VICKS VAPORUB * UNG INAL 100G

VICKS VAPORUB * UNG INAL 100G

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 steam inhalations are 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 spread a thick layer on the chest. Repeat the treatment twice a day, one of which in the evening before bed. Do not rub on the front of the chest, neck and back more than twice a day. Wear loose-fitting clothing to facilitate inhalation of vapors.2) Inhalations (adults and children over 12 years of age)Dissolve 2 coffee spoons (2x5 ml) in half a liter of hot (not boiling) water and suck up the released steam, for a time not exceeding 10 min. To avoid the risk of severe burns, do not reheat the mixture or reheat the mixture during inhalation (see section 4.4). Do not heat in the microwave. Do not exceed the recommended dose. The duration of the treatment should not exceed 3 days.THE PRODUCT MUST NOT BE SWALLOWED

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 seizures. Generally contraindicated in pregnancy and lactation (see section 4.6).

Side effects

Side effects may occur with the use of the medicine. These effects can occur in the following frequency categories: Very common (≥1 / 10) Common (≥1 / 100; Skin and subcutaneous tissue disorders Not known: erythema or heat erythema (redness and warmth of the skin caused by camphor and menthol, which have rubefacient effects), skin irritation, allergic dermatitis, itching.Disorders of the immune systemNot known: hypersensitivity, respiratory allergy symptom (dyspnoea and cough). If such events occur, the treatment should be suspended and the necessary clinical measures adopted.Eye disordersNot 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 adverse effects from 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 paragraph 4.9. Pediatric population Due to the presence of amphora, essential oil of turpentine, menthol and essential oil of eucalyptus and in case of non-observance of the recommended doses there may be a risk of convulsions in children and infants.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 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 to wounds, abrasions and mucous membranes. Do not ingest and do not apply directly into the nostrils, eyes, mouth or face. Do not make a tight bandage. Do not use with hot pack 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 who have: • hypersensitivity reactions to perfumes or solvents; • seizures or epilepsy (is contraindicated in children with a history of epilepsy or febrile seizures, see section 4.3); • Marked hypersensitivity of the respiratory tract including 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 for inhalations. Do not heat the mixture in the microwave and do not reheat it 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 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, it must not be approached to flames.

Pregnancy and breastfeeding

Pregnancy There are no or limited data on the use of camphor, essential oil of turpentine, menthol, essential oil of eucalyptus in pregnant women. There are no clinical data on the use of Vicks Vaporub components during pregnancy. Camphor is able to cross the placenta but there are no data on the other components. Animal studies do not indicate direct or indirect harmful effects on pregnancy, embryonal / fetal 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. Feeding time There is insufficient information on the excretion of camphor, essential oil of turpentine, menthol, essential oil of eucalyptus in breast milk. There are no clinical data regarding the use of Vicks Vaporub components during breastfeeding. Vicks Vaporub should not be used while breastfeeding. The product, applied to the breast of the mother during breastfeeding, carries a potential risk of apnoic reflex in the breast-fed infant.

Expiration and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

Vicks Vaporub 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 inhalation).

Overdose

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. 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, sensation of heat / flushing, 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 topical application of an excessive dose, skin irritation reactions may rarely occur. In this case, remove the excess product with a paper towel and administer, if necessary, an appropriate therapy for these reactions. B) Inhalation: the symptoms and treatment are the same as in the 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, central nervous system effects such as ataxia, convulsions and respiratory depression are possible. Treatment should be symptomatic and gastric lavage can be performed if necessary. In the presence of severe symptoms of gastrointestinal or neurological poisoning, the patient must immediately consult the attending physician for appropriate therapeutic measures.

Active principles

100 g of ointment contains:active principles: 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, cedar wood essential oil, white petroleum jelly.