1% GTT 10ML

NIAOU NEW.FA.DEM. NASAL GOCCE, SOLUTION

active ingredients

Niaouli essence New.Fa.Dem. 1% children nasal drops, solution – 100 g of solution contain Active ingredient: niaouli essence (gomenolate oil) 1 g Niaouli essence New.Fa.Dem. 2% adult nasal drops, solution – 100 g of solution contain Active ingredient: niaouli essence (gomenolate oil) 2 g Niaouli essence is obtained from the leaves of Malaleuca viridiflora and contains no less than 50 percent of 1,8 cineol. For the full list of excipients, see paragraph 6.1.

Excellent

Vegetable 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; • Infants and children under 2 years of age.

Population

Adults and teenagers (13–18 years) Apply locally 2–3 drops of the solution of niaouli essence 2% adults per nostril several times a day. Children between 2 and 12 years Apply locally 2–3 drops of niaouli essence solution 1% children per nostril several times a day. Pediatric population Niaouli essence New.Fa.Dem should not be used in children under 2 years of age

Conservation

None in particular Store in closed container, at a temperature not exceeding 30 °C.

Warnings

The application of the solution of niaouli essence can cause laryngospasm.

Interactions

Cineol, the main component of the solution for local use of niaouli essence, induces the liver enzyme system and, therefore, can reduce the effectiveness of drugs inactivated by such enzymes.

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 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.agenziafarmaco.gov.it/it/responsabili.

Overdosing

No overdose cases have been reported.

Clinical data concerning the use of Niaouli essence during pregnancy are not available. Therefore, it is necessary to use caution in the prescription of the medicine to pregnant women and during breastfeeding.

Source: Farmadati