Vicks Vaporub Inhalant Ointment 50 g

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

INDICATIONS

Balsamic treatment for diseases of the upper respiratory tract.

ACTIVE INGREDIENTS

100 g of ointment contains: active ingredients: camphor 5 g; turpentine essential oil 5 g; menthol 2.75 g; eucalyptus essential oil 1.5 g. For the complete list of excipients see section 6.1.

EXCIPIENTS

Thymol, cedarwood essential oil, white petrolatum.

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. 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).

DOSAGE

Vicks Vaporub is contraindicated in children up to 30 months of age and vapor inhalation is contraindicated in children under 12 years (see section 4.3). Children must always be supervised. Vicks Vaporub ointment can be used in two ways: 1) Topical use (adults and children over 30 months of age) Apply externally by first rubbing the chest, throat and back for 3 - 5 minutes and then spreading a thick layer on the chest. Repeat the treatment 2 times a day, one in the evening before going to sleep. Do not rub more than twice a day on the front of the chest, neck and back. Wear loose clothing to facilitate inhalation of vapours. 2) Inhalations (adults and children over 12 years of age) Dissolve 2 teaspoons (2x5 ml) in half a liter of hot (not boiling) water and aspirate the released steam for a time not exceeding 10 minutes. To avoid the risk of serious burns, do not heat the mixture a second time or heat the mixture during inhalation (see section 4.4). Do not heat in the microwave. Do not exceed the recommended doses. The duration of treatment should not exceed 3 days. THE PRODUCT MUST NOT BE INGESTED

CONSERVATION

This medicinal product does not require any special storage conditions.

WARNINGS

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 (dyspnea 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.

OVERDOSE

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. Overdose can cause skin irritation. Improper use: Ingestion of the ointment may cause gastrointestinal symptoms such as vomiting and diarrhea. Treatment is symptomatic. Acute poisoning has been observed following significant accidental intake with nausea, vomiting, abdominal pain, headache, dizziness, feeling hot/hot flashes, convulsions, respiratory depression and coma. Patients with severe gastrointestinal or neurologic symptoms of poisoning should be observed and treated symptomatically. Do not induce vomiting. A) Topical administration: in the event of application of an excessive dose topically, skin irritation reactions may rarely occur. In this case, remove the excess product with a paper towel and administer, if necessary, an adequate therapy for such reactions. B) Inhalation: the symptoms and treatment are the same as in case of accidental ingestion. C) Accidental ingestion: the symptoms are mainly due to the presence of camphor. These include gastrointestinal problems such as nausea, vomiting and diarrhea. In the event of significant overdose, effects on the central nervous system are possible, such as ataxia, convulsions and respiratory depression. Treatment must be symptomatic and gastric lavage can be performed if necessary. In the presence of serious symptoms of poisoning at a gastrointestinal or neurological level, the patient must immediately consult his doctor for appropriate therapeutic measures.

PREGNANCY AND BREASTFEEDING

Pregnancy There are no or limited data available on the use of camphor, turpentine essential oil, menthol, eucalyptus essential oil in pregnant women. There are no clinical data relating to the use of the components of Vicks Vaporub during pregnancy. Camphor is able to cross the placenta but there is no data on the other components. Animal studies do not indicate harmful effects, direct or indirect, on pregnancy, embryonic/foetal development, parturition or postnatal development (see section 5.3). However, Vicks Vaporub is not recommended during pregnancy and in women of childbearing potential who are not using contraceptive measures. The use of the drug during pregnancy should only take place after consulting your doctor. Breastfeeding There is insufficient information on the excretion of camphor, turpentine essential oil, menthol, eucalyptus essential oil in breast milk. There are no clinical data relating to the use of the components of Vicks Vaporub during breastfeeding. Vicks Vaporub should not be used during breastfeeding. The product, applied to the mother's chest during breastfeeding, poses a potential risk of apneic reflex in the breast-fed infant.

EFFECTS ON DRIVING ABILITY

Vicks Vaporub does not affect the ability to drive or use machines.