PROCTOLYN 10SUPP 0.1MG+10MG

PROCTOLYN

active ingredients

Rectangular cream A gram of rectal cream contains 0.1 mg of acetonide fluocinolone and 10 mg of chetocaine hydrochloride (equal to 8.9 mg of chetocaine). Excipients with known effects: A gram of rectal cream contains 1.5 mg of para-hydroxybenzoate methyl, 0.5 mg of para-hydroxybenzoate propile, 70 mg of propylene glycol, 50 mg of stearilic alcohol, 50 mg of cetilic alcohol. Supposes Each suppository contains 0.1 mg of acetonide fluocinolone and 10 mg of chetocaine hydrochloride (equal to 8.9 mg of chetocaine). Excipient with known effects: Each suppository contains 40 mg of propylene glycol. For the full list of excipients, see paragraph 6.1.

Excellent

Rectangular cream citric acid menthol methyl para-hydroxybenzoate propile para-hydroxybenzoate glycol propylene alcohol stearilic alcohol cetilic vaseline oil sorbitan monostearate polysorbate 60 purified water Supposes polysorbed propylene glycol menthol 60 sorbitan monostearate silica colloidal semisynthetic glycerides

Therapeutic indications

Internal and external hemorrhoids; eczema and anal and perianal eczema; anal ragadi; itching and burning anal and periana; pre- and post-operative treatment in ano-rectal surgery.

Contraindications

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

Population

Rectangular cream Just cover the sliced part gently massaging and repeating the application 2-3 times a day. For the internal application use the special cannula inserted on the tube. Supposes 1 in the morning and 1 in the evening. Rectal and suppository cream can be used for combined treatments. Pediatric population The use of Proctolyn is not recommended in children under 12 years of age, due to the lack of data on safety and effectiveness.

Conservation

This medicine does not require any special condition of conservation.

Warnings

The topical application of cortisonists 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 phenomena of sensitization. In the presence of a skin infection it is necessary to establish appropriate coverage therapy. Visual disturbances With the use of systemic and topical corticosteroids, visual disturbances can be reported. If a patient occurs with symptoms such as blurred vision or other visual disorders, it is necessary to consider referral to an ophthalmologist for the evaluation of possible causes that may include cataracts, glaucoma or rare diseases such as central serum corioretinopathy (CSCR), which were reported after the use of systemic and topic corticosteroids. Important information about some excipients: Proctolyn rectal cream contains • methyl para-hydroxybenzoate and propile para-hydroxybenzoate that can cause allergic reactions (also delayed type); • stearilic alcohol and cetilic alcohol that can cause reactions on the localized skin (e.g. contact dermatitis).

Interactions

Concurrent treatment with CYP3A inhibitors, including cobicistat-containing medicines, is believed to increase the risk of systemic side effects. The association must be avoided unless the benefit exceeds the greatest risk of systemic side effects due to corticosteroids; in this case it is necessary to monitor patients to verify the absence of systemic side effects due to corticosteroids.

Effects

In the course of topical cortisonic therapy, especially for intensive and prolonged treatments, the following side effects may occur: burning sensation, itching, irritation. You can manifest blurred vision (see also paragraph 4.4), with unknown frequency. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

No overdose cases have been reported.

Pregnancy

The topical administration of corticosteroid during pregnancy in laboratory animals can cause abnormalities in fetal development. There is no adequate data from the use of acetonide fluocinolone in pregnant women. Therefore the medicinal product, should be used only in case of need, after evaluating the expected benefit for the mother in relation to the possible risk for the fetus.

Food

When administered by systemic means, corticosteroids are excreted through breast milk. It is not known whether they are even when administered on a topical basis. Therefore, topical corticosteroids must be used with caution during breastfeeding.

Source: Farmadati