Dentinox n
Poland
Table of Contents
Patient Information Leaflet
Warning! The immediate packaging is in a foreign language! Keep the leaflet!
Dentinox N
15% + 0.34% + 0.32% gel for application to the gums
Chamomillae tinctura + Lidocaini hydrochloridum + Macrogoli aether laurilicus
Please read this leaflet carefully 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 advised by
the doctor or pharmacist.
- Keep this leaflet so that you can read it again if necessary.
- 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 you feel worse, consult your 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
Dentinox N is a traditional herbal medicinal product used to relieve discomfort associated with painful teething (irritated gums and teething pain).
The effectiveness of this product for the mentioned indications is based solely on long-standing use and experience.
If there is no improvement after 7 days, or if you feel worse, consult your 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); allergy 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);
- hypersensitivity to lidocaine or similar local anaesthetics (amide-type);
- fructose intolerance.
Warnings and precautions
Before starting treatment with Dentinox N, consult your 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 allergic reactions on the skin or mucous membranes develop, consult 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 must not be used in infants under 3 months of age.
Dentinox N must not be used in infants under 12 months of age who are simultaneously being treated with medicinal products that induce methemoglobinemia.
Dentinox N and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.
Do not use together with other local anaesthetics.
Use of Dentinox N with food and drink
Dentinox N should be used after meals.
Pregnancy, breastfeeding and fertility
Dentinox N is intended for use in children. However, in case of use by an adult, there is lack of 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 is no data available 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 gel.
The product 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, 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 unit.
Calorific 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 this patient information leaflet or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Apply the gel short-term 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 a higher than 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 use 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 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, discontinue use of the medicine and consult a doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this 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 Warszawa
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.
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.
Period of use after first opening of the tube – 1 year.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 tincture) (1:4-4.5) 1500 mg
Extracting agent ethanol 70% (V/V)
Lidocaini hydrochloridum (lidocaine hydrochloride) 34 mg
Macrogoli aether laurilicus (macrogol lauryl ether) 32 mg
Ethanol content in the product max 9.5%
Excipients:
carbomer 934 P, 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 is light brown in colour.
The pack contains an aluminium tube with HDPE screw cap, filled with 10 g of gel, packaged together with a 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, and manufacturer:
Dentinox Gesellschaft für pharmazeutische Präparate Lenk&Schuppan KG
Nunsdorfer Ring 19
D-12277 Berlin
Germany
Parallel Importer:
Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Český Těšín
Czech Republic
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Manufacturing site: Euceryn Pharmaceutical Laboratory COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45
31-353 Kraków
Marketing Authorisation Number in Bulgaria, country of export: 9600261
Parallel Import Authorisation Number: 264/20