Description
ACTIVE INGREDIENTS
Gomenolated oil.
EXCIPIENTS
Peanut Oil, Glyceryl Oleate, BHA, BHT, Hexylene Glycol, Citric Acid Monohydrate, Ascorbyl Palmitate.
DIRECTIONS
The medicine is indicated as a balsamic, expectorant, anti-catarrhal and antiseptic in inflammation of the upper airways, particularly in congestive states of the nasal mucosa.
CONTRAINDICATIONS/SIDE EFFECTS
Hypersensitivity to the active substance (niaouli) or to any of the excipients. The product contains peanut oil: do not use in case of hypersensitivity; severe liver disease; inflammation of the biliary-gastrointestinal tract; newborns and children up to 30 months of age; children with a history of epilepsy and febrile convulsions.
DOSAGE
Adults and adolescents (13-18 years): apply locally 2-3 drops of the niaouli essence 2% adult solution per nostril several times a day. Children aged between 30 months and 12 years: apply locally 2-3 drops of the niaouli essence 1% child solution per nostril several times a day. The product is contraindicated in children up to 30 months of age. The duration of treatment should not exceed 3 days.
CONSERVATION
Store the medicine in a tightly closed container, protected from light.
WARNINGS
Application of the drug solution may cause laryngospasm. The medicine contains terpene derivatives which, in excessive doses, can cause neurological disorders such as convulsions in infants and children. Treatment should not be prolonged for more than 3 days due to the risks associated with the accumulation of terpene derivatives, such as camphor, cineole, niaouli, wild thyme, terpineol, terpine, citral, menthol and essential oils of pine needles, eucalyptus and turpentine (due to their lipophilic properties, the rate of metabolism and disposal is unknown) in the tissues and brain, in particular neuropsychological disorders. A dose higher than recommended should not be used to avoid a greater risk of adverse reactions to the medicine and dosage-related disorders. The product contains peanut oil: in case of peanut or soy allergy, do not use the medicine. The medicine contains BHA and BHT: it may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes or other mucous membranes.
INTERACTIONS
The product should not be used in conjunction with other products (medicinal or cosmetic) containing terpene derivatives, regardless of the route of administration (oral, rectal, cutaneous, nasal or inhalation). Cineole, the main component of the topical solution of niaouli essence, induces the hepatic enzyme system and, therefore, can reduce the efficacy of drugs inactivated by these enzymes.
SIDE EFFECTS
Due to the presence of niaouli essence and in case of non-compliance with the recommended doses, there may be a risk of convulsions in children and infants. The following are the undesirable effects of niaouli essence, organized according to the MedDRA systemic organ classification. There are insufficient data to establish the frequency of the individual effects listed. Respiratory, thoracic and mediastinal disorders: laryngospasm.
PREGNANCY AND BREASTFEEDING
There are no or limited amount of data from the use of niaouli essence in pregnant women. The medicine is not recommended during pregnancy and in women of childbearing potential who do not use contraceptive measures. There is insufficient information on the excretion of the medicine in breast milk. The medicine should not be used during breastfeeding.
