Proctolyn 0.1 mg + 10 mg - for the treatment of haemorrhoids, fissures and itching 10 suppositories

Product Description

Suppositories for internal and external hemorrhoids, anal and perianal eczema and erythema, anal fissures, anal and perianal itching and burning, pre- and post-operative treatment in ano-rectal surgery.

Ingredients

Each suppository contains 0.1 mg of fluocinolone acetonide and 10 mg of ketocaine hydrochloride (equivalent to 8.9 mg of ketocaine).

Excipients

Citric acid, menthol, propylene glycol, polysorbate 60, sorbitan monostearate, colloidal silica, semi-synthetic glycerides.

Directions for use

1 suppository in the morning and 1 in the evening. The use of Proctolyn is not recommended in children under 12 years of age due to the lack of data on safety and efficacy.

Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in paragraph 6.1. Tuberculosis, mycosis, Herpes Symplex, viral diseases with cutaneous localization.

Warnings

Due to the presence of propylene glycol, the product may be contraindicated. cause skin irritation.

Interactions

None known.

Side effects

During topical corticosteroid therapy, especially for intense and prolonged treatments, the following side effects may occur: burning sensation, itching, irritation.

Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous 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 www.agenziafarmaco.gov.it/it/responsabili.

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 when necessary, after weighing the expected benefit to the mother against the possible risk to the fetus.

When administered systemically, corticosteroids are excreted in breast milk. It is not known whether they are also excreted when administered topically. Therefore, topical corticosteroids should be used with caution during breastfeeding.