1% GTT 20G

IN THE ABSENCE OF SELLA

active ingredients

Niaouli essence Sella 1% children nasal drops, solution 100 g of solution contain Active Ingredient: niaouli essence (gomenolate oil) 1 g Niaouli essence Sella 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

Peanut 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

Niaouli essence Sella nasal drops solution is contraindicated in children up to 30 months of age (see paragraph 4.3). 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 over 30 months and up to 12 years Apply locally 2–3 drops of niaouli essence solution 1% children per nostril several times a day. The duration of treatment shall not exceed 3 days.

Conservation

In well closed packaging, sheltered from light

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. The 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 trementine (due to their lipophilic properties, it is not known the speed of metabolism and disposal) in particular tissues. 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: – Niaouli essence Sella nasal drops solution contains peanut oil. In case of peanut or soy allergy, do not take the medicine.

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. Niaouli essence Sella nasal drops solution should not be used in conjunction with other products (medical or cosmetic) containing terpenic derivatives, regardless of the way 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

Overdosing

No overdose cases have been reported. 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 Clinical data concerning the use of niaouli essence during pregnancy are not available. Niaouli essence Sella nasal drops solution is not recommended during pregnancy and in women in fertile age who do not use contraceptive measures. Food There is insufficient information on the excretion of niaouli essence in breast milk. Niaouli essence Sella nasal drops solution should not be used during breastfeeding.

Source: Farmadati