Menthol 1% ZETA Skin Powder 100g

Menthol 1% ZETA Skin Powder - Medical Device

Active principles

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

Excipients

Talc.

Therapeutic 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 / Undesirable Effects

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 and febrile seizures.

Dosage

Evenly sprinkle the affected area 2 or more times a day. Menthol Zeta is contraindicated in children up to 30 months of age (see section 4.3). The duration of treatment should not exceed 3 days.

storage

Store the medicine in a tightly closed container, protected from light.

Warnings

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 Zeta should be used with caution in children up to 6 years of age. 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 rate of metabolism and disposal is not known) in tissues and in the brain, in particular neuropsychological disorders. A higher than recommended dose should not be used to avoid an increased risk of adverse drug reactions and dose-related disturbances (see section 4.9). Routine use in the baby's daily hygiene is not recommended as inhalation can cause lung irritation with the risk of severe breathing difficulties and death. If it is suspected that the child has inhaled Menthol Zeta, lung function should be carefully monitored as 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 intranasally administered medicines 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 talc causes irritation of the respiratory tract, coughing, wheezing, sneezing, vomiting, and cyanosis. The onset of these symptoms can occur within 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. Applying talc to 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

Menthol Zeta 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 inhaled).

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 system organ class: There is insufficient data to establish the frequency of the listed effects. Skin and subcutaneous tissue disorders Contact dermatitis. Cases of granulomas have been reported due to contamination of the umbilical cord residue with talcum powder.

Overdose

Accidental aspiration of high concentrations of the drug can cause severe respiratory damage. Following application of menthol in the nostrils, there have been reports of apnea and immediate collapse in children. Ingestion of menthol can cause severe abdominal pain, nausea, vomiting, dizziness, ataxia, drowsiness and coma, and if in contact with the eyes it can cause redness and irritation. In the event of accidental oral intake or incorrect administration in infants and children there may be a risk of neurological disorders. If necessary, administer appropriate symptomatic treatment in specialized treatment centers.

Pregnancy and breastfeeding

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

Format

100 g jar.