INHALING VICKS * RIN FL 1G

INHALING VICKS * RIN FL 1G

Therapeutic indications

In colds and congestion of the nasal mucosa, it clears the blocked nose and promotes breathing.

Dosage and method of use

Vicks Inalante is contraindicated in children up to 30 months of age (see section 4.3) and its use in children under 6 years is not recommended. 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 dose.The duration of the treatment should not exceed 3 days.

Contraindications

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

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-observance of 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 a suitable therapy.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed on the website: www.agenziafarmaco.gov.it/it/responsabili of the Italian Medicines Agency.

Special warnings

This product contains terpene derivatives which, in excessive doses, can cause neurological disorders such as convulsions in infants and children. Vicks Inalante is contraindicated in children up to 30 months of age and its use in children under 6 years is not recommended. Treatment should not be prolonged for more than 3 days due to the risks associated with the accumulation of terpene derivatives, such as for examplecamphor, cineole, niaouli, wild thyme, terpineol, terpine, citral, menthol and essential oils of pine needles, eucalyptus and turpentine(due to their lipophilic properties the rate of metabolism and disposal is not known) in tissues and in the brain, in particular neuropsychological disorders. A higher dose than recommended should not be used to avoid an increased risk of adverse drug reactions and disorders associated with overdose (see section 4.9) The product is flammable, should not be approached to flames. Prolonged use can 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.

Pregnancy and breastfeeding

PregnancyThere are no or limited amount of data 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.Feeding timeThere is insufficient information on the excretion of camphor and menthol in breast milk. Vicks Inalante should not be used during breastfeeding.

Expiration and retention

None.

Interactions with other drugs

Vicks Inalante should 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).

Overdose

No clinically significant cases of overdose have been reported.In case of accidental oral intake or incorrect administration in infants and children there may be a risk of neurological disorders. If necessary, administer appropriate symptomatic treatment in specialized treatment centers.

Active principles

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

Excipients

Essential oil of Siberian pine, methyl salicylate.