Vaporub - balsamic ointment for upper respiratory tract infections - inhalation use 50 g

Product Description

Vicks

Balsamic Treatment for Respiratory Tract Conditions

Active ingredients

100 g of ointment contain Active ingredients: camphor 5.00 g; turpentine essential oil 5.00 g; menthol 2.75 g; eucalyptus essential oil 1.50 g. For the full list of excipients, see section 6.1.

Excipients

Thymol, cedarwood essential oil, white petrolatum.

Therapeutic indications

Balsamic treatment for upper respiratory tract conditions.

Contraindications

Hypersensitivity to the active ingredients or to any of the excipients listed in section 6.1. Children up to 30 months of age. Inhalations are contraindicated in children under six years of age. Children with a history of epilepsy or febrile convulsions. Generally contraindicated in pregnancy and breastfeeding (see section 4.6).

Dosage

Vicks Vaporub is contraindicated in children up to 30 months of age and inhalations are contraindicated in children under six years of age (see section 4.3). Children must always be supervised. Vicks Vaporub Balsamic Ointment can be used in two ways: a) Apply externally by rubbing the chest, throat, and back for 3–5 minutes, then spread a thick layer over the chest. Repeat the treatment twice a day, once in the evening before bed. Do not rub more than twice a day on the front of the chest, neck, and back. Wear loose-fitting clothing to facilitate inhalation of the vapors. b) Dissolve 2 teaspoons (2 x 5 ml) in half a liter of hot water and inhale the vapor released, for no longer than 10 minutes. To avoid the risk of serious 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 treatment should not exceed 3 days. THE PRODUCT MUST NOT BE INGESTED.

Warnings and Precautions

Use the product according to the instructions. For external use only. Do not apply to wounds, abrasions, or mucous membranes. Do not swallow or apply directly into the nostrils, eyes, mouth, or face. Do not apply a tight bandage. Do not use with a 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. Convulsions or epilepsy. Asthma and disorders or pronounced hypersensitivity of the respiratory tract. It is contraindicated in children with a history of epilepsy or febrile convulsions. (See section 4.3). Inhalations: To avoid the risk of serious burns, do not use boiling water to prepare inhalations. Do not heat the mixture in the microwave or reheat it during or after use (see also section 6.6). Treatment should not be prolonged for more than 1 month. 3 days due to the risks associated with the accumulation of terpene derivatives, such as camphor, cineole, niaouli, wild thyme, terpineol, terpin, citral, menthol, and essential oils of pine needle, eucalyptus, and turpentine (due to their lipophilic properties, the rate of metabolism and elimination is unknown) in tissues and the brain, particularly neuropsychological disorders. A dose higher than the recommended one 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 should not be brought close to flames.

Interactions

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

Side effects

Due to the presence of camphor, turpentine essential oil, menthol, and eucalyptus essential oil, and if the recommended doses are not observed, there may be a risk of convulsions in children and infants. Some of the components of Vicks Vaporub (camphor and menthol) have rubefacient effects. That is, they can cause redness and a sensation of heat on the skin. Mild irritation and allergic reactions may rarely occur. More Specifically: allergic dermatitis, skin irritation, and itching after topical use, and mild eye irritation following topical use or inhalation. Hypersensitivity reactions affecting the respiratory system (dyspnea and cough) have rarely occurred. If such events occur, treatment should be discontinued and the necessary clinical measures should be taken. The product should not be ingested. To avoid the risk of serious burns, do not use boiling water to prepare inhalations. Do not heat the mixture in the microwave or reheat it after use. Other adverse events may be related to improper use of the product (ingestion); see section 4.9. Systemic effects: Due to the recommended route of administration, systemic exposure is very low, and no adverse effects due to systemic exposure have been observed. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as 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 website: www.agenziafarmaco.gov.it/it/responsabili dell'Agenzia Italiana del Farmaco.

Pregnancy and breastfeeding

Pregnancy There are no or limited amount of data on the use of camphor, turpentine essential oil, menthol, and eucalyptus essential oil in pregnant women. There are no clinical data on the use of the components of Vicks Vaporub during pregnancy. Camphor can cross the placenta, but there are no data on the other components. Animal studies do not indicate direct or indirect harmful effects on pregnancy, embryonic/fetal development, parturition, or postnatal development (see section 5.3). However, Vicks Vaporub is not recommended during pregnancy or in women of childbearing age who are not using contraception. Use of the drug during pregnancy should only occur after consulting your doctor. Breastfeeding: There is insufficient information on the excretion of camphor, turpentine oil, menthol, and eucalyptus oil in breast milk. There are no clinical data on 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, carries a potential risk of apnea reflex in breast-fed infants.