Vicks Inhalant Reinforced Bottle 1 g

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

In colds and congestion of the nasal mucosa, it frees the stuffy nose and promotes breathing.

CONTRAINDICATIONS

Hypersensitivity to the active substances or to any of the excipients listed in paragraph 6.1. Children up to 30 months of age. Children with a history of epilepsy or febrile seizures.

WARNINGS AND PRECAUTIONS FOR USE

This product contains terpene derivatives which, in excessive doses, can cause neurological disorders such as seizures in infants and children. Vicks Inhalant is contraindicated in children up to 30 months of age and its use is not recommended in children under 6 years of age. The treatment must not be prolonged for more than 3 days due to the risks associated with the accumulation of terpene derivatives, such as camphor, cineol, niaouli, wild thyme, terpineol, terpine, citral, menthol and essential oils of pine needle, eucalyptus and turpentine (due to their lipophilic properties the rate of metabolism and disposal is not known) in tissues and the brain, in particular neuropsychological disorders. A higher dose than the recommended one should not be used to avoid a greater risk of adverse reactions to the medicinal product and disorders associated with overdose (see section 4.9). The product is flammable, it must not be brought close to flames. Prolonged use may cause sensitization. In this case or in the absence of therapeutic effect, discontinue use and consult your doctor. Use the product according to the instructions. External use.

INTERACTIONS

Vicks Inhalant 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 inhalation).

SIDE EFFECTS

In general, no serious or severe side effects are expected with this product. Cases of nasal pain have been reported very rarely. Due to the presence of camphor and menthol and in case of non-compliance with the recommended doses there may be a risk of convulsions in children and infants. The use, especially if prolonged, of products for topical use can cause sensitization phenomena. In this case it is necessary to interrupt the treatment and institute suitable therapy. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system reported on the website: www.agenziafarmaco.gov.it/it/responsabili dell'Agenzia Italiana del Farmaco.