ARTISIAL Oral powder spray/100mL

Endo-buccal spray solution.
Pressurised bottle containing 100 ml, with an elongated spray nozzle.

For 100 ml of endo-buccal spray solution :

Potassium chloride: 0,062450 g
Sodium chloride: 0,086550 g
Magnesium chloride, 6H₂O: 0,005875 g
Calcium chloride, 2H₂O: 0,016625 g
Dipotassium phosphate: 0,080325 g
Monopotassium phosphate: 0,032600 g

Excipient with known effect : methyl parahydroxybenzoate (E218).

Hyposialia or asialia, in particular those secondary to irradiation of the upper aerodigestive tract.

Dosage

About 6 to 8 sprays per day.

Method of administration

For use as endo-buccal sprays. Hold the bottle upright during spraying, with the diffuser at the top and directed towards the inside of the mouth. Press the diffuser to obtain a spray.

Hypersensitivity to the active substances or to any of the excipients listed in section Composition

In the case of hyposialia leading to mucosal lesions, inform the patient of the need for strict oral hygiene and possibly combine with topical fluoride treatment by applying fluoride gels using trays.

This medicine contains methyl parahydroxybenzoate (E218) and may cause allergic reactions (possibly delayed).

The data available to date do not suggest the existence of clinically significant interactions.

Given the available data, use in pregnant or breastfeeding women is possible.

A few cases of tingling, nausea and burning have been reported.

These phenomena, whose occurrence is exceptional, resolve spontaneously on discontinuation of treatment.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website: www.signalement-sante.gouv.fr.

Pharmacotherapeutic class: Salivary substitute. ATC code: A01AD11

2 years.

Pressurised container: protect from sunlight and do not expose to temperatures above 50 °C. Do not burn or puncture, even after use.

No special requirements.