Niaouli Absence Saddle 1% Nasal Drops Children Decongestants 20 g

Therapeutic indications

The medicine is indicated as a balsamic, expectorant, anti-catarrhal and antiseptic in inflammation of the upper airways, in particular in congestive states of the nasal mucosa.

Dosage

Niaouli essence Sella nasal drops solution is contraindicated in children up to 30 months of age (see section 4.3). Adults and adolescents (13–18 years) Apply locally 2–3 drops of niaouli essence 2% adult solution per nostril several times a day. Children older than 30 months and up to 12 years Apply locally 2–3 drops of the solution of niaouli essence 1% children per nostril several times a day. The duration of the treatment should not exceed 3 days.

Overdose

No cases of overdose have been reported. In the event of accidental oral intake or incorrect administration in infants and children there may be a risk of neurological disorders. If necessary, administer appropriate symptomatic treatment in specialized treatment centers.

Contraindications

• Hypersensitivity to the active substance (niaouli) or to any of the excipients; • severe liver disease; • Inflammation of the biliary and gastrointestinal tracts; • Children up to 30 months of age • Children with a history of epilepsy or febrile seizures.

Side effects

The following are the undesirable effects of niaouli essence organized according to the MedDRA system organ class. Insufficient data are available to establish the frequency of the individual effects listed. Respiratory, thoracic and mediastinal disorders Laryngospasm

Pregnancy and breastfeeding

Pregnancy There are no clinical data on the use of niaouli essence during pregnancy. Niaouli essence Sella nasal drops solution is not recommended during pregnancy and in women of childbearing potential who are not using contraceptive measures. Lactation There is insufficient information on the excretion of niaouli essence in human milk. Niaouli essence Sella nasal drops solution should not be used while breastfeeding.

Special 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 and turpentine (due to their lipophilic properties the rate of metabolism and disposal is not known) in tissues and brain, in particular neuropsychological disorders. A higher than recommended dose should not be used to avoid an increased risk of adverse drug reactions and disorders associated with overdose (see section 4.9). The product is flammable, it must not be approached to flames. Important information about some of the ingredients : - Niaouli essence Sella nasal drops solution contains peanut oil. If you have a peanut or soy allergy, do not take the medicine.

Expiry and Retention

In tightly closed package, away from light

Active principles

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 not less than 50 percent of 1.8 cineole. For the full list of excipients, see section 6.1.

Excipients

Peanut oil