Vicks Inhalant Reinforced Bottle 1 g

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

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

ACTIVE INGREDIENTS

Each stick contains: 1.00 ml of medicinal liquor, absorbed onto a piece of cellulose. ACTIVE INGREDIENTS: menthol 415.4 mg, camphor 415.4 mg. For the complete list of excipients see section 6.1.

EXCIPIENTS

Siberian pine essential oil, methyl salicylate.

CONTRAINDICATIONS AND SIDE EFFECTS

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.

DOSAGE

Vicks Inhalant is contraindicated in children up to 30 months of age (see paragraph 4.3) and its use is not recommended in children under 6 years of age. Unscrew the cap and insert the tip of the nasal stick into one nostril, closing the other with a finger and inhale deeply. Repeat in each nostril several times a day. Do not exceed the recommended doses. The duration of treatment should not exceed 3 days.

CONSERVATION

None.

WARNINGS

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 serious 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.

OVERDOSE

No clinically significant 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 treatment centers.

PREGNANCY AND BREASTFEEDING

Pregnancy There are no or limited data available on the use of camphor and menthol in pregnant women. Vicks Inhalant 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 camphor and menthol in breast milk. Vicks Inhalant should not be used during breastfeeding.

EFFECTS ON DRIVING ABILITY

Not applicable.