NIAOULI 1% Назальные капли, раствор

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1. Niaouli essence Marco Viti 1% children nasal drops, solution, 2% adults nasal drops, solution

Niaouli essence Marco Viti nasal drops solution
Marco Viti Farmaceutici S.p.A.

Niaouli essence Marco Viti 1% children nasal drops, solution, 2% adults nasal drops, solution

Pharmacotherapeutic Category
Rhinological drug for topical use.

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

Contraindications
Niaouli essence is contraindicated in cases of:

• hypersensitivity to the active ingredient (niaouli) or to any of the excipients
• severe liver diseases;
• inflammation of the biliary gastrointestinal tract;
• Children under 30 months of age
• Children with a history of epilepsy and febrile convulsions.

Precautions for Use
Application of the niaouli essence solution may cause laryngospasm.
This product contains terpene derivatives which, in excessive doses, can cause neurological disorders such as convulsions in newborns and children.
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, terpin, citral, menthol and essential oils of pine needles, eucalyptus and turpentine (due to their lipophilic properties, the rate of metabolism and elimination is unknown) in tissues and in the brain, particularly neuropsychological disorders.
A dose higher than the recommended one should not be used to avoid a greater risk of adverse reactions to the medicine and disorders associated with the dosage.

Interactions
Inform your doctor or pharmacist if you have recently taken any other medicines, including those available without a prescription.
Niaouli essence Marco Viti should not be used in conjunction with other products (medicines or cosmetics) 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 enzymatic system and, therefore, can reduce the effectiveness 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 or limited data regarding the use of niaouli essence in pregnant women.
Niaouli essence Marco Viti is not recommended during pregnancy and in women of childbearing potential who are not using contraceptive measures.

Breastfeeding
Insufficient information is available on the excretion of niaouli essence in breast milk.
Niaouli essence Marco Viti should not be used during breastfeeding.

Niaouli essence Marco Viti nasal drops solution
Marco Viti Farmaceutici S.p.A.

Effects on Ability to Drive and Operate Machinery
No studies have been conducted on the ability to drive vehicles and operate machinery.

Dosage, Administration and Duration of Treatment

Adults and adolescents (13-18 years)
Apply locally 2-3 drops of the niaouli essence 2% adults solution to each nostril several times a day.

Children aged between 30 months and 12 years
Apply locally 2-3 drops of the niaouli essence 1% children solution to each nostril several times a day.
Do not exceed the recommended doses.
Niaouli essence Marco Viti is contraindicated in children under 30 months of age.
The duration of treatment should not exceed 3 days.

Overdose
No cases of overdose have been reported.
In case of accidental oral intake or incorrect administration in newborns and children, there may be a risk of neurological disorders.
If necessary, administer appropriate symptomatic treatment in specialized care centers.
If an excessive dose of Niaouli essence Marco Viti is ingested/taken accidentally, immediately notify your doctor or go to the nearest hospital.

If you have any doubts about the use of Niaouli essence Marco Viti, ask your doctor or pharmacist.
Undesirable Effects
Like all medicines, Niaouli essence Marco Viti can cause side effects, although not everybody gets them.
Due to the presence of niaouli essence and in case of failure to observe the recommended doses, there may be a risk of convulsions in children and newborns.
The following are the undesirable effects of niaouli essence. Insufficient data are available to establish the frequency of the individual effects listed.

Respiratory, thoracic and mediastinal disorders
Laryngospasm

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet

Shelf Life and Storage
Shelf life: see the expiry date indicated on the packaging.
The expiry date refers to the product in intact packaging, correctly stored.

ATTENTION:do not use the medicine after the expiry date indicated on the packaging.

Storage Conditions
Store in the original container, protected from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

Niaouli essence Marco Viti nasal drops solution
Marco Viti Farmaceutici S.p.A.

Keep the medicine out of the reach and sight of children.
Composition
Niaouli essence Marco Viti 1% children nasal drops, solution
100 g of solution contains
Active ingredient: niaouli essence (gomenolated oil) 1 g
Excipients: Olive oil.
Niaouli essence Marco Viti 2% adults nasal drops, solution
100 g of solution contains
Active ingredient: niaouli essence (gomenolated oil) 2 g
Excipients: Olive oil.
Niaouli essence is obtained from the leaves of Melaleuca viridifloraand contains not less than 50 percent of 1,8-cineole.

Pharmaceutical Form and Content
Niaouli essence Marco Viti 1% nasal drops, solution.
Glass bottle of 10 g with a dropper cap
Niaouli essence Marco Viti 2% nasal drops, solution.
Glass bottle of 20 g with a dropper cap

Marketing Authorisation Holder
Marco Viti 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.