Vicks Vaporub 100 g inhalation ointment

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

INDICATIONS

Balsamic treatment for diseases of the upper respiratory tract.

CONTRAINDICATIONS

Hypersensitivity to the active substances or to any of the excipients listed in paragraph 6.1. Children up to 30 months of age. Administration through steam inhalation is contraindicated in children under 12 years of age. Children with a history of epilepsy or febrile convulsions. Generally contraindicated during pregnancy and breastfeeding (see section 4.6).

WARNINGS AND PRECAUTIONS FOR USE

Use the product according to the instructions. For external use only. Do not apply on wounds, abrasions and mucous membranes. Do not ingest or apply directly into the nostrils, eyes, mouth or face. Do not make a tight bandage. Do not use with hot compress or any type of heat. This product contains terpene derivatives which, in excessive doses, can cause neurological disorders such as seizures in infants and children. If symptoms persist, consult your doctor. The product should be used with caution or under medical suggestion by patients who present: • hypersensitivity reactions to perfumes or solvents; • convulsions or epilepsy (it is contraindicated in children with a history of epilepsy or febrile convulsions, see section 4.3); • Marked hypersensitivity of the respiratory tract including those conditions such as asthma and chronic obstructive pulmonary disease (COPD) as it can cause bronchospasm in these patients Inhalations: In order to avoid the risk of serious burns, do not use boiling water to prepare inhalations. Do not heat the mixture in the microwave and do not heat it again during and after use (see also section 6.6). 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 than recommended dose 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, it must not be brought near flames.

INTERACTIONS

Vicks Vaporub 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

Side effects may occur with the use of the medicine. Such effects may occur with the following frequency categories: Very common (≥1/10) Common (≥1/100; <1/10) Uncommon (≥1/1,000; <1/100) Rare (≥1/10,000; <1/1,000) Very rare (<1/10,000) Not known (frequency cannot be predicted from the available data). Pathologies of the skin and subcutaneous tissue Not known: erythema or heat erythema (redness and sensation of heat in the skin caused by camphor and menthol, which have rubefacient effects), skin irritation, allergic dermatitis, itching. Immune system disorders Not known: hypersensitivity, symptom of respiratory allergy (dyspnoea and cough). If such events occur, treatment should be suspended and the necessary clinical measures adopted. Eye pathologies Not known: eye irritation (following topical use or inhalation). Systemic pathologies and conditions relating to the administration site: Due to the recommended route of administration, systemic exposure is very low and no undesirable effects due to systemic exposure have been observed. Not known: burns at the application site. Other adverse events may be linked to improper use of the product (ingestion), in this regard see paragraph 4.9. Pediatric population Due to the presence of camphor, turpentine essential oil, menthol and eucalyptus essential oil and in case of non-compliance with the recommended doses there may be a risk of convulsions in children and infants. 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 reactions via the national reporting system at: http://www.agenziafarmaco.gov.it/content/comesegnalare-una-sospetti-reazione-avversa.