Niaouli essence Marco Viti

Niaouli essential oil Marco Viti nasal drops solution

Patient Information Leaflet

Marco Viti Farmaceutici S.p.A.
Niaouli essential oil Marco Viti 1% nasal drops, solution for children
Niaouli essential oil Marco Viti 2% nasal drops, solution for adults
Pharmacotherapeutic Category
Topical rhinological drug.
Therapeutic Indications
The medicine is indicated as a balsamic, expectorant, anticatarrhal and antiseptic agent in inflammation of the upper respiratory tract, particularly in congestive conditions of the nasal mucosa.
Contraindications
Niaouli essential oil is contraindicated in cases of:

• Hypersensitivity to the active substance (niaouli) or to any of the excipients
• 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 essential oil solution may cause laryngospasm.
This product contains terpene derivatives which, in excessive doses, may cause neurological disturbances such as convulsions in neonates and children.
Treatment should not be prolonged beyond 3 days due to risks associated with the accumulation of terpene derivatives—such as camphor, cineole, niaouli, wild thyme, terpineol, terpinene, 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 and disturbances related to dosing.
Interactions
Inform your doctor or pharmacist if you have recently taken any other medicines, including those not requiring a prescription.
Niaouli essential oil Marco Viti must not be used concomitantly with other products (medicinal or cosmetic) containing terpene derivatives, regardless of the route of administration (oral, rectal, cutaneous, nasal or inhaled).
Cineole, the main component of topical niaouli essential oil solution, induces the hepatic enzyme system and may therefore reduce the efficacy of drugs inactivated by these enzymes.
Special Warnings
Pregnancy and Breastfeeding
Consult your doctor or pharmacist before taking any medicine.
Pregnancy
There are no data or only limited data available on the use of niaouli essential oil in pregnant women.
Niaouli essential oil Marco Viti is not recommended during pregnancy and in women of childbearing potential who are not using contraceptive measures.
Breastfeeding
There is insufficient information on the excretion of niaouli essential oil in breast milk.
Niaouli essential oil Marco Viti must not be used during breastfeeding.
Niaouli essential oil Marco Viti nasal drops solution

Package leaflet

Marco Viti Farmaceutici S.p.A.
Effects on ability to drive and use machines
No studies have been conducted on the ability to drive vehicles and use machinery.
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 Marco Viti is contraindicated in children up to 30 months of age.
The treatment duration must not exceed 3 days.
Overdose
No cases of overdose have been reported.
In case of accidental oral intake or incorrect administration in neonates and children, there may be a risk of neurological disturbances.
If necessary, administer appropriate symptomatic treatment at specialized care centers.
In case of accidental ingestion/overdose of Niaouli essence Marco Viti, contact a doctor immediately or go to the nearest hospital.
If you have any doubts about the use of Niaouli essence Marco Viti, consult your doctor or pharmacist.
Undesirable effects
Like all medicines, Niaouli essence Marco Viti can cause undesirable effects, although not everyone experiences them.
Due to the presence of niaouli essence and in case of failure to follow the recommended doses, 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 listed effects.
Respiratory, thoracic and mediastinal disorders
Laryngospasm
Following the instructions contained 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 in its original, undamaged packaging, stored correctly.
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 in use. This will help protect the environment.
Niaouli essence Marco Viti nasal drops solution

Package leaflet

Marco Viti Farmaceutici S.p.A.
Keep this medicine out of the reach and sight of children.
Composition
Niaouli essence Marco Viti 1% children nasal drops, solution
100 g of solution contain:
Active substance: niaouli essence (gomenolated oil) 1 g
Excipients: Olive oil.
Niaouli essence Marco Viti 2% adult nasal drops, solution
100 g of solution contain:
Active substance: niaouli essence (gomenolated oil) 2 g
Excipients: Olive oil.
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
Niaouli essence Marco Viti 1% nasal drops, solution.
10 g glass bottle with dropper cap
Niaouli essence Marco Viti 2% nasal drops, solution.
20 g glass bottle with dropper cap
Marketing Authorization Holder
Marco Viti Farmaceutici S.p.A.
Via Mentana, 38 – 36100 Vicenza
Responsible for batch release
Zeta Farmaceutici S.p.A.
Via Galvani, 10 – 36066 Sandrigo (VI)
June 2012