Niaouli Essence Nova Argentia 2% Nasal Drops 20g

NAME
NIAOULI ESSENZA NOVA ARGENTIA - NASAL DROPS, SOLUTION

PHARMACOTHERAPEUTIC CATEGORY
Topical rhinological drugs.

ACTIVE PRINCIPLES
Niaouli essence (gomenolate oil) 1% or 2%.

EXCIPIENTS
Olive oil.

INDICATIONS
As a balsamic, expectorant, anti-catarrhal and antiseptic in inflammation of the upper airways, in particular in congestive states of the nasal mucosa.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance (niaouli) or to any of the excipients. Severe liver diseases. Inflammation of the biliary and gastrointestinal tracts. Children up to 30 months of age. Children with a history of epilepsy or febrile seizures.

DOSAGE
Adults and adolescents (13-18 years): apply locally 2-3 drops of 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 solution of niaouli essence 1% children per nostril several times a day. It is contraindicated in children up to 30 months' diet. The duration of treatment should not exceed 3 days.

STORAGE
In a tightly closed container, away from light and heat.

WARNINGS
Application of niaouli essence solution can cause laryngospasm. This product contains terpene derivatives which, in excessive doses, can cause neurological disorders such as convulsions in infants and children. The 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 etrementine (due to their lipophilic properties the speed of metabolism and disposal is not known) in tissues and brain, in particular neuropsychological disorders. A higher dose than recommended should not be used to avoid an increased risk of adverse drug reactions and disorders associated with overdose. The product is flammable, it must not be approached to flames.

INTERACTIONS
Cineole, the main component of the niaouli essence solution for topical use, induces the hepatic enzyme system and, therefore, can reduce the efficacy of drugs inactivated by these enzymes. It must not be used concomitantly with other products (medicinal or cosmetic) containing terpene derivatives, regardless of the route of administration (oral, rectal, cutaneous, nasal or inhalation).

SIDE EFFECTS
Insufficient data are available to establish the frequency of the individual effects listed. Respiratory, thoracic and mediastinal disorders: laryngospasm. Due to the presence of niaouli and in case of non-observance of the recommended doses there may be a risk of convulsions in children and newborns.

PREGNANCY AND BREASTFEEDING
There are no or limited amount of data from the use of niaouli essence in pregnant women. It is not recommended during pregnancy and in women of childbearing potential who are not using contraceptive measures. There is insufficient information on the excretion of niaouli essence in breast milk, therefore it should not be used during breastfeeding.