PROCTOLYN*CR RETT 30G

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.

Therapeutic 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.

Dosage and method of use

Rectal cream Enough to cover the affected part 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 lack of data on safety and efficacy.

Contraindications

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

Side effects

During topical cortisone therapy, especially for intense and prolonged treatments, the following side effects may occur: burning sensation, itching, irritation. Blurred vision may occur (see also section 4.4), with an unknown frequency. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .

Special warnings

Topical application of cortisone in excessive doses and for prolonged periods can lead to 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. Visual disturbances Visual disturbances may be reported with the use of systemic and topical corticosteroids. If a patient presents with symptoms such as blurred vision or other visual disturbances, a referral to an ophthalmologist should be considered for evaluation of possible causes which may include cataracts, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR), which have been reported after the use of systemic and topical corticosteroids. Important information about some of the excipients : Proctolyn rectal cream contains • methyl para-hydroxybenzoate and propyl para-hydroxybenzoate which can cause allergic reactions (possibly delayed); • stearyl alcohol and cetyl alcohol which can cause localized skin reactions (eg contact dermatitis).

Pregnancy and breastfeeding

Pregnancy Topical administration of corticosteroids during pregnancy to 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 be used only if necessary, after evaluating the expected benefit for the mother in relation to the possible risk for the fetus. Lactation When administered systemically, corticosteroids are excreted in breast milk. It is not known whether they are also so when administered topically. Therefore, topical corticosteroids should be used with caution during lactation.

Expiration and conservation

This medicine does not require any special storage conditions.

Interactions with other drugs

Concomitant treatment with CYP3A inhibitors, including cobicistat-containing medicinal products, is thought to increase the risk of systemic side effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side effects; in this case it is necessary to monitor the patients to verify the absence of systemic side effects due to corticosteroids.

Overdose

No cases of overdose have been reported.

Active principles

Rectal cream One gram of rectal cream contains 0.1 mg of fluocinolone acetonide and 10 mg of ketocaine hydrochloride (equal 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 effect: Each suppository contains 40 mg of propylene glycol. For the full list of excipients, see section 6.1.

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 semi-synthetic glycerides