Proctolyn 0,1mg + 10mg Ketocaine Hydrochloride Hemorrhoids 10 Suppositories

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.

Rectal cream Just enough to cover the affected area by massaging lightly 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 Proctolyn is not recommended for use in children below 12 years of age due to a lack of data on safety and efficacy.

Rectal Cream One gram of rectal cream contains 0.1 mg of fluocinolone acetonide and 10 mg of ketocaine hydrochloride (equivalent to 8.9 mg of ketocaine). Excipients with known effects: One gram of rectal cream contains 1.5 mg of methyl para-hydroxybenzoate, 0.5 mg of propyl para-hydroxybenzoate, 70 mg of propylene glycol, 50 mg of stearyl alcohol, 50 mg of cetyl alcohol. Suppositories Each suppository contains 0.1 mg of fluocinolone acetonide and 10 mg of ketocaine hydrochloride (equivalent to 8.9 mg of ketocaine). Excipient with known effects: each suppository contains 40 mg of propylene glycol. For the full list of excipients, see section 6.1.

Citric acid rectal cream ; menthol; methyl para-hydroxybenzoate; propyl para-hydroxybenzoate; propylene glycol; stearyl alcohol; cetyl alcohol; Vaseline oil; sorbitan monostearate; polysorbate 60; purified water. Citric acid suppositories; menthol; propylene glycol; polysorbate 60; sorbitan monostearate; colloidal silica; semisynthetic glycerides.

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Tbc, mycosis, Herpes Symplex, viral diseases with skin localization.

Topical application of cortisone in excessive doses and for prolonged periods can result in 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.

Pregnancy Topical administration of corticosteroids during pregnancy in laboratory animals may cause abnormalities in fetal development. There are no adequate data from the use of fluocinolone acetonide in pregnant women. Therefore, the medicine should only be used when needed, after evaluating the expected benefit to the mother in relation to the possible risk to the fetus. Breastfeeding When administered systemically, corticosteroids are excreted via breast milk. It is not known whether they are even when administered topically. Therefore topical corticosteroids should be used with caution during breastfeeding.

During topical cortisone therapy, especially for intense and prolonged treatments, the following side effects may occur: burning sensation, itching, irritation. Reporting of suspected adverse reactions The reporting of suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

No cases of overdose have been reported.

Not known.

This medicine does not require any special storage conditions.