Active ingredients: Amylocaine (Amylocaine hydrochloride), Sodium benzoate
DENTINAL 0.5% + 0.5% Gingival paste
Indications Why is Dentinale used? What is it for?
DENTINAL is a soothing.
DENTINAL gingival paste is used for the treatment of pain in the gums for the birth of the first teeth of children (painful eruptions of the teeth in early childhood).
Contraindications When Dentinal should not be used
Do not use DENTINAL if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
Precautions for use What you need to know before taking Dentinale
Talk to your doctor or pharmacist before using DENTINAL.
Interactions Which drugs or foods can modify the effect of Dentinale
There are no known interactions with other medicines.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Warnings It is important to know that:
The use of the medicine, especially if prolonged, does not exclude the possibility, even if very rare, of sensitization phenomena (allergy). If they should occur, suspend the application of the medicine. Avoid contact with the nasal mucosa.
Dose, Method and Time of Administration How to use Dentin: Posology
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Apply the medicine 2-3 times a day as needed.
Warning: do not exceed the indicated doses without medical advice.
It is advisable to maintain the treatment for the period strictly necessary, especially in the case in which a treatment is carried out at the level of the mucous membranes.
Massage the baby's gums with a finger or a cotton swab, moderately sprinkled with DENTINAL.
Overdose What to do if you have taken too much Dentinal
If you use high dosages of the medicine, amylocaine can reach the systemic circulation and manifestations may occur in the gastrointestinal system, such as nausea and vomiting, and in the central nervous system, such as excitement and tremor.
In case of accidental ingestion / intake of an excessive dose of DENTINAL gingival paste, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Dentinale
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The main undesirable effects concerning the administration of local anesthetics generally occur in the gastrointestinal tract with nausea and vomiting. Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the tube and carton. The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
What DENTINAL contains
100 g of gum paste contain:
- The active ingredients are: Amylocaine hydrochloride 500 mg, Sodium benzoate 500 mg
- The other ingredients are: Saccharin, Menthol, Saffron tincture, Sweet orange essence, Anhydrous sodium carbonate, Purified water, Honey.
Description of the appearance of DENTINAL and contents of the pack
DENTINAL comes in the form of gingival paste. The contents of the package are 1 tube containing 25 g of gingival paste.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
DENTINAL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of gum paste contain:
Amylocaine hydrochloride 500 mg
Sodium benzoate 500 mg
03.0 PHARMACEUTICAL FORM
Gingival paste, tube 25 g.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Treatment of pain in the gums for the birth of the first teeth of children (painful eruptions of the teeth in early childhood).
04.2 Posology and method of administration
Massage the baby's gums with a finger or a cotton swab, moderately sprinkled with DENTINAL.
Apply the preparation 2-3 times a day as needed.
It is advisable to maintain the treatment for the period strictly necessary, especially in the case in which a treatment is carried out at the level of the mucous membranes.
04.3 Contraindications
Known hypersensitivity to the components.
04.4 Special warnings and appropriate precautions for use
The use of the product, especially if prolonged, does not exclude the possibility, even if very rare, of sensitization phenomena. If this should occur, suspend the application of the preparation.
Keep the product out of the reach of children.
04.5 Interactions with other medicinal products and other forms of interaction
Do not report.
04.6 Pregnancy and lactation
Not relevant.
04.7 Effects on ability to drive and use machines
Not relevant.
04.8 Undesirable effects
The main undesirable effects concerning the administration of local anesthetics generally occur in the gastrointestinal tract with nausea and vomiting.
04.9 Overdose
For high dosages in the event that the amylocaine reaches the systemic circulation, there may be manifestations at the gastrointestinal level such as nausea and vomiting and at the level of the central nervous system such as excitement and tremor.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
DENTINAL is a local pain reliever obtained from the therapeutic combination of antiseptic and analgesic substances (sodium benzoate and amylocaine hydrochloride).
In particular, the pharmacological action of amylocaine, at the concentrations used to produce a local effect, consists in preventing the generation and conduction of the nerve impulse, decreasing the permeability of the cell membrane to sodium ions.
05.2 Pharmacokinetic properties
The quantities of amylocaine hydrochloride that may be present in the systemic circulation are very low, also in consideration of the fact that the molecule binds to the tissues. It is also important to remember that amylocaine is rapidly hydrolyzed by a plasma esterase.
Benzoic acid deriving from sodium benzoate is also present in low concentrations in the plasma, as the molecule is rapidly absorbed only from the gastrointestinal tract, while DENTINAL is administered directly to the gums.
05.3 Preclinical safety data
The toxicity studies have shown that the components of DENTINAL are non-toxic.
The LD50 for sodium benzoate in rats (oral) is 4.07 g / kg.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Saccharin, Menthol, Saffron tincture, Sweet orange essence, Anhydrous sodium carbonate, Purified water, Honey
06.2 Incompatibility
None
06.3 Period of validity
60 months
06.4 Special precautions for storage
None
06.5 Nature of the immediate packaging and contents of the package
Aluminum tube containing 25 g of gingival paste in a cardboard box.
06.6 Instructions for use and handling
None.
07.0 MARKETING AUTHORIZATION HOLDER
MONTEFARMACO OTC S.p.A. - Via Turati n. 3 - MILAN
08.0 MARKETING AUTHORIZATION NUMBER
AIC n. 008891018
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
27.12.1984; Renewals: 01.06.1995 - 01.06.2000
10.0 DATE OF REVISION OF THE TEXT
March 2004
