MENTATION SELLA 1% 1FL 100G

MENTATION SELLA 1% POLVERE CUTANEA

active ingredients

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

Excellent

Talco

Therapeutic indications

The medicinal product is indicated in the symptomatic treatment of skin rashes due to exantematic diseases, irritation, also by rubbing, itching and burning in case of insect bites, solar erythema and burns.

Contraindications

Hypersensitivity to active ingredients or to any excipient. Children up to 30 months of age Children with a history of epilepsy or fever seizures.

Population

Menthol Sella 1% cutaneous powder is contraindicated in children up to 30 months of age (see paragraph 4.3). Spread the affected area evenly 2 or more times a day. The duration of treatment shall not exceed 3 days.

Conservation

In a closed container. Do not store at temperature above 30°C.

Warnings

This product contains terpenic derivatives which, in excessive doses, can cause neurological disorders such as convulsions in infants and children. The 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 trementine (due to their lipophilic properties, it is not known the speed of metabolism and disposal) in particular tissues. 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 medicinal product must be used only for external use; should not be inhaled and should not be applied on eyes and mucosa. It should not be applied on 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 since inhalation can cause lung irritations with the risk of severe respiratory and death difficulties. In case you suspect that the child has inhaled Menthol Sella 1% skin dust, the respiratory function must be carefully monitored because the appearance of symptoms can be delayed several hours. In infants with glucose deficiency 6–phosphate dehydrogenases exposed to menthol can occur hemolysis and kernictero. Important information about some excipients Talco It has been reported that the abuse of medications administered by nasal means, containing talc as an excipient, has caused granulomas at a pulmonary level. Although talc does not cause acute toxicity, fatal cases were reported following acute exposure to talc. The inhalation of dust caused death, mainly in infants. The inhalation of talc causes irritation of the respiratory tract, cough, tired breathing, sneezing, vomiting and cyanosis. The onset of these symptoms may occur in the following 12–24 hours. Acute exposure can cause permanent effects on the lungs. The 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. The talc is a strongly irritating agent for the eyes and can cause symblephare, in some cases such as to require surgical correction.

Interactions

Menthol Sella 1% cutaneous powder should not be used in conjunction with other products (medicinal or cosmetic) containing terpenic derivatives, regardless of the way of administration (oral, rectal, cutaneous, nasal or inhalation). No interaction studies have been carried out.

Effects

Due to the presence of menthol and in case of non-compliance with recommended doses, a risk of seizures in children and infants may arise. Below are the undesirable effects of the menthol organized according to the organosystem classification MedDRA. No sufficient data is available to determine the frequency of the effects listed. Pathologies of skin and subcutaneous tissue Contact dermatitis. Cases of umbilical granulomas were reported due to the contamination of the residue of the umbilical cord with powdered talc.

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. Accidental aspiration of high concentrations of the medicinal product may cause severe respiratory damage. Menthol Following application of menthol in nostrils, cases of apnea and immediate collapse in children have been reported. Menthol ingestion can cause severe abdominal pain, nausea, vomiting, dizziness, ataxia, drowsiness and coma. If in contact with the eyes can cause redness and irritation.

Pregnancy There are or are limited numbers available data relating to the use of menthol in pregnant women. Menthol Sella 1% cutaneous powder is not recommended during pregnancy and in women in fertile age who do not use contraceptive measures. Food There is insufficient information on the excretion of menthol in breast milk. Menthol Sella 1% cutaneous powder should not be used during lactation.

Source: Farmadati