your pharmacist.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
If after 7 days there is no improvement or the patient feels worse, contact your doctor.
Talk to your doctor or pharmacist before using Dentinox N.

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

The drug is traditionally used to relieve symptoms associated with the painful eruption of primary teeth (gum irritation and pain).
The effectiveness of the drug in the above-mentioned indications is based solely on long-term use and experience.
If after 7 days there is no improvement or the patient feels worse, please contact your doctor.

2. Important information before using Dentinox N

When not to use Dentinox N:
- if you are 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 Asteraceae family. Hypersensitivity reactions to chamomile (e.g. contact dermatitis) are very rare. A cross-reaction may occur in people allergic to plants of the Asteraceae family (e.g. mugwort);
- intolerance to lidocaine or similar local anesthetics (amide type);
- fructose intolerance.

Warnings and precautions
Avoid contact with eyes. In case of accidental contact with eyes, rinse thoroughly with water or saline.
If you experience severe redness or swelling of your gums, or if you experience a hypersensitivity reaction to your skin or mucous membranes, consult your doctor. The same applies to any secondary symptoms.
Caution should be exercised in patients with congenital or acquired methemoglobinemia or glucose-6-phosphate dehydrogenase deficiency due to an increased risk of drug-induced methemoglobinemia.

Kids
Dentinox N should not be used on infants under 3 months of age.
Dentinox N should not be used in infants under 12 months of age who are being treated concurrently with agents that cause methemoglobinemia.

Dentinox N and other medicines
Tell your doctor or pharmacist about all the medicines you are taking, have recently taken or are planning to take.
Do not use with other local anesthetics.

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

Pregnancy, breastfeeding and fertility
The drug is intended for children, but when used by adults, there is no data on its safety during pregnancy and breastfeeding, therefore it is not recommended to use the drug during pregnancy and breastfeeding.

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

Dentinox N contains propylene glycol and sorbitol
Due to the content of propylene glycol, after applying Dentinox N to the mucous membranes
oral cavity, local irritation may occur.
This medicine contains sorbitol, so it should not be used by patients with rare hereditary fructose intolerance. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor.
10 g of gel contains: 1 g of sorbitol (equivalent to 0.25 g of fructose), i.e. less than 0.1 bread unit.
Caloric value: 2.6 kcal/g sorbitol
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose.

3. How to use Dentinox N

Always use this medicine exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you have any further questions, ask your doctor or pharmacist.
Use the medicine for a short time in case of acute teething symptoms, lubricate the gums with a small amount of gel (the size of a pea) using a clean finger or a cotton bud and massage in lightly.
If you apply the gel with your finger, wash your hands thoroughly before and after using the gel.
This activity should be repeated 2-3 times a day, especially after eating or after performing oral hygiene procedures before going to bed.

Administration period
Dentinox N should only be used when necessary.
Dentinox N gum gel can be used throughout the period of eruption of baby teeth.
The same applies to the eruption of molars.
Please also pay attention to the information in the section "What Dentinox N is and what it is used for".

Taking more Dentinox N than recommended
The possibility of side effects increases.
If this happens, stop using Dentinox N and consult your doctor.
If too much gel is applied, remove the excess.

Missing the use of Dentinox N
Do not take a double dose to make up for a missed dose.
Do not apply more gel than recommended in step 3.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Hypersensitivity reactions of the skin and mucous membranes may occur, particularly those related to the lidocaine content. Hypersensitivity may manifest as burning or redness.
In case of hypersensitivity reactions of the skin or mucous membranes, discontinue use and consult a doctor.

Reporting adverse reactions
If you experience any side effects, including any side effects not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can report side effects directly to the Department of Monitoring Adverse Reactions of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Jerozolimskie Avenue 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 this medicine.

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 which is stated on the packaging.
The expiration date refers to the last day of the month indicated.
Store below 25°C. Keep the container tightly closed. Discard any remaining gel one year after first opening the tube.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What does Dentinox N contain?
10 g of gel contains:
active substances:
Chamomillae tinctura (chamomile tincture) (1:4-4.5) 1500 mg
Extractant ethanol 70% (V/V)
Lidocaini hydrochloridum (lidocaine hydrochloride) 34 mg
Macrogoli aether laurilicum (macrogol lauryl ether) 32 mg
Ethanol content in the product max 9.5%
excipients:
carbomer (934 P), levomenthol, sodium edetate, sodium hydroxide 10%, polysorbate 20, propylene glycol, sodium saccharin, liquid sorbitol, non-crystallizing solution 70%, purified water, xylitol.

What Dentinox N looks like and what the package contains
Dentinox N is a gel intended for topical application to the gums. Due to its herbal active ingredient (Chamomillae tinctura), Dentinox N gel is light brown in color.
The package contains an aluminum tube with an HDPE cap containing 10 g of gel, packed together with a patient leaflet in a cardboard box.
For more detailed information, please contact the responsible entity or parallel importer.

Responsible entity in Bulgaria, export country:
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:
Delfarma Sp. z o. o.
St. Teresa of the Child Jesus 111
91-222 Lodz

Repackaged in:
Delfarma Sp. z o. o.
St. Teresa of the Child Jesus 111
91-222 Lodz

License number in Bulgaria, export country: 9600261
Parallel import permit number: 34/12
Leaflet approval date: 14/01/2022

Important information about the drug

This is a medicine. For safety, use it according to the package leaflet. Do not exceed the maximum dose. If in doubt, consult your doctor or pharmacist.

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