Vicks Vaporub Camphor Ointment For Inhalation Use 100g

NAME
VICKS VAPORUB

PHARMACOTHERAPEUTIC CATEGORY
Prepare for colds.

ACTIVE PRINCIPLES
Camphor 5.00 g; essential oil of turpentine 5.00 g; menthol 2.75 g; Eucalyptus essential oil 1.50 g.

EXCIPIENTS
Thymol, cedar wood essential oil, white petroleum jelly.

INDICATIONS
Balsamic treatment in diseases of the upper respiratory tract.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active ingredients or to any of the excipients; children up to 30 months of age; inhalations are contraindicated in children under six years; children with a history of epilepsy or febrile seizures; generally contraindicated in pregnancy and during breastfeeding.

DOSAGE
The drug is contraindicated in children up to 30 months of age and inhalations are contraindicated in children under six years of age. Children must always be supervised. The drug Balsamic Ointment can be used in two ways: 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, once in the evening before going to sleep. Do not rub more than twice a day on the front of the chest, on the neck and on the back. Wear loose clothing to facilitate inhalation of vapors; dissolve 2 coffee spoons (2x5ml) in half a liter of hot water and suck up the free steam, for a time not exceeding 10 min. In order to avoid the risk of severe burns, do not reheat the mixture a second time or reheat the mixture during inhalation. Do not heat in the microwave. Do not exceed the recommended dose. The duration of the treatment must not exceed 3 days. The product must not be ingested.

STORAGE
None.

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 a 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. The product should be used with caution or on medical advice by patients presenting: hypersensitivity reactions' to perfumes or solvents; seizures or epilepsy; asthma and disorders or pronounced hypersensitivity of the respiratory tract. It is contraindicated in children with a history of epilepsy or febrile seizures. 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. The treatment should not be prolonged for more than 3 days due to the risks associated with the accumulation of terpene derivatives, such as camphor, cineole, niaouli, wild thyme, terpineol, terpine, citral, menthol and essential oils of pine needles, eucalyptus and turpentine (due to their lipophilic properties the speed of metabolism and disposal is not known) in tissues and 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. The product is flammable, it must not be approached to flames.

INTERACTIONS
The drug 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 inhaled).

SIDE EFFECTS
Due to the presence of camphor, 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. Some of the components of the product (camphor and menthol) have rubefacient effects. That is, they can cause redness and a sensation of heat in the skin. Rarely, mild irritation and allergic reactions may occur. More specifically: allergic dermatitis, skin irritation and itching after topical use and slight eye irritation following topical use or inhalation. Rarely there have been hypersensitivity reactions in the respiratory system (dyspnoea and cough). If such events occur, the treatment should be suspended and the necessary clinical measures adopted. The product must not be ingested. 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 after use. Other adverse events can be linked to improper use of the product (ingestion). Systemic Effects: Due to the recommended route of administration, systemic exposure is very low and no adverse effects from systemic exposure have been observed. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

PREGNANCY AND BREASTFEEDING
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 the drug 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. However, the drug is not recommended during pregnancy and in women of childbearing potential who do not use contraceptive measures. The use of the drug during pregnancy should only take place after consulting your doctor. There is insufficient information on the excretion of camphor, essential oil of ditrementin, menthol, essential oil of eucalyptus in breast milk. There are no clinical data on the use of the product components during lactation. The drug should not be used during breastfeeding. The product, applied to the breast of the mother during breastfeeding, carries a potential risk of apnoic reflex in the breast-fed infant.