Mentolo 1% - polvere per il trattamento di eruzioni cutanee 100 g

Product Description

Skin Powder

Composition:

100 g of powder contain: Active ingredient: menthol 1 g For the full list of excipients, see section 6.1.

Excipients

Talc.

Therapeutic indications

The medicine is indicated for the symptomatic treatment of skin rashes due to exanthematous diseases, irritation, including rubbing, itching and burning in case of insect bites, sunburn and burns.

Contraindications

Hypersensitivity to the active ingredient or to any of the excipients. Children up to 30 months of age. Children with a history of epilepsy or febrile convulsions.

Dosage

Sprinkle evenly over the affected area 2 or more times a day. Menthol AFOM skin powder is contraindicated in children up to 30 months of age (see section 4.3). The duration of treatment should not exceed 3 days.

Warnings and precautions

• This product contains terpene derivatives which, in excessive doses, can cause neurological disorders such as convulsions in infants and children. • Treatment should not be prolonged for more than three 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 needles, eucalyptus, and turpentine (due to their lipophilic properties, the rate of metabolism and disposal is unknown) in the tissues and brain, particularly neuropsychological disorders. • A dose higher than recommended should not be used to avoid a greater risk of adverse reactions to the drug and disorders associated with overdose (see section 4.9). • The product is flammable; it should not be brought close to flames. The medicine should be used for external use only; it should not be inhaled and should not be applied to eyes or mucous membranes. It should not be applied to open wounds or surgical gloves. Menthol Afom should be used with caution in children up to 6 years of age. Routine use in daily infant hygiene is not recommended as inhalation can cause lung irritation with the risk of serious breathing difficulties and death. If it is suspected that a child has inhaled Mentolo Afom, respiratory function must be carefully monitored as the onset of symptoms may be delayed for several hours. Hemolysis and kernicterus may occur in infants with glucose-6-phosphate dehydrogenase deficiency exposed to menthol. Important information about some excipients Talc: Overuse of intranasally administered medications containing talc as an excipient has been reported to cause pulmonary granulomas. Although talc does not cause acute toxicity, fatal cases have been reported following acute exposure to talc. Inhalation of the dust has caused death, primarily in infants. Inhalation of talc causes respiratory tract irritation, coughing, shortness of breath, sneezing, vomiting, and cyanosis. The onset of these symptoms may occur within 12 to 24 hours. Acute exposure can cause permanent effects on the lungs. Intense and prolonged exposure to talc can cause pneumoconiosis. When injected intravenously, it can cause retinopathy, emboli, and pulmonary hypertension. Applying talc to open wounds can cause severe granulomatous reactions. Talc is a strong irritant to the eyes and can cause symblepharon, in some cases requiring surgical correction.

Interactions

Menthol Afom 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). No interaction studies have been performed.

Undesirable effects

Due to the presence of menthol and in case of non-compliance with the recommended doses, a risk of convulsions may occur in children and newborns. The following are the undesirable effects of menthol organised according to the MedDRA system organ classification. There are insufficient data to establish the frequency of the listed effects. Skin and subcutaneous tissue disorders Contact dermatitis. Cases of umbilical granulomas have been reported due to contamination of the umbilical cord residue with talc powder.

Pregnancy and breastfeeding

Pregnancy There are no or limited data on the use of camphor in pregnant women. Menthol Afom is not recommended during pregnancy and in women of childbearing potential not using contraceptive measures. Breastfeeding There is insufficient information on the excretion of menthol in breast milk. Menthol Afom should not be used during breastfeeding.