Name
Menthol Sella 1% skin powder
What is it and what is it for?
The medicine is indicated for the symptomatic treatment of skin rashes due to exanthematous diseases, irritation, including from rubbing, itching and burning in case of insect bites, sunburn and burns.
What you need to know before taking the medicine
Hypersensitivity to the active substance or to any of the excipients.
Children up to 30 months of age.
Children with a history of epilepsy or febrile seizures.
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 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 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 the recommended one should not be used to avoid a higher risk of adverse reactions to the medicinal product and disorders associated with overdose (see section Overdose).
The medicine is for external use only; it should not be inhaled or applied to eyes or mucous membranes. It should not be applied to open wounds or surgical gloves. Menthol Sella 1% cutaneous powder should be used with caution in children up to 6 years of age.
Routine use in daily child hygiene is not recommended as inhalation can cause lung irritation with the risk of serious breathing difficulties and death.
If it is suspected that the child has inhaled Sella menthol, respiratory function must be carefully monitored because the onset of symptoms may be delayed for several hours.
In infants with glucose-6-phosphate dehydrogenase deficiency exposed to menthol, hemolysis and kernicterus may occur.
Important information about some of the excipients
Talc
Overuse of nasally 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, mainly in infants.
Inhaling talc causes respiratory tract irritation, coughing, shortness of breath, sneezing, vomiting, and cyanosis. These symptoms may develop within 12 to 24 hours.
Acute exposure may cause permanent lung effects.
Intense and prolonged exposure to talc can cause pneumoconiosis.
When injected intravenously it can cause retinopathy, emboli and pulmonary hypertension.
Applying talcum powder to open wounds can cause severe granulomatous reactions.
Talc is a strong eye irritant and can cause symblepharon, in some cases requiring surgical correction.
Possible side effects
Due to the presence of menthol and in case of non-compliance with the recommended doses, there may be a risk of convulsions in children and infants.
Like all medicines, Mentolo Sella 1% cutaneous powder can cause side effects, although not everybody gets them.
The following are side effects of menthol. There is insufficient data to determine the frequency of these side effects.
Skin and subcutaneous tissue disorders
Contact dermatitis.
Systemic disorders and conditions related to the administration site
Burns at the application site.
Cases of umbilical granulomas due to contamination of umbilical cord debris with talcum powder have been reported.
Following the instructions in the leaflet reduces the risk of side effects. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.