Dentinale
Italy
Table of Contents
DENTINALE 0.5% + 0.5% Gingival Paste
hydrochloride amylcocaine, sodium benzoate
Tube 25 g
L
.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
- Consult your doctor if symptoms do not improve or worsen.
Contents of this leaflet:
- What DENTINALE is and what it is used for
- What you need to know before using DENTINALE
- How to use DENTINALE
- Possible side effects
- How to store DENTINALE
- Contents of the pack and other information
1. What DENTINALE is and what it is used for
DENTINALE is a soothing agent.
DENTINALE gingival paste is used for the treatment of gum pain associated with teething in children (painful eruption of teeth during early infancy).
2. What you need to know before using DENTINALE
Do not use DENTINALE
- Do not use DENTINALE if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using DENTINALE.
The use, especially if prolonged, of this medicine does not exclude the possibility—although very rare—of sensitization reactions (allergy). If such reactions occur, discontinue use of the medicine.
Avoid contact with nasal mucosa.
Other medicines and DENTINALE
No interactions with other medicines are known.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
3. How to use DENTINALE
Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply the medicine 2-3 times a day as needed.
Warning: Do not exceed the recommended doses without medical advice.
Treatment should be limited to the shortest necessary duration, especially when applied to mucous membranes.
Massage the child's gums with a finger or a cotton swab moderately coated with DENTINALE.
If you use more DENTINALE than you should
If high doses are used, amylcocaine may reach the systemic circulation, causing gastrointestinal symptoms such as nausea and vomiting, and central nervous system effects such as excitement and tremors.
In case of accidental ingestion or overdose of DENTINALE gum paste, contact your doctor immediately or go to the nearest hospital.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The main side effects associated with the administration of local anaesthetics generally affect the gastrointestinal system and include nausea and vomiting.
Following the instructions contained in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store DENTINALE
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the tube and carton. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Package contents and other information
What DENTINALE contains
100 g of gingival paste contain:
- Active substances: Amylocaine hydrochloride 500 mg, Sodium benzoate 500 mg
- Other components: Saccharin, Menthol, Saffron tincture, Sweet orange essence, Anhydrous sodium carbonate, Purified water, Honey.
Description of the appearance of DENTINALE and contents of the pack
DENTINALE is a gingival paste.
Pack size: 1 tube containing 25 g of gingival paste.
Marketing Authorization Holder and Manufacturer:
MONTEFARMACO OTC S.p.A. - Via IV Novembre, 92 - 20021 Bollate (MI)
Manufacturer:
DOPPEL FARMACEUTICI S.r.l., Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC)
MONTEFARMACO OTC S.p.A. – Bollate (MI)