1% GTT 20ML

THE COMMISSION SHALL BE ASSISTED BY THE MEMBER STATES

active ingredients

Niaouli essence Zeta 1% children nasal drops, solution 100 g of solution contain Active ingredient: Niaouli essence (gomenolate oil) 1 g. Niaouli essence Zeta 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 Melaleuca viridiflora and contains no less than 50 percent of 1,8–cineol. For full list of excipients, see paragraph 6.1.

Excellent

Peanut oil, glyceryl oil, BHA, BHT, hexilenic glycol, monohydrate citric acid, ascorbil palmitato.

Therapeutic indications

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

Contraindications

– hypersensitivity to the active ingredient (niaouli) or any of the excipients. Niaouli Zeta essence contains peanut oil: do not use in case of hypersensitivity; – severe hepatopathies; – phagosis of gastroenteric bile routes; – babies and children up to 30 months of age – Children with a history of epilepsy and fever seizures.

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

Conservation

Store the medicine in the closed container, protected from light.

Warnings

The application of the solution of niaouli essence can cause laryngospasm. Niaouli essence Zeta contains terpenic derivatives that, 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, cytral, menthol and essential oils of pine needles, eucalyptus and trementine (due to their lipophilic properties, neuropsych is not known the speed of metabolism and disposal) in particular brain. A dose higher than the recommended dose should not be used to avoid a greater risk of adverse reactions to the medicinal product and disorders associated with the dosage (see paragraph 4.9). Important information about some excipients: Niaouli Zeta essence contains peanut oil: in case of allergy to peanuts or soy, do not use the medicine. Niaouli essence Zeta contains BHA and BHT: it can cause local skin reactions (e.g. contact dermatitis) or eye irritation or other mucosa.

Interactions

Niaouli Zeta essence should not be used in conjunction with other products (medicinal or cosmetic) containing terpenic derivatives, regardless of the way of administration (oral, rectal, cutaneous, nasal or inhalation). 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.

Effects

Due to the presence of niaouli essence and in case of non-compliance with recommended doses, a risk of seizures in children and infants may arise. 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 There are or are available in limited number data related to the use of niaouli essence in pregnant women. Niaouli Zeta essence 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 Zeta essence should not be used during breastfeeding.

Source: Farmadati