Niaouli essence Zeta

Niaouli essence Zeta nasal drops solution

Package leaflet

Zeta Farmaceutici S.p.A.
Niaouli essence Zeta 1% nasal drops, solution (for children)
Niaouli essence Zeta 2% nasal drops, solution (for adults)
Pharmacotherapeutic category
Rhinological drug for topical use.
Therapeutic indications
The medicine is indicated as a balsamic, expectorant, anticatarrhal and antiseptic agent in inflammation of the upper respiratory tract, particularly in congestive states of the nasal mucosa.
Contraindications
Niaouli essence is contraindicated in case of:

• hypersensitivity to the active substance (niaouli) or to any of the excipients. Niaouli essence Zeta contains peanut oil: do not use in case of hypersensitivity;
• severe liver disease;
• inflammation of the gastroenteric biliary tract;
• children under 30 months of age;
• children with a history of epilepsy and febrile seizures.

Precautions for use
Application of niaouli essence solution may cause laryngospasm.
Niaouli essence Zeta contains terpene derivatives which, in excessive doses, may cause neurological disorders such as convulsions in neonates and children.
Treatment should not be prolonged beyond 3 days due to the risks associated with the accumulation of terpene derivatives—such as camphor, cineole, niaouli, wild thyme, terpineol, terpin, citral, menthol, and essential oils of pine needles, eucalyptus and turpentine—(due to their lipophilic properties, the rate of metabolism and elimination is not known) in tissues and the brain, particularly neuropsychological disturbances.
A dose higher than recommended must not be used to avoid an increased risk of adverse reactions to the medicine and disturbances related to overdosing.
Interactions
Inform your doctor or pharmacist if you have recently taken any other medicines, including those without a prescription.
Niaouli essence Zeta must not be used concomitantly with other products (medicines or cosmetics) containing terpene derivatives, regardless of the route of administration (oral, rectal, cutaneous, nasal or inhalatory).
Cineole, the main component of topical niaouli essence solution, induces the hepatic enzyme system and therefore may reduce the efficacy of drugs inactivated by these enzymes.
Special warnings
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
There are no data or only limited data available on the use of niaouli essence in pregnant women.
Niaouli essence Zeta is not recommended during pregnancy and in women of childbearing potential who do not use contraceptive measures.
Niaouli essence Zeta nasal drops solution

Package leaflet

Zeta Farmaceutici S.p.A.
Breast-feeding
There is insufficient information regarding the excretion of niaouli essence in breast milk.
Niaouli essence Zeta must not be used during breast-feeding.

Effects on ability to drive and use machines
No studies have been conducted on the ability to drive vehicles or use machinery.

Important information about certain excipients:
Niaouli essence Zeta contains peanut oil: if you are allergic to peanuts or soy, do not use this medicine.
Niaouli essence Zeta contains BHA and BHT: may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes or other mucous membranes.

Dosage, method and duration of administration
Adults and adolescents (13–18 years)
Apply locally 2–3 drops of 2% niaouli essence solution per nostril several times a day.

Children aged between 30 months and 12 years
Apply locally 2–3 drops of 1% niaouli essence solution for children per nostril several times a day.

Do not exceed the recommended doses.
Niaouli essence Zeta is contraindicated in children under 30 months of age.
The duration of treatment must not exceed 3 days.

Overdose
No cases of overdose have been reported.
In case of accidental oral ingestion or incorrect administration in neonates and children, there may be a risk of neurological disorders.
If necessary, symptomatic treatment should be administered in specialized care centres.
In case of accidental ingestion/overdose of an excessive amount of Niaouli essence Zeta, contact a doctor immediately or go to the nearest hospital.

If you have any doubts about the use of Niaouli essence Zeta, consult your doctor or pharmacist.

Undesirable effects
Like all medicines, Niaouli essence Zeta can cause undesirable effects, although not everybody will experience them.
Due to the presence of niaouli essence and in case of failure to follow the recommended dosage, there may be a risk of seizures in children and neonates.
The following undesirable effects of niaouli essence are reported. There are insufficient data available to determine the frequency of the individual adverse reactions listed.

Respiratory, thoracic and mediastinal disorders
Laryngospasm

Following the instructions provided in this leaflet reduces the risk of undesirable effects.
If any of the undesirable effects worsens, or if you notice any undesirable effect not listed in this leaflet, inform your doctor or pharmacist.

Expiry date and storage
Expiry date: see the date printed on the packaging.
The expiry date refers to the product stored in its original, unopened packaging and kept under appropriate storage conditions.

Niaouli essence Zeta nasal drops solution

Package Leaflet

Zeta Farmaceutici S.p.A.
WARNING: Do not use the medicine after the expiry date stated on the packaging.
Storage Conditions
Store in the original container, protected from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.
Keep the medicine out of the reach and sight of children.
Composition
Niaouli essence Zeta 1% nasal drops, solution
100 g of solution contain:
Active substance: niaouli essence (gomenolated oil) 1 g
Excipients: Peanut oil, glyceryl oleate, BHA, BHT, hexylene glycol, citric acid monohydrate,
ascorbyl palmitate.
Niaouli essence Zeta 2% nasal drops, solution
100 g of solution contain:
Active substance: niaouli essence (gomenolated oil) 2 g
Excipients: Peanut oil, glyceryl oleate, BHA, BHT, hexylene glycol, citric acid monohydrate,
ascorbyl palmitate.
Niaouli essence is obtained from the leaves of Melaleuca viridiflora and contains not less than 50 percent of 1,8-
cineole.
Pharmaceutical Form and Contents
Nasal drops, solution.
20 ml glass bottle with dropper cap
Marketing Authorization Holder
Zeta Farmaceutici S.p.A.
Via Mentana, 38 – 36100 Vicenza
Manufacturer Responsible for Batch Release
Zeta Farmaceutici S.p.A.
Via Galvani, 10 – 36066 Sandrigo (VI)
June 2012.