Niaouli essence ago 2% drops 20g

NIAOULI ESSENZA FA * 2% GTT 20G

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 and method of use

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

Contraindications

- Hypersensitivity to the active substance (niaouli) or to any of the excipients. - Severe liver diseases. - 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

Due to the presence of niaouli essence and in case of non-observance of the recommended doses there may be a risk of convulsions in children and infants. The following are the undesirable effects of niaouli essence organized according to the MedDRA system organ classification. Insufficient data are available to establish the frequency of the individual effects listed.Respiratory, thoracic and mediastinal disorders: Laryngospasm.

Special warnings

• 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 three 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. Application of niaouli essence solution can cause laryngospasm.Important information: The container of this medicine is made of latex rubber. It can cause severe allergic reactions.

Pregnancy and breastfeeding

PregnancyThere are no or limited amount of data from the use of niaouli essence in pregnant women. Niaouli essence FARMAKOPEA is not recommended during pregnancy and in women of childbearing potential who are not using contraceptive measures.Feeding time:There is insufficient information on the excretion of niaouli essence in breast milk. Niaouli essence FARMAKOPEA should not be used during breastfeeding.

Expiration and retention

Keep container tightly closed.

Interactions with other drugs

Niaouli essence FARMAKOPEA should not be used concomitantly with other products (medicinal or cosmetic) containing terpene derivatives, regardless of the route of administration (oral, rectal, cutaneous, nasal or inhalation). Cineole, the main component of the topical solution of niaouli essence, induces the hepatic enzyme system and, therefore, can reduce the efficacy of drugs inactivated by these enzymes.

Overdose

In case 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.

Active principles

Niaouli essence FARMAKOPEA 1% children nasal drops, solution. 100 g of solution contain:Active principle: Niaouli essence (gomenolated oil) 1 g.Niaouli essence FARMAKOPEA 2% adults nasal drops, solution. 100 g of solution contain:Active principle: Niaouli essence (gomenolated oil) 1 g. Niaouli essence is obtained from the leaves of Malaleuca viridiflora and contains no less than 50 percent of 1.8 cineole. For the full list of excipients, see section 6.1.

Excipients

Vegetable oil.