NOW 2% GTT NAS 20G

IN THE ABSENCE OF NOVA ARGENTIA NASAL GOCCE, SOLUTION

active ingredients

IN THE ABSENCE OF NOVA ARGENTIA 1% children nasal drops, solution100 g solution contain: Active ingredient: niaouli essence (gomenolate oil) 1 g. NIAOULI ESSENCE NOVA ARGENTIA 2% adult nasal drops, 100 g solution contain: Active ingredient: Niaouli essence (gomenolate oil) 2 g. Niaouli essence is obtained from the leaves of Malaleuca viridiflora and contains not less than 50 percent of 1,8 cineol. For the full list of excipients, see paragraph 6.1.

Excellent

Olive oil.

Therapeutic indications

The medicine is indicated as a balsamic, expectant, anti-targeant and antiseptic in the phagosis of the upper airways, especially in the congestive states of the nasal mucosa.

Contraindications

- Hypersensitivity to the active ingredient (niaouli) or any of the excipients; - Severe hepatopathies; - Flogosis of biliary and gastroenteric routes; - Children up to 30 months of age; - Children with a history of epilepsy or fever seizures.

Population

Adults and teenagers (13-18 years): Apply locally 2-3 drops of niaouli solution 2% adult essence per nostril several times a day. Children between 30 months and 12 years: Apply locally 2-3 drops of niaouli essence solution 1% children per nostril several times a day. _ NOVA ARGENTIA is contraindicated in children up to 30 months of age (see paragraph 4.3). The duration of treatment shall not exceed 3 days.

Conservation

In well closed container, sheltered from light and heat.

Warnings

The application of the solution of niaouli essence can cause laryngospasm. This product contains terpenic derivatives which, in excessive doses, can cause neurological disorders such as convulsions in infants and children. Treatment should not be extended for more than 3 days for the risks associated with the accumulation of terpenic derivatives, such as canphora, cineol, niaouli, wild thyme, terpineol, terpineol, citral, menthol and essential oils of pine needles, eucalyptus and trementina (due to their lipophilic properties it is not known the speed of metabolism and disposal) in tissues and brains, especially neuropsychological disorders. A dose higher than the recommended dose should not be used to avoid greater risk of adverse reactions to the medicinal product and overdosage disorders (see paragraph 4.9). The product is flammable, it should not be approached to flames. Important information about some excipients: not relevant.

Interactions

Cineol, the main component of the solution for topical use of niaouli essence, induces the liver enzyme system and, therefore, can reduce the effectiveness of drugs inactivated by such enzymes. _ NOVA ARGENTIA should not be used in conjunction with other products (medicinal or cosmetic) containing terpenic derivatives, regardless of the route of administration (oral, rectal, cutaneous, nasal or inhalation).

Effects

Below are the undesirable effects of niaouli essence organized according to the organic systemic classification MedDRA. No sufficient data is available to determine the frequency of the individual effects listed. Respiratory, chest and mediastinic pathologies: Laringospasmo. Due to the presence of niaouli and in case of non-compliance with recommended doses, a risk of seizures in children and infants may arise. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

In case of accidental ingestion/intake of an excessive dose of NIAOULI ESSENCE NOVA ARGENTIA immediately notify the doctor or contact the nearest hospital. In case of accidental oral intake or incorrect administration in infants and children, the risk of neurological disorders may arise. If necessary, administer appropriate symptomatic treatment in specialized care centers.

Pregnancy: There are or are available in limited number data related to the use of niaouli essence in pregnant women. _ NOVA ARGENTIA it is not recommended during pregnancy and in women in fertile age who do not use contraceptive measures. Nursing: There is insufficient information on the excretion of niaouli essence in breast milk. _ NOVA ARGENTIA should not be used during lactation.

Source: Farmadati