Active ingredients: Eucalyptus Essential Oil, Chlorobutanol, Camphor, Thymol, Menthol
Rhinological oily solution
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
RINOSTIL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: Ess oil. Eucalyptus g 1,5 - Chlorobutanol g 0,5 - Camphor g 0,20 - Thymol g 0,04 - Menthol g 0,20
Excipients: Vaseline oil to taste to g 100.
03.0 PHARMACEUTICAL FORM
Rhinological oily solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Decongestant of the nasopharynx.
04.2 Posology and method of administration
Adults: 9-10 drops for each nasal cavity 4 or 5 times a day. Children: 2-3 drops for each nasal cavity 4 or 5 times a day. In infantile rhinitis it can be applied to the baby's nostrils using cotton balls. Do not exceed the recommended dose.
04.3 Contraindications
This product is contraindicated in those individuals who have demonstrated hypersensitivity to any of its components. It is also contraindicated in children under two years of age with a predisposition to laryngospasm and convulsions; It should also be used with caution in older children.
04.4 Special warnings and appropriate precautions for use
Warnings: If after a short period of treatment there are no appreciable results or signs of irritation and sensitization appear, stop the treatment and consult your doctor in order, if necessary, to establish a suitable therapy.
04.5 Interactions with other medicinal products and other forms of interaction
They are not known with other drugs.
04.6 Pregnancy and lactation
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04.7 Effects on ability to drive and use machines
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04.8 Undesirable effects
It is possible with prolonged or repeated use of the product the appearance of signs or symptoms of irritation or sensitization. Menthol or camphor applied nasally in children can cause glottal spasm.
04.9 Overdose
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05.0 PHARMACOLOGICAL PROPERTIES
The rhinobalsamic oil for instillations RINOSTIL is a drug that results from the association of balsamic substances with modestly antiseptic and expectorant action. The ease with which it can be applied and the fluidity of the medium in which the balsamic, antiseptic and decongestant substances are dissolved, allow the resolving and fluidifying action of the medication to be brought to the entire mucosa of the nasopharyngeal cavity.
05.1 Pharmacodynamic properties
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05.2 "Pharmacokinetic properties
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05.3 Preclinical safety data
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06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
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06.2 Incompatibility
There are no known physical and chemical incompatibilities towards other components.
06.3 Period of validity
5 years.
06.4 Special precautions for storage
It is kept in the common warehouse conditions.
06.5 Nature of the immediate packaging and contents of the package
Brown glass bottle with dropper
06.6 Instructions for use and handling
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07.0 MARKETING AUTHORIZATION HOLDER
Chemical Laboratory Deca Dr. Capuani s.r.l., via Balzaretti 17 - Milan. Rinostil is prepared, packaged and controlled by Lab.It.Bioch.Farm.co Lisapharma, via Licinio 11, Erba (Co).
08.0 MARKETING AUTHORIZATION NUMBER
011033014 marketed 11/29/1980.
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
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10.0 DATE OF REVISION OF THE TEXT
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