WARNINGS Topical application of cortisone in excessive doses and for prolonged periods can 'cause systemic absorption. The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. In the presence of a skin infection, appropriate coverage therapy should be instituted. Rectal cream: the product contains methyl para-hydroxybenzoate and propyl para-hydroxybenzoate which can cause allergic reactions (including delayed type). The medicine also contains stearyl alcohol and cetyl alcohol which can cause local skin reactions (eg contact dermatitis). Rectal cream and suppositories: due to the presence of propylene glycol, the product can cause skin irritation. PHARMACOTHERAPEUTIC CATEGORY Substances for treatments of hemorrhoids and anal fissures for topical use. STORAGE This medicine does not require any special storage conditions. CONTRAINDICATIONS / SECONDARY EFFECT Hypersensitivity 'to the active ingredients or to any of the listed excipients; TB, mycosis, Herpes Symplex, viral diseases with skin localization. NAME PROCTOLYN EXCIPIENTS Rectal cream: citric acid; menthol; methyl para-hydroxybenzoate; propyl para-hydroxybenzoate; propylene glycol; stearyl alcohol; cetyl alcohol; Vaseline oil; sorbitan monostearate; polysorbate 60; purified water. Suppositories: citric acid; menthol; propylene glycol; polysorbate 60; sorbitan monostearate; colloidal silica; glyceridisemisynthetics. SIDE EFFECTS During topical cortisone therapy, especially for prolonged intense treatments, the following side effects may occur: burning sensation, itching, irritation. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug. PREGNANCY AND BREASTFEEDING Topical administration of corticosteroids during pregnancy in laboratory animals can cause abnormalities in fetal development. There are no adequate data from the use of fluocinolone acetonide in pregnant women. Therefore the medicine should be used only in case of need, after evaluating the expected benefit for the mother in relation to the possible risk to the fetus. When administered systemically, corticosteroids are excreted through breast milk. It is not known whether they are also when administered topically. Therefore topical corticosteroids should be used with caution during breastfeeding. INDICATIONS Internal and external hemorrhoids; anal and perianal eczema and erythema; anal fissures; anal and perianal itching and burning; pre- and post-operative treatment in anorectal surgery. INTERACTIONS Not known. DOSAGE Rectal cream: just enough to cover the affected area by massaging gently and repeating the application 2-3 times a day. For internal application, use the special cannula inserted on the tube. Suppositories: 1 suppository in the morning and 1 in the evening. Rectal cream and suppositories can be used for combined treatments. Pediatric population: the use of the product is not recommended in children under 12 years of age due to a lack of data on safety and efficacy. ACTIVE PRINCIPLES Fluocinolone acetonide and ketocaine hydrochloride.