VICKS VAPORUB*UNG INAL 50G

Balsamic treatment in diseases of the upper respiratory tract.

Therapeutic indications

Balsamic treatment in diseases of the upper respiratory tract.

Dosage and method of use

Vicks Vaporub is contraindicated in children up to 30 months of age and vapor inhalations are contraindicated in children under 12 years of age (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 spread a thick layer on the chest . Repeat the treatment 2 times a day, one of which in the evening before going to bed. Do not rub the anterior chest, neck and back more than twice a day. Wear loose clothing to facilitate inhalation of vapours. 2) Inhalations ( adults and children over 12 years of age ) Dissolve 2 teaspoons of coffee (2x5 ml) in half a liter of hot (not boiling) water and inhale the released steam for a time not exceeding 10 minutes. To avoid the risk of severe 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 dose. The duration of treatment should not exceed 3 days. THE PRODUCT MUST NOT BE INGESTED

Contraindications

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

Side effects

Side effects may occur with the use of the medicine. These 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). Skin and subcutaneous tissue disorders Not known: erythema or heat rash (redness and sensation of warmth in the skin caused by camphor and menthol, which have rubefacient effects), skin irritation, allergic dermatitis, itching. Immune system disorders Not known: hypersensitivity, respiratory allergy symptom (dyspnoea and cough). If such events occur, treatment should be discontinued and the necessary clinical measures implemented. Eye disorders Not known: eye irritation (following topical use or inhalation). General disorders and administration site conditions : 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: Application site burns. Other adverse events may be linked to improper use of the product (ingestion), in this regard see section 4.9. Pediatric population Due to the presence of camphor, essential oil of turpentine, menthol and essential oil of eucalyptus 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 after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: http://www.agenziafarmaco.gov.it/content/comesegnalare-una-sospetta-reazione-avversa.

Special 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 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 convulsions in infants and children. If symptoms persist, consult your doctor. The product should be used with caution or on medical advice by patients with: • hypersensitivity reactions to perfumes or solvents; • seizures or epilepsy (it is contraindicated in children with a history of epilepsy or febrile seizures, 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: To avoid the risk of severe 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). Treatment should not be prolonged for more than 3 days due to the risks associated with the accumulation of terpenic derivatives, such as camphor, cineol, 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, especially 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, it must not be approached to flames.

Pregnancy and breastfeeding

Pregnancy There are no or limited data on the use of camphor, turpentine essential oil, menthol, eucalyptus essential oil in pregnant women. There are no clinical data on the use of the components of Vicks Vaporub during pregnancy. Camphor is able to cross the placenta but there is no data about the other components. Animal studies do not indicate harmful effects, direct or indirect, with respect to 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 not using contraception. 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 on the use of the components of Vicks Vaporub during lactation. Vicks Vaporub should not be used while breastfeeding. The product, applied to the breast of the mother during breastfeeding, involves a potential risk of apneic reflex in the breastfed infant.

Expiration and conservation

This medicine does not require any special storage conditions.

Interactions with other drugs

Vicks Vaporub should not be used in conjunction with other products (medicinal or cosmetic) containing terpenic derivatives, regardless of the route of administration (oral, rectal, cutaneous, nasal or inhalation).

Overdose

In case of accidental oral uptake or incorrect administration in infants and children there may be a risk of neurological disorders. If necessary, administer appropriate symptomatic treatment in specialized treatment centres. Overdose can cause skin irritation. Improper use : Ingestion of the ointment could cause gastrointestinal symptoms such as vomiting and diarrhea. Treatment is symptomatic. Acute poisoning has been observed following significant accidental ingestion with nausea, vomiting, abdominal pain, headache, dizziness, feeling hot/hot flushes, convulsions, respiratory depression and coma. Patients with severe gastrointestinal or neurological symptoms of poisoning should be observed and treated symptomatically. Do not induce vomiting. A) Topical administration: in the event of the application of an overdose by the topical route, irritation reactions at the skin level may rarely occur. In this case, remove the excess product with a paper towel and administer, if necessary, adequate therapy for these reactions. B) Inhalation: symptoms and treatment are the same as for accidental ingestion. C) Accidental ingestion: the symptoms are mainly due to the presence of camphor. These include gastrointestinal problems such as nausea, vomiting and diarrhoea. Central nervous system effects such as ataxia, convulsions and respiratory depression are possible in the event of a significant overdose. Treatment should be symptomatic and gastric lavage can be performed if necessary. In the presence of serious symptoms of gastrointestinal or neurological poisoning, the patient must immediately consult the attending physician for the appropriate therapeutic measures.

Active principles

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

Excipients

Thymol, cedarwood essential oil, white petroleum jelly.