VICKS VAPORUB AND INAL 100G

VICKS VAPORUB, UNGUENT FOR INALATORY USE

active ingredients

100 g of ointment contains: active ingredients: canphora 5 g; essential oil of trementina 5 g; menthol 2,75 g; essential oil of eucalyptus 1.5 g. For the full list of excipients see paragraph 6.1.

Excellent

Timolo, essential oil of cedar wood, white vaseline.

Therapeutic indications

Balsamic treatment in the affections of the first respiratory tract.

Contraindications

Hypersensitivity to active ingredients or any of the excipients listed in paragraph 6.1. Children up to 30 months old. Vapour inhalation is contraindicated in children under 12 years of age Children with a history of epilepsy or fever seizures. Generally contraindicated during pregnancy and nursing (see paragraph 4.6).

Population

Vicks Vaporub is contraindicated in children up to 30 months of age and steam inhalations are contraindicated in children under 12 years (see paragraph 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 frying first for 3 - 5 minutes the chest, throat and back and then lay a thick layer on the chest. Repeat treatment 2 times a day of which one in the evening before bed. Do not fry more than twice a day on the front of the chest, on the neck and back. Wear large clothes to facilitate vapours inhalation. (2) Inhalation (adults and children over 12 years of age) Dissolve 2 teaspoons of coffee (2x5 ml) in the middle of a liter of hot water (not boiling) and aspire free steam, for a time not exceeding 10 min. In order to avoid the risk of severe burns, do not heat the mixture a second time or heat the mixture during inhalation (see paragraph 4.4). Do not heat in the microwave. Do not exceed the recommended doses. The duration of treatment shall not exceed 3 days. THE PRODUCT MUST NOT BE SWALLOWED

Conservation

This medicine does not require any special condition of conservation.

Warnings

Use the product according to the instructions. For external use only. Do not apply on wounds, abrasions and mucosa. Do not ingest and do not apply directly into the nostrils, eyes, mouth or face. Don't make a tight bandage. Do not use with warm wrap or with any type of heat. This product contains terpenic derivatives which, in excessive doses, can cause neurological disorders such as convulsions in infants and children. If symptoms persist, consult your doctor. The product must be used with caution or medical advice by patients presenting: • hypersensitivity reactions to perfumes or solvents; • seizures or epilepsy (it is contraindicated in children with a history of epilepsy or fever seizures, see paragraph 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 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 paragraph 6.6). Treatment should not be extended for more than 3 days for the risks associated with the accumulation of terpenic derivatives, such as canphora, cineol, niaouli, wild thyme, terpineol, terpineol, citral, menthol and essential oils of pine needles, eucalyptus and trementina (due to their lipophilic properties it is not known the speed of metabolism and disposal) in tissues and brains, especially neuropsychological disorders. A dose higher than the recommended dose should not be used to avoid greater risk of adverse reactions to the medicinal product and overdosage disorders (see paragraph 4.9). The product is flammable, it should not be approached to flames.

Interactions

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).

Effects

The use of the medicinal product may have adverse effects. These effects may occur with the following frequency categories: Very common (≥1/10) Common (≥1/100; Pathologies of skin and subcutaneous tissue Notable: heat erythema or erythema (redding and sensation of heat at the skin level caused by canphora and menthol, which have rubefacent effects), skin irritation, allergic dermatitis, itching. Immune system pathologies Not known: hypersensitivity, symptom of respiratory allergy (dispnea and cough). If such events occur, the treatment must be suspended and the necessary clinical measures must be taken. Pathologies of the eye Note: eye irritation (following topical use or inhalation). Systemic pathologies and conditions for administration: Due to the recommended route of administration, systemic exposure is very low and undesirable effects due to systemic exposure have not been observed. Not known: burns in the application site. Other adverse events may be related to improper use of the product (ingestion), in this regard see paragraph 4.9. Pediatric population Due to the presence of dicanphora, essential oil of trementina, menthol and essential oil of eucalyptus and in case of non-observance of the recommended doses can present a risk of seizures in children and infants. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: http://www.agenziafarmaco.gov.it/content/comesegnalare-una-sospetta-reazione-avversa.

Overdosing

In case of accidental oral intake or incorrect administration in infants and children, the risk of neurological disorders may arise. If necessary, administer appropriate symptomatic treatment in specialized care centers. Overdose can cause skin irritation. Improper use: Ingestion of ointment could cause gastrointestinal symptoms such as vomiting and diarrhea. Treatment is symptomatic. Acute poisoning was observed as a result of significant accidental intake with nausea, vomiting, abdominal pain, headaches, dizziness, feeling of heat/vampate, seizures, respiratory depression and coma. Patients with severe gastrointestinal or neurological symptoms from poisoning must be observed and treated symptomaticly. Don't induce vomiting. A) Topic administration: In the possibility of applying an excessive dose by topical means, skin irritation reactions can rarely occur. In this event, remove the excess of the product with a paper napkin and administer, if necessary, adequate therapy for such reactions. B) Inhalation: symptoms and treatment are the same in case of accidental ingestion. C) Accidental ingestion: 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 are possible at the central nervous system, such as ataxia, seizures and respiratory depression. The treatment must be symptomatic and if necessary the gastric lavender can be carried out. In the presence of severe symptoms of gastrointestinal or neurological poisoning, it is necessary that the patient immediately consult the doctor for appropriate therapeutic measures.

Pregnancy

There are or are available in limited number data relating to the use of canphora, essential oil of trementina, menthol, essential oil of eucalyptus in pregnant women. There are no clinical data concerning the use of Vicks Vaporub components during pregnancy. The camphor is able to cross the placenta but you do not have data about the other components. Animal studies indicate no harmful, direct or indirect effects on pregnancy, embryo/fetal development, postnatal birth or development (see paragraph 5.3). However,Vicks Vaporub is not recommended during pregnancy and in women of fertile age who do not use contraceptive measures. The use of the drug during pregnancy should only take place after consulting your doctor.

Food

There is insufficient information on the excretion of camphor, essential oil of trementina, menthol, essential oil of eucalyptus in breast milk. There are no clinical data concerning the use of Vicks Vaporub components during breastfeeding. Vicks Vaporub should not be used during breastfeeding. The product, applied on the breast of the mother during breastfeeding, involves a potential risk of apnoic reflex in the breast-feeding milking.

Source: Farmadati