Proctolyn® 0.1mg / g + 10 mg / g Rectal Cream 30g
- Brand:RECORDATI SpA
- Product Code: 021925060
- Availability: In Stock
- Purchase 3 items for 6.36€ each
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Proctolyn® 0.1mg + 10mg
Rectal cream One gram of rectal cream contains 0.1 mg of fluocinolone acetonide and 10 mg of chetocaina hydrochloride (equivalent to 8.9 mg of chetocaina). Excipients with known effect: 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 stearyl alcohol, 50 mg cetyl alcohol. Suppositories each suppository contains 0.1 mg of fluocinolone acetonide and 10 mg of chetocaina hydrochloride (equivalent to 8.9 mg of chetocaina). Excipient with known effect: Each suppository contains 40 mg of propylene glycol. For a full list of excipients, see section 6.1.
Rectal citric acid cream; 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.
internal and external hemorrhoids; eczema and anal and perianal erythema; anal fissures; anal and perianal itching and burning; pre-treatment and post-surgery in anorectal surgery.
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Tuberculosis, fungal infections, Herpes Symplex, viral diseases with cutaneous localization.
Suppositories 1 suppository in the morning and one in the evening. rectal cream and suppositories can be used for combined treatments. Paediatric population of Proctolyn® is not recommended in children under 12 years of age, due to lack of data on safety and efficacy.
Warnings and Precautions
Topical application of steroids in excessive doses and for prolonged periods can lead to systemic absorption. The use, especially if prolonged, the products for topical use may give rise to sensitization phenomena. In the presence of a skin infection is established appropriate coverage therapy. Suppositories: For the presence of propylene glycol, the product can cause skin irritation.
In the course of topical steroid therapy, especially for intense and prolonged treatments, they may experience the following side effects: burning sensation, itching, irritation. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after the authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the drug. 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
Pregnancy 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 in relation to the possible risk to the fetus. Lactation When administered systemically, corticosteroids are excreted through breast milk. It is not known if they are even when topically administered. Therefore, topical corticosteroids should be used with caution during lactation.