CREMA 30G 2%

SERTACREAM 2% CREAM

active ingredients

100 grams of cream contain: active ingredient: nitrate sertaconazole 2 g Excipients: methyl– parahydroxybenzoate For the full list of excipients, see paragraph 6.1

Excellent

Polyethyleneglycol-palmite stearate (Tefose 63), lauropalmitostearic polyxyethylene glycerides (Labrafil M–2130–CS), mono-diisostearate glycerol, vaseline oil, methyl– parahydroxybenzoate, sorbic acid, purified water.

Therapeutic indications

Topical treatment of skin mycosis such as dermatofitosis, Tinea pedis, Tinea capitis, Tinea cruris, Tinea corporis, Tinea barbae and Tinea manus; Candidiasis (Moniliasi) and Pytiriasis versicolor (Malassezia furfur, Pityrosporum orbiculare).

Contraindications

Hypersensitivity to the active ingredient or any of the excipients.

Population

The use of the product is reserved for adults Dose recommended average patients: the cream must be applied slightly and evenly one or two times a day on the affected areas, covering also about 1 cm of healthy skin surrounding. The amount to be applied is variable and in relation to the extension of the sick zone. The duration of treatment to obtain healing varies from one patient to another, depending on the etiological agent and the location of the infection. In general, 4 weeks of treatment are recommended to ensure complete healing, although in many cases clinical–microbiological healing is already carried out between the second and fourth week.

Conservation

Store at a temperature not exceeding 25°C, in a dry place, in the original packaging to protect the medicine from light.

Warnings

Do not use for ophthalmic treatments. There are currently no studies on the use of the drug in pediatrics. The use, especially if prolonged, of products for topical use can give rise to phenomena of sensitization. The product contains methyl phydroxybenzoate: slightly irritating for the skin, eyes and mucosa.

Interactions

No interactions with other substances have been reported.

Effects

It has not yet been reported any toxic or photosensitizing effects. During the first days of treatment there was no evidence of any local and transitory erythematose reaction, so as to stop treatment. As with all imidazolics, particularly as a result of prolonged use, episodes of local irritation may occur (such as burning and itching).

Overdosing

The concentration of the active ingredient and the way of administration are such as to make intoxication impossible, however, in case of accidental ingestion the appropriate symptomatic treatment will proceed.

After topical application of large quantities of the drug has never been found trace at plasma level; in spite of this it is not yet demonstrated the perfect harmlessness in pregnant women, therefore the risk/benefit ratio must be assessed before applying the product in pregnancy and nursing.

Source: Farmadati