Menthol Saddle 1% Cutaneous Powder 100g

NAME
MENTHOL SELLA 1% SKIN POWDER

ACTIVE PRINCIPLES
100 g of powder contain: menthol 1 g.

EXCIPIENTS
Talc.

INDICATIONS
The medicine is indicated in 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.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance (s) or to any of the excipients. Children up to 30 months of age Children with a history of epilepsy or febrile seizures.

DOSAGE
The medicine is contraindicated in children up to 30 months of age. Evenly sprinkle the affected area 2 or more times a day. The duration of treatment should not exceed 3 days.

STORAGE
In tightly closed container. Do not store above 30 degrees C.

WARNINGS
This product contains terpene derivatives which, in excessive doses, can cause neurological disorders such as convulsions in infants and children. 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 dose than recommended should not be used to avoid an increased risk of adverse drug reactions and disorders associated with overdose. The medicine is to be used for external use only; it must not be inhaled and must not be applied to eyes and 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. The routine use in the daily hygiene of the child is not recommended as inhalation can cause lung irritation with the risk of severe breathing difficulties and death. If the child is suspected of having inhaled the drug, respiratory function should be carefully monitored because the onset of symptoms may be delayed for several hours. Hemolysis and kernicterus may occur in neonates with glucose 6-phosphate dehydrogenase deficiency exposed to menthol. Important information about some of the excipients Talc Abuse of nasally administered medicinal products containing talc as an excipient has been reported to cause pulmonary level granulomy. Although talc does not cause acute toxicity, fatal cases have been reported following acute exposure to talc. Inhalation of the dust caused death, mainly in infants. Inhalation of talc causes irritation of the respiratory tract, coughing, wheezing, sneezing, vomiting, and cyanosis. The onset of these symptoms can occur in the following 12-24 hours. Acute exposure can cause permanent lung effects. Intense and prolonged exposure to talc can cause pneumoconiosis. When injected intravenously it can cause retinopathy, emboli and pulmonary hypertension. The application of talc on open wounds can cause severe granulomatous reactions. Talc is a highly irritating agent for the eyes and can cause symptoms, in some cases requiring surgical correction.

INTERACTIONS
The medicinal product must 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.

SIDE EFFECTS
Due to the presence of menthol and in case of non-observance of the recommended doses there may be a risk of convulsions in children and infants. The following are the undesirable effects of menthol organized according to the MedDRA organosystem classification. There is 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 talcum powder.

PREGNANCY AND BREASTFEEDING
There are no or limited amount of data from the use of menthol in pregnant women. The medicine is not recommended during pregnancy and in women of childbearing potential who are not using contraceptive measures. There is insufficient information on the excretion of menthol in breast milk. The product should not be used during breastfeeding.