FORMS AND PRESENTATIONS
Nasal spray solution: 20 ml spray bottle with nasal tip and dip tube.
COMPOSITION
per 100 ml: Tenoic acid (INN) ethanolamine salt 3 g
Excipients: sodium hydrogen phosphate dodecahydrate, sodium hydrogen phosphate dihydrate, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, purified water.
INDICATIONS
Local adjunctive treatment of nasopharyngeal mucosal disorders.
DOSAGE AND METHOD OF ADMINISTRATION
Dosage :
Adult: 1 spray in each nostril 4 to 6 times a day.
Children over 30 months: 1 spray in each nostril 3 to 4 times a day.
Infant: 1 spray in each nostril 2 times a day.
Method of administration: Nasal use.
Nasal sprays are done with the head slightly tilted back and the bottle in an upright position.
CONTRAINDICATIONS
Hypersensitivity to any of the components, especially parabens.
WARNINGS and PRECAUTIONS FOR USE
The indication does not justify prolonged treatment.
In the event of associated general clinical signs, systemic treatment should be considered.
Microbial contamination may occur as soon as the package is opened, and even more so the first time a nasal preparation is used.
FERTILITY / PREGNANCY / LACTATION
Pregnancy:
There are no reliable data on teratogenesis in animals.
Clinically, no particular malformative or fetotoxic effects have been observed to date. However, the follow-up of pregnancies exposed to this drug is insufficient to exclude any risk.
Therefore, as a precautionary measure, it is preferable not to use this drug during pregnancy.
Breast-feeding:
Because of the lack of data on the passage of this drug into breast milk, the use of this drug should be avoided during breastfeeding.
DRIVING AND USE OF MACHINERY
No effect on the ability to drive and use machines has been observed.
ADVERSE REACTIONS
Possible nasal irritation.
PHARMACODYNAMICS
Pharmacotherapeutic class: Nasal preparation for antiseptic purposes (R: respiratory system).
Ethanolamine tenoate: for antiseptic and decongestant purposes.
STORAGE CONDITIONS
Shelf life: 3 years.
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